Document 91Gaa9yeyJVBXbxgb9YjzwOR

*t PROPOSED RULE MAKING . .5705' tiir- ( mi' prescribed in tire notice of pro- Tins Food and Drug Aden ir.iri ration rvvii rule tr.nk.r.q and who demo to has oe-en coi'.ductin- a national vir.ev to ;. . :it oral co'iir.u-..'.; at such r.cnnr.q den-mime t ie c.Uiit and lev-Is to which ;: by Mr: 12. YjTJ. submit an out- ('Tvdcto.anim >1 feeds are co:t'. laurai'^l ],:-., of the topics an:! time ihevwi!-h wrk VC-' f T!m survey results available to d -\f.tc to coon ic-;hc. S:a:t outlines tj c.iic 'in:.- trait ie. s than 5 |rcrr<r:;t. of : i .'.'omitted to tito Co'.v.ntissier.Lr .he li'ds sampled cental!'. PClVs. i ir.:* -i-.-j Revenue. Attention: CC: Letvis ramie Iro n no detectable coirani- ..V. Vi-Mtinnoii. DC. 20224. n at.e.n to a. maximum PCB itwi of 0 6 , . o:ts who desire a copy cf such part r-er niiiben. It yv-ears that complete :< n ror.ir.'.ciits or su.ntotioiis or out- a;i;rn it feed are r.vi a a. mi lie.'nt source 1. . and w! o desire to be assured oX of iC:Vs f .'C fo'.'.-prodi'c~r.g sr.imr'.s and their a siiabiiity on or Itefcre Lite bocm- that PCB rrr.mmiv.a'.ton of foils tor : oi such hearing should r.ottiy me fcivf-prr.!;..?.!; animals can grueruily t ron r. in writing. at t!;e above ?.tfnti itcd to avoid..bio indu.trial acci . . by May 17, 1072. In such a case, dent., and practices. luvesti muons by in V -. t hue and circumstances jjcrr.uc liJA have i cvcalcd the use of PCOr. in . Aiio. the desired copies are dcuv- neat e.-s r. >r..:o fluids used in certain i o:dy at the abate add:ess. The P -- fturi on equipment. Akhcj in heat . tor copies Is twenty-live ccms cxciu r. -i fluids in such cqurnnui.t are ; . ) per pare, subject to a minimum co:v,.o.vrod to be ill "cbtod system'." rc- C..:' l hC cf SI. cide:i',s have (xc irrca t'nat re-tilted in di Lzr. H. Hr'ritEL. Jr.. rect coutantiiiatton cf animal feed with Acting Chief Counsel. PCE's and rtib.-.iqucinly m ccptanurav.m [TT. TTec.72--1221 Piled 3-I7-72;8:S3 cal) of feed prv-.lnets such as poultry a:.a i ,qs intended for human con.-.mnufmn. Tito use of PCB -con tains n; ooatir.es on tlia D[?*RIViE!!T OF HEALTH, inner walls of silos has resulted in I he conta:iti:i'>'.io:i of silage which luvs ;n turn caused PCB rrstducs in tiie null: of [SUMl m WELFAHE dairy cows. It, is .-ti-peered that other in- dustr. \l use.-, of FCS's have also r.-nsjtctl Feed end Drug Administralion : , . C Tcris _3,_J 2U-122^122J in th.e PCii < entb mi nation of .mi i: iecd r.r.da'c-ad for r.vv:.?.v. consumption dtn-.r.g pretev-um and ruanufr.ctunng. . . 'CHLORINATED DIPHENYLS ^ Investigations hate ai=o revealed PCE migration to :c-::I iuiting zrom the . :c cf Proposed Rule'Making u^e of PCB-cortalnir.g paper food- r.: C .avussioner of Food and Dru_s cy.j.r:d about the procl ears of cc-:t- tr.:r.;r.,t.bn o? f mu with no!vchlormated b. phenyls `PC3';> ar.sir.g ir.cirectiy imm the m-e of FCE-contimniatod arunic! feed, from industrial and eavncrxr. i sources. :-ud from, file u_e of PCH-coittav.match paper iced-i'achaciriS r.uterir.ir.. No author, vii.cn has been firanfrd inker t:u Fcu-.-ral Food. Df'-, and Cosmetic Act for ai.y use of PCB's which TCitiiu. either directly or indi rectly, in RGB's L-occinir.g a component or otiicrv ire a'ltcting the characteristics of lc>.