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,W. A. K JUN 7 MANUFACTURING CHEMISTS ASSOCIATION 1825 CONNECTICUT AVENUE, N. W. WASHINGTON, D C. 20009 (202) 483-6126 May 31, 1974 TO: Food Additive Contacts in MCA Member Companies Food, Drug, and Cosmetic Chemicals committee SUBJECT: GRAS Review Gentlemen: It was decided at the May 15, 1974 meeting of the MCA Food, Drug, and cosmetic Chemicals Committee that MCA member companies sould be informed of the total process of the GRAS Review, and be requested to advise as to deficiencies or omissions encountered to date in conncetion with the review, with tire objective of identifying problems affecting a significant number of member companies.for possible MCA action. First, by way of background. President Nixon in his Consumer Message of 1969, directed the Food and Drug Administration to re-evaluate all items on the Generally Recognized As Safe (GRAS) list for safety. Then, as one phase in this review, FDA contracted with the National Academy of Sciences to conduct a survey of such substances. This survey (which went to manufacturers, processors, and distributors) covered poundage, types of specifications, processing and storage effects, safety information, and usage. FDA also contracted for Scientific Literature Reviews, and for testing (teratology screening). For the "wrapping up" phase of the review, FDA contracted with the Federation of American Societies for Experimental Biology (FASEB) to conduct the initial evaluation of the NAS production and consumption data, the Scientific Literature Reviews, and the additional toxicological test data, and to provide a report on the safety of each individual ingredient. ASI 00003558 After evaluation by FDA of a FASEB report, the procedure calls for FDA to publish in the Federal Register an appropriate proposal to (1) affirm GRAS status, (2) publish a prior sanction, (3) establish an interim food additive regulation, (4) establish a permanent food additive regulation, or (5) eliminate food use of the ingredient. The status of 439 non-flavor substances in the review, as reported in the April 1 issue of Food Chemical News, indicates that the Scientific Literature Reviews (monographs) are 70% complete, but that the FASEB Select Committee reports are only 6% complete, it was reported that this lag is due to the need for hearing and peer review, and that FASEB has completed a preliminary review of 202 ingredients. With reference to the first paragraph of this letter, there are indications that the adequacy of some of the completed Scientific Literature are open to question, although this could be due partly at least to failure to take advantage of the opportunities to provide unpublished safety data and make other inputs. The Federal Register of July 26, 1973 (pages 20051-20054) and that of April 17, 1974 (page 13798) gave notices of these opportunities. It will be appreciated if you will advise concerning any "deficiencies or omissions" you may have encountered to date in connection with any phase of the GRAS Review, for referral to the involved subcommittee of the MCA Food, Drug, and Cosmetic Chemicals Committee. Sincerely yours Food, Drug, and Cosmetic Chemicals Committee MMHjsh Distribution "A" P.S. Notices from the July 26, 1973 and April 17, 1974 issues the Federal Register concerning opportunities for input and availability of information are attached for your information. of ASI 00003559 Copied by MCA NOTICES 20051 DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Food and Drug Administration Ingredients Organisations Estimated date ot oomplotion Aliphatic Acids linear saturated Acetic acid Butyric acid GRAS OR PRIOR-SANCTIONED DIRECT HUMAN FOOD INGREDIENTS Notice of Opportunity To Submit Unpublished Safety Data The Food and Drug Administration ia conducting a study of the direct human food ingredients classified as generally recognized as safe (GRAS) or subject to a'prior sanction. As part of this study, Com sugar-syrup : ...do____ --r--- July 2,1971 Sorbase_____________ ____ do______ ___ ; Do. Tannic acid.....________ do............ . -- July 9,1973 Inositol.......;....................... do-- July 18,1973 Gelatin--.....do..--... July '25,1973 Tallow................................ do Aug. 15,1971 Succinic acid........... ...........do............... Do. Beeswax and Japan Franklin Re- June 29, 1973 wat, search Institute. Camaubawax........ -......... do............. Do. Sodium thiosulfate............do....................... July 30,1973 Citrates....................... Food and Drug Juno 29,1973 Research Labs, Decanolc acid Formic arid * Hexanolc acid Laurie arid Myriatlc arid Nonanole arid Octanolc arid Palmitic acid Propionic arid Stearic acid Valeric acid information on each ingredient (or group of ingredients) is being summarized in a series of Scientific Literature Reviews by organizations under contract with the Food and Drug Administration. The organizations preparing the Scientific Literature Reviews are responsible for including a summary of the world litera ture on safety published since January 1, 1920. In order to assure that all pertinent safety Information is obtained lor in clusion in each Scientific Literature Re view, this notice solicits from any source unpublished data and information that may be appropriate in determining the safety of the substances. The organiza tions preparing the Scientific Literature Reviews, and the Reviews now in active preparation or planned for preparation, Calcium oxide it cal- .....do..................... Do. <-ium hydroxide Sorbntes.................... ........-do. .................. Do. Butylated hydrox* ........do. .................. yanisolo. Do. Malic.Arid . ... Ascorbates..--,........ ....................July 7,1973 Propionates.............. ......... do. ....................July 30.1073 Gluconate radical-,. DoTlrins^--....... . Pantothenates........ . --do. .................. Do. Soy protein isolated. ......... do. __________ Aug. 18,1973 Kutuiot.................... . .................. Do. Copper salts used in --.--do. *................ Aug. 24,1973 -foods. Hydrochloric acid___ Tartaric acid St ....... do. .................. Ang. 31,1973 tart rales. Lard A lard oil,____ ......... do. .................. Do. Rcntomte St clay____......... do. .................. Sept, 7,1973 Papain..................... .--.do. .................. Sept. 14.1973 Gases used in foods............do. .................. Do. Starches.............................. do. .................. Sept. 21,1973 Hydrogen peroxide.., .................. Do. Oarlxm dioxide--. Lactic add it .................. Do. dtrinatives. Vitamin A..*............ .................. Do. are as follows: 1. Food and Drug Research Laboratories, Inc., 60 Evergreen Place. East Orange, NJ 0T018. 2. Franklin Institute Research Laboratories, The Benjamin Franklin Parkway, In addition, the Flavor and Extract Manufacturer's Association, 1001 Con necticut Avenue. NW,, Wash., DC 20036, is preparing a Scientific Literature Re view on the following 276 aliphatic alco hols, acids, aldehydes, and esters, used Philadelphia, PA 19103. 3. Informatics, Inc., 6000 Executive Boulevard, Rockville, MD 20853. as flavor Ingredients. The Reviews are scheduled for completion by December 15, 1973. 