Document vBr9bODE30aENNEEpQE0K1aBb

11443 Proposed Rul^ Making t' DEPARTMENT OF HEALTH, EDUCA applications shaU/ be processed t 121.50 Content and form of food ad simultaneously. ditive petitions* TION, ANO WELFAREI (6) Art application for a new drug or an amlulaLIe drug which substanso is (a) Petitions W be filed under ths pro* vlilen* ef ueLien 466 tin efths aet snail Food and Drug Administration also a food additive shall include a prac be submitted In triplicate, In the form tical, chemical assay method for en described In paragraphs (c) and (d) of E 21 CFR Part 1213 forcement of any tolerance provided this section. Any material submitted In FOOD ADDITIVES and, If edible products of food-producing a foreign language shall be accompanied animals are Involved, data establishing by an accurate English translation. Any. Procedural Regulations the residues of the substuncc or its published Information used In support of metabolites In such edible products? The Commissioner of Pood and Drugs proposes Inac trie procedural food addi tive regulations be revised as set forth below to obtain improvement in the qual ity and organization of food additive pe titions submitted and to expedite their scientific review by the Pood 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 tire Pood and Drug Administration have been incomplete or have not adequately sup ported the regulation requested and, therefore, have required subsequent supplementation, amendment, withdrawal, "or denial. (b) 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 $ 121.50 and shall be processed in accord ance with the procedures prescribed In this Part 121. _J (c) Any eesticldff 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 (a) (2) of this section. B. Scientific review of deficient and (d) A new-drug application will not poorly organized petitions is an unneces be approved for a use that results In the sary burden that wastes the time and ef substance becoming a food additive un forts of both Administration and indus til a regulation therefor Is established try scientists. Therefore, pursuant to the provisions under section 409 of the act. A food addi tive regulation under section 409 of the of the Federal Food, Drug, and Cosmetic act will not be established If the addi Act (secs. 409, 701(a), 52 Stat. 1055, 72 Stat. 1786; 21 U.S.C. 348, 371(a)) and tive results from the use of a new drug for which a new-drug application can under the authority delegated to the not be approved The new-drug applica Commissioner by the Secretary of tion and the establishment of a regula Health, Education, and Welfare (21 CFR 2.120), it Is proposed that Part 121 be tion regarding the food additive aspects will be acted on simultaneously. amended by revising 55121.7, 121.9, and (e) Applications for use of any drug 121.51 and by adding { 121.50, as follows; substance in feed or for a drug or anti g 121.7 Food additives for use in feed and drinking water of1 animals and food additives that arc also new drugs, certifiable antibiotic drugs, and/or pesticides. 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. the petition shall be submitted In reprint form. The petition must be signed by the petitioner or by an authorized attorney, agent, or official. If the petitioner or such authorized representative does not reside or have a place of business within the United States, the petition must also fur nish the name and post office address of and must be countersigned by an au thorized attorney, agent, or official resid ing or maintaining a place of business within the United States. All original, unpublished scientific studies supplied m 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 the petitioner to the Food and Drug Administration may be Incorporated In subsequent submissions provided specific reference to such information is made by giving the type of submission and the 3volume, page, and date submitted, and provided that the submission is In a food additive master file kept current by the petitioner, or Is In another form of sub mission not over 10 years old. Confiden tial material entitled to protection as a trade secret, such as method of manu facture or process Information, In food additive petitions or food additive mas ter files furnished by a person other than the petitioner may also be incorpora provided use of such Information is au thorized In a written statement sigm (a) (1) A substance that is a new drug 121.9 Food additive master files. by the person who submitted the In*] within the meaning of section 201 (p) of (a) Any person submitting or intend formation or his successor In interest. the act or an antibiotic drug subject to ing to submit a food additive petition (c) Petitions shall be assembled In the the certification requirements of sections may submit confidential information or manner prescribed in paragraph (e) of 502(1) and 507 of the act may also be a' mloo]rmatlon entitled to protection as a this section and submitted in a form food additive within the meaning of sec trade secret in the form of a "food addi suitable for binding, with all text double 1 tion 201(s) of the act because the sub tive master file." Such master file will be spaced on 8 x 10%-lnch pages with a stance is to be used In the feed of an ani assigned a number and will be retained left-hand margin or approximately 114 mal or because Us intended use In or on as available material that may be In Inches and a right-hand margin of ap-' 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 corporated In any food additive peti tion upon request from the person sub mitting such file. (b) The material In the master file proxlmately 1 inch. The left-hand margin shall be punched for a standard two-hole fastener (2%-lnch span) vertl- * fecting the characteristics of a food de shall be arranged and Indexed by page cally centered therein. Each section shall rived from the animal. numbers) as