>d for man or other animals. jiacltagir.g material. Tiiis prcb;'`;n is be ing intensively rtutheu by FDA r.r.ti ti:e paper rub food industries. Tite-e studies -haw that pansr fer tocd-packayiu;: ma terials. whether manufactured fio.u re-' cveied paver or virgin sto-k. may von tain PCE's. The source o: PCE's in revycied paver is attributed to the use cf certain kinds cf Copy in? paper and -.anting ink. '.Vhilc tite rourcc cf PCB's in virein stocf: is no; as wail defuted, it is generally attributed to the pre. ence of 1'CB's in the eqttipniem, machinery, and water used for the manufacturing of the.-e ma terials and to environmental cov.tamir.aticn. PCB's have been produced since 1929 The level of PCB contamination of end It-.vc been eutn'.oyed in a wide range feeds from puchaytr.g materials is de of indu- trial uses including neat c<- pendent, upon matey motors (c.g.. ic-ve:s chtif'pc liquids in rastcmiz.uion equip- of PCE's in focd-packaging materials, nunt; fc.mulafioiis in lubricants and hydraulic fluids; and in;rcclients oi r-iinfo, pi.'stics, rcoitts, inks, waxes, ai!iicriv:-'-, rubber, ari.-halt. and various typo of food, length of storages. Tins is shown by t.';e results of a national rur.c7 conducted by I DA, which revcaied that even t-t iueh G7 percent of the complete bu:::i:i'.tr materials. 1'Cfc r. are toxic sub food packaging tested contained' PCB's stances v hi'h. are very' stable and turnip at iev--ls as high rs Ul'-J parts per taiB.cn, persiern: in the environment. Eacnure only 19 percent of the foods in th-.-e cf O'c-tr t.i'ie.-prcrd u=e. RCF.'s have boon ronmi-o-i PCE's. The avcie-rj fcti-.d ir. food as a remit of tvVoicV.iVfj PCB concentration, in food-was 0.1 part inch...,'.rial accidents end of environmen per million, and the maximum PCU level tal cr Lndustrial coiitsin.n.v.icn. found was 5 pans per miikon. 'tin: sur Aiiiioupli if Is rot pc.vi'jlc to remove vey fun her shoueo that 75 ivrccr ' of PCI'.'s from t!;e environment, the Com- the toed product Ln packaged L.i^ui niisjioucr of Food and Drurs is taking cereal samples cor.huned PCB's. Ti;e all iv:.-.?r.ablc stc-pc to limit liie ways in v.:,!;!: fob's may otherwise ronfominarc fo>! 3;-..i to limit t!.e level of PCH's in fc-vli containing unavoidable PCB rcsidivv from environmental cr Industrial average PCI! concentre.' .on in the ccr-.-.l v...j OB r-art per million, and tiie niaxinv:m PCU level found was 1 part per million. Other information wliich became nv.ii'i.iblc sub-oiiuciit to the FDA survey sc-urrcd. shows a coiitiud.r.g and substantial re* dU'dlon In the PCB concentrations of papor-packnginn materials. For exam- tile, data on recycled paperboard currep'iy b'-lng produced show that 05 . percent of the'samples examined con tained less than 5 pans per million: d.-.ta en the same tyre of material mr.aufp.ctiiictl during 1070 and 1971 show mat or.lv 13 jyrrcc.il cf the m.mples cxamnicd coniaincd less than 5 parts per mii.'on. Other invc-ti--::iion.s show the pres ence of PCB res.dues in fr-sh wr.t< r fish and hi some fcc-ds of animal origin. Tl.e source cf these residues is ait.-.'.;u:ed in part to environment.'.! csntanui'.aiiun such r.s discharges of PCB waste eif.'ient s into water and a;r. Eared on FDA total diet studies, the dietary intake of PCB's appears to be of a law order. The TOO lood ro~r.~oy.lCA analyzed for ?CB's In the total diet mar ket !*a. ket sam.oiej for tiie pJ-st 5:i years shov ed .-.