4. Tractor Jltco, Inc., Aliphatic Alcohols 1300 East Oude Dr., Rockville, MD 20851. LINEAR SATURATED Amyl alcohol Ingredients Organitattoos Estimated date ot completion Butyl alcohol l-Decanol Ethyl alcohol Heptyl alcohol Undecanotc acid Heptanolc acid LINEAR UNSATURATED Oleic acid 4-Fentenolc arid trans-2-Hexenolc acid 3-Hexenolc arid 10-Undeeenole arid 9,12-Octadecadlenolc arid (46%) and 9.12,15-Octadecatrienoic arid (53%) BRANCHED SATURATED iso-Butyrlc arid 2-EthyIbutyric acid 2-Methylbutyrlc arid 2-Methylhexanolc acid 2-Methylheptanolc acid 2-Methylvalerie arid iso-Valeric acid BRANCHED unbaturatxd 3.7-Dimethyl-S-octenolc acid 3-Methylcrotonic acid 2-Methyl-2-pentenoic arid 2,3-Dlonethyl-2-pentenoic acid , Aliphatic Alothtdes LINEAR SATURATED Acetaldehyde Butyraldehyde Decanal Heptanal Hexanal Laurie aldehyde Myrlstaldehyde Nonanal Octanal Propionaldehyde Undecanal Valeraldehyde LINEAR UNSATVRATES Aluminum compounds. Trow* Jltoo, Inc.. June 29, 1973 l-Hexadecanol Hexyl alcohol Flllcaies................... ,..........do.................... July 27,1973 Lsuryl alcohol Magnesium salts--.............do..................... July 20,1973 Nonyl alcohol Manganese salts.............. do.____ ....... Aug. 3,1973 Starter distillate................ do........................Oct. 19,1973 Acetic acid A ____ do____________ Aug. 10,1973 1- Octanol Propyl alcohol derivatives. Undecyl alcohol Formic acid A ........do........ . Aug. 31,1973 derivatives. Methyl St ethyl ....... da..--.................Oct. 19,1973 LINEAR UNSATUSA1ED acrylate. Hydrosulfitee..................... do____ ______ July30,1973 Salts of fatty acids ....... do.................-- July 27,1973 3-Hexen-l-ol 3-Hexen-l-ol Sodium and potos- ....... do____________ Oct. 5,1973 2.6- Nonadten-l-ol sium hydroxides. frarw-2-Nonen-l-ol Vitamin D____ --....___ do_______ .... Sept. 7,1973 Corn silk............................. do--................... Oct. 5,1973 Sullamic acid____________do_____________July 13,1973 BRANCHED BATTJRATED Tall oil__________________ do_______ ___ July 27,1973 Fish oil. ____ do____________ Aug. 24,1973 hydrogenated. Soy bean oil, ;___ do____ - a Do. iso-Amyl alcohol iso-Butyl alcohol 3.7- Dlmethyl-l-octanot hydrogenated. 2- Ethyl-l -hexanol Glutamic acid and derivatives. r...-do.--... ----. June 29,1973 3,5,5-Trimethyl-l-hsxanol Cholic add A derivatives. Informatics, Inc... Juno 22,1973 BRANCHED 0N3ATORATTO Calcium 3cqucstrnti-s=;.do____ --.-----a Do, Choline salts. _______do___ Do. Oeranol Algae..------ --------------------do.____ .......a Do. Crltronellol Iodine salts used In a___do____________: foods. Pulps........ ---;;TM.-;..d0____...__ _ Acouitic add...................... do..... .............. 3 Do. Do. Do. Nerol Rhodinol Farnesol eis-3-Hexenal 10-Undecenal 9-Undecenal 4-Hep tenal 4-Deeenal CONJTJCATn* 2-Decenal 2-DodecensU 2-Heptenal 2.4-Nonadienal 2-Hexenal 2-Tridecenal 2-trans, 4-rrans-Decadlenal 2.4-Heptadlenal 2-Nonenal 2-Octenal 2.4-PentadlenaI 2-Pentenal Nona-2.troju, 6-eis-Dlenal BRANCHED SATURATED fso-Butyraldehyde 2.6-Dimethyl octanal 2-Methyibutyraldehyde 3-Methylbutyraldehyde 2-Ethylbutyraidehyde 2-Methyloctanal 2-MethylundecanaI No. 143--Pt. II----- 8 FEDERAL REGISTER, V L 38, NO. 143--THURSDAY, JULY 26, 1973 ASI 00003560 20052 BRANCHED UNSATURATED Cltronellal 2,G-Dlmethyl-5-hoptenal Cltral CONJUGATED 2.6-Dlmethyl-10-methylene-2,8,ll-dodecatrlenal 2-Ethyl-2-heptenal 2-Methyl-2-pentenal Aliphatic Ester* i: with linear saturated acid portion and alcohol portion as Indicated) linear saturated Amyl hutyrate Amyl heptanoate Amvl octanoatc Butyl butyrate Butyl heptanoate Butyl laurate Butyl stearate Decyl acetate Decyl propionate Ethyl butyrate Amyl formate Amyl hexanoate Butyl acetate Butyl formate Butyl hexanoate Butyl propionate Butyl valerate Decyl butyrato Ethyl acetate Ethyl decanoete Ethyl formate Ethyl hexanoate Ethyl myristate Ethyl octadecanoate Ethyl palmitate Ethyl undecanoate Heptyl acetate Heptyl formate Hexyl acetate Hexyl formate Hexyl octanoate Lauryl acetate Methyl butyrate Methyl hexanoate Methyl myristate Methyl octanoate Methyl valerate Nonyi octanoate Octyl butyrate Octyl heptanoate Octyl propionate Propyl butyrate Propyl heptanoate Propyl propionate Ethyl heptanoate Ethyl laurate Ethyl nonanoate Ethyl octanoate Ethyl propionate Ethyl valerate Heptyl butyrate Heptyl octanoate Hexyl butyrate Hexyl hexanoate Hexyl propionate Methyl acetate Methyl heptanoate Methyl laurate Methyl nonanoate Methyl propionate Nonyi acetate Octyl acetate Octyl formate Octyl octanoate Propyl acetate Propyl formate Propyl hexanoate LINEAR UNSATURATED Allyl butyrate Allyl hexanoate Allyl octanoate NOTtCEt 2- Hexen-l-y! acetate dJ-3-Hex*n-l-yl acetate Allyl heptanoate Allyl nonanoate Allyl propionate 10-Undecen-i-yl acetate 3- Hexenyl formate BRANCH SATURATED leo-Amyl acetate iso-Amyl formate iso-Amyl laurate iso-Amyl octanoate Ijo-Butyl acetate iso-Butyl formate iso-Butyl hexanoate 2-Ethyl butyl acetate iso-Amyl butyrate iso-Amyl hexanoate iso-Amyl nonanoate iso-Amyl propionate iso-Butyl butyrate iso-Butyl heptanoate iso-Butyl propionate BRANCH UNSATURATED Cltronellyl acetate Citroneilyl formate Cltronellyl valerate Qeranyl butyrate Geranyl hexanoate Cltronellyl butyrate Cltronellyl propionate Qeranyl acetate Geranyl formate Qeranyl propionate Aliphatic Esttxs (with linear unsaturated acid portion and alcohol portion as Indicated) LINEAR SATURATED Butyl 2-decenoate Ethyl acrylate Ethyl 2-nonynoate Ethyl sorbsto Methyl 2-hexenoate Methyl 2-nonynoate Methyl 9-undecenoate Ethyl trans-2, cis-4-Decadlenoate Ethyl eis-4-octenoate Methyl 3-hexenoate Butyl 10-undecenoate Ethyl crotonate Ethyl oleate Ethyl 10-undecenoate Methyl 2-nonenoate Methyl 2-octynoate Methyl 2-undecynoate Ethyl 3-hexenoate n-Hexyl 2-butenoate Methyl cis-4-ctenoate ' linear unsaturated Allyl sorbate 2-Methylallyl hutyrate Neryl butyrate Neryl propionate Hhodinyl butyrate Rhodlnyl propionate Allyl 10-undecenoate Neryl acetate Neryl formate Hhodinyl acetate Hhodinyl formate aliphatic Esters (with branched saturated acid portion and alcohol portion ae Indicated) linear saturated Butyl iso-Butyrate Butyl iso-Valerate Ethyl iso-Butyrate Ethyl Iso-Valerate Hexyl iso-Valerate Methyl 2-Methylbutyrate Methyl iso-Valerate Octyl iso-Butyrate Propyl iso-Butyrate Hexyl iso-Butyrate Ethyl 2-Methylbutyrate Heptyl iso-Butyrate Methyl Iso-Butyrate Methyl 4-methylvalerate Nonyi iso-Valerate Octyl iso-Valerate Propyl iso-Valerate ^ LINEAR UNSATURATED Allyl 2-ethylbutyrate 3-Hexenyl iso-Valerate Allyl iso-Valerate 3-Hexenyl-2-methylhutyrate branch saturated Hexyl-2-methylbutyrate iso-Amyl Iso-Valerate 3,7-DlmethylIocta-2,6-dlenyt 2-ethylbuta- noate 2-Methylbutyl-iso-Valerate 2-Methylpropyl 3-Metbylbutyrate iso-Amyl-iso-Butyrate iso-Amyl-2-methylbutyrate 2-Methylbutyl 2-methylbutyrate BRANCH UNSATURATED Cltronellyl iso-Butyrate Qeranyl iso-Valerate Neryl iso-Valerate Bhodnyl iso-Valerate Geranyl iso-Butyrate Neryl iso-Butyrate Hhodinyl iso-Butyrate Aliphatic Esters (with branched unsaturated add portion and alcohol portion as Indicated) LINEAR SATURATED Ethyl tiglate Methyl 3,7-dlmethyI-6-octenoate LINEAR UNSATURATED Allyl tiglate branch saturated iso-Butyl angelate The above list of 278 