If it were a portion of a have a section divider with Index tab (2) An application for a new drug or petition so that specific material may be thereon bearing the section heading. The an antibiotic drug which substance is precisely referenced in any separate subalso a food additive shall be submitted in [ sequent/petition, the form prescribed by i 130.4 of this ' (c) lrhe analytical methods and a chanter (Form FD 350V) and processed summary of the toxicological basis on gages in each section shall be Identified with the letter designation for the sec tion and consecutively numbered. In accordance with Parts 130 (new drug) which a food additive regulation Is based (d) Petitions shall be transmitted by - or 146 (antibiotic drug) of this chapter, are mot considered confidential or en a cover letter In triplicate in the follow and the food additive aspects of such titled'-to protection os trade secrets. ing form: fi 14 ', i. i. FEDERAL'REGISTER, VOL 32, NQ. 152--JUESOAY, AUGUST I, 1967 ASI 00000290 I 11444 PROPOSED RULE MAKING - Petitions Control Branch, II. Body of the petition, molecul-r weights and the methods used la Pood and Drug Administration. A. IdentlLy (on rectkin tab). making these determlna' ion* Department of Health. Education, anti Wei* This section shall identify tbe additive and b. Description 0/ the aad'rvr '* ITirr.posl- fart. the general use or combination of uses for tlon of the food-contact surface o( packag Washington, D C 20201. which it is Intended (l.e., direct additive, in ing material or food-proccedn-- equipment. Ocntlcmen: The undersigned,---------------,_______________ submits this petition suant to section 406(b) '1) of the Federal Pood. Drug, and Cosmetic Act with respect direct additive, pesticide for food additive athppeuprlficoalltoiownin, gorinrfaodrmiaatiotionn) , and as shall provide applicable: 1, Direct additive-^ -a Nomenclature and formulae. 1. Common or usual name: Unless Tl. Physical description of Cas [j-'d-contact surface, packaging, or equipment material. 111. Manufacturing proceM. including Ire food-contact surfaces the me materials and The peUtloi' is altaehed and is submitted in the form described in 5 121 60 (21 CPR 121.50; of the feed .-uld,hve regulations. Sincere!}- yours, PetlUonor By _________________________ ,____________ _ (indicate authority) Date_____ ,____ Countersigned hr -- ' Indicate authority) ' 4 Poet office address %*, Date -- (e> The food addilive petition shall con tain: .S-. I. Introduction Ion section tab). A. A detailed table of contente listing all items contained in the petition and the page numbers where located. B. A well-organized and coherent gen eral summary of the dc ta In the petition and the petitioner's conclusions, presenting a sound basis lor tlie regulation requested and Including the foil owing Information with L_ references to the pages oil which the detailed data in the petition may be found. tilt dame Is being proposed aa the common or usual name, tifs t* Mmpsfl&ia that recognise the name as common or usual. 11. Chemical name In accordance With the nomenclature rules of tho^Chemleal Ab stracts Service. pit, ill. Trade name's) and othdP'Hames used for the compound, including those used dur ing experimental besting, lv. Empirical formula(s). v. Structural formuia(s), If known or proposed. VI. Molecular weight. b. Description o/ the additive. 1. Complete quantitative composition. 11. Physical stale at room temperature. , 111. Organoleptic characteristics. ' lv. Manufacturing processfes). Including raw materlale and their specifications and tbe analytical techniques used to check the specifications. v. Food grade specifications for the addi tive, including Identity, minimum content of the desired component(s), and limitations on reaction byproducts and other impurities including specifically total heavy metals, are lc. and lead. Each specification and limitation shall be supported by a descrip tion of the analytical methods used, includ ing data establishing tbe accuracy and re liability of these methods. Data from a suit able number of representative production hatches of the additive shall be included to establish the range of Impurities and by their specifications that encomposi the basic WjMflnte (Aueli as. plaaiiliMtl, (MSIIImfi, preserve.4ii., colorants, catalysis. etc). aicbg with the Analytical technique used to ohc^is the specification* and induing .'or inci dental additive* where, how an<; xhy the additive or Its precursor haa ! incorpo rated into the process. lv. Specification* iur in food-contact surfaces, in- -1 j.. ` r ! :un* title*, the minimum ccn/-'r.* desired component^). and limii^tlcuv Including total heavy mev ii_purt:>.a catalyst residues, etc each jp* or, and limitation shall be support: > . *erup tion of the appropriate i,;; hods used. Including data eetabi sc1 - accu racy and reliability of these ire-: from a suitable number r>r -s^nt-ak^e production batches of the ford-cosset sur faces shall be Included to cslp.'. range of Impurities and byproduct :'t_ rrpeefed and to show that the proposed sLv?c:-2callQE,-j can be met. v. Reproducibility of the food-'ontact sur faces. including the product,cn contacts and tests employed to assur? U..it ^ reproducible product will be mann-Tact*!'-*'} 3. Radiation. This may radiation* Of any wavelength in the cic'trvmagnetfe spectrum. a. Radiation and radiation e-jurcef^' pro posed: I, If an Isotope. Us ard tb- type 1. Identity and compcsilion. The name of the additive and the cp-1(-ideations proposed to assure that the substance la of appropriate grade for the intended use and that It Is of reproducible composition. 2. Use. The- purpose which the additive is to serve Including an estimate of the mazimum as well as the average quantity of the food additive to be expected In the total dally diet ol the consumer and including the basis on which I lie estimate la made, 3. Technical ipect. Highlight* of the data that have been det doped to establish that the additive accomplishes the intended tech nical effect and that the amount sought to be used Is no higher than that reasonably necessary to accomplish such Intended tech nical effect. 