-l of the food ec-r.'.po-.iivs to crr.tr.in TCB residues. Caicvl.'t.d or. tiie basis of die-ary intake, the average PCB !-.el inund m the market baskets was less than O.OuO! milligram per kilo gram of bcay weight per day. The mar ket basket samples represent a high consumption diet which Is approxi mately twice the normal diet. Knowledge cf the. toxicological eff.-e-s of PCB's is limited at tins time. Ai.li able information indicate s that PCE's :..-g classified as being of nodemo rv ie toxicity. As a point of comparrio.: DDT lias a higher acute toxicity than PCB's. In contrast to the rcc: :r.irsd rhOiim ate acute toxicity of FC3's. th.e asvcc's of PCE-chrcnic toxicity, tneluding murarenicitv ar.d teratocenicitv are a: lie: well defined and thus are .ro'.criir.ilv of greater concern. The chronic to.-ivity of PCB's is bciiig extonsivelv atuihcj i;y the Government, industry, and i::r r-.ci tif:r community. Preliminary reports r.nd observations indicate that it would be prurl tv.t to reduce r.r.d, ivl.erevcr ::o>d;ig. ' ciivir.atc long-term, low-level hns.un exposure to PCB's. Oil the basis oi these investigat'ous aud other available information, includ ing the report of the InUrdeparinn-ntal PCB Task Force, the current diet^-y level cf PCB's is rot considered a:t irumrdiato haaard to the public !:-r'.:h. However, the Commissioner concludes Hint the sources and ir;!s of PCE's in animal feeds; feed components, and food for human use can and should be sigtiii'.candy reduced or eliminated so as to nur.ir.iige the overall long-term human exposure to PCB's. .Accordingly, the Commissioner makes the following pro posals: 1. Part 3 should be amended to fa> provide special provisions to preclude the direct accidental PCE contamination cf animal feed, ar.d (b) to provide ';?c::-.l provisions to preclude the direct accidental PCB contamination of feed-pack aging materials. - 2. Section 12S.4 should be amended by adding special provisions to preclude the direct -accidental PCB contamina tion of food. 3. Section 121.2546 should he emended to exclude pulp from reclaimed l.bcr* FEDERAL ElOISTHt, VCL. 37, NO. 34--SATURDAY, MARCH It, 1972 . *.V ,, .a nr 1 DSW 552380 r - ' .-v STLCOPCB4090797 - r ' -.crsous ard deleterious tained In certain pasteuriaaiion cqulo- \sis** to f;?*1 m-:ht and m ;ir>'essin2 ar.maal feed. Al imanufacture of food though ho.vf cxrhanae fluids :n such r.:: nn'cr:.'.!'. ' equipment air cor. -.dcrcd to be in "c!C'**d ;\ s :.-i;vr.iri tolerance of 5 parts systorns." accidents' have occurred that rc.u'.vd ir. c'.n c*. romaininaticn of a.a> 1 b-: keel pTPi;t- ma! ieedi vci-h PCB's and sub co.u.T.tly PCB 7 " .3 in these i.i PCB cor.'a.mr.r.tion of human food. ., ;vv a ; i.Hlc: :-n.t r^biod of time Tl.a u=e of r'CB--*ont:iinin'T ccatincs on > a:: mpurtifn.tv for the orderly the inner w lls of silos has resmt-d in : .1 cl PC3-cerfa:TV.r.g raw the ccntr.:n;nr.::cn cf .'ila.ee which has y mad in t'-.a n-.Aiiufarture ol in turn earned PCB residues in tl'.e mil7c materials. There are no of dairy cows. Othar industrial uses cf : : ; :b'.c use? oi PCB's PC'B's inch:cia. or c:2 inc'uda in the past, . ; : C; 3 JL'l.Zi.'o or 121.2571. This th-ir t. e in fvrtnulations os lubricants .. . q a.ir.ce is r.cc 'o prov-.de and hydraulic fluids and th-ir use os in- . :: u. as under the above regain- crec.ten:s of or.tr.ts. pi.'.