Document BnenBQDvgab3R7ewa2GXRoKE

r TELEPHONE HUDSON 3 6126 Manufacturing Chemists' Association, Inc. (FOUNDED 1872) 1825 Connecticut Avenue, N. W. Washington, D. C. 20009 August 11, 1967 TO: Members of the Food, Drug, and Cosmetic Chemicals Committee SUBJECT: Food Additives Procedural Regulations Gentlemen: The attached notice of Proposed Rule Making may be of interest to you. Sincerely yours. MMH:sjg Attachment Morgan M. Hoover ASX 00002124 Proposed Rule Making /DEPARTMENT OF HEALTH, EDHCATICN, AND WELFARE Pood end Drug Administration t 21 CPU Part 121 1 FOOD ADDITIVES Procedural Regulations TIm- UomoiisMonor ol Food and Dilips propose.-! lliiit the procri! 111:* 1 food addi tive regulations be revised as set forth below lo obtain improvement, in the final ity and organization of food additive pe titions submitted and to expedite their scientific review by the Food and Drug Administration. The need for such re vision is based on the following: A. Almost half of the food additive pe titions as originally submitted to the Food and Drug Administration have been incomplete or have not adequately sup ported the regulation requested and, therefore, have required subsequent sup plementation. amendment, withdrawal, or denml. B Scientific review of deficient and poorly organized petitions Is an unneces sary burden that wastes the time and ef forts of both Administration and indus try scientists. Therefore, pursuant, to the provisions of the Federal Food. Drug, and Cosmetic Act sees. 4M. 70t''. 02 Stat. 1055, 72 Flat. 1780: lU TT.S.C. 340. 371'aM and under the authority delegated to the Commissioner by the Secretary of Health, Education, and Welfare '21 CFR 2.1201, it. is proposed that Part 121 be amended by revising 5S 121.7. 121.9, and 121.51 end by adding 5 121.50. as follows: 721.7 Food additives for use in feed mid drinking water of animals and food additives that are also new drugs, certifiable antibiotic drugs, and /or pesticides. 'a' fit A substance that is a new drug within the meaning of section 201fp) of the act or an antibiotic drug subject to the certification requirements of sections 502m and 507 of the act may also be a food additive within the meaning of sec tion 200.',' of the net because the subsi ance is to be used in Lho feed of an ani mal or because its intended use in or on the animal results or may reasonably be expected to result directly or indirectly in it or its conversion product(s) be coming a component of or otherwise af fecting the characteristics of a food de rived from the animal. '2' An application for a new drug or an antibiotic drug which substance is also a food additive shall be submitted in the form prescribed hy g 130.4 of thts chapter 'Form FD 35GV> and processed in accordance with Parts 130 mow drug! or 140 'antibiotic drug' of this chapter, and the food additive aspects of such applications shall be processed simultaneously. '3) An application for a new drug or an antibiotic drug which substance is also a food additive shall include a prac tical. chemical assay method for en forcement of any tolerance provided and, if edible products of food-producing animals are involved, data establishing (he residues of the substanee or ils metabolites In such edible product;; 'hi Petitions for food additives that are nondrug substances for use in the drinking water or feed of animals shall be submitted in the form described in 5 121 50 and shall be processed in accord ance with the procedures prescribed in this Tart 121. (c) Any pesticide chemical added to processed feed for animals for the pur pose of affecting such animals will be considered a food additive and new drug subject to approval under sections 409 and 505 of the act. Petitions for such pesticide chemicals shall be submitted and processed in accordance with para graph ia (2) of this section. 'd' A new-drug application will not be approved for a use that results in the substance becoming a food additive un til a regulation therefor is established under section 409 of the act. A food addi tive regulation under section 409 of the act will not be established if the addi tive results from the use of a new drug for which a new-drug application can not be approved. The new-drug applica tion and the establishment of a regula tion regarding the food additive aspects will be acted on simultaneously. 