4. Method... Highlights of the data that establish that tie analytical methods pro vided are piact.cable regulatory ones ade quate to enforce the limitations considered necessary on the use of the additive. 5. Toxicology, Highlights of the studies provided to establish tbe safety of the pro posed uses of the additive with an explana tion of hqw the petitioner concludea that the proposed uses arc safe including summaries of any unfavorable results as -well as the products to be expected and to show that the proposed specifications can be met. vi. Reproducibility of the additive, includ ing the production controls and assays em ployed to assure that a reproducible prod uct 111 be manufactured. ell. Stability data and. If Indicated thereby, any expiration date to be shown on the labeling to assure the Identity, strength, quality, or purity of the additive. 2, Indirect oddit(re-~a. Nomenclature and formulas. Indirect additives include sub stances Incidentally present in a final prod uct because of addition for functional Use elsewhere In the production operation and substances that may reasonably be expected - to become a component of food because of their presence in food-contact surfaces.'.The following shall be provided for each sub stance or Hs reaction .product (s) Incidentally present in the food from production use and for each substance In the food-contact s irface, including polymeric materials, whet ler present because of addition In the manuf ic. tilling or as a result of a chemical react on during the manufacturing, unless adequ ite reasons for omission are advanced for p irtlcular components. 1. Common or usual name: Unless he favorable. The highlights shall Include the no-effect levels found in the several species of test animals and the maximum safe level name Is being proposed os the common or usual name, cite reference* to compen lia that recognize the name as common or usi ial.- In the diet of the consumer. Thp-Bfarglns of U. Chemical name(s) in accordance with of encapsulation used. II. If a machine sotuo1 source tubes), its complete descr.f b. Furnish engineennr: :>rcvid*ng complete Information on vrcc of the radiating mechanism t'i1- u tbe speed of movement by Uic r: - g head, the radioisotope, and the cf curies In the source used (LC Uctcoc-> -be voltage and amperage used (Lf aiicalne the total time of exposure A suiT.cmcnt erf the radiation flux calculated tbe:c'rou4 be Included. c. Furnish data provlJIn*^ complete Infor mation on the means to be useu to control the exposure. I. In the case of machines, Curnish data showing the sensitivity of iuc mcr-us of con trolling the power sources ar(< ibc way in which recorders are coupled to o*->duce rec ords of the operating voile's and amperages. II. In the case of Isotope -ujJ machines, describe the nature of dosimeur and the frequency of the dosimetry and lunnsh data showing the dosimetry and phantoms to be Used, including those data thV. h^w that the dosimeter readings odca'jni^ly ie3ect the dose absorbed by the focn during exposure. /B. Use (on section tab'. This section shall include inforaalloti on the amount of the food additif' p'cposed for safety between the no-efJge*-Wvel in the most tbe nomenclature rules of the Cheml cal use and the purposes for which it Ls proposed sensitive speclesjif-'-test animals and the Abstracts Service. together With all directions, recommenda average lev^i-vigwell as the maximum level UL Trade name(e) and other name* u ied Ukelj^te'Secur In the total diet of the con- jmfier should he stated, taking Into consider ation previously approved loot! additive uaos fgr the trbsfjn5ce"(ind"ony comparable sub- ;ancee. Also Included shall be n summary I . for the compound, Including those u**d tng experimental testing. lv. Empirical lormula(s). v. Structural formula(s), If known or d ir- p o* tions. and suggestions regaidi-nr tbe pro posed use. The petitioner shall furnish an estimate of the maximum an w^l as the average quantity of the food nddlUve to be -expected in the total dally dlev of the connuner. Supporting assumptions r.nu calcula 'of the safety published literature dealing-with the of the compound. If safety depends k P*,dvl. Molecular weight, Including for poy- upon virtual lock of migration, the rationale / merle substances the molecular weight ahall be explained briefly. tribution in the basic resin and the aval tions shall be Included. The pie^tloncr shall describe the conditions of urc he con cludes are In accordiMicc "ith good manufacturing practice \n instance ,! TTv-i' FEDERAL REGISTER, VOL 32, MO. t52--TUESDAT, AUGUST .I > IkV.r' ^SI 00000291 I PROPOSED RULE MAKING y X. 115 wherein he prop'*1' '>e SLr'.Llcr limitation. (food-packaging uia'erial or food-processing satisfactory for application to " proc II the usftgc lcve< tc be without and handling equipmenti, data shall be fur essed, and/or finished f-oci *. c . - specific limitation, th,. .^ela of usu under nished showing tho level of migration. If Ita patent results when ja'HI b*. r>vy good mamiiacturlng practice shall be sup tnlgratlon to food is q function of the oon- equipped and trained labenvw n*l plied VehtrationJ"df the_ component In such food- The method must be capaoif* ii jar*i. v^vc* 1. Direct addtl'.cfj In tre oa^c of the addi contact article, data shall also be furnished ly determining the food s/K *rr in* tives intended t? prod ; c an offect in the showing that the proposed usage leve^ of t^e conversion product In tbe D'ns#*n-' f :->'* food data obu-unod by adnqnate mrthodology substance in the food-conlacx article Is the normal components of the food ;n v i. if is Shall be sn''`r*itU.kd &hr?wl.)R the f^te Of th* level reasonably required to accomplish the to be used and in the presence of any _-.;irr food addltl'.e !d the food wi-jether the foo' intended effect in such article. If residues of Chemicals, Including f^d addUv?