-tics, resins. ir.7:s. : ... o climinat.-an of all food waxes, adi.e r.es. rubber, a.spiia!:, and . * r.i.uninq PCB's would chs- various btLldmo materials. ii.; . . ju.'ii's feed r -ei:r.:n r.r.d ib' Ti.c fol'c-vvdnc special previsions .y.aein and is r.c: w arranted arc neees.-nrv to preclude accidental PCB ; i..? rv.':u jo human health. cor.Uir.inalien of r.nima! iced: j i; ; r a.-nixed that nationwide c-.;rc'.s . . . v -es of PCB's will reduce ,a i.:-... !; c--nta:nrr.c.i:ca c: feeds. ; r:.f, o. . a tenvarary tcler- . .. (; . a t. .abliihrd for all feeds. : . -.j.....a ; acrid be prom id a r.f ?d pro ... .. . fri.'. awing temporary toiar- - -.s unavo;dV;Ir residues a peric-d of t::::e to permit .am;:: a: a:: c: such residues at the ear- . .-iceb.c t.r.i: Parta-pcr <l) Coa.Jlr.es or pa.ints for use on the contact surfaces of feed storace areas may not contain PCB's or any other harmful r.r c=lcf'ricus substances lilteiy to contaminate feed. - 2) New equipment or machinery for handling or processing feed in or arotutd an animal teed producing establisltment alwll not ctrp.tain PCB's. <3 Vv'ith.in 30 ciavs iclio-.viny the effec tive cate of this order, tl'.e m?.p.acemrr,( of establishments procucmg animal feed million shall: lari: If-,t r.-_ .St............................. .... 2. 5 .fit Have the heat exchange fluid used I.ary ffst bislsl______ 2.5 in existing equipment or machinery for ` - . cerj |.a: !--i.st _________ ... 5.0 - 7 :................................................... 0.5 -- -. '` "I r.r:c'.c.I terd____________ 0.5 a:..: . .: r'rraor.rnTS (lnchJd- I.'.............................. 5.0 - X. :: '--aWe r r'i^i________ 5.0 - cue t-.V--r feeds................ 0. 1 i' ..:.r:ug cuucT;aJ_________ 5.0 ; PCT.'sare very stable and ! ri*. the environment. ?r.v , . : rf rr.3'5 shr.-Jc be acccmplL-hed : rorr: nr hi-*It femr-erature tiegra- ; or other appropriate rr.ear.s In dec to ava-.d any em.irotur.er.tal con'...c'.c.chon v.lu'h cocuri affect fr.-cd su'o- to the : Food. Dri-r. and Ccs- ; ,:t? Ac: c- tit ccu'.d oth.ertjise ad J'dy a.fuFv me environment. - ' nv.rvj-.nt to provi'ions of ::: >o: i. Druy. and Cosmetic - -;a3. 4oo. 701. 02 Stat. :d. lCfO. ijco-t'o as 1 y.-.i. 919 and 72 Stat. 9-.0. 1 ; --02 as asncticed: 21 C-S.C. .. *,71) and under author* n l.tta <21 CFH 2.720). the ` : p: erodes to amend Parts r': ` > and to eatabfiih a new ' fviiov.s: handling and processing feed sampled and tested to determine whether it con tains PCB's. or verify the absence of PCB's In such formulations by other ap propriate mean'. Within the 30 days specified reave, cr.v such flu-ad -formu lated with PCB's must be replaced v :th a heat exenanee fluid that decs not con tain PCB's or stay other harmful or deleterious substances. . Elirmnato from the animal feed producing establishment any FC3-ccn- tainir.g f-r-t-d-rontact surfaces of equip ment and ulens:ist?nd any PCB-cor.tam ing lubricants for equipment or machinery that are used for handling or processing animal feed. ill) Eliminate from the animal f^ed producing establishment any other PC3- cor.tair.ir.g materials, whenever there is n r'T^oc^ntion fVT.t iribi- torials could cause .animal feed to become contaminated with PCB's cither a.s a re sult of r.crjv.a.l use or as a result oi ac cident. brer.'