'e> Applications for use cf any drug substance in feed or for a drug or anti biotic substance intended to be admin istered to a food-producing animal shall be submitted to the Bureau of Veterinary Medicine of the Food and Drug Admin istration for evaluation. 121.9 Food nddilivc master files. (a) Any person submitting or intend ing to submit a food additive petition may submit confidential information or information entitled to protection as a trade secret in the form of a "food addi tive master fllo." Such master file will bo assigned a number and will be retained as available material that may be in corporated In any food additive peti tion upon request from the person sub mitting such file. (b) The material in the master file shall be arranged and indexed by page numbers as if it were a portion of a petition so that specific material may be precisely referenced in any separate sub sequent petition. (c) The analytical methods and a summary of the toxicological basis on which a food additive regulation is based are not considered confidential or en titled to protection as trade secrets. 121.50 rn(cn( and fnrftf of food ;i-' ditive petitions. 'a' Petitions to be filed under the pro visions of section 409'b> of the act shall be submitted in triplicate, in the form described in paragraphs >c) and <d> of this section. Any material submitted in a foreign language shall be accompanied by :m accurate English translation Anv imhMshert inlorniutlon used m .support of 11 n- petition shail In- submitted in tt-pi ml lorni. The petition must he signed In * >> pelilinnei- or h.V an authorized allnrm . agent, or official. If the petitioner m : 'ion authorized representative dors n In:1 aor have a place of business wuh'r :`ie United States, the petition must alsc fur nish the name and post office address of and must be countersigned by an au thorized attorney, agent, or offir ml i raid ing or maintaining a place of tin -mess within the United States. All original, unpublished scientific studies supphod in the petition shall include identifica tion of the scientists who did the work and their pertinent qualifications. The omission of any material required by this section shall be noted and the reasons therefor stated. 'b> Information previously submitted by th" petitioner to the Food and Drlig Administration may be incorporated, i'' subsequent submissions provided speeifv: reference to such information is hy giving the tyiie of subml slop ai d the vn'ume. page, and date .submitted, and provided that the submission is in a food additive master flic kept current by the petitioner, or is in another form of sub mission not over 10 years old. Confiden tial material entitled to protection a: a trade secret, such as method of manu facture or process information, in food additive petitions or food additive mas ter flics furnished by a person other than the petitioner may also be incorporated provided use of such information is au thorized in a written statement signed hy the person who submitted the in formation or his successor in interest. <c> Petitions shall be assembled in the manner prescribed in paragraph <o' of this section and submitted in a form suitable for binding, with all text double spneed on a x lOf.-inrh pages with n left-hand margin or approximately l1- inches and a right-hand margin of ap proximately 1 inch. The left-hand margin shall be punched for a standard two-hole fastener '2%-inch span' verti cally centered therein. Each section shell have a section divider with index tab thereon bearing the section heading. The pages in each section shall be identified with the letter designation for the sec tion and consecutively numbered. <d> Petitions shall be transmitted by a cover letter in triplicate in the follow ing form: FEDERAL REGISTER, VOI. 32, NO. 152--TUESDAY, AUGUST S. 1962 ASI 00002125 nm PROPOSED RULE MAKING PctlMonr. Control Branch. nnd Drug Administration, Department ->' Health, Education* nnd Wel- fi: ro. \V:>' hlu?fon. H C. 201204. Hi nti kmfn The undersigned.______ __ __ . . submits this petition pur suant to sc^'o?t *09(hWl) of the Federal Food Drug, and Cosmetic Act with respect to - ----- --- --------------------------------------- fKime of Tor*I additive and proposed use) Tin.* prfiliMM *M udied and In submitted m ihr f..ri. *i#' f 111'*i( m * i:m r.n cm cpr l :* fp'i) or Mm* i.i.-d ulill'ivi* rri'HlaMmin, ; I" y Petitioner By -............ . ..................................... f Tndir^t.o authority! Date -- ___ ,, Countersigned by -------,-------------------- -----------(Indicate Authority) Fost o/nee eddrers______________________ Date ____ (p The rood Ai'lditive petition shall contain: J. Tn+mriurMon M>n section tab). A. A detailed table of contents listing All Itema rontidnofl In mjc petition and the page Mlim'if-I.l will T-p ! n<d, H A vr'i 'tri'ii'M vri and coherent gen eral , mum rn til im* data in Lin* petition find Mu- |>'>' * rw,r` rnm 1mm*mi prrMMUtm* a {.nun'1 hwr * ir Mir roi'nlul.ioti requested and Jn^lndum Mir* for uving Information wt'.li referem'*'. m H*** |* f;crx on which the detailed data in the pe+*Mn.l mav ho found. J, frtcnftfii avtl frmpotftinn. The name ot the additive nnd the speculations proposed to assure that the substance is of appropriate frado ;nr th* Intended use and that It Is of reproducible composition. 2. f.Vc. The purpose which the additive is to rerve Inrbidiog r>n estimate of tho maxi mum pp. well ac tho arrrop'' quantity of j,b<* food nddicv* to h rxprc`^1 in the total dallv diet of rhe rt usumcr and Including the ba^'o on which tho estimate in made. Trrf'tft^nf effect JTghbrjhtij of the data thn^ have b^n developed `o establish that the additive iir-omt>tiFhcs the intended tech nical rfTeo* and the nmourt sought to bo ti*ed 1r u*j jitrbnr than *hat reasonably nectary M ''c-mulish suMi intended tcch- ricl effect a. fri*hllffhtr. of tho rta*a that OPiahiioh tt tho analytical methods pro vided ire prri'tim'd* regulatory ones ade- omtn to cu-orrc the llmituMnna considered j,rrr>" ;iry o* Mi* us* of the eddit,w.o. r, 7*,> Highlight* of the stud'es provided ff> ''ViiiM^ the safety of the pro posed lu es or the additive with an explana tion of bow t>i* p'jMMoner concludes that the jroorr,rd urea are rate, including summaries of .mv unfnviiraWe results ax well ns the Tjie highlights shall Include the po-r'^ect lemin found in the several species if in ,ty nniTunts nnd the maximum safe level in MW- diet nr the 'onsunior. The margins of r?fcfv b',*.\ve*r the un-ofTcct, level lti the most rcnrbiv* specloo nf tort animals and the average level a*, well ns 'he maximum level lU-oly in occur in the diet or the con- romnr rhou'n !* rtued. to king lnt' rncfi'der- pMnu prc*iMir u- ;it;M''ii'rrl food n'id'Mvo ll*ies or fl|f. ; Ii!:,l I'l.T ,1 fill .Iliv rnrup irnhN; Mlh- : l,:iirr-, A].,.. ;r- T*w*.*I * It,ill ?>e a i.'iMiinary rhe puiiU'^icd "feralum dealing with the rafct.y nr the rororKumd Jr safety depends upon virtM.u ^a* k *' mlgrvion, the rationale ri>aU he o?r-i.lined irir(ly. IT. Body of the petition, A. Identity fon section tab). This section shall identify the additive and the General use or combination of uses for which it Is Intended (l.e., direct additive, in direct additive, pesticide for food additive application, or radiation) and sb.iil provide tl*e following Information, as ippltcahlc; 1. Direct additive^a. Nomenclature and formulas. 1. Common or usual name: Unless r.he name Is being proposed as the common or u^ual name, cite references to compendia t hat rrcogutze the name an oimutui or u- mil II chemical n:imr jn ig vord u* r \uih the !HijU,'M( l;iUt|*0 riilc-t of Mh? <'!i( iiiIc.iI ,M- i * r;u la Service. 111. Trade numcfs) and other names u:ed ."r the compound. Including tho?* used duriT'g experimental testing, lv. Empirical formulate). v. Structural formula(s), if known or proposed. vi. Molecular weight. b. Description of the additive. 1. Complete quantitative composition. 11. riiysical state at room temperature, til. Organoleptic characteristics, lv. Manufacturing process(es), Including raw materials and their specifications and the analytical techniques used to check the specifications. v. Food grade specifications for the addi tive, Including identity, minimum content cf the desired oomponent(s), and limitations on reaction byproducts and other Impurities including specifically total heavy metals, nr" lc, and lead. En^h -'pcc!ri<" tt Ion and limitation shall be supported bv a desvripMnn of the analytical methods used in* hid ing data establishing the accuricv and re liability ot these methods. Data :mm a sub* able number of representative production hatches of the additive shall he included to establish the range of impurities and by products to be expected and t<-> show that the proposed specifications can be met. vl. Reproducibility of the additive, includ ing the production controls and assays em ployed to assure that a reproducible prod uct ill be manufactured. vil. Stability data and, if Indicated thereby, any expiration