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M onsanto V W. B. Papageorge ^ ------------- March 18, 1975 Inerteen TO H. H. Ford St. Louis cc C. Patn E. P. Wheeler Jk..oo(* j B2SK Attached is the original of a letter addressed to Mr. Dan A. Albert of Westinghouse, South Boston, Virginia. The contents of this letter have been reviewed with Dave Wood and it was agreed that the letter be delivered by you personally to South Boston, giving you an opportunity to discuss with the Westinghouse representatives the proper approach that must be taken in presenting this information to avoid undue concerns and misunderstandings. Will you please deliver this letter as soon as practical. V. B. Papageorge /pd M II*1* '*( 1001253 cl GBRN GCI^C 194 i r - I B U L L E T IN n o . IC/FP 38R ] (Revnad Mtfai. t975) TRANSFORMER Inspection & Maintenance Guide I Monsanto EXHIBITS TaMI atonte S E C T IO N A T R A N S F O R M E R K A R E L S ....................................... 1 I. Introduction ....................................................... t II. Hiftory o l Trod* Neme T y p a ............................ 1 Table I -- The Composition of Transformer A sitareis ................ ' .....................2 III. Interchangeability ...................... * ................... 2 IV . Table II - Official Transformer Adt^rel Shipping S p e c ific a tio n s................. ^................. 3 V . Ordering Instructions ........................ 2 V I. S t a b ilit y ......................................... > .................2 V II. Precautions When Handling Drums, T V ik Cars and When Opening Transform ers....................... 2 A . Keep Dry During Handling ......................... 2 Table III - Handling and Pumping Tem peratures................................ 4 B. Use Ordinary Personal Precautions ............. 4 C. Precautions on Opening an Askarei Transform er..................................... S V III . Avoid Environmental Pollution ......................... 5 1. Labeling Askarei Transform ers.................... 6 2. Disposal of Liquid and Solid Wastes .......... 6 3. Conditioning of New or Recycled Askarei .6 4. Teardown of Transformers for Repair or Scrap ..................................... 7 5. Transformer Disposal ................................... 7 IX . Expected Service L i f e ........................................7 X . General Characteristics of Transformer Adtarel Fluid . ................................................. 7 X I. Sampling Transformer A d tarel Fluid. . . . . . .8 X II. Evaluation of Adtaral Received in N v E q u ip m e n t................... 8 X III . Dielectric Breakdown Voltage - Moisture R ela tio n sh ip ....................................... 9 Table IV - Relation of Dielectric Breakdown Voltage to Amount of Dissolved Water in Askarei and Mineral O i l ..................................... 9 Table V -- Approximate Solubility of Water in Transformer Askarei and Mineral Oil . . . . 10 X IV . T u r b id it y ......................................................... 10 X V . Check Points for Maintaining Askarei I nsulatkm ...........................................10 A . General Considerations................... 10 B. Modern Sealing Procedures ....................... 11 C. The Older Sealing Arrangem ents................12 X V I. Periodic Fluid Inspection and Whet Checkpoints Mean ............ 12 A. Visual Inspection........................................ 13 B. Dielectric Breakdown Voltage .................. 13 X V II. Inspection C h e c k lis t........................................ 13 X V III . Contamination in Transform ers....................... 14 Tabla V I -- Effect of Common Insulation Materials on Power Factor and Dielectric S tr e n g t h ............................ 14 Table V II - Effect of Common Insulation Materials on Volume Resistivity of A s k a re i......................................................... 14 X IX . A ST M Method for Investigating the Compatibility of Transformer Insulation and Construction Materials in A ik a r a ls ........... IS X X . Refining Askarei for R e - U a i............................ 15 A. Filtering Through Dry Blotter Paper to Remove Moisture and Extraneous Particles................................... IS X XI. X X IL Table V III - Water Removal by F ilte rin g Askarei Through a Paper Press B. Disposal of Solid Wastes C. Solid Insulation Requiring Drying 0. Earth Treatment for Maximum I Improvement of Power F a a o r and 1 Volume Resistivity ........................ Table IX j- Effect of Power factor and Volume Resistivity ............. 17 Cleaning Arced Transformers . . . 17 Sampling A s k a r e i................... ..........! . . 17 SEC T IO N B | A SK A R EL F IL L E D SW ITCHES AN D T E R M IN A L C H A M B E R S ............................... , ig I. In tro d u c tio n ....................................................ig II. Sources ofjContamination .............................. ig III. Sealing Switches and Terminal Chambers . . . 20 IV. Askarei Used Under Mild Arcing Conditions . 20 V . Maintenance for Askarei Filled Switches . . . . 20 orV I. Askarei Under Excessive Temperature Fault Conditions .....................................21 SEC T IO N C | T O X IC IT ^ A N O S A F E H A N D L IN G ............... I. In h a latio n ............................................ II. Skin C o n ta c t....................................... ! SEC T IO N O I I A N A LY T IC A L S E R V IC E S ON TRANSFORMER SKAREL A V A IL A B L E FR O M M O N SA N TO ................. Types of Analyses Available: ........................... 1) Routine Maintenance C h e c k ...................... 2) Complete A n a ly s is .................................... 3) Analysis After Earth Refinement ............ t SEC T IO N E A P P E N D IC E S ................................................... Appendix A - Askarei Stability and Composition of Arc Formed G a s ................... Appendix 'B -- Solubility of Gas in Transformer Askarels .................................... Appendix C - Effect of Temperature on Dielectric Breakdown Voltage of Askarei . . . Appendix D -- Comparison of the Approximate Viscosityjin Say bolt Universal Seconds of Transformer Askarels and Mineral O i l ............ Appendix E - The Density of Inerteen 54201 K 7336-9 and Transformer Pyranol 4 U 3 B 3 B - 3 ......................................... Appendix F -- Thermal Conductivity Values of Transformer Pyranol A13B3B-3................. Appendix G - Heat C a p a c ity .......................... Appendix H - Coefficient of Exp ansion.......... Appendix ( - Fire Resistance.......................... Appendix j -- Seals, Properties and Procurement J ......................................... Appendix K --Caution L a b e l .......................... .22 .22 .22 .2' .2 .23 .23 .23 .23 .24 .24 .24 .24 .24 ,24 25 25 N O T IC E: "1Nothing 1contained herein is to be construed as a recommendation to use any product in conflict with any patent) MONSANTO M A K ES NO W A R R A N T IE S AS TO T H E F iT N E S S F,OR A P A R T IC U L A R P U R P O S E OR M ERC H A N TABILITY OF AN Y PRODUCT R E F E R R E P TO, no guarantee of satisfactory results from reliance uc on contained information or recommendations, and dit claims ad liability forjany resulting loss or damage." | F n m ? ,5 6 1 !i ADM C C 1 9 8 1 * * w eflin1 'ij n d n f lof the exposed ib g t ln * ? ' * - w > dtrioration,liquid)seepage ts usually present. V * -- *- i- C h e c k fcr leakage at padting gland of W ild lin g shaft If ' ^ leeklng, repack widi a Sitartic ring typ gasket r,,_;vr. Askanl U n d * Excauivi Temperature or Fault > Conditions ;> Th IE E E Guida alio points out that, " Chlorobenzenes used In transformar aikarait bagin to boil t tamparatum of about 205*C, uniier atmospheric conditions. If tha m attfial is hsatad to sudi high: temperature in a saalad ystam, prassura davalops. Pressura w ill jalso davalop in the systtm if tha tikaral is arcad sufficiently to ganarata copious hydrogan chlorida gu. `Therafort, it is recommendedj that wherever possibla, waled askarel-filted equipment ba provided with pressure relief devices. These devices must ba large enough to provide immediate relief at a definite pressure, and'(to prevent further build up of pressure if decomposition continues. It must ba remembered that tha presence of devices of this sort does not necessarily preclude the rupturing of containing vessels, (since pressure build up can be extremely rapid undar violent arcing conditions.** i Ii ! ' S(5tS(3Dm(0 Toxicity& Safe Handling I. Inhalation [ A t ordinary temperatures tha chlorinated biphenyls in Aikarel have not presented industrial toxicological problems. The hazard of potential toxic exposure varies with their volatility: the lower-chlorinated, more- volatile ones present more of a potential problem from tha standpoint of both inhalation and skin contact. When Askarel fluids are used it elevated temperatures, engineering controls must be applied, either by the tree of dosad systems or by effective local-exhaust ventilation together with general workroom exhaust! Vapors of Aakarel at room temperature diould not be breathed in a confined ^ace, and no vapor of any fluid evolved at elevated temperatures should be allowed to be dispersed into the general workroom. Inhalation tests on animals indicate that the maximum safe concentra tion of vapor is in the ranga of front 0.5 to 1.0 milligram pw cubic meter of air. The threshold lim it value (maximum allowablc concen tration of an 8-hour worktng lay) w t by the Amaricen Confsrance * of Government Hygienisa are 1.0 milligram of tha lower-chlorinated biphenyl oompoundt per cubre meter of air and 0.5 miiligrem of the more-highly-chlorinted eomponds, per cubic meter of air. II. Skin Contact Prolonged or repeated skin contact with the Askarel fluids must be avoided by the use of gloves and protective girmenti, because of the possible occurrence of condition called chloracne. Afthoupi reports of this condition caused by Askarel are rara, it can be produced by excessive skin contact. If the fluid it spilled on the skin the skin should be washed in the usuel manner widi e soap solution. A bum cauwd by contact with a hot Askarel dtoufd ba treated like any ordinary bum. b Fo r d i t o n i Instructions of Askarel fluids , Section A -V ili, paga 0. * A? 22 J':> W. April 18. 1975 Dr. George Roush, Jr. Mon *4nto Company I 800 North Lindbergh Boulevard St. Louie, Mieeouri 63166 Dear George: Zfully appreciate that the meeting [on FOB1* today was not completely satisfactory and that many nagging questions remain. The enclosed is a brief summary of my personal views and 1 would appreciate any open and frank comments that you a ll may have. Please let me taow of any action that you contemplate In the way of seeking additional assistance in pathology or In contacting federal agencies. We will be pleased to be of help in any way that you may wish. * It Is my feeling that we need to get together again within the next few weeks to continue our discussions. Very truly yours. JCC:AR J, C. Calandra President cc - Dr. George Levlnskas Mr. Q m ir Wheeler Mr. Willi*m Fapageorge i i i ? \ f,-, 1007 m ) 203 B IO -T E S T /Warf, jUc REVIEW OF PCB MEETING . ,, The central issue in question it whether! the PCB'a ere carcinogens or not. The long term studies condicted at BIO-TEST ij indicate that the answer is no. Drs. Ward Richter and Donovan Cordon are of this opinion which is shared by M. L. Keplinger and J. C. Calandra. On the other hand, a study conducted byj Dr. Renata Kimbrough l presents evidence that in female rats of the Sherman strain, liver i carcinomas were found. This is the only study in which this finding I is reported in rats. BIO-TEST has no basis for refuting the findings of Kimbrough except to take exception td the design of the experiment that used only female rats and to point out that to our knowledge no one else has reported sim ilar results in rats. i It should I be noted that the I| earlier allegation by Kimbrough that bladder cancers developed in female rats fed FCB was successfully counteracted by BIO-TEST and Monsanto personnel. Kimura^ worked with KanecKLor{400, a commercial brand of PCB and in a rat study of 400 days1 duration concluded that "PCB1s j. , induced a benign neoplastic change, though it seemed to be still short of malignancy, and that the change appeared exclusively in the f e m a l e s The author expressed concern that the benign nodules in the liver may progress to carcinomas if "specific or non-specific stimuli are introduced into the anim al.11 FnO1 10073 204 G 024 B I O - T E S T ,/riAiHrtfWsrf, 2 Ito2 conducted a study in mice and jfound /Tiyperplastie nodule and well-differentiated hepatocellular carcinoma[* at a dose level of j 500 ppm of Kanechlor 500. Hepatocellular carcinomas were not in duced by Kanechlor 300 and Kanechlor 400, The evidence to date indicates that male rats are more resistant than fem ales to the formation of nodular hyperplasia as well as hepato cellular carcinoma. Rats also are more resistant to the induction of these lesions than mice. To return to the BIO-TEST studies on PCB, it should be noted that the liver sections which were read by the pathologists and reported in IBT No. 641-06672 and dated March 24, 975, were not the same slides or sections as those reported on originally. The preserved livers were reprocessed by taking 4 "cuts" from different areas to obtain as large a representative sample as possible. It is not surprising that under these circumstances a different tabulation of the various primary liver lesions was found. Studies on thyroid hyperplasia and by Richter's associate, Dr. Stanley Vesselinovitc' l, have shown that th if procedure generally results in a different qualitative and quantitative line-up of lesions that are reported by the same pathologist. Ideally one would like to be able to r e a f f i r m the o r ig i n a l findings by this procedure, but this is not always possible because of i the additional variables introduced. Serial sections of the liver would . .n i 205 1007* /fm /ifa a l B I O - T E S T /ifenfetfir, f*c . eliminate some of the covariants. The important point in the most recent study of the sections is the fact that no hepatocellular carcinomas # e were found which is in agreement with the ea:rlicr finding. It must be emphasized that the diagnosis of "hepatoma" by Gordon and Richter connotes a benign process and must not be confused with the classical definition of the term by "human" pathologists. Further, Dr. Squires reviewed a number of the tame slides on Aroclor 1260 with Drs. Gordon, Levin ska s, Kimbrough and Richter and agreed with the BIO-TEST pathologists that liver carcinomas were not present in the slides. In addition, the original slides have been in the possession of FDA since June, 1973 and :o date we have not been ! . 1informed of any disagreement with BIO-TEST findings. Dr. Squires has stated in a letter to Dr. Kimbrough dated November 12, 1974, that "I define 'discrete nodules' and 'trabecular (basophilic) hyperplasia* as precancerous lesions and thus indicative of carcinogenic resp on se.11 This reflects a viewpoint which is not shared by all pathologists and there is nothing that BIO-TEST can do to change this definition except for its pathologists to accept or reject the view. D rs. Richter and Gordon do not accept Dr. Squire's definition* Workers in the field have published! extensively on the '! fi pathogenesis of hepatocellular carcinoma in recent years and the J ! concepts have undergone considerable changes since the preparation lo m 206 10073;* A M *a h k d B 10 - T E S T 2ai*vU o\iM , of the final BIO-TEST report on chronic oral toxicity studies. One m uit note that Poppe r3 in hie tudie on Aramite in i960 postulated that hyperplastic nodules were transformed into hepatocellular cancer; however, this concept was not generally accepted by the scientific community. An excellent paper which describes "the highlights of some newer developments in our understanding of li^er carcinogenesis" has been published by Frber.^ If the concepts presented in this paper as well as those of Squires, Saffiotti and others are accepted, a number of substances would have to be reclassified as liver f icarcinogens. Carried to extreme, we could argue that any substance that results in stimulation of liver microsomal enzymes or possesses hepatocytoxic properties to any degree is a potential! liver carcinogen, BIO-TEST is unwilling to accept these concepts. The lesions seen in the livers of the rats in its PCB studies for Monsanto do not show vascular invasion, m etasteses or anapla sia - all classical features of carcinoma. We continue to view the lesions seen to be benign. Several additional things need to be done by BIO-TEST and these include: (a) Re-examine the original liver slides. F.ftOI V, i (b) Cut new sections at different levels from original paraffin blocks and read slides. \!I (c) Tabulate liver findings separately in female and male rats. (d) If possible, develop information on the reversibility of the liver changes. 1 007 BIO-TEST m U c. 5 It is im portant to point out the following: 1. The B I O - T E S T po sitio n w as and r e m a i n s that the P C 3 ' s w ere not shown to be liv e r carcinogens in its studies. This conclusion is the opinion of its resident pathologists as well as its independent consultant. 2. The BIO-TEST results show that a no-effect level for the developm ent of h y p e rp la stic nodules was found in each of its studies. 3. B IO -T EST has no m eans at its disposal to dispute the findings of K im b ro u g h th a t A r o c l o r 1260 in fem a le S herm an ra ts is a l i v e r c a r c i n o g e n except on the b a s is of e x p e r im e n t a l design. 4. BIO -TEST is not in agreem ent with the classification by Squires et al. that co n sid e rs hyperplastic liver nodules to be p re cancerous. 5. B IO -T E S T studies on P C B 's m e e t the scientific stan d a rd s of Toxicology and Pathology and we are p re p a re d to a s s is t Monsanto in any a d v e r s a r y situation in o r out of g o v ern m en t. J . C. C alandra A p ril 18. 1975 Reference s 1 K im u ra , N .T . Gann 64:105 (1973). 2 Ito. N. J. Nat. C an cer Inst. 51:1637 (1973). 3 P opper, H. C ancer 13:1035 (i960). 4 F a r b e r , E. Arch. Path. 98:145 (1974). 1001 208 10073."j Monsanto MONSANTO INDUS RIA CH EM ICA LS CO. RWOOUCT roclor 1016 ORAOC coot mo 10^0-016-16-03 OATt tvPtc1T.vc une 10, 1975 Characteristics LIMITS| Color (*nul Cspo n. d iotri. o n8sa ; .; _c ko Max. Clear! . 1.36*1-1.378 Acidity (mg KCH/gJ Moisture 0.010|Mx. 36 ppm Max., Refractive Index, 25C Inorganic (free) Chlorides Pour Point 1.6215-1.6235 0.05 ppm Max, -lAC|Max. 1 Dielectric Constant A .80-4.95 (60 Hz, 100SC) Hydrolysis Stability Teat 0.5 ppm Maxi (as Chlorides) Monsanto Stability Teat 0.4 ppm Maxi (aa Chloride} Distillation Range (ASTM D-20 Corrected) 100 (by weight) 323C 'Min. 90* (by weight) 35C Max. Higher Bolling Homologs 0.4* Max. Sulfates _ Dielectric Strength 25C, KV Plash Point, f Donc I 35 Kin. 338 Ain. fire Point Vise. 100P (SUS) None to B.f. 71-81 f Power Pictor, 100C, 60 Hz Max. Bulk Druaa 41 ..00** .c '\ Vj ' 'M i l, ! * . >,,! GfiRft 001S7A Yoro^*4. il ( Monsanto MAWOeoaVANV GDftPOUTf MtDt&ftL D*P**TW*NT TQxffTY tMftoaua ncv TOXICITY INFORMATION ON: I 1AROCLOR* 1016 Capedter Dielectric TOXJOTY The n t Muta oral LDw of AROCLOft 101C i> 2 J grsmaftilogram. When M O in continuous 24-hour contact with rabbit akin, tha darmal I Dm was estimated to ba batwaan V U grama/kilogram and 2.0 gramaftilogram. Thus. AA0 0 .0 R 1016 a considered to ba sflghtiy toxic by ingasuon in aingla doaaa and by tingle dermal appiicaoona. Whan undllutad AROCLOft 1016 waa placad into tha conjunctival aac of tha rabbit aya. alight degree of irritation resultad. Tha average acora of tha 24-. 