Food Safoty Washin$on, D.C. D6partmont of and lnspection 20250 Agriculturo Sarvics

May20,20O5

Rendall C. Boyce Vicc Presidcnt & Gcnerat Counsel Foster Fanns l0O Davis Strloet U"irg*on, CA 953344457

Dear Mr. Boyce:

A.4l_l]:?ms, tf appealing ccrtain language used in rhe Notice 31*mrendec ry: Enrorcancn ry* !"oo of fnOrclg9 g" Noeice of Suspcnsion NOSJ sent to Esr. p;iAC Foster Famu, Kelso, . Wirh G;;liu supptiea trvo docum€ors prcpared by experts that you raainod: ',od

by Dr. 9* lfqer1q F.p"r"d Melvin lftamer with EHA Consulting Gtoup, Inc., reviewod thc epidcniological evidcncc co'ected by thc etatee of washington and orcgon from a number ofcases ofhuman sarnonelruit-cadby erinelk Heiderberg. Dr- K.-; giii_},1qlTology of the various caso of s. i.ia"ru"qs i" fr"rl,irrd--o trrEgm ooes not tmplicate your corpany's brdd of .

The.secmd documenr, @ prreparcd by Dr. l,ansour Sanudpour of the InstiUrrc for cnuronrncntar HealoL dqcrib€s his analyees ofzE cutt'res of.s. Heiderberg washingon obtained ftom and orcgon thar were foundiy tt sr.rrr ro u" rr"t"a;rr, sliaa"ii*g.-iL samadporn usod a di{fccnr "" rrcthod than try,. *4 ty w"rrr"grotr arxt or€on to investigare the pattems PFGE of the zg cultures. He claims in liis,"pon fir"r r* :13r.e.:g l1!l1r usq by the rwo srates. ne conctrics ira ni, prcf-rfi""t;.ti.d.i; _rr* a, snow ue tl age bdweql tlle vsrious cas€s. ""i

In otder to carefully considcr the scientific merits of lour appeal, I refcned the documarts prepared by Drs. Kramer and Samadpour lo FTd lafery a;i fnspoction Ser"ice (psxsi-- sciernifc experts fo their revicw and aavice. wirh all due 6ccq it seems that th€,r€ is a differcnrcc of opinion on the zubject bctwaen the exports tt u$u n ."t ined and the agerrcy's scientifi c €aperts. ""

In re'ads to rh. Kramer's rcrnrq he reviewed the epidemiorogic informrrion regarding individuals and gnoups, dismfuod varioug .eeidg{orogicaivaspects oithe inforition, and thcn &ery difrerent qy.H ro e'minate,;i-liroro groups'iTl*':* lit individuals or In additioq he inaoduced inro his rriscussionln"Jiioo."rrpo.ific orooo;1r".;;il;.* illncsses in orher stares pr€sumabrv *il tt;h;""d;;frr*, wer€ These other ilrnesses not pres€nted in tte NOIE einoe t'9r epiaemiofofiJly of yvlre uoretateC Th;;;#"" thcc urnerated ilrness invcstigations in the appiar *nfo,id, tt is.ue and disuacts from the conclusioas basod on epidenrlot.d" " "rd-fr;p**ffijn?" ,voI". Further, Dr. Knmer dis'rlisscs_ thc inv€stigative 4proach ofclusler identification th'ough pFGB pattern f combinarion marching with zubscquent cvaluation of cpidcmiological rink*'!o detennine whctherrhe cluster is representative ofan outbreak. one ofDr, *ramcr" uoaotying assumflions soems to be that the pr€s€nc€ ofsporadic cases negues the prescnce Lfin outbrEak We disagree with this prernise.

Dr. Kmcr's rtport sbtcs that the individual worting ot 8 Fo6t6 Farm' growing facility in pregon wtro developcd salmonellosis has 'ho linkagi betrveen his ilncsi'and ai'y Foster Farms product." while it is true that there is a levei-ofoccupdional rar-oneuosis *roog chicken ferm worters, this would not diecredit the possible relationrhip to roo,t." panar- producr' but rather would stsengthan it. The fact that gowing facilitiei are independently owned 'rr,. and operated does not negate that ttre facility providCchickcns ro Foster r"r.r. growing facility could r€pr$ent a source of J. Heideiberg intrcduc€d to Fostcr Farms, prescntiag a credible potemtial epiderniorogicar rink in tracing bacr the source of coutamination.