flavor ingredients represents the initiation of Scientific Literature Reviews of 1,550 natural and synthetic flavor substances. An. an nouncement will be made in the Fed eral Register when other flavor com pounds are selected for Review, so that appropriate unpublished information and data may be submitted. All flavor ingredients listed in 51121.101(e) and (g), 121.1183 and 121.1164, or otherwise submitted or known to FDA, are intended for eventual inclusion in a Scientific Literature Review. Other ORAS and prior sanctioned food Ingredients Intended for an immediate or planned Scientific Literature Review are listed below under their appropriate categories. IMMEDIATE SCIENTIFIC LITERATURE REVIEW Adipic acid Casein and caseinates Hypophosphites Pectin and pectlnntes Gum guatac Ascorbic acid Carotenes Iron, reduced Niacin and niacinamide Fyndoxlne and pyrldoxine hydrochloride Riboflavin and rlboflavln-S-phosphate Caflelne Glycerophosphates Dextrans ftDHAl REGISTER, VOL 3R, NO. 143--THURSDAY, JULY 26, 1973 ASI 00003561 NOTICES 20053 Vegetable oil* Sucrose Biotin Citric add Lecithins P&ra-bydroxylbenzyllsothlayaoat* Thiamine Urea Vitamin 8U Sodium and potassium chloride* PLANNED SCIENTOTC* LITERATttXX REVIEW Amines (filming) Benzoyl peroxide Borax Brandy Calcium stearate Carbon Char smoke flavor Collagen (avltene) Cyclohexylamlne Enzymes (proteolytic) Perrocyanlde salts Olucono delta lactone Glycerol lactopalmltate Besperldln complex Lignin Malt syrup Milk powder (whole, enzyme modified) Amino trl (methylene phosphoric acid) sodium salt Bergamot oil Bouillon (vegetable, smoked) Butter rat, enzyme modified w/added butyric acid CandellUla wax Carboxymethyl hydrozyethyl celluloee Chlorophyll Corn mint oil (mentha arvenls Oil) Enzymes (bacterial) Ferrous citrate Furcelleran Gluten (com) Gums (vegetable) Iron citrate Liver tractions Methylpolyslllcone Mono and dlglycerldes (sodium aulfoacetate derivatives) < Morpholine <Nlckel < Octadecylaminss Ottlcla Peptone (pepsin-modified soy been protein; brewers peptone) Piperazine dihydrochloride Potassium gluconate Butin Silver-silver dragees Sodium fluoride Sodium metasllleate Soya fatty acid amine (ethoxylated) Starch (food, modified) Vitamin B complex and syrup Yessts Pepsin Potassium bromate Potassium phosphates Sausage casings (HC1 and cellulose fibers) Sodium chlorite Sodium hypochlorite Sodium zinc metasllleate Stearyl alcohol Wax (shellac) Zeln powder To be considered for inclusion in a Scientific Literature Review, two copies of all relevant safety data, and Infor mation shall be submitted to the organi sation preparing the Review before the listed completion date, and the original and two copies of all such information shall simultaneously bo sent to GRAS Re view Branch (BF-335), Bureau of Foods, Food and Drug Administration, 200 "C" Street SW, Wash., DC 20204, Imme diately upon receipt of any such submis sion, one copy will be placed on display at the Office of the Hearing Clerk, Food and Drug Administration, Rm. 6-88, 5600 Fishers Lane, Rockville, MD 20852, where it may be reviewed during work ing hours, Monday through Friday. If the contractor has not been named, the original and four copies of any such data and information shall be submitted to the GRAS Review Branch (address above), which will distribute two cop ies to the contractor for the Scientific Literature Review when he is selected. A copy of all such submissions will also immediately be placed on display at the office of the Hearing Clerk, at the above address. If the estimated date of completion of the Review has passed, copies of any such safety data and information shall be submitted to the Select Committee on GRAS Substances and the GRAS Review Branch as provided by the notice pub lished elsewhere in this issue of the Federal Register, and a copy of any such submission will immediately be placed on display at the office of the Hearing Clerk pursuant to that notice. Dated: July 19,1973. A, M. -Schmidt, Commissioner of Food and Drugs. JFB DOC.73-1S220 FUsd 7-25-73:8:45 am] SAFETY OF GRAS AND PRIOR-SANC TIONED OIRECT HUMAN FOOD INGRE DIENTS Notice of Opportunity To Present Data Information and Views The Food and Drug Administration is conducting a study of the safety of direct human food ingredients classified as generally recognized as safe (GRAS) or subject to a prior sanction. As part of this study, information on each such ingredient (or group of ingredients), gathered from literature searches and other sources, is being summarized in a series of written Scientific Literature Re views by organizations under contract with the Food and Drug Administration. The organizations preparing the Scien tific Literature Reviews are responsible for including a summary of the world literature on safety published since January 1,1920. Opportunity is provided, elsewhere in this issue of the Federal Register, for any interested person to submit unpublished safety data and in formation on these food ingredients for inclusion in Scientific Literature Re views now under preparation. Several Scientific Literature Reviews have now been completed and submit ted to the Food and Drug Administra tion. A list of those completed Reviews appears elsewhere in this issue of the Federal Register, (38 FR), and notice is given of their public availability. The Food and Drug Administration briefly examines each Scientific Litera ture Review before accepting it. This brief examination covers only the general quality of the work, to make certain that the major scientific information is in cluded in a balanced and complete presentation. The examination Is not in tended to determine that all pertinent scientific Information Is Included. Notice Is therefore hereby given that any inter ested person who, after study of a Scien tific Literature Review, believes that additional pertinent published or un published data or information should be included in considering the safety of the ingredient(s) covered in the Scientific Literature Review, may submit ten copies of such written data, Information, or views to: Select Committee on GRAB Substances, Federation, of American Societies for Ex perimental Biology, 9660 Rockville Pike. Bethesda, MD 20014 The original of this material and two additional copies shall simultaneously be sent to: Bureau of Foods, Food and Drug Administration, GRAS Review Branch (BF-335), 200 "C" street, s.w,, Washington, DO. 20204. Immediately upon receipt, one copy of any such submission will be placed on display at the office of the Hearing Clerk, Food and Drug Administration, Room 6-88, 5609 Fishers Lane, Rockville. MD 20852, where it may be reviewed ^during working hours, Monday through Friday, The Select Committee on GRAS Sub stances is utilizing the services of special consultants with particular expertise in considering specific issues that arise in the evaluation of these substances. The Select Committee also recognizes that the presentation of oral views with respect to the safety of these substances may be helpful in its work. Therefore, an opportunity will be provided for any interested person to present oral views on the safety of these substances to the Select Committee at a hearing, as part of the evaluation process. Notices pro viding