40- and 72-hour readings waa L I on a acala of 110.0. Tha irritation in 4| of 6 treated ayaa had ubaidad by 73 hour aftar doaing. Tha otiwr two treated ayaa had regained a normal ppearanca by 160 hour after doting. I A aavare degree of Irritation reaufted when-*undiluted AROCLOft 1016 waa held in continuous 24-hour contact with intact and abraded rabbit akin. The Primary Imtation Index waa U o n i scale of L0. HAN0UNG PRECAUTIONS Cere should be taken to amid AROCLOft 1016 contact with the akin. In ease of, skin contact, immediately wash axpotad surfacat thoroughly with soap and water. If irrrtation contuft a priyaioan. In c m of eye contact, fluah immediattfy with large voiumee of water. H irritation persists. contuft a physician. AROCLOft 1016 haa a negligible vapor pressura at room temperatura and it is not expected to present a significant vapor inhalation hazard under ambient conditions. However, prcautions should be observed to avoid inhalation of increased vapor concentrations which may occur if AROCLOft 1016 ia used at elevated temperatures. ENVIRONMENTAL HAZARDS | Ouring die past several years, evidence haa accumulated to indicate that polychlorinated biphenyls are whdefy dispersed throughout the environment and that they can have ave rse ecological and toxicological affects. Extrema care shoultL therefore, be taken by all users of AROCLOR 1016 to prevent any entry into the enviroment through spills, leakage. 11W7t.Y-7t.2U ii GO** 001575 T * a tm m i f i s! 1 1 1 a 1 i i1 M V 1 mw MM [ 1 4w r w i w f M m M | t i n -- i m m - ' * -- ><- M i M e m >w t m M an i-- [ t r~ i V e% l m 4M i e i e . i J i i T It Foni 265 14 I \I I a*, mi Monsanto Industrial Chemicals Company Sales AKRO N, OHIO 44313 290 Senfifmm O nn lonvom Oontopnwm Tar* T9. (2 l l 994111 ATLAN TA, G EO RG IA J3E0JO3t39tomata A tortl Tarkvmf 7W. (40*1432-7111 BOSTON, M ASSAC H USETTS f0W2a.1r14m991la71w39n79010 CHICAGO, ILLIN O IS 3C1m59AoOitnmTr.tuitJminaoAn n. 001i TaL 01212999699 O ffiIcis! HOUSTON, T EX A S pm I 1200Tom O n ToM r niNUMirarffMtf r k (713) 21-9950 LOS A N G ELES, C A LIFO R N IA 90040 9701 HotiSL fot. (201 723-2492 !! NEW YO RK, NEW YO RK 1003 1114 Annuo o t tho Tat. (2121704-5000 I' S J. LO U IS. M ISSO URI 4SC3O1N6.6 I 9t*d, r k 0141 94-1000 CIN CIN N ATI. OHIO 4&206 1901 UaOmn Roo Tot. 19131 7919707 U900uE0OTNtRfUo0rOWIT. tAn, tMefTtI.Co4Hw40InG75MANtf T9.121212979910 SAN FRANCISCO bX y a r eX 2S71io0 LOifonr.anCaotti. 99052 T 9 (4091242-0414 W ILM INGTON, D ELAW ARE 19S10 3411 SVnrrnm * 0 * T9.1202) 479-4400 UC*SAHTQ,900N. UN0*G H 41 VO.. 57. LOUIS GBRN 0 0 i 5 ?o H IM 9 6 15 *" ^ For Approved 0MB MO. 44-R1387 Approvel Expires: July 30, 1972 I.S. K P i t l G t B t Gf U G G MATERIAL SAFETY BATA SSS-- SECTION I For No. OSHA-2 Hey, 1971 1 MONSANTO COMPANY ( '14) 6q- lnon Sod NonJT ijmJbcrcK houicv'aT, St. Louis, Missouri 63164 S |j *1 ittlT# ` "'W lo rT n a te d Aromatic ____ eroelo r IP flV 1 Mixture _ It 1 i H SECTION It wv-wiaK ' r ^ a i i r _______ ritaft, MtillviUMV MtMaM C*t*4*tfT % llHtaw*'l til# AMI afTALklC COaTMCI 9AMMfif1th Mhtm | | VfBCll MlAtucjesaltai *00*1*1 0***1 IHhtlCMOfTtATihaefit CO1MAtUV OfIrt 1 atutMui aiiTuflti a# ora Ltawtat, teuev tata i Tk* Ul i 1 I 8 1 1 % MtJAlHt) y5 ! 1 11 8 I 11 1 1 a SECTION I I I ' HYS'lCM. O'aTA g aic >*f rij 76q ea 3; 5-360C a... VA*oi-ito -- <155-19 5*c) 3 vM a>< ***>! n( it A v a il M9*teOiaatimWort*<mi I1 IVAfOtthOft All I 1 i *>o 8 N. A . | <1 1 *"iO C n . r l l c l h l * <0^01* eo .orlcas o i l 1. 1 | s lir r it aromatic odor 8 IV; SCCTtON MAE AND EinO SllO N HAi ZARD DATA w,t#fi---------------------c.o.c. I80*e fotBi co? op dpr e h (>l u l | (-V -V -I- .T -- MCiaa< ! MIAMI |1 n1 vapors or gases is p o ssib le; I1 U V eftY v*io V fi#V?TrreaM?te h lo rld e 3 and c h lo rin e ) can be evolved In fire s of th is product. || G8RN 001577 F .0 0 1 9jR 7 16 Aroelor 1 2 SECTION V HEALTH HAZARD OATA 1,0 W m 3 of H r . t<f<Sifnlrrt?tion In the fora of chloracnc, systematic leada to nausei, vomiting, loss of veignt, tdena and mirjiiCf *ho <>ir4 m o o o u m i ,, Remove from exposure. Remove contaminated clothinr. r eontaeted are* with large amounts of water and soap. i n t o x lcatl abominai .-pain Vaah Refer to physician. SECTION VI REACTIVITY OATA nH'it j VRitVJI IS 11 1nuu UTjikiTv/mimmim 1x 1 MwiMoout oicawoiifiOM K U || ________________ CO. CO? smoke - aoc t. chlorides and chlorine ilOOM 1ur occu* COMTlO*t rto4VOIO n men OCCL* 2___ * 1 1 jj " fi G . -1 SECTION VII SPILL OR LEAK PROCEDURES inn IJ M I**!.>cH it'IU^UO 0 ViulU I .Absorb nn eUv, ^ v d m t or sfcsorte^nt Place la dnuaa and bury In approved chemical landfill In accordance with local and state regulations. "t ll'l InMMUutrMnt^4n an approved incinerator in accordance with loeal and state laws. SECTION VIII SPECIAL PROTECTION INFORMATION 1l>aTO* N01ICTIO l i f t * *#*/ 11 V1Mflw4llOM locu i4i T es - for vapors * C M * t M tCmmmit | tMCMt 1 | * J r*oic>i 6.0V Bubber m M o u c w cjjtni C4i goggles Of-o XQMCINI IfluMKT I | SECTION tX SPECIAL PRECAUTIONS MICiWhMl ro M r.M* #**& .wo IJO*4 _i ' Avoid akin And eve eantict. avoid Inhalation of vapors. otatimcwi* OOl^T &b*H While the Information end recommeodatlont te't forth herein are believed to be accurate as of the date hereof, MONSANTO COMPANY MAKES NO WARRANTY WITH RESPECT THERETO ANO DISCLAIMS ALL LIABILITY FROM RELIANCE THEREON. JAO:H0H:JT0:VBP 1/ 2R/72 Y "Y iI 18 / Mv 0C l I1U It T ittALl K A i A R O OA' J^s W T T O . 'lTftr rresairvroric*`t a:j.g !*< ***** 0 .5 mn/m-J o f a i r (MIC'1 0f 0w1MMlUitl _ _ '.J| i Skin irritation in the form of chlcracne, systematic j loads to n a u s e a ; vomiting, less o i weijen;, c u e r X ana 3 Intoxication asaosinai pa liUKfwCi lUki *iq N O U M d 1 1 ' -------- i Remove from exposure. Remove contai n * tri contacted rea with la r c c mounts of witcr.'ane soapl Refer to I physician* SECTION VI REACTIVITY DATA 1*!*,.I* W fO iK I *'**1 >y **m |t*M( Iik<Oy*AffKllli M(Mil UAiOOyi accouwoiilto* MOOWCCIOV, C_ O?, . smoke. !1 1* . s o o t, c h lo rid e s and chlorine PROUtTUWOfOflJUAtTlO* MATOCCUA *ni 0 oeeu> CO0*tiO*rti VOavOiO \ X I1 E t * 1 SECTION VII SPILL OP. LEAK PROCDURES 'l*k `- et I**.*I***.i .1,1rtrycrbucoS drums. Bury in approvec er.eeieai ianefili in aceoraanee with local and state regulations. B urn In an aeoroved incinerator in accordane* with loeal and state regulations. d 9 1 i SECT I nil v i l i SPECIAL PROTECTI Oil IMfORMATIOH ......"Surecu o f Klr.cs raroved rtv*n:r.ntor for o r n n l c WlNfllAtttfi locAi immisi c s - fo r vapors 1 wuiA* vapors. U(otM( *4/U**U fWOUCMwt uO*(l Rubber Addi NQIICIlwi (QyMMl | | <*'* j IM.1( e lijc c i c a l r.orr.iu s ! SECTION II ii SPECIAL PRCCAUTjlOJlS f i ' 1 || " ' C4W l d ` ^ fin n'Jv'` *eor.Va'ct, avoid 014niCUliOM inhalation! o f vanors 1 i| 26RN OCl5t aesscuva While the Inforoatton and recommend*t1ons set forth herein *re believed to be accurate at of the date hereof, HOHSAiiTO QOHPAMY HAKES no warranty WITH RESPECT THERETO AND OISCLAIHS ALL LIABILITY; TAOH RELIANCE T H E R E O N . .AO:HOH:JTG:WDP . .j ! 1/25/72 V Monsanto Monismo Company 00 N. Lindfeorgh loglsvard S t. Louis. Missouri 63166 POono: ;3l<: 664-1000 July 18, 1975 Dr. J.C. iCalandra Industrial BIO-TEST Laboratories 1810 Frontage Rd. Northbrook, 111. 60062 re: AROCLOR 2-year Rat Feeding Studies Dear Joe: n The attached table summarizes a comparison .of the 3 revised AHOCLOR reports (12*12, 125*1, 1250). j In 2 Instances, the previous conclusion of fslightly tumorigenic" was changed to "does not appear to be carcinogenic". The latter phrase Is preferable. May we request that the AROCLOR 1254 report be amended to say "does not appear to be carcinogenic'. I The number of hepatomas reported for AROCLORS 1260 and 124-2 have been interchanged. This appears to haye arisen from con fusion regarding the numbering of th animals. The original reports show tumors in animals with numbers Iin the 100-300 range jfor AROCLOR 1260 and In the 500 to 00 range for AROCLOR 1242. This leads me to conclude that the numbering scheme shown in the second set of reports is correct. With AROCLOR 1254 confusion is compounded. The original report showed tumors in animals with numbers in the units to teens, but the[revised report shows animal numbers ranging from 40 to 1000. Can this be straightened out? I was unable to reconcile the differences In the animal numbers between the first supplemental report and the original reports, I had inquired as to the changes in the numbers. As I recall, I was told that the sections had been renumoered when the new slides were made and that a key relating to the sets of numbers CPtAINTIFITS^ i o n i c i100737 RECEIVED jUl. S1 'S'5 a iA . T P Q T Dr. J.C. Calandra July 18, 1975 Page - 2 - 7 < would be supplied. This has not been done . It may not be necessary for AROCLORS 1260 and 12^2, but AROCLOR 125^ remains unresolved. Insofar as I can see, the remainder of the reports appear acceptable. Kindest personal regards, Sincerely, --/ / George J. Levlnskas, PhD Mgr., Environmental Assessment and Toxicology /bkp att. cc: Dr. George Roush, Jr., M.D. , 1i ii 1001272 1007 r i Product - Supplemental Report #1 (mailed) I AROCLOR 1260 c o n c lu s io n slightly tumorlgenlc hepatomas 3 range of test animal nos: p. 9 600 to 800 p. 10 1000 series p. 11 p. 12 p. p. 113 70 to 100 500 to 600 600 to 700 700 series Supplemental Report 1#2 (JCC delivered) does not appear carcinogenic 7 100 to 300 800 to 900 10 to ftO 80 to 200 200 to 300 200 to 300 AROCLOR 125^ conclusion hepatomas slightly tumorlgenlc 6 slightly tumorlgenlc 6 AROCLOR 12U2 conclusion slightly tumorlgenlc does not appear carcinogenic hepatomas range of test animal nos. 7 as In report #2 for AROCLOR 1260 3 as In report #1 AROCLOR 1260 Fnm TO 10073!) I August 4, 1975 Dr< George J. Leviaskas, Manager Earlronmeatal A ssessm ent ad Toodcology Monsanto Company 800 North Llndbergh Boulevard Su Louis, Missouri 63166 i *: - ' Bear Georg: Re: Aroclor 2 Year Rat Studles la regard to the comments and questions covered la your Utter dated July 18, 1975, pertaining to the above, please note the following: 1. We will amend our statement In the last paragraph on page 2 of the Aroclor 1256 report to read, "doss not appear to be carcinogenic" in pUee of "slightly tumorigealc" as requested. 2. In regard to the animal numbers in the Aroclor 1242 and 1260 reports, they are correct in our finaljrcvieed report. In the original reports, the Aroclor titles for these two matcrUls were reversed. 3. The animal identification numbers appearing In the reports on evaluation of additional liver sections are jthe same as those la our original report. The animals were not renumbered. 4. We cannot find any discrepancy in animal Identification numbers la the reports (original, re-evaluation, final revision) on Aroclor 1254. However, la the report on re-evaluation of additional liver sections dated March 24, 1975, thsrejwes a typo graphical error on page 1 which referred to Aroclor 1260 instead of 1254. Perhaps this is the basis of your confusion.I I hope that this will serve to further cU rlfy the sitaatit Thank for your assistance and cooperation. II ^PLAINTIFF'S r , it; Sincerely yours, J. C. Calandra President in m 9.74 10071 G 02138 Monsanto [ *r*T3- v (jP g .<?.f.jr t & T<'i MONSANTO INDUST RIAL CHEM ICALS CO. I MoeucT OA*oc Aroclor 1254 cooi no 1040-281 ATt KPPICTivC August 5, 1975 CTIMUTIC Color (APKA) Condition Sp. Gr. 45/15.5C Acidity (ag XOH/g) Moisture Refractive Index 25C Inorganic Chlorides Pour Point Dielectric Constant (60 Bs, 100C) Distillation Range (by vt.) (ASTM D-20 Corrected) 10% SOI 901 Dielectric Strength 25C Pire Point Power factor (60 Bs 100C) Bulk Druas Corrosion Tests Weight change AC. Color (APHA) A.C. Condition ~ A.C. Aeidity (ag XOH/g) A.C. Inorganic Chlorides Viscosity 210Or (SUS) flash Point iav. (fu *< I LIMITS SO M X . I Clear j 1.495 - 1.505 0.010 aax.I 35 ppffli sax. 1.6375 - 116415 0 . 0 5 ippm, aax. 7-12*C 1 4.25 |- 4.55 344-378C 371-363C 379-3940C 35 BV, min J Bone 1.01 isax. 4.01 max. I0.01 60 aax. Clear 0.010 aax. 0.05 ppm, max. 44-41 Hone 0 0 l S V 6B*n 10019*75 90 r c i, ini Monsanto Industrial Chemicals Company Sales Offices AKRO N , OHIO 44313 390 Spnnfmdi Ohm MorireO neo/nm Art T. (31919994111 ATLAN TA. G EO RG IA B O ifitn it* Norm T. (404) <32-7111 BOSTON. M ASSACHUSETTS 02149 Smrm Satn T. fit? ) 247-5010 CHICAGO, ILLIN O IS 21a O n Afar/wiAm. OmNunm. Minori tOCli T. (2131 299-9699 C IN C IN N A TI. OHIO 45206 1901 Abtfwf Mood T. {9121 7214707 O ETRO IT. M ICHIGAN 900 Nmmim X T om n rtta Sm ttm C m . i d t. 40079 T. {21212970010 HOUSTON. T EX A S 77027 1300 Arm 0 * Tow * SCSI T (7121931 OSSO I1 LOS A N G ELES. Ca l if o r n ia !90040 99701. fh tiltS L T. (3121 733-3493 Ii NEW y OR K, I NEW YO RK 10026 1114 A offfw T. (3121 794-SOCO I1 ST. LO U IS. M ISSO U R I 63166 I OOOH.kindbrri'Oi*. T 014) 04-1000 iI SAN FRANCISCO BAY REA 3710 tNrnrw Smm On. C*rf. 9SOS3 T (4091342-0414 I W ILM INGTO N. 0 EL W A R E 19610 2411 rn n m Aoa4 T. (331479-4900 MONSANTO. SOON UNO StAG* 4L VOL. ST. LOUIS G6RN 001562 I ;nm 21 Monsanto Meeting - Septenfcer 4, 1975 1. Monsanto has been working with sub stitu te flu id since 1959. 2 . With pressure on PC B 's, Monsanto sees very Joss 1blie term ination of continued use o f PCB as f a r as Monsanto's continued supply of the m a te rial. 3. D ie le c t r ic Research Groups: D ie le c tric s (winch & Bryant) A n alytical (Mie'ure, Seeger) Medical (Levlnsjkas) 4. Environmental Impact: I a. Biodegradation b. Accumulation in animal tissu e . Biodegradation s tu d ie s : Main emphasis 1n a ctiva te d sludge te s ts . Described d e ta ils of te sts. Monsanto fe e ls comfortable with MCS 1238 degradation because a l l components (hydrocarbon & sultone portion) biojdegrade even though the biodegradation rates are not s ig n ific a n tly higher than for MCS 1016, Accumulation studies on r a ts : 30 day feed +| 75 day recovery period. Curve comparing 1242 and 1238 presented shows 1233| accumulation to be In s ig n ific a n t compared to 1242. 1016 accum.jhas also been measured and is about h a lf that o f 1242. Higher chlo rin ate^ types such as 1254 or 1260 accumulate more than 1242 and recovery is also much le s s . 5. T o x ic ity data (Levinskas) Have s ta rte d in h a la tio n studies on one-month expos ures on various animals and w i l l check fo r l iv e r and other organ damage. This w ill be complete a t about the end o f the year. | Acute t o x ic it y (LD50 value) fo r 1238 discussed. Skin i r r i t a t i o n is less fo r 1238 than fo r 1016. Vapor In halation is not strongly objectionable. j New m aterials 2 - stage review: (p resen tly between 1st & 2nd stage) ( 1) continued inhalation studies (2) carcenogenic stu d ies: now running p ilo t study. Complete study w i l l be a t end o f 1977 or f i r s t o f 1978. Reasonably confident that th is n a te r ia l w ill not be carcenogenic. (3 ) Acute fis h t o x ic it y to also be complete! at en'd o f 1977. Oisposal o f 1238 would have to be handled s im ila r to mineral o i l. Could be In cin e ra te d as is motor o il or fuel o i l . 6 . Industry status o f non-PCB cap. d ie le c t r ic : a) Monsanto has made decision to o ffe r only 1238 to cap. industry. No other m aterial is planned to be offered at |this time, nor are the 1238 components to be offered sep a ra te ly. b) Use of e s te rs : reprocessing causes gradual degradation and also a h yd ro lysis problem e x ists. 1.0 0 1 ? .7 7 7. P ro p e rtie s : a) auto Ig n itio n temp is 835F (446C) ..y b) r e f r a c t iv e index: Monsanto w ill get. c) Monsanto to check s a le a b ilit y o f 1238 vs. temp, down to -40C. d) W ill get absor. of PP and 1238. e ) A d d itiv e s : Unox 4221 has been found to give bietter resu lts than o ther epoxides on other hydrocarbons. but 1238] has only been te s te d with 4221 fo r ac cap acito rs. For dc c a p a c ito rs , Monsanto has tested guinones and they enhance l i f e on dc. f ) E le c t r ic a l breakdown o f f lu id w ill generate no| strong acid by products (H^S and H2O plus some sulphona^ed compounds). g) L if e T est: B a lla s t capacitors impreg. by preheat fo r 2 hours in a i r oven 125C, vacuum dry at 125C, impregi. with de-gassed f lu id heated to 95C, cap. a t 1-5/t before flood ing a t 125C cap. temp, then vacuum is broken, cool to room' temperature and then so ld er sealed. A ccel, l i f e te s t 90C oven temperature, 1000 v o lts rms 60 Hertz on 2 sheets of ,00066 (.9 d'en) 1238 units have run more than 1000 hours. Measure P.F. p e rio d ic a lly (" e a c h week). 8. No need fo r antioxidant with 1238 even for long time storage. 9. Avoid use o f epoxy-type sealants fo r b a lla s t type cap. cans. DC S2348 (Dow Corning) - O.K. 3M E Cl 447 (Ph en o lic Type) - O.K. 10. Westinghouse to supply Monsanto with FPF unijts (75-50-75) for l i f e te s ts (process 8 at a time) - need 100 to 200 u n its . George E. Mercier V1 1 ,0 0 1 9 . 7 8 177 -2 MONSANTO TH TP September 4, 1975 Westinghouse Personnel: R. Sawyer K. Kelly L. Shoalf G. Mcrcier L. NamJelcorn Monsanto Personnel: Tom Gossage, Dir. Marketing David Wood, Marketing Manager Dielectrics Bill Moore, Marketing Representative Dr. Ralph Munch, Distinguished Science Fellow Jim Bryant, Senior Research Specialist Dr. Jim Mieure, Group Leader Applied Science Vic Saeger, Applied Science Dr. George Levins <as, Medical Dept. Representative 1238 Price and Availability A. Test quantities. We estimate a requirement of 500 gallons in drums over the next six months. I I Price until 10/1/76 $.71/lb. LTL Drums ( .A#/gal. est.) Price after 10/1/76 $1.05/lb. TL Drums $1.07/lb. LTL Drums Availability Two drums are on order. Will ship by 9/15/75. Present capacity 2-400 gal. /day. B. Production Quantities. We estimate 1 tank car/month (8,000 gal. 1st year. We estimate 2 tank cars/month (16,000 gs 2nd year. To achieve production quantities in|6-9 months, temporary facilities would be required. These would be used until a new plant could be built in 18-24 m o n t h s 1. (For 1-1% years.) Price first 1-1% years of production: est. $1.00/lb.