* "'.at additive rp'nia' \MCha: r^n In such food a Food-addll]ve are present In processed food can be reasonably expected tc o*' pr^^nt :n or whetb^r it '* -er^a tu another sub because the additive has boen used in tlio such food Validation data roust '>e included, stance by ' o'ddfi^oh. degradation, production or proctssing of rood and the l.s., blanks (untreated food) am? or reaction . tivuta of ii-.e food or residues do not accomplish an Intended effect (food with additive at varlovs icvt's othenv'so, arid " nny such con In such processed food, datn sha1! be fur ing level of usage). The analytics. version Tnb' uKtii- :* ' ' ' 'UiCi* specimens nished showing that the proposed tolerance shall be written up In stepwise u Trith of ail labels tr/i Iiibe.mr :.iclosed lor the level reflects a reduction of such residues to any critical steps indicate-'7, and exp i.i.icd direct food .ni',.:. ^ the extent possible In good manufacturing 3. In the case of an add'tiv.: vhai is to os 2. Indira^ au.- ' " > ir^rsicr to food practice. limited only to good manufacturing p o;. results or "<v '2 rc. s expected to result from \w~ rt ' r.~of ndditlve in processing, ;n ; 'rkft_-,np irr.lerial, jr In food- processing ;.:'l; i.i equipment, the petitioner si..VI '*s'rlnr the conditions of use in douV 'r-r,r:-.t to th? individual foods or cla^' .*<5 V ' '-'`.c :ontActed lnforma* tlon on -he ''cr.r'h* vi use shall include such tiling '* n.rT ri?pature and period of contact mvj l'.1' "',o ?f w?irht of food to contac* r.u.'iv;- a??.n. The petitioner shall furnish an e:.'trout* V 'i.t 'W'urr.um as well as the average qv" t i;* v 'he food additive and IU convex sic r prn> <o bo expected in the total dar? 't. of courumer. This estimate sha ! q-* b.si.-: on experimental migration data Lain; the food itself or on extraction data so*vents that simulate various type? of .rcr* . 1 h^so data shall reflect the most se* ore ennuif^ns as well as the more usual cooditl'r.s o' the proposed usage. The food or the rT*TPr't-" are to be analyzed by methodr of a^qua'^ sensitivity and reliability for the ferq Mldl'.tve components of the food-contact sur^ce Details of the analytical procedure .nrt be fumi.sbed in cluding c'a:a cr:jfy the claimed sensitivity and rVlV.-jI,tv of the methods. 3 Radio.'ion in the ca^e of radiation, this section shaii jn< j"<J^ information on the dose mreef, to be .** ! arri the purpose for which the radiation lp. proposed together with all direction* j "'`^nmendations, and suggestions r^zar'i:'* the proposed use, in cluding information z>:\ -i' Atomic Energy CommisBior. Ucen^t uiM*t which any iso topes arc used 'Hi'-, section should also include specimen* of lnvcllng to be used on the radia.ioc source:- '.wi any labeling to bo used on the tr^aicd food, Technra; ofTcci ion section tab). 'This sccth'U :W.Q into the fol lowing SuboCOtil'Ll.* 1. A detailed tabic of contents for this section. Thi- may bo n-a^-duced from the original ecn plota 's> <n contents If the vlatter Is suff.eiou'.ij detailed 2, A summary i in explanation) of what the petitioner claims this section shows. 3. An analysis and interpretation of the data provided bv hr use of tables, charts, graphs, nicturrr, statistical evaluation, or by whst/'vc1' m*-ans Ir appropriate, including references bj tl>-TM pae? numberS'Of the raw data analyzed arci I: '.rrpreted. 4. The raw data as follows; a, Dv'cc4 ad.hii* r: 'Hie raw data developed to establish that thr food additive will have the intended physical or other technical ef fect for which ft l? help" tfddsd to the food and to establish that iJir amount requested is not higher than the amount reasonably required to acoompiiah the intended physical or other technical rScct These data shall in clude control data ui sufflclent detail to per mit an accurate evaluation of the technical effect of graduated levels of the additive when tested experimcntalJv. b. Indirect uddh/'Ut. If tha food additive -- c. Radiation, In the case of radiation, ex perimental data shall be submitted chowtng that the radiation dose proposed accom plishes the Intended technical effect and does not exceed the amount reasonably re quired to accomplish the intended effect. 1. 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 20 million electron volts. If different radiation fluxes are to be 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 tho 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 be fully described, including data establish ing the sensitivity and reliability of the methods, - 111. Data shall be provided to establish that the Irradiated food has not been significantly altered in organoleptic or other physical characteristics so as to render the material otherwise unfit 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 lr' radiated food is appropriately stored and/or shipped. lv. Whenever the effect produced is related to h given dose of radiation, the basis upon which that dose la 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 tab), This section shall be divided into the fol lowing subsections: 1. The petitioner's evaluation of the ana lytical method (si 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 a con version product In order to protect the pub lic health, a practicable regulatory method ahall be furnished to enforce tbe 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 eon- the petitioner shall provide t,- alytlcal method suitable for dotc-m** ?, - *yio amount that has been added tr` the provide information purporUAg 'o * `ju- the good manufacturing practic likely to be exceeded. r. .>t 4. In the case of food-cont&'.L nj. ; :: .petitioner shall provide the tests to >-, .- i in checking the speclflcatlona 2jrop.