an opportunity to participate in a hearing, for the presentation of such oral views to the Select Committee, will be published in the Federal Register at the appropriate time. Following completion of its evaluation, the Select committee will prepare a re port to the Commissioner of Food and Drugs containing its evaluation and rec ommendations, with respect to the safety of the particular ingredient(s) covered by a Scientific Literature Review. Upon acceptance of the report by the Food and Drug Administration, it will be made available to the public in accordance with the notice on this matter published else where in this issue of the Federal Regis ter. After evaluating this report, the Commissioner will publish In the Fed eral Register, an appropriate proposal to (1) affirm GRAS status, (2) publish a prior sanction, (3) establish an interim food additive regulation, (4) establish a permanent food additive regulation, or (5> eliminate food use of the ingredient. These proposals will be Issued pursuant to the procedural provisions contained in g 121.40, 121.41 published In the Fed- federal REGISTER, VOL 38, NO. 143--THURSDAY, JULY 26, 1973 ASI 00003562 T 20054 eral Register of December 2, 1972 (37 PR 25705), and S 121.2000 published in the Federal Register of May 15, 1973 (38 FR 12737). The Commissioner to pro posing elsewhere in this issue of the Federal Register, to establish new 121.104 Substances added directly to human food affirmed as generally recog nized as safe (GRAS), 121.105 Substances in food contact surfaces affirmed as gen erally recognized as safe (GRAS), and 121.106 Substances prohibited from use in food. Thus, each food ingredient will be proposed for inclusion in one of these three new sections, In Subpart D (direct human food additives), in Subpart E (prior sanctions), in Subpart F (indirect human food additives), or in Subpart H (interim human food additives). Following publication of any such pro posal, all interested persons will have an opportunity to submit written com ments on the proposal. Where good cause is shown, the Commissioner may order a public hearing at which an oral presen tation of data, information, and views may be made. The final regulation will be final agency action from which ap peal lies to the courts. The Commissioner urges the coopera tion of all segments of the public in this Important work. Dated; July 19,1973. A. M. Schmidt, Commissioner of Food and Drugs. [FR Doc.73-15221 FUed 7-25-73;8:45 am] STATUS OF REVIEW OF GRAS ANO PRIORSANCTIONED DIRECT HUMAN FOOD INGREDIENTS Notice of Availability of Information Food ingredients that are generally recognized as safe (GRAS). or that were sanctioned through action by the Food and Drug Administration or the United States Department of Agriculture prior to enactment of the Food Additives Amendment of 1958, may be utilized in food without first obtaining approval through a food additive regulation. After enactment of the law, the Food and Drug Administration published a partial list of GRAS and prior-sanctioned in gredients in 121.101. This list was de veloped without a thorough scientific review of each ingredient. In his Consumer Message of Octo ber 30, 1969, President Nixon directed the Secretary of Health, Education, and Welfare to initiate a full review of all GRAS ingredients. To implement this mandate, the Food and Drug Adminis tration contracted with the Food Pro tection Committee of the National Academy of Sciences to survey the entire food industry to determine the national production of all GRAS ingredients and the amount of each such ingredient used in any particular food. The National Academy of Sciences report to the Food and Drug Administration Incorporated the results of independent surveys con ducted by the United States Department of Agriculture as part of Its 1965 House hold Food Consumption surveys to de termine the sizes of food servings used by consumers, and by the Market Re search Corporation of America, to deter mine how frequently representative con sumers eat Individual servings of foods in specific food categories. The results of the NAS Survey, describing incorporation of USDA and MRCA data, is now available. The complete Survey report also con tains various tabular computer print outs describing the use of GRAS food ingredients in NAS food categories and the total exposure of GRAS food ingredi ents in human foods. The Food and Drug Administration also contracted with the Franklin Insti tute Research Laboratories, The Ben jamin Franklin Parkway, Philadelphia, PA 19103, to conduct a search of the world literature since January 1, 1920 on the following 72 GRAS food ingredi ents that were determined to be a matter of high priority: Ammoniated glycyrrhizln Sodium nitrite Sodium nitrate Potassium nitrate Potassium nitrite Saccharin (acid) Sodium saccharin Calcium saccharin Ammonium saccharin Potassium bisulfite Potassium metabisulflte Sodium bisulfite Sodium metablsulfite Sulfur dioxide Oil of mustard Asr 00003563 FEDERAL REGISTER, VOL. 38, NO. 143. THURSDAY, JUIY I*, 1973 NOTICES 200$5 OU at garlic Oil of nutmeg Oil of rue Oil at clot* Caramel Benzole acid Sodium benzoate Methyl paraben Propyl paraben Propyl gatlate Carrageenan Sodium alginate Gun tragacanth Gum arable (acacia) Cacob bean gum Ghattl gum Sterculla gum Guar gum Furcelleran Sodium carrageenan Sorbitol Mannitol Butylated bydrozyanlsole Butylated bydroxytoluene Hydrogen peroxide Dlacety tartaric acid esters of mono- and dl- giycerides of edible fats and oils, or edible fat-forming acids Stannous chloride Diacetyl Monosodium glutamate Monopotassium glutamate Glutamic acid Glutamic acid hydrochloride Monoammonium glutamate Zinc sulfate Zinc gluconate Sodium thiosulfate DUauryl thlodlproplonate Thtodtproplonlo acid Calcium propionate Bentonite Camauba wax Sodium aluminosilicate Tricalcium silicate Vitamin A Vitamin A acetate Vitamin A palmltate Vitamin D, Vitamin D, Zinc chloride Zinc oxide Zinc stearate Aluminum calcium silicate Calcium silicate Magnesium silicate Sodium calcium aluminosilicate, hydrated This literature search Is being ex panded to Include all of the GRAS sub stances for direct human food use In cluded in } 121.101(d) and a number of substances possessing such GRAS status by virtue of a communication from the Pood and Drug Administration. A com plete list of these substances, and their scheduled coverage by Scientific Litera ture Reviews. Is Included in a notice pub lished elsewhere In this Issue of the Fed eral Register. Each scientific literature search Is de signed to discover any articles that considered (1) chemical toxicity, (2) occupational hazards, (3) metabolism, (4) reaction products, (5) degradation products, (6) reported carcinogenicity, teratogenicity, or mutagenicity, (7) dose response, (8) reproductive effects, (9) histology, (10) embryology, (11) be havioral effects, (12) detection method ology, and (13) processing. The results of this search are then Incorporated In a (Sgrceiednietnifitc(oLritegrraotuupreofRcehveiemwicoanllyeascimh iilnar ingredients). Additional toxicological screening tests vere conducted on 42 selected GRAS in gredients for mutagenisis and teratology. Teratologlcal screening was conducted on all 42 ingredients in