Dr. Kr8m€r statcs that '"fhere is sorne information thx the chicken might have becn purchaeed ftom costco which cardes Fost€r Fsnn producf' for the washington si'tr p.ty n"ia'*---. Novcnber 2Q 20o4. In fact, there is slpport of a direct link beweeo prodrrct served at the pafty and human illness. It was docume,lrted during the investigotion ihal th" p.ti purchaccd 200 pounds of Foeter-Farm chickor p{r6aA diddy from rst, on No;",ot"rgftr r & 2004. In additiort washington srate obtained some o'fth€ Foster Fann products aircsdy fi;m tlrc pcrty organizer's ficez:r for analysis. Also, FSIII obtained a portion of*,is pr"d; wsshington fi"; Stale for analpis. Serotlpe analysis fot Satmouella-indica"a tret ifr tn" isor"ree werc -- Heiderberg. In addition, cDQ pubghJrl co.firmorr that the pFGE p"tt combination'€mt)?ed,s. * oftbc f. Hciderberg from the srspecr chicken wrs indistinguishabk G. pattein previously d di;- identified in hurnan cases (pensons who anenaeA ffref,artyy

Dr. Kruer statcs that Nationar Antibiotic Resistoce Monitoring systems (NARMS) data--- ftom thc rstail er-rles do"' rot specift brand name in maitionir rforting. I{" ;to, tury trrougn o"tol"r, zool,'r"cloi rcrcr!11:E_9 ry l*:l$sr".ro.m to ro"-t"ree"d 'Farm8 Foduct. He then ooncl,dcs that has potentially skewod their nniom selatim ofproduct o incrude more Foster Farms icrsus m"d" io tt NARMsntai- food shrdy. "in", "

Tbc fact is ftat the NARMS protocol coltection Form for the NARMS Retail Food ct*dy for staffto asks rccond cotlection &rc, product type, proa*i u"a"a and usc-by/sell-by &n"" 6. samples collcctod ar retail. FSIS. was notifi* uy oregon that "[ hol& they wcre sampling various of chicken prodrrcts in an anempt ro-se" how wiiespread was ti* contaminstion9!yp"r sotiir"tt" of reta chicken produots within (i- regon. They were not spocificary targetinl the Fost€r Fa''n bred. Nine retair chickefl sarnplesicsted by ttre sate oioregon i;lda;' Heid€lb€rg with thc PFGE pattems of intacs't coming Eom ;$ p-6164a seic'itcRMs umplcs collectcd in 2004 firom rerail chictcn goducts produced by Esr p_6 I 64A heve test€d ryr!* tt S. Heidelberg with eith€r PFGE pattern .fi)t Zlno Bln or pFGE panern -@471-@59. Furthcr,lhe state cpidemiologists also collected two retait chitken samplcs ftom Est P-6164A with usc-by or &roeze-by dates of t 0/06/04 anrt t0/17l(X from coirco in october, 2fix. one of these retail sanrples of raw intact chicken prodwts fiom Est. p{164A test€d positive for .9. Heidelberg wirh PFGE pattem .00 I 2/.000 I . The other sample tcsted positive for S. Heidelberg with PFGE psttsm .OO47 I .c[Sg . Dr. Kramer's conclusions seern to heavily rety on his beliefdrat rhe PFGE pa,,: o!.L Heidclbqg arc not closciy tinieA. Dr. SanaCpour,e r€port Eer:;i support11cut!g this thesis- However, a review ofOr. Samaapour,s rcport by f3IS, sci, Euggests that Dr. samadpo'r's oonctusions 8re not d cbar+ut, for ieveral rea-.,,

Dr. Smad_pour subjectod the 7g .9. Heidelbcrg icolatcs to four rechiction anzyme rue llt),in aagiFon t",#atini il. two enzyrnes areaoy res,, , *^1;a_!^!lltlwasftngton and oregon pubric - health laboratories ()oa r, Brn I). The report'

one mcasure ofscientific vetting wourd-be the deveropment ofa s€d'hlbre, comparable database' corryarabrc databases for additional restric.i- ory.o L"" not teen'gpn;lv acceptcd in the rcientifc mmm.nity. hrlscNct, canters fc oiscase control il*dJo, is worh rtnowned as a moreoular subtyping nawor*- isis i, p"rt o in purrel.Iet",,i and rcries solely on thi! arbtyping newodq as ftl currrot -"rtoOs e"ef"y"a" fV pufo"NJ;;;ri;-- accepted in the scientific community.

