Document qdgygO8M9eop2bNXe4d0KJ4YE

FILE NAME: WR Grace (WRG) DATE: 1995 DOC#: WRG 180 DOCUMENT DESCRIPTION: 1995 Federal regulation 0 2 /1 2 /1 9 9 6 15: 61735648S7 V w *' PAGE 573,940 21 CFR Ch. I <4-1-95 Edfflattf labeled. P roduction controls shall in clude analyeiB eu fflclan t to ad eq u ately 1=*MmJSOMrt Uirftgfcns* m onltor quality, Ce) Tho .bel o r labeling- o f t o y se le nium premix ana ll te a r adequate direc tions and cautions for ute including th i s sta te m e n t; ' `C au tio n :. F o llo w la b e l directions. The. a d d itio n to feed of h ig h er levels o f th is premise c o n ta in in g BHTffiutyteted rtydrarytoiwnai ,,..,,..s... 2 Mmhipninp hy^ncucyanalog and fc atidu/n alts r Ptswatins, piOToain# sarta QA Sodium ... ......... . 1 UPSS -......- .............. ------------ .-- ..... . ; VJlAnWn* .. * . . __ 5 (c) It is used In feed as an anticakfog seienlum is n o t p erm itted ." (f) The ad d itiv e is o rally ad m in is tered to beef an d d a iry c a ttle as a n osm otieally controlled, constant raleaaa bolus containing' sodium 3elemtn_ B ach agent in an am o u n t not to exceed th a t reasonably required to accom plish its' intended effect an d in no. cam in on am ount to exceed 2 percent by w eight of the finished feed. bolus c o n ta in s 350 m illig ra m s o f s e le $ S73.960 S o rb ttn n n u m o o tearat . nium as sodium selenite, and delivers 3 m illig ra m s o f s e le n iu m p e r d a y fo r 120 T h e food a d d itiv e B orbitan. m onoste -' day. To e n su re sa fe u se of th e ad d i r a t e m a y b e sa fe ly used- a lo n e o r in tive: c o m b in a tio n w ith p o ly a o rb a te 60 a s an (1) T h e o a m o tlc a lly c o n tro lle d , c o n e m u lsifie r In m in e ra l p re m is e s <uid'die s ta n t release bolus is for use only in ta ry supplem ents for anim al feeds. , b eef ma d a iry c a ttle m ore th a n 3 m o n th s o f a g e o r o v e r 200 p o u n d s b o d y w eight. C3i O nly on* b o lu s c o n ta in in g '3) m il ligram s of selenium as sodium selenite is adm inistered orally to each anim al la 120 days. (3) T he la b e lin g s h a ll b e a r th e follow , lug; "This bolus delivers th e m axim um daily allowable am ount of selenium and shall be th e sol* source of supplem entation. Do not use in areas containing excess selenium . Do not feboius w ithin i m onths." $573.980 T a u rin e . T he food ad d itiv e ta u rin e (2-amlno* ethancsul/onie acid) m ay he safely used' in reed in accordance w ith th e follow ing prescribed conditions; . t'a) f t is u se d ax a. n u tr it io n a l aupplc- rnent in the feed o f grow ing ch ick e n s. (b) I t is added to com plete feed* eo th a t the to ta l tau rin e c o n te st does not ex ceed 0.054 p e rc e n t of th e feed. ' (c) To assu re sare use of th e additive, the label and labeling shall bear in ad dition to the o th er inform ation re quired by th e A ct: [52 F R 10888, A pr. 5, 1887; 52 F R 2K1. J u n e 4. U) The nam e of th e additive. 1987, as am ended a t 4 F R 14215. Apr. JO. 1998; (2) The q u a n tity of th e a d d itiv o con 54 F R 15874, A pr. 1, 18891 tained therein, Effective Date Note: At 53 FR 47873. Sees. is. 1.779, th e amendments to fflSBOO th at were published a t $2 FR 10387, Apr. 8. 1367-, 52 F R 21001. J u n e V 18*7; a n d 61 F R 14214, Apr, 10, 198 w ar* s ta y e d u n til f u r th e r n o tic e . A t 58 F R 45973. S ep t. . 1S*4. th e S tay w as continued. (3) A d e q u a te d ire c tio n s fo r use. 1673.1000 V ersate. T he food ad d itiv e v erx ita may be safely used in anim al feed is accord ance w ith th e following prescribed con d itio n s : . *57aS40 Silicon dioxide. T he food ad d itiv e silicon dioxide m ay be safely used in anim al feed in accord ance w ith th e follow ing conditions; (a) The food ad d itiv e is. m anufactured (a) Tha additive la a mugneatuxu-nlum inum -iron silicate conform ing to one of the following: U)(i) V erm granules: T he additive c o n ta in s a m in im u m o f 98 p e rc e n t of, hydroblotitc; it is therm ally expanded by vapor phase hydrolysis or by other and has a bulk density of from 6 to 9 m eans whereby th e particle slae is such pounds per cubic