<- i : r the purpose of limiting to sale / v = migration to food of the componeutc )f t.-#e food-contact surface. E. Safety (on section tab) This section shall conto-iu the fct'ow.ng subscctloTis: 1. A detailed table of contents :?^r Vil** sec tion. This may be reproduced inm the orig inal complete table of contents If the latter is sufficiently detailed. 2. An explanation of whal the petitioner claims this section shows. Including; a. The petitioner's appraisal of the safety data. b. The no-effect levels found in the ->ev*raj species of test animals. c. The petitioner's conclusion V:- .,t`- mum safe level in the diet the c. stating the margin of safety. r, 3. An analysis and Interpret1 ' * tho provided data by the use or ta j * ' graphs, statistical review, or ?rj i- r - t n"t: means. This shall include suiuro:-'* - or '--* i the favorable and unfavorable <jiu^ t"':: references to tbe page numbers ot * ^ raw data analyzed and Interpreted 4. The raw data upon whi^h if.*ty (inclusions are baaed. This section ir ,y be regarded as incomplete unless i. . full reports of adequate tests rear'-*"H'y ap plicable to establish whether <,r not iw trod additive Is safe for Its intended use The re ports ordinarily shall include defied dr ta derived from appropriate ammJ and other biological experiments In which the methods Used and the results obtained are I 'r. rlT *et forth. The petition ahaii not ott.il i.iout explanation any reports of investigations conducted including any that wouid bias an evaluation of the safety of the addltl-e./ F. Tolerances-regulaMon (on section tab/ This section shall contain a proposed reg ulation In the format established by tne Pood and Drug Administration. lDci'iding proposed tolerances, if tolerances are re quired to assure that the contemplatr<i use of the additive is safe. O. Amendment (on section tab) Full information on each proposed change of existing regulations shall be submitted with the changes to be made indicated by bracketing proposed deletions and italicizing revised or added material. Italics may be in dicated by underlining. (I) Data in a petition regarding 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 is a component of n foud-coutaot article sumd or otherwise disposed of. It must be ministrative hearing preliminary to any FEDERAL REGISTER, VOL 32, NO. t52--TUESDAY# AUGUST ft, 1*$r ASI 00000292 11440 PROPOSED RULE MAKING judicial proceedings under the act. The scription of the proposed use(s) in gen scientific bases of safety on which any eral terms or as appropriate. A copy of food additive regulation rests including) the notice will be mailed to the petitioner food additive analytical methodsfaiid when the original is signed and for a summary of the toxicological data are warded for publics ton in the Federal not considered confidential. Register. The publication of the notice g 121. SI Processing of food additive petitions. of filing Is to give notice to interested parties and is required by section 409 (b) (5) of the act, The notice of filing fa' Within 15 days after receipt of Is not to be construed as the promulga three copies of the petition by Petitions tion of n regulation or amendment to a Control Brunch of the Food and Drug regulation, ^dmiulstr-iuon, tire petitioner will be (c) If upon a complete evaluation of notified of the assigned petition number ;the petition the Commissioner deter and of the fact that his petition has been mines that additional information or an filed for scientific review, or will be noti examination of samples or both are re fied and that why. his petition During this has not been period of 15 filed' days, quired ..safety to resolve questions regarding of the use of the additive, or the the new petition will be reviewed only : physical or other technical effect it pro for determining that data are present, duces, he may request such information and suitably arranged for an efficient .or samples of the food additive, includ scientific cvoiuaticn. Unless otherwise, ing the food-contact article containing indicated in the fifing letter, the date of ^the food additive, substances used as this notification letter becomes the date" components of the food additive, and the of filing of the petition for the purposes food with which the food additive is of section 409(b) (5' of the act. j used or contacts. The Commissioner will - (1) II the petition cannot be filed, twb specify In the requests for samples a of the three copies of it will be returned quantity deemed adequate for any study to the petitioner. One copy of the subt or investigation reasonably required with mitted material will be retained as an respect to the safety of the-use of the official record. The extra copies of the food additive, or the physical or other unfiled petition are returned so that If technical effect it produces. The date the petitioner supplements the original used for computing the 90- or 180-day material, the supplemented petition can limit for the purpose of section 409(c) be submitted as a completely rearranged (2) of the act shall be moved forward and indexed document In triplicate for one day for each day taken by the peti reconsideration by the Food and Drug tioner to submit the samples requested, Administration. beginning with the mailing date of the (2) The petitioner may, after receiv request. If the information or sample ing a letter refusing the filing of his peti is requested a reasonable time in ad tion, reium the two copies to the Peti vance of the 180 days, but Is not sub tions Control Branch and state in writing mitted within such 180 days after filing that he is resubmitting the petition to be of the petition, the petition will be con filed over protest. In tills case, it will sidered withdrawn without prejudice. A be filed and the petitioner so notified. copy of the notice of withdrawal will The fact that the petition has been filed be mailed to tlie petitioner when the over tiie Food and Drug Administra original Is signed and forwarded for pub tion's protest will be included in the pub lication In the Federal Register. lished notice of filing. (d) If upon completion of the scien (b) A notice of filing will be published tific reviews the petition and other rele in the Federal Register within 30 days vant data hove been found to support a following the petition's filing date. The regulation, the Commissioner will for notice of filing shall contain the name ward for publication in the Federal Reg and post office address of the petitioner, ister. within SO days of the filing of the the name of the additivc(s), and a de petition (or 180 days If the time was ex tended pursuant to see. 473 2' o' the act), a regulation or amendment to a regulation prescribing the condlilcc* under which the food adu.may be safely used Including, but :<.