.tc.gc. or other misiicp. <bv> E";:m:r.a:e the use of any fccd- rr.ch.aging materials that contain in ex cess of the 5 purls per million temporary tolerance for PCB's established in J 122.10 of this chapter. ` a--S7/JE.V7ENTS Or GcMEclAL <c> For the purpose of this section, ; -'-iCY 0.1 IMSRPr.ETATiCM the term ''.animcJ feed" includes all arti cles used for food or drink for animals Py : lu.r.ir the follotvitij new seo- . other than man. - n i\-ri 3: 3...- I'-e of pollrliloriii.ti-fl l.iphenjU * ' -1* rliloritijled l>iplieti>ln (I'ffiM in I'-litljli-ltnirnly tiiiiiiitfuc- (1 ) in I'm pr<t<ttic'li(m and stur* on.i ,'iiimal feed. turius food-pia hajj'ins noilcriiil-. fa' PCB cothuminalion has been de '.m Ii.M- f-a'ions by the Food n.nd tected in paper f jo.l-pu<:kanng mate 7 h; .::: '.ration have revealed rials. Such co:;:.imhiat!tin may have In ixus m teat cxchance Culds con some case* resulted from the use 0/ PGTVs In heat exchange fluids or other PCB-containing m.Vcn.vls ucd In tite est.VclL'.hmcnt manufacturing food-pack aging materials. <b) Itie following 'ncclcl provision'? are ncccc-sar/ to preclude ti;e :icc:dcntal IXIB. ccntammation of food-packaging mr.tciials: < 11 New equipment or machinery for manufacturing lood-packa wnq materials shall rot contain or use PCB's. 2) Within 3J cays following the ef fective date of this orcim. the manage ment of establishment? manufacturing food-packaging materials shall: 1 i 1 Hive the heat exchange fluid used in existing equipment for manufacturing food-packaging materials simpled and tested to determine wiierhcr it contains PCB's. or verify the absence of PCB's in such formulations by other appropriate means. Within Lite 30 a.'.-s specified above, any such fluid formulated with PCB's rr.u-;t be replaced with a heat ex change fluid that docs not contain PCB's or any other harmful or deleterious substance. 1 ii' Eliminate from the establishment any other. PCB-ccr.tair.ing materials wherever there is a reasonable expecta tion that such materials could cause food-packaging materials to become con taminated with PCB's either as a result of normal u'e or as a result of accident, breakage, or other mishap. PART 121--FOOD ADDITIVES 2. In Part 121 by revising 5 121.2545 tb in subparagraphs (1) and (2), as follows: - ; 121.2516 I'ulp from reclaimed fiber. . > fb' * tit Industrial waste from the manu facture of paper and paperboard prod ucts excluding that which bears or con tains any poisonous or cie'.e; cr:ous sub stance which is retained in the recovered pulp and that migrates tc the food. i2` Salvage from used paper and paperboard excluding that which iu bears or contains any poisonous or dele terious si-bstatice which is retained in the recovered pulp and migrates to the fcoci or (ii) has been used for shipping or handling any such substance1. PART 122-- UNAVOIDABLE NATURAL, ENVIRONMENTAL, Cl INDUS TRIAL CONTAMINANTS IN FOOD AND FOOD-PACKAGING AAA- TESIAL Subparl A--Definitions and Proce dural and Interpretative Regula- ' lions i 3. By adding a new Part 122 consist ing Initially of two sections, as follows: g 122.1 Definitions and interpretations. (a) The definitions and Interpreta tions of terms contained In section 201 of the Federal Food. Drug, unci Cosmetic Act shad Lc applicable to such terms when used In tills part. 1 1 4 I\ ! i i 1 i I11 i i i i 1 ffOEKAl Hfctsrit, VOL 37, NO. 54--SATUR0AT, MARCH II, t71 .* 4 , OSIN 5523W ! ! STLCOPCB4090798