-$.85/lb. In new plant: Objective price $.65/lb. (at today's costs] C. Monsanto's Market Position Monsanto ma y terminate production o:f PCB Their programs are structured on the basis that PCB will be discontinued. T. Gossagc estimates that PCB will be eliminated through government edict, Monsanto decision, or utility industry decision, within six months to one year. Monsanto is offering only 1238 as a substitute for Aroclor for the total capacitor industry. |They will not offer either or both components of 1238 to the industry. Development costs of 1238 will be borne by Aroclor buyers. A 3c/lb. increase across the board on Aroclor wil'l be effective on F0 0 1 2 7 9 44 174 10 2 on 10/1/76. Another larg* increase is predicted for 1977. (Settlements of law suits do not represent a portion of the 1016 c o s l the amounts are not significant") D. Monsanto's Decision to Invest $10,000,000 capital investment will be required to build a plant to produce 1238. This decision will hinge on: a) Continued favorable reports from the Medical Department. b) Acceptance by most of the industry (of 1238. They need a volume of 10-15 mill lion lbs./year. c) An estimated life of 1238 of ljO years. E. Affect on transformer Aroclor To achieve production within 6-9 months in temporary facilities, one of the two transformer fliuids now used by Westinghouse, P D S 5 4 2 0 1 K A or 54201CM, would be * discontinued. A decision to discontinue should prcjbably be made four months ahead of beginning production of 1238 (two months for physical changes, two months to announce to the trade) . The transformer divisions have not b'een advised of this possibility. Monsanto would like guidance from this division on how to go about thijs. F. 1588 1588, which has been tested by R & ri, will be withdrawn by Monsanto. At this time the price is raised to $1.17/lb. LTL drums. Monsanto recommends that tests be discontinued. G. Contracting for 1238 j Monsanto expects to sell 1238 under jthe terms of their standard sales agreement. No indemnity ajgreement is planned. Such an agreement is considered undesirable since it would imply that the material is hazardous. Because of frequent changes in railroad policy, Monsanto does not know whether or not a trip lease agreement will be required for rail shipment. Monsanto intends to reserve the right to Increase prices with 15 days written notice. j` ii (nm ?fio 100718 175 UNITED STATI ENVIRONMENTAL PRQTECf ION AGENCY N WASHINGTON. D.C. 20460 ^ QCT17 1975 OFFICE OF ENFORCEMENT Monsanto Industrial Chambeala Company 800 N. Lindbergh Boulevard St* Louis Missouri 63166 Gentlemen: OCT 22tS5 Recent governmental sampling data indicate the! presence o Polychlorinated Biphenyls (PCBe) and comparable chemical substances in the air, in water bodies, and in fish in severalj areas of the country. In order to determine the nature and extant of the possible adverse effects resulting from the presence or PCB compounds In the environment, the Environmental Protection Agency (EPA), In cooperation with other federal and State agencies, is attempting to determine the sources and amounts of PCBs entering the environment. It la Important that this effort be carried out without delay'. It is our understanding that your company handles PCB compounds or mixtures or comparable chemical substances] In Its operations. I am therefore requesting, pursuant to the authority provided by Section 308 of the Federal Water Pollution Control Act, as amended, 33 U.S.C. 1318, and Section 114 of the Clean Air Act, as amended, 42 U.S.C. 1857c-9, that your company furnish PA with Information pertaining to your use and handling of PCBs and comparable chemical substances. In addition to a general description, which should Include Information as to sources, quantities, uses, and ultimate disposition, you should respond in detail to the enclosed questions. If any question Is not applicable to your company or operatlons, please so Indicate by responding "not applicable." The Information requested herein must be provided notwithstanding Its possible characterization as confidential Information or trade secrets. tShould you so request, however, any Information (other than effluent or mission data) which the Administrator of this Agency determines .to constitute methods or processes jentitl'ed to protection as tgada secrets will be maintained ap -confidential, pursuant to procedures specified In 40 CFR Part 3k W W 19 8 1 ADM 0 0 6 2 9 0 2 Within 14 days of receipt of this letter, your company must "^provide 11 infofiliation concerning your current status and activities and coveting the'twelve month period immediately preceding receipt of ,,ibis'-letter. | Within 30 days following receipt of this letter, your company must provide all Information for all of the prior years Indicated. The information required herein should be sent direct!^ the address indicated below. If you have any questions you may c*31 "the person `indicated below or Mr. Blake A. Biles of our office ai-i202i,755-*731. / * '` We appreciate your prompt cooperation in this matter. Enclosure Regional Contact: **J- > Mr. Earl J. Stapiienabfc Director, Enforcement Division Environmental Protection Agency 1735 Baltimore Kansas City, Missouri 64108 Telephone: (816) 374-2576 ia wV i` 1001 ?S2 ADM 0 0 6 2 9 1 / ' i ( k POLYCHLORINATED BIPHENYL (PCB) COMPOUNDS OR MIXTURES Within 14 days of receipt of this letter, your company must provide ill information concerning your current status and activities -en? covering the,twelve* month period Immediately preceding receipt of this letter. A j \! Within 30 days f o i l i n g receipt of this letter, your company must provide all information for all of the Iprior years indicated.' FOR PURPOSES OF THIS LETTER, THE PHRASE "PCB (COMPOUND OR* MIXTURE" INCLUDES ALL CHEMICAL' SUBSTANCES KNOWN OR BELIEVED BY YOU TO BE PCB COMPOUNDS OR MIXTURES OR OF A (SIMILAR CHEMICAL NATURE, IRRESPECTIVE OF TRADE NAME, AND SPECIFICALLY INCLUDING v CHLORINATED TERPHENYLS.. i . For each PCB compound or mixture produced or * by your company, for each company facility, during each year of 1971^ 1972. 1973._1974^_and the first two quarters of 1975 a. The total amount of each PCB compouni or mixture produced or Imported. b. The name and address of each of your company's facilities which handle PCB compounds or mixtures* (Including production facilities and wholesale end retail outlets'), snd the .4 amount of each PCB compound or mixture distributed through each facility. The name and address of each customer of each PCB compound* or mixture, the amount of each PCB compoundjor mixture obtained by emch customer from each facility, and each customer's delivery point(a) for the receipt of each PCB compound or mlxtura. 2. For each PCB compound or mixture incorporated your company into its products, for each company facility, during each year of 1971, 1972, 1973, 1974, and the first two quarters of 1975i I a. A description of each product/ j b. For each product tha total amount incorporated of each FCB compound or mlxtura. t* eA //> * i K001983 AOM 006292 -.V (continued) ~ 2 r v ^ For each produejt the name and address of each source from vhlctfyour company obtained each FCB compound or mixture, and the amount if each FCB compound or mixture obtained from each source. d. The name and address of each of your company's facilities which handle such products (Including production facilities and wholesale and retail outlets), and the amount of each product distributed through each facility. e. The name and address of each customer of each product, and II the amount of each product obtained jby each customer from U each facility. For consumer products list] only the total l production of each product at each facility and the total I number of customers. Do not provide the name and address \ of each customer of consumer products* 3. For each PCB compound or mixture used by your company In Its operations other than for incorporation Into Its products, for each company facility, during each year of 1971, 1972, 1973, 1974, and the first two quarters of 1975: a. A description of each use. b. For each use the total amount of each PCB compound or mixture. WJ' c. For each use the name and address of each source from which your company obtained each FCB compound or 'mixture, and the amount of each PCB compound or mixture obtained from each souree* 4. For each FCB compound or mixture reclaimed by your company, for each company facility, during each year of 1971, 1972, 1973 1974, and the flrat two quarters of 1975: 4 a* A description of each m e t h o d of reclamation'. b. For each method of reclamation, the total amount of each PCB compound or mixture reclaimed. c. The total amount of aach PCB compound or mixtura reclaimed. 1001 ADM 0 0 6 2 9 3 3 -d. T h g name and_address of each source from which your 7" company obtained PCB compounds, or mixtures^ and the aasunt of each PCB compound or mixture obtained-from '"''bach source. ' . 1 For each method o f reclamation, the location of every reclamation site,`the name and address of each party . Involved In the reclamation of each PCB compound or i : mixture, and the amount of each PCB compound or mixture reclaimed by each party. , 5. For each PCB compound or mixture disposed of by your company (with or without the involvement of other parties), for each Company facility, during each year of 1971, 1972, 1973, 1974, and the first two quarters of 1975: a. A description of each method of disposal. b. For each method of disposal the total amount of each PCB compound or mixture disposed. c. The total amount of each PCB compound or mixture disposed. d. The name and address of each source from which your company obtained PCB compounds or mixtures, and the amount of each PCB compound or mixture*obtained from each source. . For each method of disposal, the location of every disposal site, the name and address of each party Involved in the disposal of each PCB compound or mixture, and the amount of each PCB compound or mixture disposed of by each party. 6. The composition by chemical name and percent b y weight of each PCB compound or mixture j^jgduee, Imported, sold, reclaimed, used, _ and/or.disposed of by your company since January 1. 1971. *" 7. The result# of any and all sampling!and analysis^ performed by your company. Its agents or contractors sines January 1, 1971, concerning the following: e. Concentrations of PCB compounds or mixtures In the effluent of eny discharges by the company (Into1,waters of the United States or Publicly Owned Treatment Vorfcs) or In the emissions of the company into the air. Korn ?85 ADM 0 0 6 2 9 4 4 -b. Th$ flow and/or composition of any discharges or emissions bjTtKe company (into vaters of the United States or Publicly (Sffied Treatment Works, or into the air) which contain PCB -- -- -- 1compound or mixtures. Concentrations o ^ P C B compounds or mixtures ij.nu rteceeiivviinnjg vaters (both upstream and downstream)| of any discharges by the company which contain PCB compounds or mixtures and concentrations of PCB compounds or mixtures in the jH the area of the company. 1 8. the methods by which PCB compounds or mixtures are transported to, by, and/or from your company, Including; a. A description of each method of transportation, and the form in which PCB compounds or mixtures jare trans ported by each method. Where diffrent methods of trans; portation are used at different facilities specify which transportation method is used'et each facility. b. The names and addresses of all known transporters of PCB |l compounds or mixtures. 9. All occasions (including spills) of which you are aware on which / PCB compounds or mixtures have or may have been Introduced into the environment. In particular, describeeuch occasions Insofar as 'they Involved PCB compounde or mixtures in their liquid state, es Incorporated Into closed systems, or as incorporated Into open systems. For ssch occasion, Indicate name and address of party involvad; datas, tlms, and location of the discharge or spill; and the amounts involved. .10 A description of any advarse health or environmental effects which you know or believe to have resulted from the Introduction of PCi compounds or mixtures into the environment. Indicate any specific occasions including dates, times, locations, amounts, and partita. Involvad for which such effects are known. 11. Any and, all, other Information which you possess concerning: iI The production, Importation, reclamation, use, distribution, end disposal of PCB compounds or mixtures. 1.001? S 6 OH 006295 5 b. fbb discharge of PCB compounds or mixtures Into the environment. In addition to the above| EPA vould appreciate receiving any other Information which you p o & e s s concerning the [distribution and discharge of PCB compounds or-.mixtures by sources other than your company, Including your company's Customers and sources. \ t VnM?K7 AOM 006296 M onsanto _ rmsm j mi locat ,OM. David Wood-St. Louia-B2SD Dati uajccT , 0a*ober'`30, 1975 f-EPA l'IRINCl COMMENTS ON SPA LETTER REC'D 10-17 TO W. B. Papageorge ^ B2SK -* 1. Bill, this seems to be a new version* i2. Page 1. Cl. Terphenyls specifically mentioned. 3 . a) Production records answer 1(a). | b) Remember we warehoused PCBs for short period 1974 ahead of labor contract renewal. | c) Question lc raises a problem that has been at back o f - my mind. #2 report is supposed to 'show "ship to" address, but if this is case, why do 3rd party W/5E shipments appear under "bill to" locations. 4. Q2 a) No problem b) No problem c) No problem d) No problem e) Policy - Hanley level? 5. Q3-No problem except 71/72 6. 04-No reclamation. 7. Q5-a) No problem b) Difficult. Can split Diel[ec/HT/Pydraul 1 But some returns mixtures of .oil/PCB, etc. c) Can do. d) Difficult ... e) Difficult k> i* 8. Q6 -- Available <* 9. Q7 - a) Guess we have b) Guess we have AQM 006288 c) Guess we have C 10. Q8 - a) Bulk Rail F0ft1?88 Bulk R - 3 accounts Drum - Specify.drum construction PLAINTIFFS b) B. M. Potter IN - 10 * V . W T * 11. Q9 - -4i~ -- Should * answer * * from our activity? ** -- 9 12. Q10 - None? "Yusho? sClonene* years agio M 13. Qll - a) Might get HUB again? Dangerous Question. b) Should write this one very carefully - can make some positive points in this section. /deb David Hood A* vV i H t- I b i ** tr I ADM -006209 lorn ?S9 C* CC3 C 00 1? s o X f Tig* 2 E le c tr ic heater for^ m aintaining ch lorinated diphenyl a t a constant temperature in p la ce a t in flo w end o f box* 1 ACM CC3<t2 1 l F001991 r lorn 992 C I I I I I A L M C C 3<t^3 Kom9.93 --I Specially designed pyrex glass fla ales (figura 4)a 7 3/4" long and with a diameter of 1 1/2", vara used to bold the Seated vaxea* Thaae flasks ware made with a aida ana and tuba blob extandad to the bottom. The top of the flask was ground, and Into this fitted a abort tube 1 1 /2 " ia length. ;Tbia abort tuba vaa inaerted into a 'large rubber atopper which t fitted tightly into a bole cut cut of the 7-i'nch pipe cn the under V i1 aide (aaa figure 2). Thi flask in turn was placed In an electric heater ' lI cade to cower it completely below the side arm and ground glasa top. II Rubber tubing connected the aide arm with a compressed air reservoir and a gentle stream of air blown through the &elted wax kept It in Imotion and assured uniform heating. Into each flask was inserted t long stem centigrade thermometer which was kept in place end could bo read at any time above the 7-inch pipe through ^ilcL it passed (see figure 2). Approximately 23 gm. of pulverized a?nc*i i n i m u ^ i i >ar m r t n g iuntf chlorinated diphenyl were placed in the VmpbriziAgir.jj, flask lI and melted In the electric heater. Freeh samples were used every other day. Turniha I i4a iaA4 QQ I tiam iffTlfl H.lAhjL ik The collected sublimate was a l m y s removed from the upper part of the flask and a clean top used each day. Ho sample was ever used for core than two runs. I 1The flask plus the contents was carefully weighed at the beginning of the run and at the end, and the loss In weight used t0 oelculate the average amount in a cubic meter of air par minute as determined by a aarlea of flow meter readings, jibe figures obtained were not absolute because of slight variations in the air flowing through the boxes and because of deposition of material on the tharaoceters end on the Inside surface* of the box, but they checked well with dlreot determinations through air samples. AC*- C02"'2"' Knm?94 Approximately <xie hour g allowed for the wax la the flasks to zaIt and coo* to a ocnatant temperature. At that t i n tha lox to ora irera tightly dosed, ilr bubbled through tha flasks, Lad the blowers turned on. Thla wma tha beginning of tha axpoaura period. 3y motaa of tha theostata I 1c d tha fans and the damper* la tha outflow pipes, the amount of air flowing through the boxes w^s adjusted and an attest was made to keep 4 the four bozea aa uniform as* possible -- usually between 165 and 175 cubic feat per minute*. Experiments Exposure to chlorinated diphenyl was begun on July 1, 1936 and ceased on November 16 of the same year. I ITha average length of exposure was 16 hours dally for 6 days a week. Each morning at about 9:00 exposure ceased, end between this time and 4:00 pj.a* the rata ware cleaned, fed, weighed, etc. In order to secure uniformity of exposure the cages were ahifted on a regular schedule, since wax concentrations were somewhat higher at the inflow end of the boxes. Preliminary runs I Ishowed that once properly adjusted, wax concentrations In the air remained very uniform from day to day, but to insure absolute safety readings of temperature, elr-flow, etc. were made every night between 10:00 and 1200 p*m. as well as on starting and stopping!. At different times during the eourat of the experiment tests for free chloride were mads but ware uniformly negative and Showed that under the tanperaturea used no deecnposltlon occurred. Table 1 Conditions Maintained In Inhalation Experiment from July 1 to Nov. 18 CC3<*c5 Mattrial Chlorinated diphenyl Temperature Average eoncentrat on of air In box Total length of exposure Average dally exposure C 163-175 Mg./ouJJ. Hange CU5.7, High, 1.19 Low 0.23 hours hours 1896 16 Knni ?.95 R esu lts of Tnh*iatlan Experiments Ho ebnarmalitias war# a i at any tins la th# living rata. Blood 1 1and urin#. examinations v#r# mad#; thar# war# no losses la weight, and on# would, hav# considered that th# animals war perfectly sound. Howaver, rats aacrlflead aft#r 6 weeks exposure showed alight liver damage, which' advanced during the naxt Iwo months* Th# changes consisted In alight to i || moderate swelling of th# liver cells, Increased granularity, and cany mitotic figures* 1 iHyalins I n d u s lens were present and were invariably plentiful In animala receiving chlorinated diphenyl by Inhalation or by mouth* On# la foread to conclude from the experiment's that an average concentration of 0*57 mg* per cubic meter inhaled 16 hours dally produces I| deflnlts slight changes in the liver and In this organ alone* These changes are resists! efficiently by the animals and cause no depredation of health* The situation is not Unlike that salsa In factories hers acute yellow atrophy of the liver has occurred. In the case of such Instances the patients have bean singled out in soma way or othor from large groups of follow workman who have been perfectly healthy* m um | jIn considering tho entire matter It seemed to us that tha chlorinated hydro-carbons,/if inhaled In sufficient concentration, might !1 cause, a slight degree of damage to th# liver." This damage Is resisted efficiently and cause# no depreciation of health, but if th# Individual in guasti o h hsppens to suffar san# ordlaary diseaa# of the liver tha conditi an ls aupsriapossd u p m a substratum of injury* In accordane# with thl# hypoth##is w# &#t#rain#d that a dot# of 0*75 ce* of carbon tetrachiori da plus 0*75 co* of ethyl alcohol per kilogram of rat was entlrely non-todc to norma! animale* ben, howsvar, thie dose vas given to animals which had Inhaled chlorineted diphenyl as has been 1 1.001 /9bdeaeribed In thie experlnent, the result use aeute yellow atrophy. - r t n C I -0- of the H r or* It would soon therefor* that Inhalation of a concentration I of chlorinated diphenyl in the manner I hare described la capable of producing a condition vhioh may he dangerous to the individual inhaling it though of Itself no Tlslhls harm will be done* ' J Animals removed from piposure to chlorinated diphenyl after two months inhalation and g i v u months for recovery still showed liver chsnges hen killed and examined, so that it is evident! the alterations , produced by this hydro-carbon i 1l 1 are persistent and individuals ho