four mammalian species: Rat, mouse, hamster, and rabbit. Chick embryo tests were also conducted on 41 of those ingredients. The mutogenic test conducted on 40 of the ingredients, used the host mediated assay, the domi nant lethal, and the cytogenic assay pro cedures. These studies were designed primarily to evaluate these relatively new toxicological screening tests, and an as sessment of their value is not yet possible. The Food and Drug Administration then contracted with the Federation of American Societies for Experimental Bi ology (FASEB) to conduct the initial evaluation of the Scientific Literature Reviews, the NAS production and con sumption data, and the additional toxi cological test data, and to provide a report on the safety of each individual Ingredient. The Life Sciences Research Office of FASEB In turn appointed a Select Committee on GRAS Substances (SCOGS) which has been working since June 1972 to conduct this evaluation. Notices appear elsewhere in this issue of the Federal Register requesting nomina tions for additional qualified scientists to serve on this Select Committee, providing an opportunity to submit unpublished safety data and information on GRAS or prior-sanctioned direct human food In gredients to the organizations preparing the Scientific Literature Reviews, and providing an opportunity to present data, information, and views on the safety of these ingredients directly to the Select Committee for their consideration in the evaluation process. To implement the review of GRAS and prior-sanctioned direct human food in gredients, the Commissioner of Food and Drugs has published in the Federal Register several regulations and notices. In announcing the review of GRAS food ingredients in the Federal Register of December 8, 1970 (35 FR 18632), the Commissioner proposed new criteria for determining GRAS status. These criteria were promulgated in final form in the Federal Register of June 25, 1971 (36 FR 12084). A notice published in the Federal Register of October 23. 1971 (36 FR 20546) urged that all interested persons obtain and complete the survey ques tionnaire being used by the National Academy of Sciences to obtain broad representative information on the pro duction and use of direct human food ingredients that have been listed in S 121.101 as GRAS or that were subject to a prior sanction. In additional to pub lished GRAS substances and known prior-sanctioned substances, the NAS questionnaire also requested information on direct human food ingredients used on the basis of a conclusion that they are GRAS, but which are not published In $ 121.101. Neither the Food and Drug Administration study nor the NAS survey includes indirect human food ingredients or animal food ingredients. A procedure governing affirmation of GRAS status and determination of food additive status was promulgated in the Federal Register for December 2, 1972 (37 FR 25705). The same Federal Regis ter notice promulgated a new Subpart H to govern the promulgation of Interim food additive regulations. Subpart E was amended in the Federal Rxoister for May 15, 1973 (38 FR 12737) to provide for publication of all prior sanctions for food Ingredients, and to permit the addi tion of limitations where justified by new toxicological information. The list of direct human food Ingredi ents published as GRAS in S 121.101 in cludes 533 ingredients, 261 of which are flavors. The 272 non-fiavor published GRAS ingredients will be covered in 120 Scientific Literature Reviews, all of which are completed. In progress, or planned for contract, as indicated else where In this issue of the Federal Register. The Food and Drug Administration has contracted with the Flavor and Extract Manufacturers Association to prepare similar Scientific Literature Re views with respect to 276 flavor sub stances, listed elsewhere in this Issue of the Federal Register. Scientific Litera ture Reviews will then be prepared on all remaining flavor substances, includ ing those published as GRAS in } 121.101, those published in such food additive regulations as $! 121.1163 and 121.1164, and those used on the conclusion that they are GRAS although they are not published in S 121.101. The next priority matter will Involve additional substances subject to food additive regulations and prior sanctions. A schedule and priorities for these have not yet been determined. Upon receiving a Report from the FASEB Select Committee evaluating the safety of an ingredient, the Commis sioner, after conducting his own evalua tion, will publish in the Federal Register an appropriate proposal to affirm GRAS status, to publish a prior sanction, to establish an Interim food additive reg ulation, to establish a permanent food additive regulation, or to eliminate food use of the ingredient. These proposals will be published pursuant to the proce dural provisions contained in 39121.40. 121.41, and 121.2000. The Commissioner, is proposing to establish new ! 121.104 Substances added directly to human food affirmed as generally recognized as safe (GRAS), S 121.105 Substances in foodcontact surfaces affirmed as generally recognized as safe iGRASl, and 121.106 Substances prohibited from use in food. elsewhere in this issue of the Federal Register. Thus, each of these food in gredients will be proposed for inclusion in one of these three new sections, in Subpart D (direct human food addi tives), in Subpart E (prior sanctions), in Subpart F (indirect human food ad ditives) , or in Subpart H (interim human food additives). Following publication of any such proposal, all interested persons will have an opportunity to submit written com ments on the proposal. Where good cause FEDERAL REGISTER, VOL. 3, NO. 143--THURSDAY, JULY 36, 1973 ASI 0000'^564 20056 NOTICES Is shown, the Commissioner may order tions or limitations imposed upon its use National Technical Information Service a public hearing at which an oral pres could in any event also be imposed on the (NTIS). 5285 Fort Royal Road. Spring- entation of data. Information, and views prior-sanctioned uses under the adul field, VA 22151. This_report is now may be made. The final regulation will teration provisions of the Act as provided available. be final agency action from which appeal in 3 121.2000, published In the Federal 2. A series of computer print-outs of lies to the courts. Register of May 15. 