( "n ... d go. identification of the pa.`lcuffir food r Class fes' of food in which or .- or tact with which such add'live nia;- be used, the maximum quantity the.7 may be i.Td or permitted to remain in such food, rie manner In which such ad,`r- -.my be added to or used in conUur with such food, and any directions r r o'her ing or packaging requlrcmr..'-, icr such additive deemed necessar- L-v h .r. to as sure the safety of such. list. r/.;: tire Com missioner shall notify Ur - .inner rf such order. (e) If upon completion of ,,':c cientific reviews the petition s: d ' ei'j'.ani data have not been feu; . i rr*. j. regulation, the petitiooe: -' 1 v ;y formed and given the ' `r hi ry'ir and will be offered ar 7::y--*y ty r,. Withdraw the petition tv..'-a.-t pieppchce to a future filing. If the p-.ri.c ier does, not withdraw the petition - V.v' ar- days Of such notification, an oid-t denying the regulation may be put..sued in. the Federal Register. (f) If the Commissio-ei "etersvines within 90 days of filing fuel audit,onal time is needed to study a-d investigate the petition, he shall bv vniten notice to the petitioner ex+end n.r original evaluation period for not mmo than 180 days after the filing of the petition. Any Interested person may. within 60 days from the date of pub..'.Thor, cf this notice in the Federal Fccta-T1'. Tc wth the Hearing Clrrir. > ; - in rnt of Health. Education, .and -noiii 5440, 330 Independence ,V e\ ST7., Washington, D.C. 20201, ccru- ments, preferably in <;uu;'urdr_,.:-. on. this proposal. Comments h'.; up rccom- panied by a memorandum o; brief in support thereof. Dated: August 1, isgt. JiiVSG L. CO'.TAlfl. Commissioner of Foci r;:ii Drugs. [PA Doc, 67-02401 FU:J. tyg. 7, J967; 0:47 a-i'T-i H-C >cVaJ fRSERAL RIGISTEK, VOL 32/ NO. 152--TUESDAY, AUCOTT $, TOT ASI 00000293 I 11334 PROPOSED RULE MAKING (23.42 of said marketing agreement amended (7 U.S.C. 181 et seq >, by adding 348(d)) and under the aui.lv.rU;- dele aud artier. a new { 201.99 dealing with the purchase gated to the Commissioner by the Secre 'j 3 All persona who desire to submit written data, views, or arguments In connection with the aforesaid pro posal should file the same, In quad ruplicate, with the Hearing Clerk, U5. Department of Agriculture, Room 112, Administration Euliding, Washing ton, DC. 20250, not later than the 10th day after the publication of tills notice In the Federal Rscst-fti. All written sub missions made pursuant to tills notice will be made available for public inspec tion at the office of the Hearing Clerk during regular business hours (7 CFR l-27<b>>. Dated: August 1. 19G7. of livestock by packers on a carcass grade, carcass weight, or carcass grade and weight basis. The notice provided that written data, views or arguments concerning the proposed amendment should be filed in duplicate with the Hearing Clerk, TI.S. Department of Agri culture, Washington, D.C. 20250, within 30 days from the publication of the notice In tile Federal Register. On June 27, 1967, a document was published In the Federal Register (32 F.R. 9101) ex tending the time for filing such data, views or arguments to and including July 29,1967. Pursuant to a request from Interested parties, the time for filing written data, tary of Health, Education, and "v.fie (21 CFR 2.120), it is proposed th.rt Cart 121 be amended by adding to Subpai i F a new section as follows : 121.------- Synthetic organic rclorrili In paper and paperboard. (a) Conditions of use. Synthetic or ganic colorants may be safely usr-.j to Impart color to food-packaging psper and paperboard otherwise complying with regulations in this Subpart F K one of the conditions set forth In subpara graph^ (1) through (4) of this para graph plus the conditions set fonh in subparagraph (5)"oF this paragraph are met': " I Paul A. Nicholson, Deputv Director. Fru.it and Veg views or arguments concerning the pro (1) There Is a functional barrV: be posed amendment Is hereby exLended to tween the colored paper or pare 'o. r.l etable Division. Consumer and and including August 15,1967. and the food. 3 Markclinq Service, Done at Washington, D.C., tills 28th , (2) The colorant Is listed as a color [FA Doc- 67-9129. Filed, Aug. 3, 186T, day-of July 1967. additive for food use by a i.,guLi!..,u 0.49 ajn.J Glenn G. Bierman, Fart 8 of this chapter. Acting Administrator, Packers (3) The colored paper or paperboard 1 17 CFR Pari !004 ] and Stockyards Administration. is used or Intended for use In contact 1 [put. Doe, 67-9091: Filed, Aug. 3. 1967; with a dry food the surface of wi. r' [Docket No. AO-1BO-A34] 6:46 Ann] contains no free fat or olL ' MILK IN DELAWARE VALLEY MARKETING AREA Notice of Extension of Time for Filing Exceptions to Recommended Deci sion on Proposed Amendments to Tentative Marketing Agreement and to Order (4) The colorant Is applied to the DEPARTMENT OF HEALTH, EDUCA paper or paperboard only prior (o the sheet-forming operation, the colc-ed paper or paperboard Is used or intended TION, AND WELFARE for use In contact with food con1.