have 1 been caused trouble by It should be removed completely and for a long time* The Inhalation of a sanswhat higher concentration of chlorinated diphenyl over an B hour day Material Chlorinated diphenyl Table 2 Temperature 0 C Average concentre tlon of air it box I i, M./cu.m. Han Total length Average of exposure dally expos Hours Hours 153-174 0.93 High 3123 Low 0*03 920 a Igaln 80 rats were used la this experiment* one at any time showed the slightest evidence of Illness Idlcroseoplc examint Ions, however, showed a I i idegree of c h u g s very comparable to that found in the 16 hour experiments which have been described and the carbon tetrachloride test was uniformly fatal. General frumnary;* From these experiments we ere forced to conclude that caieeirtratlezLS of chlorinated* diphenyl in worlffoane should not be allowed to rise above 0.5 mg. per cubic metar of air. This ecucantrail an is readily obtained by careful iooi ?9n alK C G ^ 7 I ' II ' hooding. It 1 in opinion safe for r t a a a oho would not be exposed with the absolute steadiness characteristic of ouriexperiments on rets V. I1 3 and each a concentration limit would probably do away with the troublesome skla leiIona * l o h hare beta the particular cause for worry la regard to these compounds In the past* j la add itlea to ^he inhalatica experiment e many feeding experiments * jI | cere don# w t t h / c U M l M t V diphenyl. The general change# la the U r e r TOrt the same as those already described, ilo diarijhea or gastro-inte^atinal aspects seemed to be preeeat. (] 1* O p 1* V.001?98 c $ C C BACKGROUND INFORMATION ON POLYCHLORINATED BIPHENYLS Office of Occupational Health Surveillance and Biometrics National Institute for Occupational Safety and Health November 3, 1975 k *' 1 Frin? 9 9 ACh CC t e o <t 224 *tl POLYCHLORINATED BIPHENYLS Introduccin I IReports of adverse health effects In humans and the demonstration o carcinogenic effects in certain animal species have led to the reexamination of the distribution of polychlorinated biphenyls (FC3s) in the environment and the'potential health effects of human exposure. Because the Industrial environment represents the major source of potentially high exposures to FCBs, the National Institute for Occupdonai Safety and Health (NIOSH) has gathered pertinent information on the manu facture , uses, and reported deleterious effects of polychlorinated biphenyls and is advising the occupational health community of these hazards. Background Polychlorinated biphenyls (PC3s) describe a group of synthetic chlorinated organic compounds having the following structure: i**' 2 *--1- v rT--. -- ,-r where each of the ten Z*s can represent either a hydrogen or a chlorine ! J ,.ate. There are two hundred nine different chlorinated biphenyls and they are collectively referred to as PCBs although many are not actually polychlorinated. Approximately half of these compounds have been synthesized and characterized. i n m 300 fiCf CCs f 'S C : - -T e y 2- Mixtures" of polychlorinated biphenyls are important industrial products. The most common tradenames for these mixtures are Aroclor,3 be d| Inerteen, Kanechlor, and Pyranol. Other known tradenaaes for PC3- containin"g products are listed in Table I. PC3-containing dielectrics (electrical insulators) a are generally referred ti as "askarels" in the electrical industry.*' Mixtures of polychlorinated biphenyls ar very resistant to I degredation, are thermally stable, and resistant to oxidation, acids, bases, and other chemical agents. IThey are soluble in most of the common organic solvents and lipids, but only slightly soluble in water, glycerol, and glycols. PC9s are good electrical Insulator's. Although most Individual polychlorinated biphenyls are' solids at room temperatures, the mixtures vary in consistency from mobile oils to viscous liquids or sticky resins. ?C3s are generally prepared industrially tjy the chlorination of biphenyl with anhydrous chlorine in the presence of iron filings or a ferric chloride catalyst. Trace quantities of chlorinated naphthalenes an d.chIo$inatq/i e, een.#_reorted^ in some comercial samples of PCBs and it has been suggested that the presence of these impurities may be of toxicological significance.(1, 2,3) Aroclor Is a registered trademark of the Monsanto Company Inerteen Is a registered trademark of the Westinghouse Electric Corporation for its brand of FCB containing dielectric fluids c Kanechlor is a registered trademark of the Kanegafuchl Chemical Industry Company, Ltd. i d Pyranol is a registered trademark of ! the General Electric Company for Its brand of PCB containing dielectric fluids. CGfcSSe At* 226 - 3- Commercial PC3s are g e n e ra lly m ixtures of many d iffe r e n t c h lo rin a te d b ip h e n y ls , as shown in Table I I , manufactured to meet o p e ra tio n a l s p e c ific a tio n s (such as d ie le c t r ic constant, fla sh point, f ir e point, d e n s it y , percent c h lo r in e , and c o lo r ) ; these commercial m ixtures mav varv c h e m ic a lly from batch to. batch . PC3s have found wide use in in d u stry and have been manufactured in the U nited States s in c e 1929. The major domestic m anufacturer, Monsanto Company, produces PC3s at Sauget, I l l i n o i s and re p o rts m anufacturing 40 m illio n pounds o f PCEs in the United States d u rin g 1974 (down from 85 m illio n pounds in 1 9 7 0 ).(4 ) M onsanto's domestic production and sa le s of PCBs by grade and categ ory from 1957 through the f i r s t q u a rter of 1975 are shown in Table I I I . Uses ( PC3s are employed in c a p a c ito rs and transform ers because they combine a t t r a c t iv e d i e l e c t r i c p ro p e rtie s w ith chem ical s t a b i l i t y and f i r e r e s is t a n c e . A pproxim ately tw ice as many pounds of PCBs are used in the manufacture of ca p a cito rs as in the manufacture of transform ers. ,, P r io r t<? the environm ental concern surrounding the p e rsiste n c e and u b iq u ito u sn e ss o f PCBs, (5) they were more w id ely used in in d u stry as f lu id s fo r heat t r a n s f e r system s, h y d ra u lic system s, gas tu rb in e s , and vacuum pumps, as f i r e re ta rd a n ts , and as p la s t ic iz e r s in a d h e sive s, t e x t i l e s , su rfa c e c o a tin g s , s e a la n ts , p rin t in g , and ca rb o n le ss copy paper. Bgi nnlng in 1971, Monsanto v o lu n t a r ily r e s t r ic t e d i t s domestic s a le s of PCBs to clo se d system d ie le c t r ic a p p lic a tio n s in ca p a c ito rs and tran sfo rm ers . (6) Other cu rre n t domestic a p p lic a tio n s of PCBs include use e In investm ent c a s t in g p ro ce sses, as heat exchange f lu id s , and as h y d ra u lic l 001002 AC* CCe e c 7 227 .-4- fluids. Imports of FCBs have been estimated to cxceed 375,CCO pounds for 1974. Reclaimed PCBs also are reported to be available. (7.) More chan 95 percent of . all power capacitors contain PC3s. Among their applications are use on electric utility lines, in air conditioners, and in the ballast of.fluorescent lamp fixtures. PCBs are employed for safety, reliability, and long life, as well as to achieve size compatibility with equipment and installation requirements. However, nonPCB power capacitors are being manufactured (e g General Electric1s Econol line and Sprague's Eccol line) which may serve as alternatives. (8) PCBs are employed in transformers at locations where their proximity to people and/or property demand a fire resistant dielectric. Approximately 5 percent of transformers are PCB filled and each of the transformers so filled contains between 40 and 500 gallons of PCBs (about 235 gallons is average). Possible alternatives to PCB filled transformers may include dry transformers (which are larger) as well as transformers filled with silicone fluids or other materials under evaluation. (*,9) Chlorinated terphenyls, as well as PCBs| are used in some formulations . _of_wax for investment casting processes.(8) | The chemical structure of chlorinated terphenyls resembles that of PCBsJ Chlorinated terphenyls have been reported to have toxicological effects similar to those of PCBs.(10) Approximately 330,000 pounds of chlorinated terphenyls were imported Into*the United Stateas during 1974(11) and 25,532 pounds during 1973.(12) Toxicity PCBs are poorly metabolized and tend to accumulate In animal tissues, Including humans.(13,14,15,16,17) The accumulation, particularly in I0M 303 228 A L P C C fc fc c e ! -5- tissues and organs rich in lipids, appears to be higher In the case of I I Ipenta and more highly chlorinated biphenyls.08) Studies have revealed PCBs in human fat tissue and blood plasma. PCBs, in amounts greater than 2 parts per million, were reported in 193 of 637 (31 percent) samples of human fat tissue taken from the general population of 18 states and the District of Columbia.(14) PC3 residues ranging up to 29 parts per billion have also been found in 43 percent of 616 plasma samples collected from volunteers In a southeastern U.S. county.(15) Human : The known toxic effects of PCBs in jhunans include an acnelike skin eruption (chloracne), pigmentation of the skin and nails, excessive I! 1Idischarge, swelling of eyelids, and distinctive hair follicles.(19) eye For a number of years, chloracne of the face and neck has been reported among workers exposed to chlorinated hydrocarbons. Workers exposed to PCBs in the process of insulating cablcs,(20) in the production of condensers (21) and In the manufacture of chlorobiphenyls(22) have reporte'd**' thesV"sKirTTesIons~'alotig~vftfr'syYferne*-iffV'Such V*' disturbances, edema of the face and hands, burning of the eyes, impotence, and hematuria.(16,22) The toxic effects of PCBs in humans are further illustrated by a 196A outbreak of poisoning in Japan that involved over 1,000 people who Ingested PCB contaminated rice bran oil for a fieri.od of several months. The contamination of the oil (estimated 1,500 to 2,000 ppm) occurred when heat transfer pipes Immersed in the oil during processing developed pin- sized holes. The clinical aspects of the poisoning included chloracne, Foni 304 o cCeB 229 6- brovn pigmentation ^of the skin and nails, distinctive hair follicles, increased eye discharge, swelling of eyelids, transient visual j disturbance, and systemic gastrointestinal symptoms vith jaundice(19) In ' I I some patients, symptoms persisted 3 years after PC3 exposure was discontinued. Infants Sorn to poisoned mothers had decreased birth weights, and showed skin discoloration due to PC3 placental passage. Two stillbirths to PC3 exposed women were also reported.(23) Animal: The toxic effects of PCSs in animals have becn studied extensively. Reports of malignant, non-calignant, and reproductive effects are shown in the following three tables; HALICNAX? PATHOLOGIC EJ7TCTS ISDUCED BY PCBS IN ANIMALS PCB Mixture Treatment . Animal Zf foets Kanechlor 500(24) Kancchlor 400 Kanechlor 300 500 pps, 250 ppm and 100 ppm In diet for 32 weeks Klee Livei-j w e i g h t I n c r e a s e d w i t h p e r c e n t chlorine and dosage. Kanechlor 400 and 500 produced liver cell hypertrophy.! 500 ppm of Kanechlor 500 produced hyper** ^ l a s t i t ''hifirdA ^ frr T ^of' V2 o i t r bn3 hepatocellular carcinomas in 5 of 12 icc Mo nodules or carcinomas In controls Aroelor 1254(25) 300 ppo in diet Klee for 6 4 11 mont h s Increased liver weight. Adenoflbrosls In all m i c e fed for 11 months. None of 22 Slice fed forjll months had hepatomas. One of 24 lice fed for 6 months Lad a hepatoma. Ko hepatomas In control mica. Aroelor 1260(26) 1 0 0 p p m I n d i e t for 21 months Rata Uepatocellular alteracin ln 183 of 184 rata f e d P C B s a n d i n 2 8 o f 1 7 3 c o n t r o l r a e s . Meoplastle nodulos ln 26 of 184 FCS Ccd raes and none la control rata. H c p o t o Ie c l l Iu l a r c a r c i n o m a s l n 2 6 . o f 1 8 4 r a e s lo m 305f e d r e o s a n d : L n 1 o f 1 7 3 c o n t r o l r a e s . CC865G AC* 230 NON-MALIGNANT PATHOLOCIC EFFECTS INDUCED. BY PCBS IN ANIMALS PCB Mixture Animal Route of Administration Effect g ACUTE EFFECTS Unspecified Product Containing 42 Z Chlorine(27) Guinea Pigs Rats Rabbits Subcutaneous injection Skin application feeding Fat(ty degeneration and central atrophy of the liver. Aroclor 1242(28) Arcelor 1254 Guinea pigs Rats Klee Rabbits Cat Inhalation AtocIot 1242 produced no ill effects on basis of mortality, growth, pathology, organ enlargement, liver function, or hematological changes. At o c Iot 1254 produced no harm ful effects regarding growth or mortality, but did produce enlarged livers with micro scopic evidence of hepatic cellular injury. Aroclor 1248(29) Monkeys Peedlng Weight loss, hair loss, mouth and eyelid edema, acnefors lesions, decreased hemoglobin ana hemato crit1, severe gastric mucosal ulceration and extreme hypertrophy of the liver.'' CHRONIC EFFECTS Aroelor 1254(30) Rats feeding i__ Hypertrophy of the liver cells, :'*e^con4P-p4-gmfint,iA. h.erXupfcfeTT^-,.< eella, lipid accumulation in the cytoplasm of hepacoeyces end adenofibrosis. CCh ; S 1 At* ^ 1001 ^06 231 I 8- CV.. PROD U C TIVE EFFECTS.OF PCBS IN ANIMALS PC3 Mixture Animal Route of Administration pEffccrs Aroclor 1242(31) Aroclor 1234 Aroclor 1260 Chickens Feeding Aroclor 1254(32) Aroclor 1254(33) Hallards Bobwhitcs Pheasant Feeding . Feeding A r o c l o r 1 2 4 2 a n d 1 2 5 4 reduced * 8 8 p r o d u c t i o n a n d hatchabilicy a n d ' c a u s e d c h i n eggshells. Aroclor 1260 produced no harmful effects. 1N o a d v e r s e e f f e c t s . 1 Reduced egg production and hatchabillcy. Aroclor 1254(34) Kink Feeding Severely affected reproduction. Aroclor 1248(29) Female nonkeys Feeding -Reduced ability to become pregnant. Pregnancies produced small infants with 'FCBs in tissues. *. k r ; F,noi 3vn ACi* CCee9i 232 9- Occunatlor.al Exposure , It Is estimated Chat 12,000 people are occupationally exposed to polychlorinated biphenyls. The 'majority of these exposures are in capacitor production and in Investment casting processes. Permissible Occupational-Exposure The current Occupational Safety and Health Ac ministration, Department of Labor standards for chlorinated biphenyls are, 1 mg/cubic meter for 42 percent chlorine mixtures and* .5 mg/cubic meter for 54 percent chlorine mixtures. These are based on the Threshold Limit V alues (TLV) e sta b lish e d by the American Conference of Governmental ndustrial Hygienists.(35) a c* c c o e s i ja m 3ft8 233 BIBLIOGRAPHY 1. Hutzinger, 0., Safe, S., and Zltko, V.: The Chemistry of PCB's, CRC Presst Cleveland, Ohio, p. 22, .1974 2. Bowes, G.W., Mulvihill, M.J., Simoneit, |B.R.TJ, Burlingame, A.L., and Ris.ebrough, R W ,: IdentificatIon of Chlorinated Dibenzofurans in American Polychlorinated Biphenyls, Nature, 256:'305, 1975 3. Curley, A., Burse, V.W., Jennings, R.W., Villanueva, E.C., and Kimbrough, R.D.: Evidence of Tetrachlorodibenzofuran (TCDF) in Aroclor 1254 and the Urine of Rats)Following Dietary Exposure to Aroclor 1254, Bui Environ Contaa and Toxicol, 14 (2): 153--58, 1975 4. Communication from Honsanto Industrial Chemicals Company, St. Louis, Missouri, September, 1975 5. Interagency Task Force on PCBs: PCBs and the Environment, COM-7210419, Washington, DC, March 20, 1972 6. Polychlorinated Biphenyls: Monsanto Conpanyj's Program of Restricted Sales and Controlled Manufacturing Practices, Monsanto Industrial Chemicals Company, St. Louis, Missouri, jOctooer, 1974 7. Glenn Schweitzer, Office of Toxic Substances, U.S. Environmental Protection Agency, testimony at an August, 1975, Wisconsin hearing, quoted in Toxic Maxerials News, p. 139, Septem ber 15, 1975 8. Personal coraunications with representatives of the industry, October 1975 9. Dow Corning Dielectric -Liquids for Ijover Transformers, Dow Corning Corporation, Midland, Michigan, received September, 1975 (booklet not % *-5 dA-tedJ. -? i . * ---Mr-j_ 10. Allen, J.R., Abrahamson, L.J., and Norback, D.H.: of Polychlorinated Biphenyls and Triphenyls on the Environmental Research, 6:344-54, 1973 | VI Biological Effects Subhuman Primate, 11. Telephone conversation with a representative of the U.S. International Trade Commission, Washington, DC, September, 1975 !I 12. U.S. Tarrlff Commission: Imports of Benzoid Chemicals and Products, Washington, DC., p. 24, 1973 13. Biros, F.J., Walker, A.C., and Medbery, A.: Polychlorinated B i p h e n y l s In Human Adipose Tissue, Bull Environ Contain and Toxicol, 5:317-23, 1970 14. Yobs, A.R.: Levels of Polychlorinated Biphenyls in Adipose Tissue of the General Population of the Nation, Environmental Health Perspective, 1:79-80, 1972 A C f c C B b `>`' E n n iR 0 9 15. F i n k l e a , J . , P r i e s t e r , - L . E . , Creason, J . P . , Hauser, T'., Hinners, T . , and Hammer, D.I.: Polychlorinated Biphenyl Residues in Human plasma Expose a Major Urban Pollution Probien,IAJPH, 6 2 ( 5 ) : 6 4 5 - 5 1 , 1972 16. Kimbrough, R.D.: The Toxicity of Polychlorinated Polycyclic Compounds and Related Chemicals, Critical Reviews Toxicology, CRC Press, Inc., 2(4):465--98, 1974 17. International Agency for Research on Caneen, IARC Monographs on the Evaluation of Carcinogenic Risk of Chemicals to Man, 7:251-89, 1974 18. Hutzinger, 0., et al., op. cit., p. 2 19. Kuratsune, M., Yoshiraura, T., Matsuzaka, J., and Yanasuchi, A.: Yusho, a Poisoning Caused by Rice Oil Contaminated with Polychlorinated Biphenyls, HSMHA Health (Report's, 36:1083-91, 1971 i 20. Pulton, W.B. and Matthews, J.L.: A Preliminary Report of the Dermatological and Systemic Effects lof Exposure to Hexachlorc- Naphthalene and Chloro-Diphenyl, Bureau of Industrial Standards, Harrisburg, Pennsylvania, 1936 | 21. Mayers, M.R. and Silverberg, M.G.: ISkin Conditions Resulting from Exposure to Certain Chlorinated Hydrocarbons, J Indust Hyg Toxicol, 20:244-58, 1938 .j * 22. Schwartz, L.: Dermatitis from Synthetic Resins and Waxes, An J Pub Health, 26:586-92, 1936 ! 23. Miller, R.W.: Cola-colored Babies, Chlorobiphenyl Poisoning in Japan, Teratology, 4:211-12, 1971 24. Ito, N., Nagasaki, H., Aral, M., Hasayuki, A. , Maklura, S., Suginara, S.( end Hirao, K.: Histopathologic Studies jon Liver Tumorigenesis Induced in Mice by Technical .Polychlorinated_ Biphenyls and _ Its '' ` promot:iinngg TFfec c*on^ive "^ndt-cecT* by *benzene''Hexa'chlbf1o'e ' JNCI, 51(5):1637-46, 1973 25. Kimbrough, R.D. 'and Linder, R.E.: Induction of Adenoflbrosis and Hepatomas of the Liver in BALB/cJ Mice by Polychlorinated Biphenyls (Aroclor 1254), JNCI, 53(2):547-52, 1974 26. Kimbrough, R.D., Squire, R.A., Linder, R.E., Strandbcrg, J.D., Montali,. R.J., and Burse, V.W.: Induction of Liver Tumors in R a t s by Polychlorinated Biphenyl Aroclor 126, JNCI, (in press), December, 1975 ! 