foot. as to accom plish th e intended efleet. (il) It is used or Intended ror use: (b) It is used o r intended for use in (a) In p o u ltry feed ac a level n o t to feed com ponents as an o n ttcak iu g exceed 5 p e rc e n t or tft w eight o f the agent, and/or g rin d in g aid, as follow: finished feed as a n o tm utrltive Bulging 518 Food and Drug Administratt agent for restrictin g calorii p u lle t re p la c e m e n t feed. (3) AS a n a n tt o a ti n g o agent, p elletin g aid, o r at carrier for the in co rp o rate eats in p o u ltry , swing, doi n an t feeds, in an am ount no th a t necessary to accompi tended affect and in no cant 1.5 p e r c e n t of th e dog feed c of the final feed for eth er a n (3)(i> V e rx ite fla k e s: Tb co n ta in a m in im u m of 96 hydrabiotite: it has a bulk from 20 to 30 p o unds p er cut (13) I t is u sed o r in te n d e d an ontlcaklng o r blending a m lnant feeds in an am ount csed t h a t n e c e ssa ry to aCC( intended effect and in no cae 1 percent by w eight of the il ru m in an ts. (35(1) V e rx ita g rits; Th ad ta in s a m in im u m of 80 hydrobiotite; it has a bulk from 40 to SO pounds p e r cubi (ll) i t 1 u sed or in te n d e d l partial roughage replacemw nant feeds in an am ount no th a t n e c e s s a ry to a-Ccounpl tended effect and in no cast l percen t by w eight o f th e fit (b) To assu re safe use of tl th e la b e l of any feed addit m ent, feed additive couceo additive prem ix. or camplet pared therefrom shall bear, to th e o th e r in fo rm atio n i the Act, th e nam e of th (verxite granule, verxite verxite grits), adequate dir use, and, w hen th e additive in excess of 1 percent, a st the q u a n tity of the oddittvi therein an th e term "nonm Juxtaposition therew ith, 5573.1010 H unth a n gum . The food additive xanthat bo safely used in a n im a l ) lows: (x) T h * food a d d itiv e is to, as d e n n e d i n 1 7 2 .8 8 5 O f t,' and. m e a ts a ll o f th e sp thereof. (b) I t is used or intended stabiliser, em ulsifier, thic Pending gent, o r bodying s m ai reed as fallows: 02/12/96 15:03 TX/RX NO.4725 P.013 0 2 /1 2 /1 9 9 6 1 5 :0 2 6 1 73564SS7 SSHC PAGE 14 Mil u u o 21 CFJt Ch. 1<d-1-9$ Edition MipenfrH HT friflyrtggj ... ............. ...... ighiontas hydrwy analog and to a M u * afe UttltBtton* (pans**) 2 1 Q 1 5 (q) I t is used in Teed a s a n a n tlc a k in g g n at In an am ount n o t to exceed th a t Buonft&ly required to accom plish its atended effect an d In no case in an m o u n t to exceed 2 percen t by w eight t th e d a b b e d feed. 57 IJW S orbita q o n o eteu n te. T he food ad d itiv e so rb !tan m onoatea, ate m ay be safely need alone or in o m b in atio u w ith p o ly s o rb a te SO aa a n m ulstfler in m ineral pram txes and die a ry supplem ents for an im al feeds. S73-Odd T au rin e . T he food additive ta u rin e (2-aminothaneeulfOnio acid) m ay be safely used a feed in accordance w ith the followog prescribed conditions: Cal I t is used a s a n u tr itio n a l sup p le ment in th e feed o f grow ing chickens. (b) I t is added to com plete feeds so h at th e to tal taurine content does not x o eed 0.054 p ero en t o f th e feed. (a) T o assure safe use o f th e additive, he label and labeling shall bear in adifcion to th e o th e r in fo rm atio n re m in d by the Act; (1) T h e nam e o f th e a d d itiv e . (2) T h e q u a n tity o f th e a d d itiv e conained thervin(3) A dequate d ir e c tio n s fo r use. 573.1000 Vemdte- The food additive verxite m ay be afely used in anim al feed in accord- n ce w ith the follow ing prescribed con- itio n s : (a) The additive is a magn*ium-alu- ainum -ircn silicate conform ing to one >f th e follow ing: . (1X1) V erx ite g ra n u le s : T h e a d d itiv e contains a m in im u m of 03 p e rc e n t of lydrobiotite: i t b th erm ally expanded md baa a b u lk d e n sity o f 0-om 5 to 9 xrands per cubic foot- ill) I t Is used or Intended for use: Co) In p o u ltry fe e d a t a lev el n o t to xoeed 5 percent of th e w eight of the tolshed feed as a non tiu tritiv e bulking. Food and Dm g Administration, HHS 5579,12 g e n t fo r r e s tr ic tin g c a lo rie in t a k e in (1) In c a