1973 (38 PR 12738). the combined data from the NAS, USDA, Section 121.101 is not limited to di Accordingly, the Commissioner has and MRCA Surveys may be purchased rect human food ingredients. Many of the concluded that regulations based upon from NTISr These print-outs are now substances listed in 5 121.101 have been the review of GRAS and prior-sanctioned available and are explained In the NAS regarded as GRAS for Indirect food in direct human food ingredients will ini report. gredient use, in or on food-contact sur tially be proposed on the assumption that 3. The reports of the 1965 USDA Sur faces, and for use in pet food and animal no prior sanction exists. Because prior- vey on "Food Consumption of Households feed. Accordingly, when an ingredient sanctioned status constitutes an exemp in the United States" may be purchased listed in 8 121.101 is affirmed as GRAS tion from section 409 of the Act, it should separately from Superintendent of Docu Tor direct human food use, it will be re be construed narrowly, and the bur ments, U.S. Government Printing Office. tained in 5 121.101, with the explanation den of coming forward with evidence Wash., D.C, 20402, order number HFCS that it has been affirmed as GRAS, and of the sanction properly rests upon 1965-66, Report No. 1. These documents cross-referenced to the applicable para the person who asserts it. In the event are now available. graph in new 5 121.104. When an ingre dient is transferred to an interim food additive regulation, permanent food ad ditive regulation, or prohibited status, for direct human use, a decision will be that any person responds to a pro posed regulation with proof of a valid prior sanction, a final regulation will be issued under Subpart E Substances for which prior sanctions have been 4. Each Scientific Literature Review may be purchased from NTIS as it be comes available. The following Scientific Literature Reviews are now available: made as to whether the ingredient may granted, as well under any other appli remain as GRAS for uses other than di cable sections of the regulations. In this rect human food use, or should be re way, all possible uses of the ingredient Review title Ordering Printed No. copy price stricted or eliminated from such uses, will be fully covered. Any regulation pro and 8121.101 and other applicable reg ulations will be amended accordingly. In the event that additional toxi cological testing Is required before the ingredient may be affirmed as GRAS or approved by a permanent food additive regulation, an interim food additive reg ulation will be proposed (unless there is a reasonable likelihood that a health hazard exists). Pursuant to 8 121.4000, use of the Ingredient must cease unless an Interested person satisfies the Com missioner, In writing within 60 days fol lowing the effective date of the interim food additive regulation, that studies adequate and appropriate to resolve the questions raised about the ingredient have been undertaken. The Food and Drug Administration may itself under take such studies, but this will occur only in very rare instances, if at all. As a general rule, the Food and Drug Ad ministration intends to institute little or no testing for the purpose of provid ing data necessary to justify continued marketing of food ingredients, because of its conclusion that this is properly mulgated pursuant to this review will constitute a determination that excluded uses would result in adulteration cf the food in violation of section 402 of the act, and failure to submit proof of an applica ble prior sanction in response to any proposed regulation will also constitute a waiver of the right to assert such sanc tion at any later point in time. Any pro posed regulation will also be construed as a proposal under Subpart E, in the event that a prior sanction is asserted In com ments submitted on it. This procedure is necessary because of the unavailability of any comprehensive list of prior sanctions. In the past, it has been customary practice for the Food and Drug Admin istration to issue advisory opinions that a substance is GRAS, or is subject to a prior sanction, or is not a food additive because it is used in or on food-contact surfaces and there is no detectable mi gration. The Commissioner has con cluded that all such past correspondence Is publicly available, except that trade secrets will be retained as confidential, Gum Arabic (Acacial.................... FB-22I-301 Butvlntcd Hvdroxytoluen* PB-221-202 Carob Dean Gum......... ........... PB*-221-303 Gum Tragacantb...................... . FB-2Zi~2fH Storculia........ ....__ ___ PB-22I-20S Carrageenan........ ............ PB-221-200 Propyl i lallate......... m-221-207 Benzoates.................................. FB-221-208 Parabens......................................... FB-221-200 Sorbitol........................................... PB-221-210 Mannitol..... ..... .................... FB-221-211 Oil of Rue....................................... PB-221-212 Gum Ghattt...... ................... ..... . PB-221-213 Zinr Salts .... ...___ PB-221-214 (Ml of Mustard................................ PB-221-213 (nar Gum__ ________ _ ......... PB-221-216 J-ulfitinc Agents........................... PB-221-217 Paranio!.......................................... PB-221-21S Oil of Garlic......... .. ........ m-221-219 N'itraU^-Nitntes............................ PB-221-220 Oil of ('love................................. . PB-221-221 Oil of Nutmeg...--...--.-........ -- PB-221-222 Till.................................................. PB-221-223 Phosphates........................ . - PB-221 -224 Agar-Agar.................................... . PB-221-225 Alginates........................................ PB-221-ZZfi Glycerine and Glycerides........ ..... PB-221-227 Cellulose............... ...................... PB-221-22S Oopivlir Add...,.......... . PB-221-229 Olyevrrhiza....................... ....... . PB 221-230 Carbonates................. . ......... PB-321-231 Srnnnous Chloride...... ............ . PB-221-232 Propylene Glycol and Deriva* PB-221-233 Sulfates...... ................ ................. - PR-221-234 Ammoninam ton................ . PB-221-23S Iron and Iron Salts Used In Foods. PB-221-236 Tocopherois............................... .... FB-221-237 *4.85 4.60 3.00 8.00 3.00 4.90 3, rs ft. 45 3.75 4. M 4.M 3. no 3.00 5.43 4.50 3 75 6.00 3-75 3. 75 9.00 3.75 3. no 3. no 6.0 a. 4.90 6.75 4, M 4.50 3.75 5. 13 4. 50 4.50 4. *>5 6 15 5,45 a 73 the function of private industry. and that all future opinions relating to Many of the substances published as GRAS in 121.101, or used on a deter mination that they are GRAS without publication in 8121.101, were approved by the United States Department of Agri culture for use in meat or poultry, or were approved by the Food and Drug Administration for use in various foods pursuant to correspondence, food stand' ards, regulations, informal announce\ ments, or in other ways, prior to 1958. \ Thus, many of these ingredients are sub ject to specific prior sanctions in addi ction to GRAS status. No comprehensive list of such prior sanctions exists. To the extent that one of these substances is affirmed as GRAS for all prior-sanc tioned uses, the fact that it may also be subject to a prior sanction is largely of historical interest and has no regulatory GRAS or prior-sanctioned status will be Issued in the form of Federal Register notices proposing appropriate new reg ulations. Opinions solely with respect to no-migration status of food-contact in gredients will continue to be handled by letter rather than by regulation because of their limited applicability, and all such correspondence will be publicly available, except that trade secrets will be retained as confidential. The Commissioner recognizes that the data and Information obtained in the process of conducting this review of di rect human food ingredients is of broad interest to the public. Accordingly, this information is available for public dis closure in the following ways. 1. The report of the National Academy of Sciences on "A Comprehensive Survey Each Scientific Literature Review may be purchased in microfiche form for $.95 with the same ordering numbers listed above. 