27. Hiller, J.W.: Pathologic Changes in Animals Exposed to a C o r a n e r c i a l Chlorinated Diphenyl, Pub Health Reports, pp. 1085-93, August 18, 1944 1 i ACM CCS c95 f h o ir io I 28. Treon, J.F., Cleveland, F.P., Cappell, J.W., land Atchley, R.W,: The Toxicity of the Vapors of Aroclor 1242 and Aroclor 1254, Am Ind Hvg Quart, 17:204-13, 1956 I! ' 29. Allen, J.R.: Response of Primates to PCB Exposures, Federation Proceedings, 34:1675-79, 1975 30. Kimbrough, R.D., Lijader, R.E., and Caines, T.B.: Morphological Changes in Liver of Rats Fed Polychlorinated Biphenyls, Arch Environ Health, 25:354-64, 1972 31. Keplinger, M.L., Fancher, O.E., and Calandjra, J.C.: Toxicologic Studies with Polychlorinated Biphenyls, Toxicol Appl Pharmacol, 19:402, 1971 I I 32. Heath, R.G., Spann, J.W., Kreitzer,* J.R., and Vance, C.: Effects of Polychlorinated Biphenyls on Birds, Proc 15th Intern Ornithol Congr, Leiden, Holland, p. 476, 1972 33. Dahlgren, R.B., Linder, R.L., and Carlson, C.W. : Polychlorinated Biphenyls: Their Effects on Penned Pheasants, Environ Health Perspect, 1:89, 1972 34. Ringer, R.K., Aulerich, R.J., and Zabik,' M . : Effect of Dietary Polychlorinated Biphenyls on Growth and Reproduction of Mink, ACS piv Water Air and Waste Chemistry, Preprints of Papers 12:149, 1972 35. Federal Register, Vol. 37, Ho. 202, p. 22140, Wednesday, October 13, 1972 CCccVt ALf I TABLE I i TRADENAMES FOR K N O W PCB CONTAINING PRODUCTS ii i Tradename Tradename Owner Aroclor Chlorextol Monsanto Company St. Louis, MO I Allis-Chalners Milwaukee, VI Clophen Farbenfabricken Bayer GmbH Germany I Dykanol Federal Pacific Electric Co. Newark, NJ Fericlor Caffaro S.P.A. Italy Inerteen Westinghouse Electric Corp. Pittsburgh, PA Kanechlor Kanegafuchi Chemical Industry Co., Ltd. Japan No flamo1 Vagner Electr; c Corporation Newark,iNJ Phenoclor Prodelec France Pyralene Prodelec Frnte - X Pyranol General Electric Co. Schenecitady, NY Santotherm Hitsubi'shi-Monsanto Japan Theralnol* Monsanto Co. St. Louis, MO *Theralnol products now formulated in the U.S. do not contain PCBs. Vont 312 0Ce 1 i AC* 237 TABLE l i DESCRIPTION OF PCB HIXTURKS Approximate Chlorine Content Aroclor 1221* 21Z Aroclor 1016a 42Z Aroclor 1242* 42Z Aroclor 1254a 54Z Aroclor 1260b 60Z Ka^chlor 30DC ii $X Kanechlor 40C 48Z Cooponenta Biphenyl 11 Honochloroblphenyla 51 Dlchloroblphenyla 32 Trlchloroblphenyls 4 -- Tetrschloroblphenyls-- __ 2 Pcntachloroblphenyls <0.5 Bexachloroblphenyla none detected Ueptachloroblphanylo none detected Octachloroblphenylo q Wonachlorobiphenyla nona detected <0.1 1 20 57 21 1 <0.1 none detected none detected <0.1 1 16 . 49 25 a 1 <0.1 <0.1 0.5 1 21 48 23 <0.1 6 none none detected detected 12 38 41 8 1 V ,( f* A T iit. b p io i? *3 fe.S V P1*' \?> i* .i 3 33 44 U 5 i - Kanechlor 500C 53Z 5 27 55 13 . S; Aroclor la a registered trademark of the Monsanto Company, Kane eh lor la a registered trademark of the Kanegafuchl Chemical Industry Company*, Ltd. .4 I t m u s t b e e m p h a s i z e d t h a t t h e s e a r e a p p r o x i m a t e c o m p o s i t i o n s o f t h e P C S m i x t u r e *s a n d t h a t a p a r t i c u l a r p r o dmu c e .Euy vary chemical composition from batch to batch. j fe * W e i g h t - w e i g h t p e r c e n t . N o n e d e t e c t e d " l e s s t h a n O . O I Z . S o u r c e o f c o m p o n e n t c o m p o s i t i o n a l HOAMACO Company, quoted in Ilutslnger, 0., et al., op. clc., p. 23 r. P e r c e n t . S o u r c e o f c o o p o n e n t c o m p o s i t i o n s : T h r u s t o n , A . , P C B N e w s l e t t e r , Noj 3, J u l y 19 7 1 , q u o t e d 1a H utzlngar, 0., at al., op. clt., p. 23 c P o r c e n e . S o u r c e o f c o m p o n e n t c o m p o s i t i o n s : Ito, N., o c a l., op. c l t . , p. 16jJ7 ACM CC6S 00 m c" * t II.S. PRODUCTION DOMESTIC SALES U.S. EXPORT SALES 1965 60400 51796 4234 1966 65049 59078 6852 p c NAHurAcnmr: and sales j MONSANTO INUUSTKlAL CHEMICALS COMPANY! 1965 THROUGH 1975 (Thousands of Pounds) J 1967 1968 1969 1970 1J *1971 V 1972 75309 62466 8124 82854 65116 11231 76309 67194 10624 85054 73061 13651 \34994 38600 34301 26408 'i 6388 1973 42178 37742 8346 (1st quarter) 1974 1975 40466 34406 5395 8532 7986 1538 DOMESTIC SALES BY CATEGORY Heat Transfer Hyd.raul ics/ LubrI cants rfisc. Industrial T ransformer Cupac1tor Plasticizer ApplIcatlons Pe trolcum Additives 1237 4616 1841 8657 23749 11696 -- DOMESTIC SALES BY PCB GRADE Aroclor 1221 Aroclor 1232 Aroclor 1242 Aroclor 1248 Arne lor 1254 Arotlor 1260 oc lor 1262 Aroc 1Ar 1268 Aroclor 1016 * . 369 7 31533 5565 7737 5831 558 196 0 1766 4250 1779 8910 28884 13481 -- 528 16 39557 5015 7035 5875 768 284 0 2262 4643 1426 1171 29703 13361 -- 442 25 43055 4704 6696 6417 840 287 0 2529 5765 1283 1T585 29550 14404 -- 136 90 44853 4894 8891 5252 720 280 0 3050 8039 1079 12ros 25022 16460 1439 507 273 45491 5650 9822 4439 712 300 0 3958 7403 1627 3B2B 26708 19537 3060 %*! 752 1552 if 1155 t 0 0 "TIT34"' 14141.JT 25656 3259 ?%M 0 -- 1476 260 48588 4073 12421 4890 1023 330 0 --; 0 1> 2215 a 171 171 f 219R1 >; 728 213 807 4661 3495 i1725 305 1o 0V o 3334 i 20902 37742 35 .0 6200 0 7976 0 0 0 23531 34406 57 0 6207 '0 6165 0 0 0 21955 7986 10* 0 2201** 0 2115** 0 0 0 3660* * Used primarily In capacitors ** Used primarily In transfomers portisi 4 <r> n <o o o X u 1957 pen MANurACTimi' and sales j MONSANTO INDUSTRIAL CHEMICALS COMPANY. 1937 Tlinmir.ll 196A t- (Thousands of Pounds) tjj 1958 1959 1960 ii 1961 ; 1962 1*63 1964 U.S. PRODUCTION DOMESTIC SALES U.S. EXPORT SALES DOMESTIC SALES BY CATEGORY Heat Transfer llydrniil Ics/Lubricants Miscellaneous Industrial Trans former Cnpacitor Plasticizer Applications Petroleum Additives DOMESTIC SALES BY PCB CRADE Aroclor 1221' Aroclor 1232 Aroclor 1242 Aroclor 1248 Aroclor 1254 Aroclor 1260 Aroclor 4262 Aroclor 1268 Aroclor 1016 ' (1) 32299 (2) O) 26061 (2) (1) 31310 (2) 1612 704 12955 1*7028 <0 . 1549 755 5719 1`4'099"~ 3939 -- 2685 1569 5984 1"6*4'9'9" 4573 -- 23 196 18222 1779 4461 7587 31 -- -- 16 113 10444 2559 6691 5982 184 72 -- 254 240 13598 3384 6754 6619 359 102 -- 37919 35214 (2) 2523 1559 7921 16967 ' 6244 -- 103 155 18196 2827 6068 7330 326 189 -- 36515 37538 98353 38043 (2) :(2) V 4110 2114 6281 15935" 9098 -- 94 241 I i ; i57 i3915 " y 1681 f 7984 '5382 8924 hl1" V: t. ) 140 $ 224 19827 4023 6294 6540 361 158 -- (20654 j 3463 i 6325 4 6595 .1 432 J 210 'A ---- 44734 38132 3647 582 3945 1528 7290 15606 9181 -- 361 13 18510 5013 5911 7626 414 284 -- 50033 44869 4096 929 ^4374------ 1692 7997 19540----10337 596 13 23571 5238 6280 853S 446 190 '-- ;---------------------------------------------------------------------- r ^L) Production(figures and Plasticizer Applications figures unavailable during year Indicated. (2) U.S. Export Sales figures unavailable during year Indicated. f# * * SOURCE: Monsanto Industrial Chemicals Company, St. Louis, Missouri, September, 1975. t i t C' O u (N \Jr a) in O U et*. *(-J DEPARTMENT OF HEALTH, EDUCATION. AND W ELFARE PUBLIC HEALTH SERVICE I CENTER FOR D ISEASE CONTROL November 4, 1975 N A T IO N A L IN S T IT U T E FOR O C C U P A T IO N A L 5 * p ETY AND HEALTH 3600 FISHER S LA N E R O C K V IL L E . M A R Y L A N D 20132 iSift Hr. V. B. Papageorge Speciality and Process Chemicals Division Monsanto Industrial Chemicals Company 800 North Llndberg Boulevard St. Louis, Missouri 63166 Dear Mr. Papageorge: tThank you for your assistance In providing us with Information on polychlorinated biphenyls. Enclosed is a copy of the current intelligence bulletin on polychlorinated biphenyls which was released yesterday afternoon. Sincerely, Enclosure Harvey PL Stein, Fh.D. ..x X Priorities Evaluutt!ion Brinch Office of Occupational Health Surveillance and Biometrics -.t . 1 1 -- I I I I p o m Til 6 *C h CC6B2 222 I DEPARTMENT OF HEALTH, EDUCATICI^, ANO WELFARE " PUBLIC HEALTH SERVICE I c en t e r por d isea se co n tro l n a t i o n a l INSTITUTE FOB OCCUpATiCN.TL SAFETY AM O*C*LTm S600 FiSk DS LANE ROCKVILLE. MARYLAND QSS2 N O V 3 1975 Dear Colleague: The enclosed background m aterial has been prepared by th is o ffic e to inform the occupational healthjcommunity of current knowledge concerning in d u s tria l uses and t o x ic it y of polychlorinated biphenyls. Your comments and suggestions fo r changeIs to fu1ture reports are so licite d . Sincerely/yours, Enclosure 0, W illiam 11yd , Scfch D)iirecto r I( I, O ffice of Occupational Health Su rveillan ce and Biometrics * .*;-A -Tv*-iv CCcct AtP 223 I. n J,l l.i a lil L ' J fon C * lOC*IO* J . C o le m a n W eber November 17, 1975 PCB DISCUSSIONS GOVERNMENTAL AGENCIES " `NOVEMBER 13' AND 14 T O E. H. Harbison R. G, Potter W. C, Hamman D. L. Sliney C. Patn D. Wood R. A. Pohl W. B. Papageorge G^Rpush ^BT^R, Bishop K. W. Easley W. W. Withers T. H, Bottini 31ND Attached is a summary of our review of PCBfs with the various government agencies. JCW: smt Att. i J, Coleman Weber - IO f tv . I/T2 I I FOfll 318 I ( I \ oetf.r 4 2 82 PCB DISCUSSIONS GOVERNMENTAL AGENCIES NOVEMBER 13 AND 14, 1975. Monsanto Representatives -- G. Roush W. B. Papageorge J. C. Weber K. `W. Easley J. Calandra-- Industrial Bio Test Labs Puroose of Discussions 1. To show that positive action was taken by Monsanto in response to Dr. Kimbrough's report that Aroclor 1260 . caused malignant tumors in the liver of the rat. [ .2 To report that the recent review by Industrial Bio Test and Eppley Institute Consultants confirmed t*hat high levels of PCB1s does cause liver damage in the rat:, but: the lesions are not hepatocellular carcinomas. N IO S H John Finklea * Director (Present for the introductions only) K. Bridbord - Assistant to the Director R. A. Rhoden - Criteria Documents ` R. Moore - Editor "Alert" Bulletin R. Stein - Criteria Documents .D. P. Brown - Epidemiologist, NIOSH Cincinnati Laboratory E. J. "Bud" Fairchild Director, Cincinnati Laboratory T. Kopp - EPA, Office of Toxic Substances j R. Shapiro - FDA, Bureau of Foods, Office of Science Renate Kimbrough - Center for Disease Contrjol Discussion centered on the fact that we and Dr. Kimbrough agree that PCB's cause lesions in the liver of the rats but. disagree with her interpretation that some of these are hepatocellular carcinoma** Our interpretation is that these lesions are the expected damage you would see in the liver caused by chlorinated hydrocarbon*. Dr. Kimbrough's work was done oh f*e"*m*a-lie~ r~ats using only Aroclor 1260* The point was made thal: the production of Aroclor 1260 was stopped in 1971. There is a real problem in that the people concerned with PCB's treat them as one chemical like "DDT" and do not recognize the difference between Aroclor 1260# 1242# etcl i oni si 9 100925 4 / ^ Dr. Brown and Dr. Fairchild of the Cincinnati office plan to conduct a mortality study at Wes.tinghouse'si Bloomington, Ind. capacitor plant covering the past 30 years.) This study will take about two years to complete. Dr. Roush discussed our review of causes of- death of employees assokiate'd with the , production of PCS's.over the past 25 years.! Dr.I Fairchild offered to help us complete our study. j NIOSH. is concerned that there is poor control in containment and plant practices once the PCB leaves our plant. NIOSH men tioned a "use permit" as a control. It appearsjNIOSH will not , recommend the banning of PCS's but very, restrictive practices on using then. J CSQ - (Council of Environmental Quality) Warren Muir - Assistant Director- i Peter Winkel - TNO - Netherlands | David Walsh - OSHA j Short discussion on our revi.ew with NIOSH(<coverI.ing the same ground. CEQ has no specific plans regarding PC3*s. Dr. Muir did report the Administration is backing the McAllister bill in the House on toxic substances. jI Dominick Daniels (N.J.)' House Subcommittee Manpower, Compensation Health and Safety Daniel Krivit - Counsel I Mrs. Susan Nelson - Staff Assistant These people are interested in PC3's because they are concerned that NIOSH and OSHA are not carrying outf their responsibilities as directed by Congress and can use PC3's as a political tool. Also PCB's are important to them because)Representative Daniels will be proposing a bill called "Hazardous Substances Dispersion Act" and will use PCB's tb-'sh'ow the need1 for 'such legislation. We expect that this Subcommittee will conduct! hearings on the PCB problems. Krivit's and Nelson's knowledge about PCB's is very limited, but they are eager to establish a working relation-? ship with the chemical industry and invite active discussion with Monsanto. J . j Krivit was involved in drafting the current Occupational Health and Safety Act. * ( F,001T20 id o o n n 4284 / NCI Dr. Jim Peters - Director,-Division of Cancer,Cause and Effect Dr. Garry Flamm - Assistant Director jI Dr. Herman KraybLl. - 'Toxicologist * '! R. A. Rhoden - NIDSH R. Shapiro - FDA ~ Bureau of Foods j Short discussion of our interpretation of Dr. IKimbrough*s data and Industrial Bio Test report. Dr. Peters readily recognized the problem that the pathologists need to resolve the differences: Dr. Peters recommended that HEW's Toxicology (Coordinating Committee take it under advisement. This committee is chaired by Dr. David Rail. '* | NCI also reports that Aroclor 1254 is included in(the Stanford Research Institute's multi chemical chronic feeding studies with rats. FDA Dr. A1 Kolbye - Ass. Director for Sciences,isureau of Foods Ray Shapiro - Bureau of Foods -J Charles Jalinek - Bureau of Foods I Jerry 3urke - Bureau of Foods j Larry Garthoff - Bureau of Foods jj Al Pohland - Bureau of Foods j' l A. R. Bennett - Office of the General Council S. M. Pape - Office of the General Counsilf I II We reviewed the data we had presented to the other agencies. Kolbye1s concern is body burden. The FDA as considering lowering the allowable level of PCB's in fish. If this happens, it will have a serious'impact on sport fishing as (many /lakes and streams will be out of bounds. Kolbye reports that Canada will soonannounce a guideline of 2 ppm PCB's maximum allowed in edible fish. Kolbye is also.disturbed about,the[lasting effect of the Japanese PCS incident that happened in 1968. * EPA John Buckley - Consultant Leonard J. Guarraia Arthur J. Pallotta - Toxicologist Lawrence A. Plumbs - M.D.. A. M. Kuamack David Garrett - Office of Toxic Substar R. M, Hutlif - Office of the General Cc Blake Biles - Attorney, Enforcement .Ofi R. E. Shapiro - FDA Bureau of Foods E001321 ti 100927 428 'EPA is continuing their concern about the high chlorinated homologs of PCB's in the environment. In general this group of EPA was not receptive to our concept that: PCB'js are not cancer causing agents. "EPA most probably will treat PCB's as such which appears to be consistent with their desire to have a Toxic Substances Act. I In general, it appears that our visit to these agencies on an individual basis was beneficial to Monsanto and did cause them to recognize the bigger problem of defining a cancer causing agent. This definition is extremely important nbt only to the status of PCB's but any other chemical that* may cause lesions in an animal. J. Coleman Weber I11/17/75 smt E001352 1 002~ 4 286 I / MQNlJjrro iMQusmr*<. CIM CJU.S CO. IQO M.t.iMSr$n lj.1* St. Lim. Untavi) 13 Cl PMar (31 114*1000 Oeeeober 11. 1975 I (II Hr. Sari J. Stephenson Director, Enforcement Division Environmental Protection. Agency 1733 Baltimore Kansas City Missouri 64108 Dear Mr. Stephenson: Attached is a response to the questionnaire which accompanied Mr. Stanley Legro's letter dated October 17 1975. To the best of ay knowledge end belief the in foras tion contained la this response represents the best information available to Monsanto. If X can be of further assistance, please let ae know. I Sincerely, j ,,y frC/. If. B. jFapageo'rge '' Manager. Product Acceptability Process Chemicals Division jt Attachment CC: Mr. Stanley w. Lcgro1 US Environmental Protection Agency 401 "y* Strive, sw KA*hingu,n# O.C. 10460 F001323 ^<*Rass;*.- c llNlIFF'S^ afBfrf .il *,l Ci.ni.f ACM 007 241 t ' POLTCHLHINATTO SIPHEMYL (PCS) C C M P C W O S OR MIXTJRES Za response the phrase "PCS compound or mixture" includes chose materials listed' under Bass Products in Exhibit! A. . 1. (a) Honsanto Industrial Chemicals Company does not import PCS . compounds or mixtures. Amounts produced for 1971, 1972, 1973, 1974 and tha first three quartate of 197S art included la Exhibit C. (b) Production facilities': T**o* W 7 1 and 1923 Monsanto Company Box 249 Anniston, Alabama 36201 for 1971 to present Monsanto Company Pouts 3 Sauat, Illinois 62201 The amounts produced at the Annistcn,| Alabama plant are shown on Exhibit 0. The Sauget, Illinois unit produced the amounts shewn on Exhibit E. Wholesale and retail outlats are not used. (c) See Exhibit P for 1971, Exhibit; G for 1972, Exhibit H for 1973 and 1974 and Exhibit I for 1975. Th PCS compounds or mixtures from the Anniston, Alabama facility are listed in Exhibit 0. The remaining were shipped from the Saut, Illinois facilit/. 2 (a) See Exhibit A - pages 2, 3 and 4 and Exhibit B. Ob) Sm Exhibit A - pages 2, 3 and 4. (c) The PCS compounds or mixtures used were produced by Monsanto 1(b). (d) Production facilities are those shown under lib) and for 19*1 and 1972 also included Monsanto Company, 1700 South Second Street, St. Louis. Missouri 63177. | Produces distributed 'through Monsanto's Anniston, Alabama unit are shown on E/hihit Zt, All Py traul ;>roi-cti2 wore distributed through the St. Louis, Missouri facility. | Ketnaindwr o C products distributed through the Sauget, Illinois unit. Amounts discrib' axo shown on the exhibits listed in 2c below. 1001324 q Q7 I - 2- () k Exhibit r for 1971, Exhibit G for 1973, Exhibit H for 1973 sad 1974 and Exhibit i for 1973. [Th products' obtained from t h e Ann is eon, Alabama facility are list lid in Exhibit D. The Pydraul products origins tad at this St. Louis, Missouri unit. Th retaining wars shipped froa the Sauget, Illinois facility. Ha do not nanufactura consumer products! containing PCS coepounds or mixtures. * J 1| if 3. (a) During 1971 and 1972 PCS compounds or aixeuras vara usad as host transfar fluids, hydraulic fluids and in trans formara and capacitors. During tha latter part of 1972, 1973, 1974 and 1975 PCS compounds or.mixtures ara only present in transformers and capacitors. *... 0) Sae Exhibit J. Amounts shown ara for total Monsanto Company usage. No records ara available [to determine specific company facility. Inerteen was used in transformers. Pydrauls in air compressors. Tha n i n o is .in industrial heat transfer systems. (e) The PCS products vert all produced by Monsanto Company. I Ispctific sources are shown on Exhibit J. 4 PCS coapsunds or mixtures are not reclaimed The.- I. 5 (a) During 1971 and 1972 solid waste material contaminated with PCS compounds or mixtures were buried jin a secure landfill located within a fenced area on jproperty owned by Monsanto Company at the Anniston, Alabama facility. Similar waste has also been buried in a secure landfill Jloeated on Monsanto Company property at the Sauget, Illinois facility during the period 1971 - 1973. Liquid wastes have been |disposed by incineration for the period 1971 - 1975 in a (high temperature unit located at the Sauget, Illinois facility. During 1973 solid waste was sent to Texas Ecologists, P. 0.1 Box 307, Robstown, Texas 78380. (b) Haste materials containing PCS compounds or mixtures are received from many sources. Th type of PCS compound or mixture in the waste is unknown). Tha concentration is also unknown. Solid waste is estimated as 'containing levels ranging from the ppm level to 50i by weight Liquid waste is estimated to contain about 90\ PCS compound or mixture. For amounts disposed see Exhibit K. re,fer to the total weight of waisto. un tnovn. Noto the amounts shown The actual PCS concent is (e) Sc: Exhibit r. for total waste disposed. Concentration anJ type of PCS compound or mixture are unknown. Pam!?? 5 243 007 1 - 3- i ! . .i r. , 'i * 1. l) Im Exhibit L. Total amounts o f vaste *rt shown. Concentration M d type of PCB compound or mixture i n unknown. 