lf m ilk re p la e e rs a t a m a x i p u llet replacem ent feeds. m u m u se lev el o f 0,1 p e rc e n t, a s fed. (0) A s a n a n tie a k in g o r b le n d in g (3) In lia u id food su p p le m e n ts f o r r u agent, pelletin g aid. or u o u n u tritiv e m in an t anim als a t a m axim um use c a r r ie r fo r th e in c o rp o ra tio n o f n u t r i lev el o f a.26 p e rc e n t <S p o u n d s p e r to n ), en ts in p o u ltry , swine, dog, o r ru m i (c) To assu re safe use of th e ad d itiv e: n a n t feeds. In a n a m o u n t n o t to ex ceed (1) T h e la b e l of its c o n ta in e r s h a ll th a t necessary to accom plish its in bear, in addition to other inform ation tended effect and in no case to exceed required by the act, the nam e of the 1.5 p e rc e n t o f th e dog feed o r 5 p e r c e n t a d d itiv e . of th e Dual feed for o th er anim als. (2) T h e la b e l o r lab e lin g o f t h e ad d i (2) Ci) V e n d tu flag ea: T h e a d d itiv etiv e c o n ta in e r s h a ll h e a r a d e q u a te d i c o n ta in s a m in im u m o f 98 p e rc e n t o f re c tio n s fo r use. hydroW otite: it has a bulk density of fto m 20 t o 30 R ounds p e r c u b ic to o t. X9 F R 44630, N ov, 5. IBM] (11) I t is u se d o r In te n d e d fo r u se ae a n antlcaicing- o r b le n d in g a g e n t in r u 573.111X0 Yellow pniiviatM o f HMia. m in a n t feeds in a n a m o u n t n o t bo ex ceed th a t necessary to accom plish its Intended effeot and in no case to exceed 1 percent by w eight of the final fend for rum inantB. Yellow prussiate or soda (sodium ferro cy an id e decah y d rate: NaAFafCn'M'IDH4O) m a y be sa fe ly u se d a a n anticaking agent in salt for anim al c o n su m p tio n a t a le v e l n o t t o e x c eed 13 (3) (1) V erx ite g rits : T h e a d d itiv e c o np a rts p e r m illio n . The a d d itiv e c o n ta in s a m in im u m of 80 p e r c e n t of ta in s a m in im u m of 99.0 p e rc e n t b y hydrobiotite; it has a b u lk d e n sity of w eight of sodium ferrocyajaide decaby- fro m 40 to 50 p o u n d s p e r c u b ic fo o t. draxa. ! fill I t is used o r Intended for use as a partial roughage replacem ent in rum i n an t feeds in an am ount n o t to exceed [41 F R 3M5T. 8 p t, 10, 197: 41 F R 46100, N o v . 3. 1975] th a t necessary to accom plish its in tended effect and in no case to exceed PART 579--IRRADIATION IN THE 1 percent by w eight of the final feed. PRODUCTION, PROCESSING, (b) To a ssu re safe u se of th e a d d itiv e , AND HANDLING OF ANIMAL th e la b e l o f a n y feed a d d itiv e su p p le FEED AND PET FOOD m e n t, feed, a d d itiv e c o n c e n tra te , feed additive prem ix. or com plete feed pre S ubpad A--G eneral Previsions pared iheretoom shall bear, in ad d itio n tc the other inform ation required by the Act, the nam e of th e additive (verxite granules, verxite flakes, or Ssc. 579.13 incorporation of regulations in p art 179. verxite grits), adequate directions for use, and. w hen th e additive la present in excess of 1 percent, a sta te m e n t of the quantity of the additive contained therein an the term "h o n n u tritiv s" in Subpari 8--Radiation c o d Radiation Source* 573.22 Ionising radiation for treatm en t of lab oratory anim al diets. juxtaposition therew ith. 073.1010 T enth nn gum. A c r s o a r r y : Sec*, a n , 402, 4Q3, 409, m o f Federal Food, Drug, and cosmetic Act (21 U .S.C . 331. 343. 843, 348, 3T15. The food additive x au th an gum m ay bo safely used in a n im a l food a s fol lows: - (a) The food additive is x an th an gum ae d efin ed In 172.595 o f th i s c h a p te r and m eets all of the specifications thereof. 0>) I t is used o r Intended, f o r u se a s a stabilizer, em ulsifier, thickener, sus pending agent, or bodying ag en t In a n i m al feed m follows: Subporf A--General Provisions 579.13 In co rp o ratio n o f reg u la tio n s In pftrt 179. Regula-Slona providing for ir ra d ia tio n in the production, processing, an d han d lin g o f fo o d In p a r t 179 o f th is c h a p te r axe incorporated in subohaptsr E At ap plicable to use in the production, proc essing, handling, and labeling of an i- 519 02/12/96 15:03 TX/RX NO.4725 P.014