5. Copies of each Scientific Literature Review will be placed in the Library of Congress as they become available, under the title, "Scientific Literature Reviews on GRAS Food Ingredients," L.C. Card No. 73-600105. 6. Each report to the Commissioner from the FASEB Select Committee may be purchased from NTIS as It becomes available. The following reports are now available: Carcb Bean (Locust Bean) Gum Parabens Sorbitol Mannitol significance. To the extent that one of of Industry on the Use of Food Chemi 7. A copy of each of the reports of these substances is not affirmed as GRAS cals Generally Recognized As Safe" (Sep the following toxicological screening for all prior-sanctioned uses, any restric tember 1972) may be purchased from the tests may be purchased from NTIS: FEDERAL REGISTER, VOL. 38, NO. 143--THURSDAY, JULY 26, 1973 ASI (<<(003565 NOTICES Ingredient Tern- Mat* tology genesis Sodium Saccharin., ... X X ... X Glycine..,........... ......... Sodium Bisulfite......... fcoditnn Meti'bisuinte.. MtuunUd....,........ . Snrbiiol..................... Sodium TbiosuHate. Stannous Chloride... Calcium Fropionaie. Sodium Henroate___ Propyl i iallaie......... Calcium Sillcated (Hydrated;. ... XY ... XY ... XY ... XY ... XY ... XY ... XY ... X ... X ... XY ... XY ... XY ... XY ... X ... X ... X (inm Ohatti. Guar (ium... Talc.. ... X ... XY ... XY ... XY ... XY ... XY ... XY ... XY ... XY ... XY X X X X X X X X X X X X X X No final chick embryo test reports hare been received, to date. X--Ttted in Rats, Mice. Hamsters and Rabbits. XV-Tested in Raw, Mice and Hamsters. 8. A single copy of all of the above data and information is available for review in the Office of the Hearing Clerk, Food and Drug Administration, Rm. 6-88, 5600 Fishers Lane, Rockville, MD 20852, during working hours, Monday through Friday. Additional information relating to these matters will also be placed on display at this office as they become available. Dated: July 19,1913. A. M. Schmidt, Commissioner of Food and Drugs, [FR Doc.73-15206 Filed 7-25-73:8:45 am | 20057 FEDERAL REGISTER, VOL 38, NO. 143--THURSDAY, JULY 26, 1973 Copied by MCA Sdnttfk UUntun mtai Review title Printed Ordwing No. copy prtc* TtntolOfp teretmMt latt--CgnlinMd Ingredient > Printed OiMniNA >Py price* -*RAS OR PRIOR-SANCTIONED DIRECT HUMAN FOOD INGREDIENTS Notice of Availability of Information In notices published in the Federal Register of July 26, 1973, ,the Commis sioner of Food and Drugs announced the current status of the review of food in gredients classified as generally recog nized as *safe (GRAS) and the avail ability of data and information compiled during this review <38 FR 20054); solicited public participation in the re view by requesting nominations for the Select Committee on GRAS Substances (38 FR 20054); provided public oppor tunity to present unpublished safety data to organizations under contract to the Food and Drug Administration for preparing Scientific Literature Reviews on GRAS substances (38 FR 20051); and provided public opportunity to present data. Information, and views on GRAS . substances directly to the Select Com' mlttee on GRAS Substances (38 FR 20053). Elsewhere in this Issue of the Federal Register, opportunity is provided for Interested persons to submit unpublished safety data to organizations under con tract to FDA to prepare additional Scientific Literature Reviews. This notice announces the public ^reliability of new data and information ^Balned by the Food and Drug Adminis^Ktlon in conducting its safety review of / AS substances. In addition to the an` ncement of new materials now avail- aoie, purchasing information on. avail able reports and screening tests not pre viously announced is Included. The Commissioner recognizes that data and information on GRAS food in gredients are of broad Interest to the public. Accordingly, this Information is available for public disclosure in the fol lowing ways: 1. Copies of each Scientific Literature Review have been placed in the Library of Congress under the title, "Scientific Literature Reviews on GRAS Food Ingre dients." L.C, Card No. 73-800105. 2. The following Scientific Literature Reviews, Reports of the Select Committee on GRAS Substances to the Commis sioner of Food and Drugs, and reports of toxicological screening tests are now available for purchase from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22151. In addition to the NTIS ordering Information given below, each document may be purchased in microfiche form with the same ordering number. Micro fiche document prices are $1.45 each (for those designated--/AS) and *0.95 each for all others. Butylatad Hydrrwyenleole PB-223-883/A9 (BHA). Aluminum Compounds,,*... PB-22S-862/AS Sorbic Add and Derivatives.. PB-223-864/A8 Citrates |____ __... PB-223-650/AS Calcium Oxide and Hydrox PB-223-S51/AS ide. Malic Acid.............................. . PB-223-865/AS Ascorbates............................. . PB-223-860/AS Cholic Acid and Derivatives.. PB-223-844/A9 Calcium Sequestronts........... FB-223-843/A8 Tallow and Stearic Acid...... PB-223-850/AS Beeswax and Japan Wax...... PB-223-354/A8 Choline Salts............................ PB-223-645/AS PB-223-846/A8 Iodine and Iodine Salts. Com Sugar.................... Camauba Wax.............. PB-223-849/AS FB-223-8S3/AS PB-223-855.US Pulps............................ Aconitic Acid--........... Sorbose.......... ............... Tannic Acid__________ Sodium Thiosulfate___ PB-223-848/a8 PB-223-847/.1S PB-223-852/A8 PB-223-858/AS PB-223-856/AS Succinic Acid................. Inositol_______________ Gelatin...-----------...... PB-223-360/A8 PB-223441/AS PB-223-857/A9 $3.50 4.50 3.75 4.25 2.75 3.75 3.75 4.25 4.50 3,75 3.00 3.00 3.00 3.75 8.00 2.75 2.75 2,75 2.75 3,75 3,50 3.00 3.50 4.25 Rtportt of tin Settct Commttta to tht Commtuioner Report title Ordering No. Printed copy price Carob Beau (Locust Beau) PB-221-G53 Gum. Parabens (Methyl and PB-221-050 Propyl). Sorbitol,..-*.................... .... PB-221-951 Mannitol*... . PB-221-Q5S $3.00 100 3.00 3.00 Tcrotolon tatmino tttit Ingredient1 Printod Ordering No. copy price1 Aiumoni*tdglycyTrtiitin(X). PB-221-798 Amaranth (Red No. 2) (X),,_ PB-221-771 Sodium saccharin (X)........ PB-221-772 Calcium saccharin (X)....... PB-221-771 Saccharin (insoluble) (X)____ PB-221-791 Ammonium saccharin (X)___PB-221-792 Sodium nitrate (X)................ PB-221-775 Potassium nitrate (X)_______ PB-221-774 Sodium nitrite (X).......... FB-221-794 Potassium nitrite (X).............PB-221-7M Glycine (XY).-.-............... PB-221-809 3odiom bisulfite (XY)........... PB-221-788 Sodium metabisulflte (XY).. PB-221-795 Butylated bydroxyanisole PB-221-783 (XY). Butylated hydroxytoluene PB-221-782 (XY). Mannitol (XY).......................... PB-221-781 Sorbitol (XY)............................ PB-221-806 Sodium thiosulfate (XY)-... PB-221-779 Stannous chloride (XY).--. PB-221-780 Calcium propionate (X)..,... FB-221-77B Sodium bensoate (X)........ PB-221-777 Propylgallate(XY)..--... PB-221-790 Methyl paraben (XY)............ PB-221-785 DilauryIthiodlpropionic acid PB-221-776 (XYf Calcium silicate (hydrated) PB-221-001 (XY). _ Sodium carrageenan (X)--... PB-221-812 Calcium carrageenan (X)......... PB-221-787 Carob bean (locust bean) FB-221-784 un (X)- __ Gum arable (acacia) (X)..... PB-221-793 Gum tragacanth (X)_______ PB-221-797 Gum ffhatti (X)...._..--... PB-221-799 Guar gum (XY)....................... PB-221-8Q0 Btercinia (karaya) gum (XY). PB-221-799 Progylene glycol alginate FB-221-7M Talc (XY)..................... PB-221-604 Caffeine (ST)........................... PB-221-803 Oil ot nutmeg (XY)PB-221-8OT Sodium tripolyphoiphate PB-221-808 (XY). Zinc sulfate (XY),^,t.,,... PB-221-905 Lactose (XY)_____ PB-221-8U Adipic add (XY).---.,, PB-221-802 $3.75 4.50 4.50 4.50 4.50 4.50 4.50 4.50 4.50 4.50 3.75 3.75 3.75 3.75 3.75 3.75 3.75 3.75 3.75 4.50 4.50 3.75 3.75 3.75 175 4.50 4.50 4.50 4.50 4.50 4.50 3.75 3.75 3.75 3.75 3.75 3.75 3.75 3.73 3.75 3.75 Furfellerao (XY)................... PB-221-B10 SiUcaaerogel (syloid) (X)--,. PB-ZM0B/A8 DL^Alpba tocopherol acetate PB-223-80e/A3 Sodium sUlcoaltxznlnate (X).. PB-223-810/A8 Oil of clove (X)......................... PB-223-SU/A9 Oil of mustard (X)....................PB-223-812/AB Manganese sulfate (mooohy* PB-223-813/A6 drate) (X). Citric add (X)............... PB-223-814/AS Menthol (natural Brazilian) PB-223-815/AS (X), Propyl gallate (Y).................... FB-223-815/AS Methyl paraben (Y)..................PB-223-817/AS Sterculia (karaya) gum (Y)_,, PB-223-818/A9 Guargum (Y).PB-223-819/AS Agar-agar (X)................. PB-223-820/AS Tartancaeid (X)......... PB-223-82VAS Tropylene glycol (X)_________ PB-223-822/AS Methoccl (methylcellulose) PB-223-823/AS (X) Dilaurylthiodiproplonic acid PB-223-824/AS (Y). Lactose (Y).......... PB-223-825/AS Sodium tripolypbosphate PB-223-820/AS Caffeine <Y)............................. PB-223-827/A8 Talc (Y)................... PB-223-828/A9 Calcium siUcate (hydrated) PB-223-829/AS (Y). Oluconodeltalactone (X)..........PB-223-830/AS Sodium add pyrophosphate PB-223-831/AS Sodium aluminum sulfate PB-223-632/A9 (XY). Starter distillate (XY)........... PB-223-833/AS UUTAQEN1C SCagININO TSOT9 Amaranth (Red No. 2) (X).. PB-221-814 Saccharin (insolublo) (X)___ FB-221-824 Sodium nitrate (X)__ _.. PB-221-S17 Sodium nitrite (X)..................PB-221-818 Sodium metabisulflte (X)___ PB-221-825 Butylated hydroxytoluene FB-221-827 Sorbitol (X)________________ PB-221-815 Calcium carrageenan (X)....... PB-221-S20 Carob bean (locust bean) PB-221-819 gum (X). Gum arable (acacia) (X)........FB-221-821 Gumghatti(X)................. PB-221-822 Guargum (X)........................... PB-221-815 Sterculia (karaya) gum (X).. P B-221-823 Propylene glycol alginate (X). PB-221-826 3.75 3.50 3.50 3.50 3.50 3.50 3.90 8.50 2.75 2.75 2.73 2.75 8.50 3.50 3.50 3. r0 2.75 2.75 2.75 2.75 2.75 2.75 3.50 3.50 3.00 3.00 *5.45 4.85 5.45 5.45 5.45 5.45 .5.45 . 4.85 A 85 5,45 4.85 5.45 4.85 5,15 * (X). (Y), or (XY) listed next to an ingredient In dicates the following: X* Report of rats, mire, hamsters, and rabbits; Y-Report of rabbits only; and XY Report of rats, mire, and hamsters. The first 42 teratology reports listed above (PB-221771 through PB-221-812) are available from NTIS for $110 (PB-221-770 SET). 3. The report of the National Academy of Sciences to the Food and Drug Ad ministration, "A Comprehensive Survey of Industry on the Use of Food Chemi cals Generally Recognized as Safe," was reported available in the Federal Reg ister of July 26.1973 (38 FR 20054), with out ordering instructions. This report is available for purchase from NTIS for $9.00 with the order number FB-231-949 and may also be purchased with all 28 accompanying use and consumption tables for $154.00 (PB-221-920 SET). The tables may be purchased separately or In microfiche form by requesting this spe cific Information from NTIS. 4. A single copy of all of the data and Information given above Is available for review in the office of the Hearing Clerk, Food and Drug Administration, Rm. 8-86, 5600 Fishers Lane, Rockville, MD 20852, during working hours, Monday through Friday. Additional Information relating to the review of GRAS sub stances will also be placed on display at this office as it becomes available. Dated: April 9,1974. Sam D. Fine. Associate Commissioner for Compliance. FEDERAL REGISTER, VOL 39, NO. 75--WEDNESDAY, APRIL 17, 1974 (I K Doc.74-8GG2 Filed -IG-74;8:45 am| ASI 00003567 SCIENTIFIC LITERATURE REVIEWS ON GRAS OR PRIOR-SANCTIONED DIRECT HUMAN FOOD INGREDIENTS Notice of Opportunity To Submit Unpublished Safety Data In the Federal Register of July 26, 1973 (38 FR 20051), the Commissioner of Food and Drugs published a notice soliciting public submission of unpub lished data and information that may be significant in determining the safety of generally recognized as safe (GRAS) or prior-sanctioned food ingredients. The notice Included a list of the Scientific Literature Reviews then being prepared by organizations under contract to the Food and Drug Administration. Many of these Scientific Literature Reviews have been completed, and notice of their availability is published elsewhere in this issue of the Federal Register. 1 This notice gives information on as signments of new contracts for the prep aration of Scientific Literature Reviews on ingredients (or groups of ingredients) previously listed as planned for immedi ate public review, and it also solicits pub lic submission of unpublished safety data and information on these ingredients. The organizations assigned each Review are as follows: 1. Informatics, Inc., 6000 Executive Boule vard, Rockville, MD 20852. 2. Tracor Jltco, Inc., 1300 East Gude Dr., Rockville, MD 20851. Ingredients Organizations Estimated date of completion Biotin.......................... Informatics. Inc... Attff. 5,1974 Niacin and ....... do..................... Do. niacinamide. Pyridoxines.**...** - **.**do..*........ ...... Do, Thiamin.*_________ ....... do................... . Do. Riboflavin* __ -do____ _ Do. Carotene#_____ __ .* ...do.,.* July 1,1974 CafToine_.,,..*__ .... ....... do..................... Do. Dcxtrans................... ....... do.......... Do. Sodium and potas Tracor Jltco, Inc*. Do. sium chlorides. Casein and caseinates.... -do.*.*..**........ Do. Citric acid____,,* **.__do..*................ Aug, 5,1974 Lecithins*__________ ....... do............ . Do. Urea............................ ........do................. Do. Vitamin Bu_______ _ Do. Ascorbic acid___ Do. Nickel___ July 1,1974 To be considered for inclusion In a Scientific Literature Review, two copies of all data or information should be sub mitted to the organization preparing the Review before the listed completion date, and the original and two copies of all such Information simultaneously sent to the GRAS Review Branch (BF-335), Bureau of Foods, Food and Drug Admin istration, 200 "C" St., SW,, Washington. DC 20204. Immediately upon receipt of any such submission, one copy will be placed on display at the office of the Hearing Clerk, Food and Drug Adminis tration, Rm. 6-86, 5600 Fishers Lane, Rockville, MD 20852, where it may be re viewed during working hours, Monday through Friday. Dated: April 9,1974. Sam D. Fire, Associate Commissioner for Compliance, [FR Doc.74-8661 Filed 4-16-74:6:45 am]