date to be shown on the ladling to assure the identity. stTencth. uuallty. or purity of the addit:ve 2. Indirect additive~a. Nomenclature and formulas. Indirect additives include subftances incidentally present in a final prod uct because of addition for functional use elsewhere In the production rperatlon and substances that may reasor.ablv be expected to become a component of tood because ot ^ffctr presence in food-contaot surfaces. The fallowing shall be provided for each sub stance or its reaction product. Incidentally present in the food from prodwDon use mb for each substance in the ff od-contact sur face, Including polymeric mairn-ils. whether present becauso of addition in tho manufac turing or as a result of a chemical reaction during the manufacturing, unless adequate reasons for omission are advanced for par ticular components. I. Common or usual name: Unless tho name Is being proposed as the common or usual name, cite references to compendia that recognize the name as common or usual. II, Chemical name-.si in accordance v"th the nomenclature rules of the Cbcnurai Abstracts Service- ill. Trade name(s) and other names used for the compound, Including those used dur ing experimental tenting lv. Empirical formula(s). v. structural foriuuliUM. If known *r pro posed. vl. Molecular v/eJght, Including for poly meric substances the molecular weight dis tribution in the basic rcstn and the average mo'ecu' >r and the method** u*od m mfikuu? these dcronulnat'^ns, h P-'^r.ption rf ittr addit'vr, | C nipo* U tlon of fhe food-rontnrt * urfaco of fMck'1;- inr mtcriii! or f^'id-processtug ori'U'w.'.* U r!iysi*d dc -:`ipt:"n of the fot <i-e<'n Un'4- rurfiiee. p.id: ig.ug. or equ pa-on: ill ^'aulf',.rturiug process, including for fcvKl-confeol' rurfaoes the raw materials at*(i thc!^ fperinea'Ions that encompass ih<* rc". >m * pni^niers cud the ndjmrents V.*-:uch a". pi ' " -^rc. `r iMb Tr? prc'xr\ ati\ c- fire- * .,* r i( 'y . i'ti il'lll' u t t in' i . 1 -I f- . ! T'.*'d *. dll, 'll .............. 11 ml iruhidtng liir i' f'M- .... diu' U .iHiUMm *. abi-re, how. atlll v IM add* f,w fP 'MS precursor h,;s been M ' lit' r.i* ' *bc pr< 'cesr. i'\ ions lor tho add!1 r . r' Ml fpori-rontjc* *ir-f:icM, Including tlu-r ic'cn- titir*-. :he minimum content of the desired comnonentfs*. nnd limitations or Impurities including total heavv metals, mr omers, ra^alyst icslduos. etc. Each rperlhciii.on anti hm:tat',^;i shah bo supported hv -i .i^crin- ti^-u of the appropriate analytical mcthoris used, Jurludloq data efitabllsdilug the ac^urr'OT- and r^ilnvnty of these method*; Data from t\ suitable number of rourn'entatlve production hatches of the food-contact rur- f.ircs shall be Included to establish the r.mire of impurities and byproducts to be expected and to f how that the proposed prc:i:ca*.:ons c;ju b* met. v, R^p-odrrlbilfty of the food-contact, surfao*a, inMmtittg the production cp'i'' Is and tori* rmplovcd to :urfre tli.U ,t r*ur Hn lb,o nroditoi w'UI ho manufactured d Utu*:nhi'U, f !i !>* may InvUair rt?*jU!i'n of ar*v w.uidcngtii in the electromagnet* i p*'r| nun a ParlfnMon and radial km source i **), i'*-. posed -V Tf an Isotope, its Identity and th* t;po of rne'ipsu1ot|n used !i. Tf a machine source (including sourr* tub*s). its complete description. b Furnish engineering data providing complete Information on the geometry of the radiating mechanism, luciucl.ug tho fpred of movement, by the radl.ath *: head, the radiolFotope, and the number of curica In the roiirre u-wl Mf lsotopesl, the volt *go and amperage urd Mf machine), nd the total time of exposure. A staicment o? tho radiation flux calculated therefrom shall bo Included. r. Furnish data providing complete infor mation on the rrenna to be used tc cor M e! the cxposi'ro 1, In the case of machines. furnS'U d*`a showing ho ronritivlty of the mc:*n * of u- tr'',!lng fhe power sources and F'O :o which rrrorders arc coupled to pT^d 'cc ord- of t'ie operating voMo."i*a n*d ainp*rapcK b. In the coac of Isotopes and m vrhti'o:; <lef'rr|b* the nature of dor.lmctcr and the frequency ot the dosimetry and furnish da* *, showing the dosimetry and phantoms to h* used, including those data that show tba+ the dostme^e* readings adoqnote**- rofc^* the dose ab*orbed by the food during expoKi're. B. Use (on section tab). Thir, section shall include Information on the amount, nf the food addhiLC po`;o- cd for UFO and the purport, for which It is propojc<l together with :Ul directions, r^^'mineiid**- tlons, end eufcw*' Mons regarding the nru- pored ut*. Tho petitioner shall furnif.!' ::* csMmnte nf t'*e maximum as weU ar t`'c ;M t*ra*:c fiiiaTifitv of the food ndddbe* be ev|M*c| *1 'O Mi* hi I ilailv fMi't, ol Mir < `M - i.moc** s fifpm 1 tic' iiM.iiuipt.tont. ml ca'cula- t'oiia ; hah be Included, The pet Moiht j.b *11 describe the rfuwhttnns or use tha^* he ov cludea are m accordance with pe^d maim'.