-lining not over 2 weight percent of free dray- Food and Drug Administration [ 21 CFR Part 121 I able liquid, and It passes the extraction , and discoloration tests described in para graph (b) of this section. Pursuant to the provisions of the Agri cultural Marke'ing Agreement Act of 1937, as amended (7 U.S.C. 601 et seq.), and the applicable rules of practice and FOOD ADDITIVES Synthetic Organic Colorants in Paper and Paperboard (5) The colorant contains, if at nil. only useful adjuvants that: (I) Are permitted to be added lL-tcLO' to food by a regulation in Subpn t i) nf procedure governing the formulation of The Commissioner of Food and Drugs tills part; or marketing agreements and marketing has evaluated data submitted by Syn (II) Are otherwise permiUu! in orders (7 CFR. part 900). notice is here thetic Organic Chemical Manufacturers manufacture of paper and pupe. bor by given that the time for filing excep Association of the United States, 261 a regulation In this Subpart F a. d ,-c tions to the recommended decision with Madison Avenue, New York, N.Y. 10016, so used as to meet any limitalioir, pre i respect to the proposed amendments to and other relevant Information, and con scribed by such regulation. I the tentative marketing agreement and to the order regulating the handling of milk In the Delaware Valley marketing area, which was issued July 25, 1907 (32 Fit, 11030), Is hereby extended to Au gust 4, 1967. cludes that a food additive regulation should be proposed that would provide for the safe use under certain conditions of synthetic organic^ colorants In food packaging paper and paperboard. Ac cordingly, pursuant to the provisions of Failure to meet the appropriate tonditions prescribed by tills paicgrau'i will cause the colorant to be deemed a rood additive for which no regulation exisis. (b) Tests, The tests referred Irj In Signed at Washington, D.C., on July 31. 1967. the Federal Food, Drug, and Cosmetic Act (sec. 409(d), 72 Stat. 1787; 21 UJS.C. paragraph (a)(4) of this scciion arc as follows: i S. R. Smith, (1) Food-simulating solvents. Food-simulating solvents are chosen from tlx < Administrator. following table: Type* of food Solvent [FJL DOC. 87-0090: Piled, Aug. 3, 1387,' 6.40 a.m.| 1. Nonacid, moist products; may contain salt or sugar or both Water.1 (pB above E.O). n. Acidic, moist products; may contain salt or sugar or both, and Water,1 dale ncii.* Packers and Stockyards Administration including oll-ln-water emulsions of .high or low fat content. XXL Moist, acid or nonacid products containing free oU or fat; may Water,1 citric oclu,1 ' contain salt, and Including water-ln-oU emulsions Of high or lard oil.* I 9 CFR Part 201 I low fat content. XV. Dairy products and modifications_____ _____ __ Water.' lard oil.* LIVESTOCK V. Low-moisture fate and oils____________ ....... Lard oil.* Purchase by Packers on Carcass Grade and/or Weight Basis; Extension of VI. Bakery products, except dry foods------------------------- -------- -- VH. Dry solids with the surface containing no free tat or oU___ Water,1 lartl oil.* No end test in quired. Time To File Comments ' On May 3U, 19G7, there was published in the Federal Reclsteh (32 FJt. 7858) notice of a proposal to amend the regu lations (B CFR 201.1 et seq.) under the VIH. Dry solids with the surface containing free fat oil. XI. Fruits and vegetables, raw___,,___________ ___ ____ Lard oil.* Water.* s Water--either distilled or demineralised. / *Oltrio acid eolation--30 percent sucrose solution containing 1 percent citric acid ad justed to pH 3A. * Land oU--on industrial grade of lard oil Is satisfactory. Packers and etocliyards Act, 1021, as * Omit unless food Is acid. : FEDERAL REGISTER, VOL 32, NO. ISO--FRIDAY, AUGUST 4; 196V JASI 00000294 PROPOSED RULE MAKING 1 ITT' (*' Drainable liquids in foods The (I) Equipment, (a) Glass-fiber filter All Interested persons are Invited vo tet. for drainable liquids In food is as paper. submit their views In writing, preierr.biv follows: A 100-gram sample of the food (b) Aluminum foil. in quinlupllcate. regarding this prcpo.it,;. In question Is placed on a 5-lncli diam (c) Tweezers. Such views and comments should : : eter, US. standard sieve No. 8. tilted (d) Appropriate solvents simulating addressed to the Hearing Clerk, Depart approximately 30* from the horizontal the foods to be contacted by the paper or ment of Health. Education, and Vi'si- and drained for 2 minutes at ambient paperboard under test. fare, Room 5440, 330 Independence Ave temperatures of not less than 05* F. The (e) Approximately l-lr,ch squares of nue SW., Washington, D.C. 20201. wiUfin weight of the extracted liquid shall not the paper or paperboard to be tested, 30 days following the date of pubbea- exceed more than 2 weight percent Of the sufficient to provide one square for each tion Of this notice In the Federal Reois- original sample. of the required food-simulating solvents. ter. Comments may be accompanied by a (3) Color transfer. The test for color (f) Fluorescent brlghtenlng-a gent memorandum or brief In support thereof. transfer from treated paper and paper- transfer standard: Prepare solution f as board ("sandwich Lest"' involves visual an aqueous solution of 10-50 milligrams Dated: July 20,1907. Comparison against a standard of a moist per liter of Fluorescent Brightening J. K. Kirk. filter paper held in contact with the Agent 28 and determine Its absorbance In Associate Commissioner colored paper under lest for a standard a 1-centimeter cell at a wavelength of for Compliance- period of time <1' Equipment, (a') 350 millimicrons In a suitable spectro Color transfer photometer against distilled water In the [FR. Doe. 67-9143: Filed, Aug. 3, U47; 8:51 am.] standard: Color standard No 4 of the blank cell. Prepare a working solution by "Ofllcia! chart for Measuring Transfer weighing out another amount of the ence of Color of the American Association of Textile Chemists