1 (4) Sm Sa for m m nd loeaeloa. In fa h lib lt X for ueunc dUpc.d. i; S Exhibit A. Monsanto Company does not Import or reclaim PCB compound* or mixtures. Composition of disposed material is unknown but esn range from ppm level to 100% Iby weight PCB. U ) See Exhibit H for Sauget. Illinois facility wesce effluent analyses. See Exhibit N for Anniston] Alabama facility water effluent analyses. .,For PCB emissions to the atmosphere at the Saug'et# Illinois facility see Exihibit 0. Analytes of air estlssions were naqjaade at the Anniston# Alabama facility. (b) See Exhibits M# H and 0. j 1 (e) No information is available regarding the Anniston# Alabama facility. No information is available relating to PCB con- centration in the air in the area of the Sauget# Illinois facilii Samples of the Mississippi Rive`Lr w-e-r-e-] taken in 1-9-7-2. Results w e n as follows: / . .. t t Sample Pate Location 10/30/72 12/13/72 12/12/72 t Analytical T.B. Bridge (downstream) C h a i n of Rocks Bridge (upstream) H. of 111. River (upstream^ i i Ii II bla nk v a l u e at 0 . 0 0 0 0 3 * 0 . 0 0 0 1 7 I i Pea 0.00012 0.0002 - Q.OO 0.0002 * 0.001 r* (a) PCI compounds or mixtures are 'liquids and are transported in bulk or in stesl drums. :> I ./ (b) See Exhibit P for transporters cf PCB compounds or mixtures from Monsanto facilities. Transporters of material returned for disposal can bo any common carrier serving the St. louis. Missouri area. ! rum**' 9 ' 4 f Monsanto Compiny lo not war of any occasion in which FC3 compounds o r m ix tur** wart introduced into the environment which i s n o t tiraaly k n own to representatives of the Environoantai protection Agency, examples include the contamination of fish meal in North Carolina the drainage of fluid from a transformer in transit in Tennessee and the leakage of fluid from a damaged transformer /in the Ouvaaiih waterway in Washington. [ II 10 Monsanto Covp+nY i* not aware of any health or environsaental effects resulting from the introduction of PCS compounds or/mixtures into the environment which has not been reported in the scientific and popular prssa and siready.Xhowm ta representatives (f the environmental Pro tec tiorj Agency. / * 11. * % (a) Monsanto Company has received reports fthat shout 1800 drums, of PCS compounds or mixtures are being of*r*d jby a coaptny located in the U.S. for sale forjsriy application. This information was reetived from Kr. Sobert Laham, Hub Fabric leather Company 7 Charlton Street Everett' Massachusetts 0*14P: .This has been discussed with a representative of the Environ**! Protection Agency. `' l l Pacently Pyramid Chemical Salas Company 103$ Virginia Ori ve * Fort Washington Pennsylvania 1503 jl has advertised the availability for any application of' Arcelor 1221 Aroelor 1232 and A r d o r 5460. A representative /of the Environmental Protection Agency has been informed. *0 007 I I I I i r ./ * \ t 4 OQ\tt^ * ADM 0071*2 o\ J i P0LTCH1QRtHATCD 8IPt!g?TYL A?fP POLYCHLORINATED TSRPHENYL PRODUCTS - m o m s a h t o it^ o s t r i a l c h s m i c a l Ss c o m p a n y - -- 1971 - 1975 Rase Products Aroclor 1016 Polychlorinated biphenyls (41.3% chlorine by weight) Aroclor 1221 - Polychlorinated biphenyls (21% chlorine by weight) * * [I Aroclor 12M* % Polychlorinated bipKfcnyls (32% chlorine by weight) Aroclor 1242 Polychlorinated biphenyls (42% chlorine by weight) Aroclor 1248 i Polychlorinated biphenyls (48% chlorine b y weight) Aroclor 1254 Polychlorinated biphenyls (54% chlorine b y weight! Aroclor 1260 Polychlorinated biphenyls (60% chlorine b y weight) Aroclor 1262 Polychlorinated biphenyls (62% ehlorine by weight) Aroclor 5060 Polychlorinated terphenyls (60% chlorine by weight) Aroclor 5432 Polychlorinated terphenyls (32% chlorine by weight) Areelor 9442 j Polychlorinated terphenyls (42% chlorine1by weight) 946 Polychlorinated terphenyls (60% chlorine by weight).-. Wydraul icn/I ui*ci cants Pydraul AC- Aroclor 5432 Pydraul AC-n winter Grade Aroclor 5442 loot 100 100 100% 10p% 100% 100% 100% 100% 100% 100% 100% 53.5% 14.0% ADM 007143 Fydraul A - 200 Arelor 1242 'Arcelor -1249 fydrtul A-200I Aroclor 5432 Pydraul M A Aroclor 5432 fydraul 135 Aroclor 1232 Aroclor 1242 Pydraul 13A* Aroclor 5432 Pydraul ISO Aroclor 1242 Pydraul 1S0A Aroclor 5432 Pydraul 230 Aroclor 1221 Aroclor 1242 Pydraul 23OA Aroclor 5432 Pydraul 312 Aroclor 1242 Pydraul 312A Aroclor 5432 Pydraul 54CA Aroclor 1242 Aroclor 5442 S40A Aroclor S432 Pydraul 42S.\ Aroclor 5432 Santovae 1 Arcelor 1248 Santovac 2 Aroclor 1254 --2 - 33*3% 66.7% 30.0 39.9 9.5 34.5 27.1 23.C Uiu% 3 3.0 54.7 29.3 47.3 31.1 39.8 15.7 42.0 60.0 100.0 100.0 A D * 007l<r* HydraulIca/lub ricanta (cont'd) TUIIBt tll . Anelar 1321 /, Anelar 1242 Haat Trinafar Fluida Tharminol m - 0 Aroclor 1242 ; Tharminol PR-0 Lev Tacparatura,, Aroclor 1242 ^ Tharminol FR-1 Aroclor 1242 Tharminol FJl-2 Aroclor 1248 Tharminol FU* 3 Aroclor 1254 Trinaformar and Capacitor Fluid Capacitar 21 Aroclor 1221 Inartaan PPO Aroclor 1260 Inortcon 70-30 Aroclor 1254 Incrtaan 10C-42 Aroclor 1242 T n f f 54201 A9 Aroclor 1242 XaorOMti 54201 Aroclor 1242 Inerteon 54201 KA Aroclcr 1254 Znortaen 54201 KJ Aroclor 1221 Aroclor 1010 CS 140 A r o c l o r 1010 4.4% 1*5% 0.0% 50.0% 100.0% 100.0% U^.0% i 100.0% 40.6% 70.0% 100.0% 45.0% 99.9% 70.0% 32.5% 32.5% 90.0 * Transferier and Capacitor Fluid (cant'd)- f f t m t d A 1 U (also Fyranol 1476) Acodar 1254 altctrical grada Fyranol A 131 31 Aroclar 1260 Fyranol A13S 31-2 < Aroclor 1254 ^ Fyranol A13B 31-3 Aroclor 1254 "* Flastlclrar Application Aroclor 6037 Aroclor 5460 Aroclor 1221 Aroclor 6040 Aroclor 5460 Aroclor 1221 Aroclor 6050 Aroclor 5460 Aroclor 1221 Aroclor 6062 (10% Xylan#) Aroclor 6062 Aroclor 6062 Aroclor 5460 Aroclor 1221 Aroclor 6070 (10% Xylano) Aroclor 6070 Aroclor 6070 Aroclor 5460 Aroclor 1221 Aroclor 6090 Aroclor 5460 A.roclor 1221 Aroclor 44CS Aroclor 12G2 Aroclor 5460 Montar 5 'o'/chlorinated polyphenyl 100.0% 45.0% 45.0% 60.0% 27.0% 62.0% 50.0% 50.0% 90.0% 62.0% 38.0% 90.0% 70.0% 30.0% 90.0% 10.0% 50.0% 50.0% 103.01 NEWS FOR RELEASE IMMEDIATELY 1976 I i i Monsanto i i M O N SA N T O IN D U ST R IA L C H E M IC A LS D* R . Q i s h o D (314) 694-2391 PUBLIC *LAT>Oh s 0PA(*tV WO N Ltndbrgn B o m tv ira Si. Louis. M istoi *t U1CA . MONSANTO RA ISES PCS P R IC E C IT E S PHASE OUT EXPENSES ST. LOUIS, Dec. 17 -- Monsanto ( Company j said t o d a y1 that e f f e c t i v e Jan. 1, 1977, it w i l l increase the p r i c e of all grades o f its p o l y c h l o r i n a t e d b i p h e n y l (PCB) .dielectric i n s u l a t i n g fluids i| by about 2 4 per cent. Monsanto market^ PCBs exclusively to the li elec t r i c a l power supply industry for use as fire resistant dielec t r i c fluids in transformers and 'capacitors. I M o n s a n t o a n n o u n c e d last O c tober its intentions to terminate the production, sale and distribution of its PCB products by ' ' iOct. 31, 1977. The c o mpany said that it w o u l d have withdrawn sooner, but a majority of its customers required that much lead time to complete field testing and convert to replacement products. IA c c o r d i n g to Monsanto, this p r o t r a c t e d p h a s e out p r o g r a m has caused certain production imbalances that make efficient o p e r a t i o n i m p o s s i b l e . T h e c o m p a n y saijd the r e s u l t i n g higher unit c o s t s , c o m b i n e d w i t h o t h e r p h a s e - o u t - r te l a t e d e x p e n s e s , were m a j o r reasons behind the price increase. a0H 002323 248 NEWS FOR RELEASE IM M ED IATELY 1976 Monsanto M O N SA N T O IN D U ST R IA L C H EM IC A LS D. R . B is h o o (314) 694-2891 PU BLIC fleurions 0PA*r*i 900 H LindMrgn 6ouitiQ 51. Lout. Misidi *t 431C9 MONSANTO RA ISES PC3 P R ICE CiI T E S PHASE OUT EX PEN SES S T . LO U IS, D ec. 17 -- M onsanto Com pany s a id to d ay th a t e f f e c t iv e Ja n . 1, 19 77, i t w ill in c re a s e the p r ic e o f a l l grades I] o f i t s p o ly c h lo r in a t e d b ip h e n y l (PCB) d i e l e c t r i c in s u la t in g f l u i d s by a b o u t 24 p e r c e n t . M onsanto m arke ts PCBs e x c lu s iv e ly to the e le c t r ic a l pow er su p p ly in d u s try fo r use as f i r e re s is t a n t d ie le c t r ic f lu id s in tra n sfo rm e rs and c a p a c ito rs . M onsanto announced la s t O cto b e r i t J in t e n t io n s to te rm in a te th e p r o d u c t io n , s a le and d is t r ib u t io n o f i t s PCB p ro d u c ts by i1 O c t. 3 1 , 1 9 7 7 . The com pany s a id th a t i t w o u ld have w ithd raw n I| s o o n e r , b u t a m a jo r it y o f i t s c u s to m e rs r e q u ir e d t h a t much le a d tim e ^ to ^oitija let_e fi,e.ld_ t e s t i n g ^and^ppnv%.rt..tJo ..je^lac^men^. ^pro^Rcts*^ A c co rd in g to M onsanto, t h is p ro t ra c t e d p h ase out program h a s c a u s e d c e r t a in p ro d u c t io n im b a la n c e s th a t make e f f ic ie n t o p e ra t io n im p o s s ib le . The company s a id th e r e s u lt in g h ig h e r u n it c o s t s , co m b in e d w it h o t h e r p h a s e -o u t -re la t e d e x p e n se s, w ere m a jo r re a so n s b e h in d th e p r ic e in c r e a s e . i -o0o*f AOH C 0 2 3 2 3 248 I I I F. J. Fitzgeraldj V ice-President, Monsanto Chemical Company J a n u a r y 14, 1976j Good afternoon, my name is Jack Fitzgerald. I am a vice president of Monsanto Company, a memberj of its Corporate Administrative Committee and managing director of Monsanto In dustrial Chem icals Company, an operating unit of Monsanto Com pany. Since I am responsible for the operating unit whiph manufac tu r e s polychlorinated biphenyl dielectric fluids} John Hanley, our p re s id e n t, has a sk e d m e to re p re s e n t him today and reaffirm to you M onsanto's com m itm ent to continue working with the EPA and the electrical industry in finding solutions to the PCB issue. Let me state at the outset that Monsanto agrees wholeheartedly w i t h E P A 1s d e s i r e to w o r k t o w a r d th e g o a l o f e v e n t u a l l y e l i m i n a t i n g all uses of P C B 's. ! Monsanto has already taken several ste p s designed to re s tric t the entry of P C B 's into the environment, I F i r s t , M onsanto began re stric tin g the u se of P C B 's solely to c lo se d e le c tr i c a l s y s te m s , for which no viable a lte rn a te s existed. back in 1970. It should be noted that this voluntary p rogram was f u ll y i m p l e m e n t e d p r i o r to th e c o m p l e t i o n ofj th e s tu dy do ne on P C B 's by a F e d e r a l Interagency Task F o r c e in 972. Secondly, Monsanto has been working for a num ber of years on n on-P C B re p lacem en t products. These m a te ria ls , designed to rep lace PCB fluids in capacitors and tra n s fo rm e rs , are currently being evaluated by the m a jo r electrical mjanufacturers in the United .States^.. ^ . - ** j - - ' ~ - - V r ..x V , - r ^ While the PCB issu e is a tough one to handle, the difficulty does not n o r will not in the future stem from any la'ck of cooperation on t h e p a r t of M o n s a n t o . T h e p r o b l e m s t h a t [we f a c e , c o l l e c t i v e l y , a r e r a t h e r r o o t e d in t h e u n i q u e c h a r a c t e r i s t i c s of] P C B ' s and the i r replaceable role they have served in our electrical-industrial envi.ronment for the past 45 years. The challenge: Replacing them in an o rd e rly m a n n e r without creating another hazard of equal or potentially g re a te r consequence, while at the same time avoiding serious power and transportation disruptions. L e t m e e m p h a s iz e that wc have no d e s i r e to rem ain in thu J'CH m a n u f a c t u r i n g b u s i n e s s any l o n g e r than) i s n e c e s s a r y . By this I m ean as soon as we a re satisfied that the electrical power supply industry's needs for usable, acceptable altern ate dielectric fluids have been m e t by w h o m e v er, Monsanto w ill voluntarily shut down its PCB m anufacturing unit. In the in te rim , we will continue to work with industry and government to ensure that the restrictive m e a s u r e s a n d c o n t r o l s w e i m p l e m e n t e d in t h e e a r l y 19701s r e m a i n in force and are-diligently pursued. S' E n n it f 6 247 B U L L E T IN NO. JC/FF-38R-2 1 (R a v i d Augit- 1976) TRANSFORMER Inspection & Maintenance Guide Monsanto SC* 1t1-ET X iti H.*ITi B>tT*I"rA?T*\L*i*jvv'*--' A1i 'J# vs> ^2ii ry m ^ fe ACM I CO 195 i TM bRffl ff SECTIO N A T R A N S F O R M E R A S K A R E L S .........................................1 I. Introduction-....................................^................... 1 M. History o fT red e N am eT yp ei . . . .*....................1 Table I - The Composition of * Transformer A skarels ....................^................. 2 Ml. Interchangeability ........................... * . .............2 IV . Table II - O fficial Transform er Adtarel Shipping S p e c ific a tio n s .....................*.............. 3 V . Ordering Instructions ........................' .............. 2 V I. S t a b ilit y .............................................................. 2 V II. Precautions When Handling Drums, Tank Cars and When Opening T ran sform ers....................... 2 A . Keep Dry During Handling ..........................2 Table III - Handling and Pumping Tem peratures................................. 4 3. Use O rdinary Personal Precautions ............. 4 C. Precautions on Opening an Askarel T ran sfo rm er......................................5 V IM . Avoid Environm ental P o llu tio n .......................... 5 1. Labeling Askarel T ransform ers.................... 6 2. Disposal of Liquid and Solid Wastes ..........G 3. Conditioning of New or Recycled Askarel 6 4. Teardown of Transformers for Repair or Scrap ......................................7 5. Transformer Disposal ....................................7 IX . Expected Service L i f e ........................................ 7 X . General Characteristics of Transform er Adtaret F lu id ....................................................... 7 X I. Sampling Transformer Adtarel Fluid ............... 8 X II. Evaluation of Adtarel Received in New E q u ip m e n t............................................. 8 X III. D ielectric Breakdown Voltage - Moisture R e la tio n s h ip ........................................ 9 Table IV -- Relation of D ielectric Breakdown Voltage to Am ount of Dissolved W ater in Askarel and Mineral O i l ......................................9 Table V - Approxim ate So lu b ility of W ater in Transformer Askarel and Mineral O il . . . . 10 X IV . Turbidity .................................. 10 X V . Check Points for M aintaining Adtarel Insulation ........................................... 10 A . General C onsiderations............................... 10 B . Modern Sealing Procedures ........................11 C. The Older Sealing A rrang em ents................ 12 X V I. Periodic Flu id Inspection and W hat C hed tpointi Mean ................................. 12 A , Visual In sp e ctio n ....................................... 13- B . D ielectric Breakdown Voltage ................. 13 X V II. I ra p m io n C h e c k lis t......................................... 13 X V III. Contam ination in Transform ers................. . 14 Table V I -- Effect of Common Insulation Materials on Power Factor and D ielectric S tre n g th ........................................... 14 Table V II - Effect of Common Insulation Materials on Volum e Resistivity of A s k a re l..........................................................14 X IX . A STM Method for Investigating the Com patibility of Transform er Insulation and Construction M aterials in A s k a re ls ..........15 X X . R ef ining A d u ret for R e - U se ............................ 15 A . Filtering Through D ry Blotter Paper to Remove Moisture end Extraneous P a n ic le s ....................................15 Table V III L Water Removal Askarel Through a Paper PrKS ' erm^ 3. Disposal of Solid Was* >6 C. Solid Insulation Requiring n rv'inrt ........... ! ? D. Earth Treatment for Maximum 9 ...........5 I Improvement of Power Factor and | volum e Resistivity Table IX - (Effe ct of Power 15 X X I. X X II. Factor and|Volume Resistivity Cleaning Arced Transformers Sampling skarel . . SECTIONa j A S K A R E L F IL L E D SW IT C H ES A N 0 T E R M IN A L C H A M B E R S ............ I'. In tro d u c tio n ..................... II. Sources of 'Contamination III. Sealing Switches and Terminal Chambers ' IV . Askarel Used Under Mild Arcing Conditions V . Maintenance for Adcaral Filled Switches V I. Askarel Unjder Excessive Temperature or Fault Conditions .......................... 19 . 19 .20 .20 .20 2\ SECTIONC J. . . . . . . . . . . . . . . . . . . . . . .T O X IC IT Y AND SA F E H A N D L IN G .......................... 2 1^8 I. Inhalation ^ II. Skin C o n ta c t.................................................. 21 SECTIOND i A N A L Y T IC A L S E R V IC E S ON TRANSFO RM ER ASKAREL A V A IL A B L E FR O M M O N SA N TO ..............................22 Types of Analyses Available: ....................................... 22 11 Routine Maintenance C h e c k ....................................... 22' 2) C om plex A n a ly s is ................................................. 22 3) Analysis After Earth Refinem ent ...................... .22 SECTIONE A P P E N D IIC E S . . ..|.........................................................23 Appendix'A -- Askarel Stability and Composition of Arc Formed G a s .............................. 23 Aopendix B - Solubility of Gas in Transformer Askarels .............................................. 23 Aooendixlc -- Effect of Temperature on Dielectric Breakdown Voltage of Askarel . . . . . . . . 23 Append!xlo - Comparison of the Approximate Viscosity in Saybolt Universal Seconds of Transformer Askarels and Mineral O i l ....................... 24 Appendix E - The Oensity of Ineneen 54201 KA 7336-9^ and Transformer Pyranol IA13B3B-3 ................................................... 24 Appendix F -- Theijmal Conductivity Values of Transformer Pyranol A1383B-3................ 24 AppendixG - Heat C a p a c ity ........................................24 Appendix1H - Coefficient of Ex p a n sio n .......................24 Appendix'I -- Fire Resistance..................................... 24 Appendix J --Seals1, Properties and Procurement j ..................................................... 