*ctor!ng nmetire in any lnrt.ir' e )?f>7fEOERAl fll^lSTEH, VOL 32, NO, 152---TUESDAY, A^OUST 8, ASI 00002126 PROPOSED RULE MAKING nr, wherein he proposes no stricter limitation. If the usage level is alleged to be without ppcciflc limitation, the levels of use under pood manufacturing practice shall be sup plied. i Divert In the ease of the addl- Uve'i intended to prnriiico nn efTcct in the mod. data. obtained by adequate methodology Hmll he submitted showing the fate of the fond additive In the food, whether the food additive r n:i*nft uii'hiuigcd In such food, ir wbHh,i` It in ettoviitf'd T* another .tih r:t.>ncj hv rrjxon of oxidation. degradation, or mutton w`ih components of the food or otherwise, and the decree of any such con- vc**Hon. Thh` motion shall Include specimens of ll .-Pd labeling proposed lor the direct food odfMtlvc. 2. Indirect addttivcs. If transfer to food results or may be reasonably expected to result from the use of a food addltivo in processing, in packaging material, or In food- processing and handling equipment, the petitioner ehall describe the conditions of use in detail with respect to the Individual foods or Hasses of foods contacted. Informa tion on the conditions of use shall include such thlngr. aa the temperature and period of contact and the ratio of weight of food to contact surface area. The petitioner shall furnish an estimate of the maximum an well ns the average quantity of the food additive and Its ''onvcrcdon products to be expected In the total daily diet of the consumer. This estimate shall he based on experimental migration data mtng the food itself or on extraction data using solvents that Hmtilate various types of food. These data shall reflect the most severe conditions as well as the more usual conditions of the proposed usage. The food or the extractr*. are In ho analyzed by methods of adequate sensitivity and reliability for the food additive components of the food-contact surfAce. Details of the analytical procedure must be furnished in cluding nufllctcnt data to verify the claimed sensitivity and reliability of the methods. 3. Radiation, In the cose of radiation, this section shall Include information on the dose ranges to be used and the purpose for which the radiation la proposed together with all directions* recommendations, and suggestions regarding the proposed use, in cluding information on the Atomic Energy Commission licenses under which any iso topes are used. This section should also Indiuto specimens of labctlng to he used on the radiation vourees and any labeling to be used on the treated food, 0. Technical effect Ion section tab), This section shall be divided into the fol lowing subsections; 1. A detailed table of contents for this section. This may he reproduced from the original complete table of contents If the latter is sufficiently detailed. ?. a summary fan explanation) of what tho petitioner claims this section shows. 3. An analysis and interpretation of the data provided by the use of tables, charts, graphs, pictures, statistical evaluation, or by whatever means Is Appropriate, including references to the page numbers of the raw data analyzed and Interpreted. 4. The raw data as follows: a. Direct additives. The raw data developed to establish that the food additive will have the intended physical or other technical ef fect for wbJHi it is being added to the food and to establish that th* amount requested )u not. higher than the amount reasonably required to aeeompIJsh the Intended physical nr other technical effect These data shall in clude control data In sufficient detail to per mit an accurate evaluation of the technical effect of graduated levels of the additive when tested experimentally. b. Indirect additives. If the food additive is a component of a food-contact article (food-packaging material or food-processing and handling equipment!, data shall be fur nished showing the level of mlgratton. If Its migration to food Is a function of the con centration of