and Coiorists." (b) Glass-fiber filter paper. (c) Aluminum foil. id) Tweezers. brightening agent equal to: 11.8 x concentration (grams per liter) of brightening agent in eolation l Absorbance at 350 millimicrons DEPARTMENT OF TRANSPORTATION (e) Appropriate solvents simulating Transfer this amount to an actinic 500- the foods to be contacted by the paper or milimter volumetric flask. Make to vol paperboard under test, ume and mix thoroughly as solution 2. Federal Aviation Administration [ 14 CFR Part 39 1 </) Approximately 1-Inch squares of Dilute 5 milliliters of solution 2 to 100 i [Docket No. 0309] the paper or paperboard to be tested, milliliters volumetrlcally with distilled sufficient to piovide one square for each water as solution 3. Dilute 10 milliliters AIRWORTHINESS DIRECTIVES of the required food-simulating solvents. (11) Determination of color transfer. (a) Saturate the filter paper in the se lected solvent at room temperature (no of solution 3 to 100 milliliters with dis tilled water using an actinic flask for the preparation of solution 4 as the working- standard solution. British Aircraft Corporation Mode! BAC 1-11 200 and 400 Series Airplanes lower than 65* F ) and place the satu (II) Determination of fluorescent The Federal Aviation Administration rated filter paper, "screen" side up, upon brightening-agent transfer, (a) Using is considering amending Part 39 of the a piece of aluminum foil of appropriate tile "sandwich" technique described In Federal Aviation Regulations by adding size, handling the filter paper with subparagraph (3) of this paragraph, ex an airworthiness directive applicable to tweezers. tract the brightening agent from the British Aircraft Corp. Model BAC 1-11 (b) Using tweezers, promptly place test paper onto the moist filter paper. 200 and 400 Series airplanes. There ha- e the test square upon the wet filter paper lb) Place a drop of approximately been several instances of corrosion T ::i; being sure UiaL the food-contact side 0.05 milliliter of the working standard found within the bore of the mag nos;-mi of the test sample is in contact with the solution (solution 4) on another glass- bearing housing in the flap second,i v filter paper. fiber filter paper and let dry. Moisten transmisslon system. Heavy corrosion (c) Complete a four-ply "sandwich" this spot with the same food-simulating deposits In this area can interfere with by covering the upper side of the test solvent as used on the test paper and the free operation of the bearing and in paper with a cover of aluminum foil of compare the standard spot with the moist extreme cases penetrate the exterior on suitable size. filter paper under ultraviolet light. If the the underside. Since tins condition is Id) Seal the entire sandwich in com fluorescence of the test sample does not likely to exist or develop in other aircrr/t plete cover of foil or in a polyethylene exceed the fluorescence of the standard of the same type design, the proposed envelope to prevent loss of solvent during spot, the fluorescent brightening agent airworthiness directive would req uire pe test period. shows no significant migration and meets riodic Inspection of the support beai in,:.. (e) Subject the sandwieli to a pres the transfer test. In the flap secondary transmission slwf' - sure of 10 pounds per square inch of test (5) Test for the discoloration of color lng and the replacement of corroded paper and maintain the pressure con ants. Prepare a solution (or suspension) bearing housings with unused magne tinuously for at least 20 hours. containing approximately 10 milligrams sium bearing housings until the mag if) At the conclusion of the contact colorant in 1 liter of the food-simulating nesium housing is replaced with an period remove the pressure, carefully solvent. Measure the absorbance of the aluminum alloy housing. open the envelope, and remove the lay solution at a suitable wavelength. Hold Interested persons are Invited to par ers down to the filter paper by use of the solution at room temperature in the ticipate in the making of the proposed tweezers. dark for 20 hours, then again measure rule by submitting such written data, (g) While still wet, compare the filler absorbance at the predetermined wave views, or arguments as they may desire. paper with the color transfer standard. length. This test Is repeated for each of Communications should identify the If the color of the filter paper Is not the three food-simulating solvents docket number and be submitted in du darker than the color transfer standard, (water, 1 percent citric acid solution, and plicate to the Federal Aviation Adminis the colorant shows no significant migra lard oil), described In the footnotes to tration, Office of the General Counsel, tion and meets the transfer test. the table In subparagraph (1) of this Attention: Rules Docket, 800 Independ (4) Brightening-agent transfer. The paragraph. If with any solvent the ab ence Avenue SW., Washington, DC test for brightening-agent transfer from sorbance after 20 hours dark storage is 20590. All communications received on or treated paper and paperboard involves a 10 percent or more below the original before September 5, 1967, will be con visual comparison under ultraviolet light absorbance, the colorant may not be sidered by the Administrator before of a moist filter paper held In contact used 'In paper or paperboard Intended taking action upon the proposed rule. with the colored test paper for a period for use in contact with food except fOr The proposals contained In this notice of time against a spot containing a dry food of type vn Identified In the may be changed in the light of comments known amount of fluorescent brighten table In subparagraph (1) of this para received. All comments will be available, ing agent, _ graph. both before and after the closing date lor FEDERAL REGISTER, VOL J2, NO. ISO--FRIDAY, AUGUST , 1967 ASI 00000295