In a&itioru the ttrec tables inctrded in Dr. sanradpour's rcport do not include a idemiologic irformation ava -ep_ abre regarding the'..Epi Li'i;;e". speunJry, nurt6re clusters havc epidadologic links, and it"r" tilt" o.ittua iom the list "o in the tables. so, as I indicated ealis, FSIS' scieNrtific €xp€rts havo arrived at different corrclusions ftom tlroee of thc two-experts that py rirur, yo'r qpear to ancnd language in oe and ryrajned. llon zubsoqueirt Nos l€tters is d€nie4 wittr one notante &ception. t nav" iaiminea tt* G last scntence of para- the rhird fulr graph on page z or the NoS should be modifi;. Th"*;;, I am dirating that a "correction- be ttre Nos 6le copy g,d be made available to all .Con€ction-"tt "nua-to intcrestcd parties. The will state :

Thc stetemont on page 2 of the January 2g,265 Notification of Surpcnsion (NOS).. . "The agency reircrates that ii has clealy cxprcss€d and continuec to exprers tbat therc is sufficient epiderniological iniormation linkcd to S. p-6r64A Heidelberg to belicve Est. is impricatcd in foodborne outbreaks in sev€n rtrtcs over the past year, 2fiX". .. is not supportod by the available informarion, and therefore is hercby retracted.

Finally, even orough I have decided to 6le a 'torrcction', of the one scntcncc in the N( ): which rmequivocally *linkage- $atod a of Est. p{164A product to foodbome outbr, in sevcn {eidelberg staes in 2004, FSIS nwerthetess rernains quite concerne.d abor Heidelberg illnesses in Washington and Orcgon. And, we are *peciafly conccrne,, pe'formance of the food ssfety p{t64A { 8y'tem at Est. during the pcriod oftime when thc u illnesses were occurring.

Non-tlphoidal .la hnonetto arc. rcportd,to be rcsponsible for an estimated l ,4 t 2,49g cases of human satmoneltosit, 95% of which r"*riil;';;;';r"d thmugh food products. A rec€rfi litenrtur€ revienr conducred by RTI Inr€rn tio,'r ro.'rsn ,m*i rt"t i.'iJa"rt"rg r, thc sccond m*t ootnnxm semtlpe dound in s,^*ii tit fiom bmilerq ftoquency i* oco'ring at a of 23.8ty" - atnogt one in wery I isolates- ir F,;"b*:s. was iiinaU. iil;T;- tlrc fourtlr most common serot)De i*ittinoo io ru*-r'fron twz-zoo2,*,r, *Jgirix mcan prwalence of 6J0%. "

A revics of FSIS ssmole dera drcws ttat of all fuhnonethsamptes taken by tbe agarcy Jruarv l,^2003' tbroogtt frrom lnt-"tr rs, zms,,rt",-to;;;aih"d 15 s. Heidcrbergpositivcs, the most of anv mear or ooultry plant ir tti" urt"a iJ,* iri"g t ir p"ri"o of tisre. At Est. P{ I 64d chickeos ,r" *o"o*ra ot .pp-i^J"ry ilo a mitrut"' r rhus, thenumbor 5 hours a &v. of.$.-Heiderbers posrrr*-r-tpi* ii*iitlilv"r".ir" rsft l.'riJ,. prod{ct s'ious q,"sio* ffii;;" *rrtffi-i;iffiuct overa'night be '.is"u ** the problcmatic"iix fr}ffi* scrorlpe and be distributed to consumersln washington

In emmary, the widance prcscnted in dre NOIE ard Nos incruded the plant,s difficutry in regulrly meeting ttre satnoneta pcrrormaace ctanaaruir"tius; tne pkr'" higlrly complex wisceratica cquipmcnt that ** n"q"-rfy mruqTTgr's oprrarrj'ouoiA" tn" oqoip.*r specificatione (resulting in o,ics"'ui Jr,ito",i"o contento); tv digestive hrcr the dooumcntcd incfcclycncss ortn" pr"rtt wrt-, r.. carcesses; ard 0re cpideminloeic€l *iuu""t o dara. rrris eriiarce ,uffi the "rl-fiJiir"administrative taken' Thege rrions facts remain unc-hangcd.eren rt orgrr rooffi-&*.;;"rdfi; have unquc*ionabrv demonsnateia ilffi, dir* ririr6;;;;;'*t"y syEtem probre,ns P'6164A ro rhe food consruned at Eer. by those and oregon from J. Hei

FSIS is committed to coatinue to closcly monitor the operations at EsL p{164A, including increasing thc intensitv of thc egency's rnicrobiologi-JrJiJ** p-6 ,orirrg in order to ens're thar EsL t64A prcdud is noiinj,fo"* ; dr"-;_u6il, ;;1t Sincerely, 740J*/,' William C. Smith Assistant Administrator Offrce of Field Opcrations