the component In such foodcontact article, data shall also be furnished showing that tho proposed usage level of the substance In the food-contaci. article Is the level reasonably required to accomplish the Intended effect In auch article. It residues of a food additive are present In processed food beeiotse the additive bn;. been iced in the p-oiluct,lon or processing of food and (he rcMfloes do not accomplish an liuonded effect in such processed lood, data shell bo fur nished showing that tho proposed tolerance level reflects a reduction of such residues to the extent possible In good m iiiulacturlng practice. c. Radiation. In the case of radiation, ex perimental data shall be submitted showing that the radiation dose proposed accom plishes the Intended technical effect and docs not exceed the amount reasonably re quired to accomplish the Intended effect. I. Information shall be Included showing that there Is no induced radioactivity in the food or packaging material or In the ex tractants therefrom. This can include a theoretical discussion, but some actual ex perimental data should be provided to sup port the theory advanced in the case of packaging materials, and in all cases where radiant energies exceed 10 million electron 'oils. If different radiation mixes arc to bo used, those materials subject to the highest flux and dose contemplated shall be selected for testing for induced radioactivity. A de scription of the methodology and the sen sitivity of the methods used to establish the absence of Induced radioactivity In the treated foods or packaging materials shall be furnished. II. Data shall be provided to establish the extent, if any. to which the nutritive com position of the irradiated food has been altered by exposure of the food to the highest dose and under the highest fluxes expected. If any such changes are considered insig nificant, they should be so designated and the reasons detailed for their claimed insig nificance. The methodology employed shall he fully described. Including data establish ing the sensitivity and reliability of the methods. III. Data shall be provided to establish that the Irradiated food lias not been slgnlllcantly nttered in organoleptic or other physical characteristics so as to render the material otherwise unlit for food. In the case of a food ordinarily stored for a period of time at particular temperatures, data shall be In cluded reflecting the results when the Ir radiated food Is appropriately stored and/or shipped. lv. Whenever the effect produced Is related to a given dose of radiation, the basis upon which that dose Is measured shall be In cluded. If no actual dosimetry can be de scribed. a full explanation shall be included detailing the way In which the reported dose has been calculated. D. Methods (on section tabl. This section shall be divided into the fol lowing subsections: 1. The petitioner's evaluation of the ana lytical method(s) with respect to reliability, accuracy, precision, and practicability as a regulatory method shall be furnished. 2. If usage of the food additive requires a tolerance for the food additive or for n con version product In order to protect the pub lic health, a practicable regulatory method ehnll be furnished to enforce the tolerance. A practicable regulatory method is one that will provide satisfactory results within a rea sonable period of time considering the rate at which the material sampled may be con sumed or otherwise disposed of. It must be satisfactory for application to the raw. proc essed, and/or finished food; i.c,. give con sistent results when used by properly equipped and trained laboratory personnel, Tlie method must be capable of quantitative ly determining the food additive or M* f 'i>vrr'.on product In the presence of Mir normal rompouonU. of l ho food in w mob " i>. to |>e used end iti Mir presence of tiny oilin' Hiom.r.ds. Including tood nddltives, rur ran he rcnron.ib^v expected to be prr4nil i > i ni'll Tood. Validation data nur-t be tnHndr.t, I r , Planks (untn\iU*d I nod) and room ot ti(Nu with .tddl(tv* at various Jowl?, jntr !"Vc! of iiaugr). The analytical ntclinrl shall be written up in stepwise fashion with any i ritual stops indicated and explained. :t. in the case of an additive that is i > he limited only to pood manufacturing practice, the petitioner Mmll provide data on on >nalytical method suitable for determining *br amount Unit jwp, been added to the food, or provide Information purporting to show that the good manufacturing practice level is not likely to be exceeded. 