25 Appendix K --Caution L a b e l......................... 25 N O T IC E :; "N othing contained herein is to be construed as a recommendation to use any product in conflict with any patent. M O N SA N TO M A K E S NO W A R R A N T IE S A S TO T H E FIT N E SS |F O R A P A R T IC U L A R PU R PO SE OR M E R C H A N T A B IL IT Y O F A N Y PRO D U C T R E F E R R E D TO, no guarantee of satisfactory results from reliance up on contained inform ation or recommendations, and dis claims all liability for any resulting loss or damage." F n n r r ACM 0 0 1 ^ 5 3 , \ \ *% by swelling in d 'craA in g o f t h r exposed edge. In ct a n of n w i deterioration, IQuid H e p tg i is usually present, a. Chide fo r leskagie at pedcing gland of sw itching'shaft. it leaking, repack w ith i Silastic ring type gaA at. Askant I l V I. Undar Excewive Temperature or Fault Conditions \ [ Tho IE E E Guide also points out that, "Chlorobenzenes used|in transformer askarels begin to boil at ' temperatures [of about 205*C, under atmospheric conditions. If the material it heated to such high temperature in a sealed system, pressure develops. Pressure will also develop m the system if the askarel is arced sufficiently to generate copious hydrogen chloride gas. || 'Therefore, it is recommended that wherever possible, sealed askarel'filled equipment be provided with pressure relief devices. These devices must be t'arge enough to provide immediate relief at a definite prenure, andjto prevent further build up of pressure if decomposition continues. It must be remembered that the presence of devices of this sort does not necessarily preclude the rupturing of containing vessels, since pressure build up can ba extremely rapicj under violent arcing conditions." i@ fom G Toxicity& Safe Handling y I. Inhalation A t ordinary temperatures :ne chlorinated biphenyls in Askarel have not presented industrial to x co logical problems. The hazard of ootantial toxic exposure varies witn their vo la tility: the lawer<hlorinated, mare* volatile ones present [more of potential problem from the standpoint of both inhalation and skin contact. When Askarel fluids are used at elevated temperatures, engineering controls must be applied, either by the use of dosed systems or by effective local-exhaust ventilation together w ith general jworkroom exhaust. Vapors of Askarel at room tem perature should not be breathed in e confined space; and no vapor of any fluid evolved at elevated temperatures should be allowed to be dispersed into tho general workroom . Inhalation tests on animals indicate that the maximum safe concentra tion of vapor is in the range of from 0.5 to 1.0 milligram par cubic meter of sir. The threshold lim it value (maximum allowable concen tration o f an 8>hour|working [day) set by the American Conference o f Governm ent Hygienists are [1.0 milligram of the lower-chlorinated biphenyl compounds [per cubic meter of air and 0.5 milligram of the more-hi^tly-chlorineted compounds, per cubic meter of air. II. Skin Contact [ Prolongad or repeated skin contact w ith the Askarel fluids must be avoided by the use of gloves and protective garments, because of the possible occurrence of a condition called chloracne. AJthou^s reports o f this condition caused by Askarel are rare, it can be produced by excessive A in contact! If the fliiid is spilled on the A in the skin should be w u h ed in the uiuaijm anner w ith a soap solution. A bum caused by contact w ith a hot Askarel should be treated like any ordinary bum. [ 1 VIII,For disposal instruction* o f A A arel fluids, see Section A - page 6. FT vrw f oov^ tr? L - / 7 K f Monsanto ^ Jk . TO MDUSTfUAL CHEMICALS CO. N. lindborgh Boulovard S t Louis. M issouri 63166 Phfcna. G U ) 694-1000 ` September 22, 1977 rp > JPCOALTYCHEMICALSDivision r. Dick Jones, Senior Buyer Westinghouse Electric Corporation ^69 Sharpsville Avenue Sharon, Pa. 16^16 Dear Mr. Jones: As you know, Monsanto will completely withdraw as a supplier of PC3 dielectrics October 31, 1977. Concurrent with this withdrawal date, Monsanto will stop making available to ackarei users the "Transformer Askarel Inspection and Maintenance Guide", Bulletin No. IC/FF-38R-2. Although operators of askarel transformers have used this askarel guide as a reference manual in the past, environ mental regulations on PCB's are changing rapidly and have made the bulletin obsolete. This bulletin will not be updated. (May I suggest that you destroy all copies in your files and offices so we don't inadvertently supply obsolete information to the industry.) If your company has ever used our bulletin as a supplement to your own literature, we want you to be aware of our decision. Equally, v/e ask you to note that in your own use of this bulletin you recognize that tne last edition was issued August 1976. It should not be relied upon new or in the future. Sincerely, C/ /; /;> /. , J- f* J. A. Alley1*. Industry Specialist Dielectrics tme a unit of M o naanto Company IO O 324 I PAG E 1 OF 4 Monsanto material safety data 9 N O TE: I N O R E P R E S E N T A T IO N IS M A O E A S t o T H E A C C U R A C Y O F TH E IN FO R M A T O N ANO R EC O M M EN D A T IO N S H E R E IN . S E E P A G E 4 FO R C O N D IT IO N S U N O ER W H IC H D ATA A R E F U R N IS H E D MONSANTO PROOUCT NAME PO LY C H LO R IN A T ED B IP H E N Y L S -- P C S ' * S m page 4 fo r d efin itio n and note M ONSANTO COM PANY 800 N. LIN D B ER G H BLVD . S T LO U IS. M O . 63166 EM ERG EN CY PH O N E NO. (C A LL CO LLECT) (314) 694-1000 PRODUCT IDENTIFICATION Synonym Trad# N am e (C om m only u**d M o n sa n to products) P C B 's C h lo ro d ip h e n yl (__ % Cl) C h lo rin ated b ip h en yl Po lych lo rin a te d b ip h en yl C h lo rin ated bip henyl# (ap p ro x. _ % C l) Askarel** A ro clo r** Sen e 1016,1221,1232,1242, 1246, 1254,1260 Pyren o t** Serie# i In e rteen *' Series T h e rm in o t*1FR Se ries I See page 4 for notes C A S N o. 001336363. 053469219, 021672296. 01109769. 011096825 and o th e rs I WARNING STATEMENTS Fed eral reg u latio n s un d er th e Toxic Su b stan ces Control A ct require PC 8 's and PC B item s to be m erited. (Check reg u latio n s for d e tails.*) THIS EQUIPMENT CONTAINS PCB (Am CAPAcrroRfs) CAUTION CCKUM) PCS* FONmorti otSPOULncxMiTio* comici us tmoMtfftm moncnoa teuer i v i v i i j o i i i u M A I t K I A L S A F f c T Y D A T A EMERGENCY AND FIRSTAID PROCEDURES In g e stio n -- C o n su lt a p h ysician . Do not induce vom iting or g ive any o ily lax atives. N O T E TO P H Y S IC IA N -- If larg e am oun ts ingested, g astric lavag e jis suggested . S k in -- If liquid or so lid P C B 's are splash ed or spilled on skin, contam inated clo th in g should be rem oved and th e skin w a sh ed th o ro u g h ly w ith soap and w ater. N O T E TO P H Y S IC IA N -- H ot P C B 's m ay cause therm al b u rn t. i E y e s -- Eyes should be irrig ated im m ed iately w ith copious quantities of ru n n in g w ater for at least 15 m inutes i if liq u id or so lid P C B 's get into them . A petrolatum -based ophthalm ic o in tm en t m ay be applied to the eye to re lie v e the irritatin g effects of P C 8 's. J| In h a la tio n -- R em o ve to fresh air. If skin rash or respiratory irritation p ersists, consult a physician. NO TE TO P H Y S IC IA N -- If ele ctrical eq uip m ent arcs over, P C B 's or other chlorinated hydrocarbon dielectric fluids m ay H im MXdecom pose to produce HCI, hydrochloric acid, a respiratory irritant. G 4048 250 ADM OC2159 Monsanto material safety data 4P A G E i O F NOTE: a l t h o u g h t h e in f o r m a t io n a n o r e c o m m e n d a t io n s s e t fo r t h in t h is s h e e t a r e b e l ie v e d to BE CORRECT AS OF THE DATE HEREOF, MONSANTO COMPANY MAKS NO REPRESENTATION AS TO THE COMPLETENESS OR ACCURACY OF SUCH INFORMATION AND RECOMMENDATIONS. MONSANTO COM PANY SHALL IN NO EVENT BE RESPONSIBLE FOR ANY DAMAGES OF WHATSOVER NATURE DIRECTLY OR INDIRECTLY RESULTING FROM THE PUBLICATION OR USE OF OR RE .IA N C E U PO N SU C H IN FO R M A T IO N AND RECOMMENDATIONS. NO WARRANTY. EITHER EXPRESS OR M PUED, OR MERCHANTASUTY OR FITNESS OR OF ANY OTHER NA-ftjRE WITH RESPECT TO THE PRODUCT OR TO THE INFORMATION AND RECOMMENDATIONS HEREIN IS MADE HEREUNDER. T h is form h a t been a p p ro ved by th a O ccupational S a fe ty and Haafth A dm iniatrafion as " q u iv a le n t to " O SH A Form 20. MATERIAL S AF E T Y D A T A Monsanto 'P O L Y C H LO R IN A T E D B IP H E N Y L S F o r regu latory p u rp oses, under the Toxic Su b stan ces C ontrol A ct tna term "P C B 's " refers to a ch em ical sub stan ce lim ited to th e b ip henyl m olecule that has been chlorinated to varyin g degrees or an y com bination o f sub stan ces w h ich con tain 50 ppm (on a dry w eigh t b asis) or greater o f such substance (40 C FR 761). C h em ically, h o w e ve r, P C B 's are defined as a series of tech n ical m ixtures, consisting of m any isom ers and com p o und s th at v a ry from m obile o ily liquids to w h its crystallin e solid s and hard non-crystalline resin s. T ech n ical p rod ucts v a ry in com position, in the degree o f chlorination and possibly according to batch. T h e m ixture g e n e ra lly used con tains an averaga of 3 atom s chlorine perjm olecule (4 2 % ch lo rin e) to 5 atom s of ch lo rin e per m o lecu le (5 4 % chlorine). They are used as d ielectric fluids in transform ers and cap acito rs. P rio r to 1972. P C S ap p lica tio n s in clu d ed heat transfer m edia, hydraulic[and other industrial fluids, plasticizers, carbonleas paper, p ain ts, inks and ad hesives. "Fed e ral regu latio ns now sp ecify that non-totatty enclosed PC B a c tivitie s are p erm itted o n ly if sp ecifically exem pted or au th o rized ." (40 C FR 761 see F E D E R A L R E G IS T E R . V ol. 44, P. 31514, M ay. 31,1979) C A S No. X 1 336363: Fo r gen eral class of com pounds TRADE NAM ES A S K A R E L -- G e n e ric n am e for a broad class of fire-resistant synthetic chlorinated hydrocarbons used as d ie le ctric fluids. | 91 R eg istered trad em ark o f M onsan to C om pany I * R eg istered trad em ark o f G en eral Electric C om pany I * ' R eg istered trad em ark o f W estin g h o u se Electric C orp oratio n T h is list o f trad e n a m es is rep resen tative of several co m m o n ly used M onsanto products (or form ulated w ith M onsan to p ro d u cts). M a n y other tradem arked products w e re m arketed by M onsanto and other chem ical m anufacturers. PC 8*s w ere also m anufactured and sold by several European and Ja p a n e se producers. Con- tact th e m an u factu rer o f th e tradem arked product d irectly, if not in this listing, to determ ine if the form ulation contained PCB's. ! DATE Sep tem b er 15.1980 REVISED SUPERCEDES A ll prior to 9/1S80 FO R A D D IT IO N A L N O N - E M E R G E N C Y IN FO R M A TIO N . C O N TA C T : 80-010 253 Jo h n H. Craddock. M anager. Product & Environm ental Sa fe ty M onsanto Industrial Chem . Co. 800 North Lindbergh B o u levard St. Louis. M issouri 63166 (314) 694-4764 FOiVI^ ADM 0021o2 I PCS M ANUFACTURING ANO SA LES J MONSANTO IN D U ST R IA L CHEM ICALS COMPANY 1967 thru 1978 j (Thouuods of Pound) | U .S PR O D U C T IO N D O M EST IC S A L E S U .S EX PO R T SA LE S 1967 196 1966 ID ID (!) 32299 26001 31310 (2) 12) (2) I960 1961 37919 36515 35214 37538 1962 19631 1964 l 38353 44734 50833 1 36043 36132 44869 1966 1966 60480 65849 51796 59078 .12) (2) (2) 3647 4096 4234 6852 D O M EST IC S A L E S BY CATEGORY H u t Transfer H y d ra u lic a /L u b rica n o Mise. Industrial Transform er 0 1612 704 12955 0 1549 755 5719 0 2688 1569 5984 0 2523 1559 7921 0 4110 2114 6281 f157 3915 f 1681 798 582 ( 3948 I 1528 929 4374 1692 729(3 7997 1237 J1766 4616 4258 1841 1779 6657 8910 Cacao tor Wtsticiztr Aeeiieations 17023 ID 14099 3939 16499 4573 16967 6244 1S93S 9098 15382 r 8924 15608 i 9181 19540 10337 23749 11696 23884 13481 Patrolaum Additiv 0 000 0 000 D O M EST IC S A L E S BY PCS GRA E c doctor 1221 Aroclor 1232 Aroclor 1242 Aroclor 124S Aroclor 1254 Aroclor 1260 Aroclor 1262 23 196 18222 1779 4461 7507 31 16 113 10444 2559 6691 S9S2 18 254 240 13596 338 075 6619 359 103 155 18196 2827 6068 7330 326 94 241 19627 4023 6294 6540 361 j1140 224 20654 i 3463 j 6325 j 6595 432 361 596 369 |l3 13 7 18510 I 5013 I 5911 7626 23571 5238 6280 8535 31533 5565 7737 5831 414 446 558 528 16 39557 5015 7035 5875 768 Aroclor 126t Arodor 1010 0 72 102 169 158 210 284 190 196 284 0 00000 000 0 (11Production figure and Ra*ticiz*r Apications figuras unavailable during year indicated. (2) U.S Export Salts figuras unavailaWadurmg ytar indicataci. . ` ack o c c e u f 254 fI 1967 1968 1968 1970 1971 1972 1973 1974 1975 1976 75309 82854 76389 85054 46417 42178 40118 29710 29592 624 8124 6S116 11231 67194 10624 73061 13651 34301 10648 32242 6388 37742 8346 34406 5395 25611 5'M2 24329 Ji 4 744 1977 13330 12701 1548 1978 0 0 0 2262 2629 3050 3958 3060 752 0 0 0 0 0 4643 5765 8039 7403 1562 0 0 0 0 0 0 1420 11071 29703 13361 1283 1156S 29550 14404 1079 1627 12106 .13828 25022 26708 16460 19537 1155 11134 14141 3259 0 11314 20176 0 0 14176 23566 0 0 12394 22012 0 0 121'63 12848 0 0 ! 61302 I 18327 0 0 1617 11084 0 0 0 1439 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 442 136 507 1476 2215 26 35 57 28 20 0 26 90 273 260 171 43055 44853 45491 48588 21961 0 6537 0 6200 0 6207 0 f 6435 0 * 118 0 51 4704 4894 5650 4073 213 0 0 0 0 0 0 6696 6891 9622 12421 4661 6115 7976 6185 6328 584 1566 6417 5252 4439 4890 1725 414 0 0 0 0 0 840 720 712 1023 1 0 0 0 0 0 0 287 280 300 330 0 0 0 0 0 0 0 0 0 0 0 3334 20150 23531 21955 12820 18307 11084 0 0 0 0 0 0 0 0 0 Fnm ^4 00SV3 255 I PCB YEARLY SALES TOTALS WESTINGHOUSE - ALL LOCATIONS ALL PCB PRODUCTS 1954 - 1977 1954 4,681,644 lbs 1955 4,346,780 lbs 19 56 " 7,083,144 lbs 1957 8,367,139 lbs 1958 4,562,464 lbs 1959 5,648,271 lbs 1960 8,294,977 lbs 1961 6,591,368 lbs 1962 5,843,134 lbs 1963 7,517,688 lbs I ! I I ! f I I I j ! I | fnoia*5 AO* CCbSTi 256 1964 7, 492,896 Ibs 1965 9,271,259 lbs 1966 8,027,542 lbs 1967 10,856,219 lbs 1968 10,316,063 lbs 1969 8,038,072 lbs 1970 9,071,230 lbs 1971 6,851,689 lbs 1972 6,740,904 lbs 1973 7,951,141 lbs 19 74 9>980,243 lbs 19 75 7,754,663 lbs 1976 5,456,521 lbs 2 ii Fnm 36 ACM C0897J 1 257 I i O 1977 693,993 lbs 3 Total All Years: 170,539,344 lbs Fnni 37 4 0* CGfl7* 258 Mortality of PCB Workers at the Monsanto Plant in Sauget, Illinois J u d it h A . Z a c k an d D a v id C Musch D ecem ber 14, 1979 pam ^8 oono I raye x Sum m ary An historical prospective mortality study was conducted on workers exposed to polychlorinated biphenyls at the Monsanto Company plant in Sauget, Illinois, Eighty-nine workers exposed to' PCBs for minimum of six months during the period 1945 to 1965 were followed for their mortality experience. Observed deaths were not statistically different from expected deaths for any of the cancer sites examined. No deaths were observed from cancer of the lkver or! pancreas or from malignant melanoma. No excess was seen in deathsi from liver cancer, A statistically significant excess of circulatory disease, exclusive of arteriosclerotic heart disease, was seen in white males. Background The term "polychlorinated biphenyls" (PCBs) describes a group of mixed chlorinated biphenyls which vary in consistency from light free-flowing liquids to crystalline and non-crystalline solids depending on the degree of chlorination, PCBs have been in commerical use since 1929. Their electrical properties, fire resistance, and inertness have made them popular for many applications. They have been used particularly | in the production of electric capacitors and transformers and in the insulation of electric cables and wires. i Reports of adverse health effects in roan and carcinogenic effects in certain animals species prompted the National! Institute of Occupa t i o n a l S a f e t y and H e a lt h (N IO SH ) t o re q u e s t t h a t e p id e m io lo g ic a l s t u d - ies be carried out on PCB-exposed worker populations. In a prelimin ary study of workers exposed to PCBs at the Mobil Oil Company plant in Paulsboro, New Jersey, Bahn reported an excess of deaths from malignant melanoma and pancreatic cancer among research and production employ* ees.^ At the same time, Roush reported the findings of a preliminary mortality study of PCB workers at the Monsanto Company plant in Sauget, Illinois (G. Roush, written communication, September 1976) No cases of malignant melanoma or pancreatic cancer were found. vom ruQ 1 009^1 Ea =e 2 The accidental poisonings with PCBs in Yusho, Japan provide informa tion on the acute toxic^effects of PCBs for man. PCB poisoning occur red following the ingestion of Kanemi rice oil contaminated with PCBs. The general symptoms of Yusho disease included neuroendocrine disturb ances, abnormal lipid metabolism, disturbances of the respiratory II 2 system, acneform eruption, pigmentation, ana ocular changes. Yusho disease, however, has also been attributed to the ingestion of poly chlorinated dibenzofurans (PCDFs) present in the rice oil as PCB con taminant. The presence of PCDFs obscurs the relationship of PCBs to the clinical picture of Yusho disease. In 1976, the Monroe County Board of Health conducted biochemical tests among Bloomington, Indiana residents exposed to ^CBs. Serum levels of gamma glutamyl transpeptidaise and plasma triglyceride levels were found to show a direct relationship to serum PCB levels.^ In a recent study, Warshaw et al. evaluated! pulmonary function in 243 workers exposed to PCBs in the manufacture o[f capIacitors. 4 Thirtyfour of these workers (14%) were found to have ainormal forced vital capacity measurement. Of these thirty-four[ twenty-seven demonstrated a restricted pattern of impairment with virtually no radiographic change The relationship between restrictive spirometrie impairment and duration of PCB exposure was not addressed in this study. Extensive studies of PCB toxicity for animals have been conducted and have been throughly reviewed. 5 In a two-yearI chroInic oral toxicity test of PCBs, no carcinogenic effects were observed in the rats and beagles tested. Hyperplasia, hypertrophy, extensive fibrosis, and several, benign tumors were observed in the livers of the rats, but there was no evidence of malignancy of any of the test animals.b Other investigators have reported liver tissue effects ranging from hyperplasia to well-differentiated hepatocellular carcinomas in rats or mice fed with various PCB-containing diets. Kimbrough fed rats PCBs and observed lipid accumulation, hypertrophy, and adenofibremas, but no maligancies in the livers of the tesIt animIals. 