4. In the cope of food-contact surface':. tiv petitioner shall provide the teste to be in checking the specification* proposed for the purpose of limiting to safe amounts the migration to food of the components of the food-contact surface. E Safety < on section tab). This section shall contain the following suir-c^Mons* J A detailed table of contents for this s^r- tlmi. This may 1m? reproduced from the orig inal complete table of contents if the latter la sufficiently detailed, 2. An explanation of what the petitioner claims this section shows, including: a. Tlic petitioner's appraisal of the safety data. ' b. The no-effect levels found In the several species of test animals. c. The petitioner's conclusion on the maxi mum safe level in the diet of the consumer, stating Mm margin of safety. 3. An Analysis and interpretation of the provided data by the use of tables, charts, graph*-, statistical review, or any appropriate means Thin shall include summaries of both the favorable and unfavorable data, wlrfi references to the page numbers of the raw data analyzed and interpreted. 4. The raw data upon which the safety conclusions are baaed. This section may be regarded as Incomplete unless it includes full report* of adequate teats reasonably ap plicable to establish whether or not the food additive Is safe for its intended use. The re ports ordinarily shall Include detailed data derived from appropriate animal and other biological experiments In which the methodr used and the results obtained are clearly set forth. The petition shall not omit without explanation any reports of investigations conducted Including any that would bias an evaluation of the safety of the additive, F. Tolerances*regulatlon (on section tnh) This section shall contain a proposed reg ulation in the format established by the Food and Drug Administration, includin'': proposed tolerances, If tolerances are re quired to assure that the contemplated up of the additive is safe. G, Amendment (on section tabl Full information on each proposed change of existing regulations shall be submitted with the changes to be made indicated by bracketing proi*osod deletions and ttalirk'lnff revised or added material. Italics may be in dicated by underlining. <f> Data In a petition rcnardinfi any method or process entitled to protection as a trade secret will be held confidential and will not be revealed unless it is neces sary to do so In a regulation, or In an ad ministrative hearing preliminary to any FEDERAL REGISTER, VOL 32, NO. 152--TUESDAY, AUGUST S, 1967 ASI 00002127 111 ic PROP SED RULE MAKING .iudViAl r'i'i'C'Cilinrts under the Act. The scription of the proposed use's' in gen tended pursuant to sre 409(e> <2' of (lie `ricniific biM'K of safety on which any eral terms or as appropriate. A copy of act,), a regulation nr amendment to a frmrl additive regulation rests including the notice will be mailed to the petitioner re-iilation prescribing the conditions fond additive analytical methods and when the original Is signed and for under rliich (he food additive nun lie a wimmni'v of the toxicological data are warded for publlcaton in the Federal safo'y used including, but not limited to. not considered confidential. Register. The publication of the notice identification of the particular food or 1:21.31 Processing of food additive petition*. (a) Within 15 days after receipt ol three copies of the petition by Petitions Control Branch of the Food and Drug Administration, the petitioner will be notified of the assigned petition number end of the fact that his petition has been filed for scientific review, or will be noti fied that his petition has not been filed and why. During this period of 15 days, the now petition will be reviewed only for determining that data are present and suitably arranged for an efficient scientific evaluation. Unless Otherwise indicated in the filing letter, the date of this notification letter becomes the date of filing of the petition for the purposes of section 400<b> '5) of the act. 'li If the petition cannot be filed, two of the three copies of it will be returned to the petitioner. One copy of the sub mitted material will be retained ns an official record. The extra copies of the unfiled petition are returned so that if the petitioner supplements the original material, tho supplemented petition can be submitted as a completely rearranged and indexed document In triplicate for reconsideration by the Food and Drug Administration. f2' The petitioner may, after receiv ing a letter refusing the filing of his peti tion, return the two copies to the Pctlt ions Control Branch and state In writing that he is resubmitting the petition to be filed over protest. In this case, it will be filed and the petitioner so notified. The fact that the petition has been filed over the Food and Drug Administra tion's protest will be included in the pub lished notice of filing. of filing Is to give notice to interested parties and is required by section 40!) (b) (5) of the act. The notice of filing is not to be construed as the promulga tion of a regulation or amendment to a regulation. (c) If upon a complete evaluation of the petition the Commissioner deter mines that additional information or an examination of samples or both are re quired to resolve questions regarding safety of the use of the additive, nr the physical or other technical effect it pro duces, he may request such information or samples of the food additive, includ ing the food-contact article containing the food additive, substances used as components of the food additive, and the food with which the food additive is used or contacts. The Commissioner will specify in the requests for samples a quantity deemed adequate for any study or Investigation reasonably required with respect to the safety of the use of the food additive, or the physical or other technical effect It produces. The date used for computing the 90- or 180-day limit for the purpose of section 409(c) (2) of the act shall be moved forward one day for each day taken by the peti tioner to submit the samples requested, beginning with the mailing date of the request. If the information or sample is requested a reasonable time in ad vance of the 18(T days, but is not sub mitted within such 180 days after filing of the petition, the petition will be con sidered withdrawn without prejudice. A copy of the notice of withdrawal will be mailed to the petitioner when the original is signed and forwarded for pub lication in the Federal Register. (d) If upon completion of the scien class(es) of food in which or in contact with which such additive may be used, the maximum quantity that may be used or permitted to remain in such food, flic manner in which such additive may be added to or used in contact with such food, and any directions or other label ing or packaging requirements for such additive deemed necessary by him to as sure the safety of such use, and the Com missioner shall notify the petitioner of such order. (e > If upon completion of the scientific reviews the petition and other relevant data have not been found to support a regulation, the petitioner will be so In formed and given the reason therefor and will be offered an opportunity to withdraw the petition without prejudice to a future filing. If the petitioner docs not withdraw the petition within 30 days of such notification, an order denying tho regulation may be published in the Federal Register. 'f' If the Commissioner determines within 90 days of filing that additional time is needed to study and investigate the petition, he shall by written notice to the petitioner extend the original evaluation period for not more than 180 days after the filing of the petition. 1 Any Interested person may, within 60 days from the date of publication of this notice in the Federal Register, file with the Hearing Clerk, Department of Health, Education, and Welfare. Room 5440, 330 Independence Avenue SW., Washington, D.C. 20201, written com ments, preferably in qulntuplicatc, on this proposal. Comments may be accom panied by a memorandum or brief in support thereof. 'h' A notice of filing will be published tific reviews the petition and other rele Dated: August 1,1967. in tho Federal Register within 30 days vant data have been found to support a following tho petition's filing date. The regulation, the Commissioner will for notice of filing shall contain the name ward for publication In the Federal Reg James L, Goddard, Commissioner of Food and Drugs. and post office address of the petitioner, ister, within 90 days of the filing of the [F.R. Doc. 67 0240; Filed, Aug. 7. 1007: the name of the addltlvets', and a de petition (or 180 days If the time was ex 8:47 a.m.| 0000212 AS I FEDERAL REGISTER, VOL 33, NO. 152--TUESDAY, AUGUST *, 1967