7 In a later 100952 Page 3 experiment, the same researcher reported the induction of hepatocellular carcinomas and neoplasti*c nodules of the IliverI. I The literature on PCB toxicity points to several organ sites in man that could potentially incur toxic effects of exposure to PCBs. The present study represents a completed analysis of the preliminary study of Monsanto PCB workers reported in 1976. This study will examine the mortality experience of PCB workers with particular attention given to overall cancer, liver and pancreatic cancer, and malignant melanoma Population and Methods This study focused on workers exposed to polychlorinated biphenyls at the Monsanto plant in Sauget, Illinois. PCBs were manufactured at this [| plant during the period 1936 to 1977. All male employees from the hourly roll who worked in the PCB departmentjfor at least six months L| between January 1, 1945, and December 31, 1965, were selected for study During the period of study, the PCB process remained relatively unchanged The process, in brief, involved the batch chlorination of biphenyls in the presence of iron and iron chloride catalysts. The crude mixture produced in the chlorinators was aerated, distilled, earth treated, filtered and transferred`to storage tanks. Mo industrial hygiene data were available to quantify the PCB exposure levels. Through inter views with plant personnel, it was determined that exposure levels to PCB did not vary considerably within the PCB department Therefore, all workers in the PCB department were considered to have common exposure level. Other exposures in this department included hydrochloric acid, tri- and tetrachlorobenzene, biphenyl, and chlorine gas. The PCB worker cohort was identified from the plant's computerized work history system. Eighty-nine male hourly employees met the criteria for inclusion in the study. The vital status of each member was deter- IJ mined as of December 31, 1977, using standard followup techniques. A death certificate was obtained for each person found to be deceased. i i 100953 I The underlying cause of death was coded to the Eighth Revision of the International Classification of Disease. AdapIted 8 by an experienced independent nosologist. The data were analyzed by the modified life table method using the g Monson program. Standardized mortality rati os were calculated for nineteen selected cause-of--death categories, Mortality comparisons were made with the general U.S. population, Statistical significance was determined at the 5% level assuming a Poisson distribution. Results Eighty-eight of the eighty-nine members of the study cohort were traced, Fifty-eight were verified living and thirty were ^erified deceased by jdeath certificate. The results of this vital status tracing are shown in Table 1. I The person-years of observation contributed by the eighty-nine member study cohort are shown in Table 2. A total of 1800.1 person-years were observed at all ages. Most of these person-years were observed in the middle-age range with 1333.1 person-years (74%) observed for ages 35-60. I ! I II Table 3 categorizes duration of exposure to |PCBs by vital status. For both living and deceased workers, the majority were exposed less than three years. The next frequent exposure class was for five or more years of exposure. The least number of workers fell in the three to five years of exposure category. Overall, the average length of expos ure for living and deceased workers was similar with deceased workers \ having 3.7 years of exposure and living wor cers having slightly less at 3.2 years. The mortality experience for all males is summarized in Table 4. The mortality of white and nonwhite males is examined separately in Tables 5 and 6. Observed and expected deaths and SMR's are shown for each of the nineteen cause-of-death categories examined. Foni os i *n f9 ~ .t For all males, there were 30 deaths observed and 22.88 expected (Table 4 s j ,The overall SMR was 131 For malignant neoplasm 8 deaths were obser ved with 4.46 expected. The SMR for all malignant neoplasm was 179. No deaths were observed from liver or pancreatic Jcancer or from malig nant melanoma. " The SMR for lung cancer was jhigh at 278. The only statistically significant difference seen in thisj table is seen for diseases of the circulatory system, exclusive of arteriosclerotic heart disease. Nine deaths were observed with 3.98 expected, yielding a SMR of 226. Table 5 shows the overall SMR remains high for white males at 133. There were 4 deaths from cancer with 2.70 expected. None were from liver or pancreatic cancer or from malignant melanoma. The high SMR's seen in Table 4 for lung cancer and the resiidual diseases of the circula ! tory system appear to be explained by the high SMR's for these causes in white males. There were 3 deaths observed from lung cancer with 0.94 expected, yielding a SMR of 319. For he category of circulatory disease, exclusive of arteriosclerotic heart disease, the SMR was 526 with 7 observed and 1.83 expected deaths. This difference was the only one of statistical significance in this table. For nonwhite males, there were no statistically significant differences seen in Table 6. The overall SMR was also high at 128. Four deaths from cancer were observed with 1.76 expected, but none from liver or pancreatic cancer or from malignant melanoma. Case histories for the eight cancer deaths are summarized in Table 7. Discussion | . if The results of this study do not corroborate an excess risk of pancreati cancer or malignant melonoma among workers exposed to PCBs as reported in the study of Mobil workers. Nor do the results uphold translating to man the outcome of animal tests, in which hepatomas have been associ ated with long-term PCB exposure. In this study] no deaths were ob- F n n i fisa i "0n9"5 served fr<xn pancreatic or liver cancer or frjcc malignant melanoma. I I The SMR for all causes was elevated from What one would expect in an industrial cohort. The high SMR for white males is, for the most part, explained by the excess in deaths from circulatory diseases exclusive of arteriosclerotic heart diseases. This cause-o[f-death category includes deaths from rheumatic heart disease, cerjebrovascular disease, and other forms of heart disease, all of which are unlikely to be related to exposure in the workplace. It is urged that a larger study to be undertaken of the total Krummrich plant population to evaluate the overall risk of death from all causes and from cardiovascular dis eases . 100956 i References 1. Bahn AX, Rosenwaike I, Herrmann N, et al|: Melanoma after Expo-r sure to PCB 's NEJM 295:450, 1977 .2 Kuratsune* M, Masuda Y, Nagayama J: Some of the Recent Findings Concerning Yusho, in Proceedings of the National Conference on Polychlorinated Biphenyls, November 19-2`l, 19j75, Chicago, EPA560/6-75-004. US Environmental Protection Agency, Office of Toxic Substances, 1976, pp 14-29 3. Morbidity and Mortality Weekly Report: Polychlorinated Biphenyl Exposure - Indiana. Center for Disease 'Control, 27 (12):99-100, 1978 4. Warshaw R, Fischbein A, Thorton J, et al1: Decrease in Vital cap acity in PCB-exposed Workers in a capacitor manufacturing facility. In Health Effects of Halogenated Aromatic Hydrocarbons. Annals of the New York Academy of Sciences, New York, 1979. Vol 320 5. International Agency for Research on Canceri Polychlorinated biphenyls and Polybrominated biphenyls. | Iarcj Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans, Lyon, 18, October 1978 6. Kimbrough RD, Linder RE, Gaines TB: Morphological changes in liver of rats fed with polychlorinated biphenyls. Arch Environ Health 25:354-364, 1972 ; I 7. Kimbrough RD, Squire RA, Linder RE, et al: Induction of liver tumors in Sherman strain female rats by (polychlorinated biphenyl Aroclor 1260. J. National Cancer Inst. 55:1453-1459, 1975 8. Eighth Revision, International Classification of Diseases, Adapted for Use in the United States. U.S. Department of Health, Education and Welfare, Public Health Service, PHS (Publication No. 1693. Washington: U.S. Government Printing Office, 1977 9. Monson RR: Analysis of relative survival and proportional mortality. Comput Biomed Res 7:325-332, 1974 Fnm 100957 XJ Table 1 Polychlorinated Biphenyl Workers, Results of Tracing as of 12/31/77 Total to be traced Status Known Verified Alive Verified Dead Death Certificate Found Death Certificate Not Found Status Unknown 89 88 58 30 30 0 Table 2 Person-Years of Observation Contributed by Workers Exposed to P C B 's by Five Year Age Groups Age in Yars Person-Years of Observation 20-24 25-29 30-34 35-39 40-44 45-49 50-54 55-59 60-64 65+ 1 1114 63 L8 14216 222l5 283'.2 3251.3 294'.5 207 L6 134; 0 115>.2 Total - All Workers 1800J. 1 Vnni 100959 I I Table 3 Duration of Exposure to PCB's for Workers by Vital Status Years of Exposure Living N=58 Deceased N-30 Unknown N=1 . < 1 yr. 1-3 yrs. 3-5 yrs. > 5 yrs. Average Length of Exposure 20 5 20 12 64 12 9 3.2 vrs . 3.7 vrs.1 i 1 I 0 1I 0 j! 0 1 017 vrs. Total N=89 26 32 10 21 3.3 vrs. Lifetime exposure prior to 1-1-66. p-nfv W 1009G0 I.C.D. No. (Eighth Rev ) 140-209 140-149 150-159 155,156 160-163 162,163 185-189 200-209 390-458 410-413 460-519 520-577 800-998 ' Table 4 Observed and Expected Deaths, All Males Cause of Death Observed All causes of death All malignant neoplasms Buccal cavity and pharynx Digestive organs and peritoneum Liver All other digestive organs Respiratory system Lung All other respiratory organs Genitourinary organs Lympatic and hematopoietic tissue Other sites Diseases of the circulatory system Arteriosclerotic heart disease All other diseases of the circulatory system Diseases of the respiratory system Diseases of the digestive system All other diseases External causes of death 30 8 0 1 0 1 4 4 0 1 1 1 16 7 9 1 2 2 1 ___ Number of persons observed * 89 * p <.05 Expected SMR 22.88 131 4.46 179 0.16 -- 1.33 75 0.10 1.23 81 1.53 ' 261 1.44 278 0.09 0.51 196 0.40 250 0.53 109 11.17 14 3 7.19 97 3.98 226* 1.27 79 1.20 167 2.40 83 2.38--- --- 42- -- 5n o H. O #3 O CO 7D C5 Table 5 Observed and Expected Deaths, White Males I.C.D. No. (Eiqhth Rev.) 140-209 140-149 150-159 155,156 - 160-163 162,163 -- 185-189 200-209 -- 390-458 410-413 460-519 520-577 800-998 Cause of Death Observed All. causes of death All malignant neoplasms Buccal cavity and pharynx Digestive organs and peritoneum Liver All other digestive organs Respiratory system Lung All other respiratory organs Genitourinary organs Lymphatic and hematopoietic tissue Other sites Diseases of the circulatory system Arteriosclerotic heart disease All other diseases of the circulatory system Diseases of the respiratory system Diseases of the digestive system All other diseases External causes of death 18 4 0 0 0 0 3 3 0 0 0 1 11 4 7 0 1 2 0 Number of persons observed - 60 *P <.05 3 Expected i?*53,v 2.'70 0.09 0.75 0.05 0.70 0.94 0.89 * 0.05 0.28 0.28 0.36 6.82 4.99 1.83 0.73 0.75 1.10 1.4-3 SMR 133 148 -- -- - - 319 337 - - 278 161 80 526* 133 182 I.C .D . No. (Eighth Rev.) 140-209 140-149 150-159 155,156 -- 160-163 162,163 - 105-189 200-209 -- 390-450 410-413 - 460-519 520-577 800-990 Table 6 Observed and Expected Deaths, Nonwhite Males Cause of Death Observed Expected All causes of death 12 All malignant neoplasms Buccal cavity and pharynx 4 0 Digestive organs and peritoneum 1 Liver 0 All other digestive organs 1 Respiratory system 1 Lung 1 All other respiratory organs Genitourinary organs o 1' Lymphatic and hematopoietic tissue 1 Other sites 0 Diseases of the circulatory system 5 Arteriosclerotic heart disease 3 All other diseases of the circulatory system 2 Diseases of the respiratory system 1 Diseases of the digestive system 1 All other diseases 0 External causes of death --------- "1-- -- -- 9.35 H76 0.07 0.58 0.05 0.53 0.59 0.55 - 0.04 0.23 0.12 0.17 4.35 2.20 2.15 0.54 0.45 1.30 -- 0.-95 Number of persons observed = 29 SMR 128 227 -- 172 -- 189 169 102 435 833 115 136 93 185 222 -- 10.5 Race Nonwhite Nonwhite Nonwhite White White White Nonwhite White Table 7 Case Summaries of Cancer Deaths Among PCB Workers Year of Birth 1909 1913 1909 1893 1912 1916 1907 1906 Year of First Exposure 1942 1954 1951 1943 1951 1951 1945 1940 Year of Death 1959 1965 1968 1963 1968 1977 1964 1957 Duration Ever Exposed to PCB1s 1 yr.. 1 mo. 7 yrs., 1 mo. 2 yrs., 4 mos. 2 yrs., 10 mos. 2 yrs., 4 mos. 2 yrs.. 9 mos. 8 mos. 6 yrs.. 7 mos. Death Certificate Statement of Cause of Death Carcinoma of pplon (153.8) Carcinomatosis primary site kidney (189.0) Carcinoma of the lung (162.1) Carcinoma right lung" (162.1) Cancer of lung (162.1) Carcinoma" of lung (162.1) Multiple myeloma (203.0) Metastatic carcinoma carcinomatosis (199.0) `TTJ C5 H 1 -fcv Monsanto uoHtiAirro iNousjmuk c h iu c ju j co. IOC N Liflditrgn loui#rg St levia. M tiaeurijsjisa 314) 814-1000 I I Dear Sir: We are writing to advise you that Monsanto has adopted c e r t a i n r e s t r i c t i v e policies w i t h r e s p e c t to its fur t h e r .sale and delivery of all polychlorinated biphenyl (PCB's) products used as dielectric fluids in|transformers and capacitors including but not limited to^those sold under t r a d e n a m e s such as A r o c l o r In'e r t e e A , and P y r a n o l a nd u n d e r the g e n e r i c terra askarel. E f f e c t i v e 15 J a n u a r y 1972 Monsanto w i l l sell and deliver these products only to manufacturers of transformers or c a p a c i t o r s w h o h a v e entered into| a g r e e m e n t to indemnify and h o l d h a r m l e s s M o n s a n t o in the u s e | o t hese products. The two copies of such an agreement are attached. The a c c e p t a n c e b y M o n s a n t o of such an a g r e e m e n t is subject to r e ceipt of financial and other information from you (such as evidence of adequate insurance protection) which, in Monsanto's opinion, makes the agreement meaningful. As we have previously advised you# studies indicate P Q ' s m a y b e acc u m u l a t i n g in the environment. In some instances# PCB's h a v e b e e n found in food or in the food chain. For y o u r i n f o r m a t i o n , attached is an a r t i c l e b y Carl G. G u s t a f s o n of the Federal Water Qualityj Administration a p p e a r i n g in "Environmental Science & jTechnology" which deals with this subject. Because of Monsanto's concern over this problem, we are discontinuing sales of PCB's in any applications except as dielectric fluids for use in transformers and capacitors. RUNTIFFS; Exhibit t unii al Meniamo Cam 001 133 AO. CG< 72 Pig 2 If you desire to continut purchase of these products from M o n s i n t o after IS January, please h a v e the attached copies of agreement signed b y an authorized officer on behalf of your company and forward a fully signed copy, together with your most recent audited financial statement and any other i n f o r m a t i o n w h i c h you feel w i l l a s s i s t M o n s a n t o in its evaluation. If y o u h a v e any q u e s t i o n s p lease t e l e p h o n e (314) 6 9 4-2455 or w r i t e d i r e c t l y to Mr. H. S. Bergenj, M o n santo Company, P. 0. B o x 14617, St. Louis, M i s s o u r i ,63178. W e s i n c e r e l y r e g r e t any h a r d s h i p s tha^t this decision m a y c a u s e y o u b u t it is t a k e n in an jefforjt to continue to make available these products for critical electrical applications. Verjy tru Ly yours, /jf Enclosures Howard Bergen, Director Specialty Products Group Monsanto Industrial Chemicals Co. 134 A C M O C I Monsanlto MOMtAwra iNau|rRiAL chimicjuj ca 900 kOuii^if|| St.louii. UiiQgri|s3igg (314) ft4 .1000 SPECIAL UNDERTAKING BY P U R C H A S E R S OF P O L Y C H L O R I N A T E D BIPHENYLS Monsanto Company ("Monsanto") manufactures certain poly c h l o r i n a t e d b i p h e n y l p r o d u c t s ("PCB 's " ) w h i c h _________ ("Buyer") desires to purchase. While B u y e r desires to purchase PCB's| because of certain desirable flame resistant and insulaor properties. Buyer a c k n o w l e d g e s that it is aware and has b e e n advised b y Monsanto that PCB's tend to persist in the environment; t h a t care is required in their handling, possession, u s e and. d i s p o s i t i o n ; that tolerancej limits h a v e been or a r e b e i n g established for PCB's in various food products. Monsanto has therefore adopted certain restrictive policies with respect to its further production, sale and delivery of PCB's, including the receiptjof undertakings from its c u stomers as set forth below, and B u y e r is willing to a g r e e to such undertakings with respect to sales and/or deliveries jof P C B ' s b y M o n s a n t o to Buyer, A c c o r d i n g l y , B u y e r h e r e b y c o v e n a n t s a n d ag r e e s that,, w i t h respect to any and all PCB's sold or delivered by or on behalf of Monsanto to Buyer on or after the date hereof and in consideration of any such sale or delivery. Buyer shall defend, indemnify and h o i k h armless Monsanto, its present, past and future directors, officers, employes and agents, from and against any and all|liabilities, claims, damages, penalties, actions, suits, losses, costs and e x p e n s e s a r ising out of or in c o n n e c t i o n with the receipt. purchase, possession, handling, use, sale or disposition of such PCB's by, through or under Buyer whether alone or in combination with other substances, including, without impliec li m i t a t i o n , any c o n t a m i n a t i o n o|f or, a d v e r s e effect o n hum a n s , marine and wildlife, food, animal feed or the environment b y reason of such PCB's. , .A ll 4f W lN IIA II C t n i l A V 1 135 AC W OC n 1 I - 2- All xisting contracts for the sal of PCS*s by Monsanto to B u y s r irt h rby amended to contain th provisions st forth above. N o t h i n g h e r e i n shall craata or Imply a n y duty or obligation of M o n s a n t o to sail or dalivar any P C B ' s to Buyar. No condi' tions, undarstandings or agreements purporting to nedify or vary tha terms hereof shall be binding unless hereafter made in w r i t i n g specifically referring to|this agreement and signed by tha party to be bound and no modification or variance of tha above undertaking shall be affected b y tha acknowledgment or acceptance of any sale document, purchase order, shipping instruction or other forms containing terms or conditions at variance herewith. BY; TIT 12 : OATS: (Buyer) MONSANTO COMPANY BY!_________:________ Fn/v 136 A C M CC FOLYCHLOAI??ATEO BIFtfgriYt AND POLYCKLORINATEO TgAPHEXYt, PAOPCCT3 HOHSAHTO INDUSTRIAL CHEMICALS' COMPANY 1971 - 1975 B i n Product Aroclor 1016 Folycblorinaeed biphenyls (41.3% chlorine by weight) Aroclor 1221 * Polychlorinated " biphmen+yls (21% chlorine by weight) Aroclor 12 M * ^ Polychlorinated biphbnyls (32% chlorine by weight) Aroclor 1242 Folychlorinsted biphenyls (42% ehlorine by weight) Aroclor 1249 i Folychlorinsted biphenyls (43% chlorine by] weight) Aroclor 1254 Polychlorinated biphenyls (54% chlorine by weight) Aroclor 1260 Folychlorinsted biphenyls (60% chlor'ine by weight) Aroclor 1262 Folychlorinsted biphenyls (62% chlorine by weight) Aroclor 5060 Folychlorinsted terphenyls (60% chlorine by weight) Aroclor 5432 Folyshlorinated terphenyls (32% chlorine by weight) Aroclor 5442 Polychlorinated 0 t Aroclor 5460 Folychlorinsted terphenyls terphenyls (42% chlriAe by weight) (60% chlorine ay weight),* 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% Hydraul icr./t uiri cants Pydraul AC-A Aroclor 5432 Pydraul AC*n winter Cradc Aroclor 5442 53.5% 14.0% I T n-n * o r e7^ ADM 0 0 7 l <*3 /""*v () pydraul A-200 ArOclor 1242 1A r e l a r 1248 t* Pydraul A-200 Aroelor 5432 Pydraul F-9A Aroelor 5432 Pydraul 135 Aroelor 1232 Aroelor 1242 Pydraul 135* Aroelor 5432 Pydraul 150 Aroelor 1242 Pydraul 150A Aroelor 5432 Pydraul 230 Aroelor 1221 Aroelor 1242 i Pydraul 230A Aroelor 5432 Pydraul 312 Aroelor 1242 Pydraul 312A Aroelor 5432 Pydraul 54CA Aroelor 1242 Aroelor 5442 Pydraul 540 ` Aroelor 5432 Pydraul 023A Aroelor 5432 Santovac 1 Aroelor 1246 Santovoe 2 Aroelor 1254 - 2- 33.3% 64.7% 30.0% 39.5% 9.5% 36.5% 27,5% 23*C% 14.U% j 3.0 54.7% 29.3 47.3 31.1 36.6% 15.7% 42.0% 60.0% 100.oi 100.0% Foni AD* 007l<t* - 3- Hvdraulics/Lubricanta (cont'd) Turbili! 153 Aroclor 1221 4 Aroclor 1242 H M t Transfer Fluida - Therminol FR-O Aroclor 1242 t Therminol FR-0 Low Temperature, Aroclor 1242 * Therminol FR-1 Aroclor 1242 Therm!noi FR~2 Aroclor 1248 Theroinol FR-3 Aroclor 1254 i Transformer and Capacitor Fluida Capacitor 21 Aroclor 1221 Inerteen PPO Aroclor 1260 Znerteen 70*30 Aroclor 1254 Inerteen 10C*42 Aroclor 1242 Xnrtoen 54201 A9 Aroclor 1242 Znerteen 54201 c m Aroclor 1242 Znerteen 5-:201 KA Aroclor 1254 Inerteen 54201 KJ Arotlor 1221 Aroclor 1010 mcs UL0 Aroclor LOIG 6.4% 81.5% 80.0% 50.0% 100.0% 100.0% 1<.0 r 100.0% 60.6% 70.0% 100.0% 65.0% 9 9 .9 % 70.0% 32.5% 3 2 .5 % 90.01 AQH 0071^ I - 4 - M * T r a n r f o r m r and Capacitor fluidi (cont'dl- P y r i M l AI 311 U I j o Pyranol 1476) A s o d o r 1254 ltctrical grado Pyranol A 131 38 Aroclor 1260 Pyrinol A138 3B-2 Aroclor 1254 Pyronol A l 38 38-3 Aroclor 1254 * 100.0% 45.0% 45.0% 60.0% Plaiticlror Applications Aroclor 6037 Aroclor 5460 Aroclor 1221 Aroclor 6040 c Aroclor 5460 Aroclor 1221 Aroclor 6050 Aroclor 5460 Aroclor 1221 Aroclor 6062 (10% Xylono) Aroclor 6062 Aroclor 6062 Aroclor S46 Aroclor 1221 Aroclor 6070 (10% xyleno) Aroclor 6070 Aroclor 6070 Aroclor 5460 Aroclor 1221 Aroclor 6090 Aroclor 5*160 Aroclor 1221 7< i ii- i 37.0% 63.0% $0 .0% 60.0% 50.0% 50.0% 90.0% 62.0% 38.0% 90.0% 70.0% 30.0% 90.0% 10.0% Aroclor 4405 Aroclor 1262 Aroclor 5460 Montar 5 1`oJychJorinatcd poJyphonyl residue troni 50.0% 50.0% io3.o% a o h ocm<*6 I EXHIBIT B v n n i ffTO ADM 0 0 7 U 7 WOaCCTS CONTAINING POLYCHLORINATED BIPHENYLS L. AMD/OR FOLYCHIORINATED TSRPKS'nYLS SOLD IN 1971 Aroelor 10l6 Aroelor 1221 Aroelor 1222 . Aroelor 12^2` Aroelor 12U9 *Aroelor 12=U Aroelor 12O Aroelor 1262' Aroelor ^6*5 Aroelor 5060 Aroelor 5^32 Aroelor z^ 2 Aroelor 5^00 Aroelor Aroelor 66o0u37o Aroelor 6050 Aroelor 062 .Aroelor 6070 Aroelor 6090 V C a p a c ito r 21 * Xntrtean PPO Inarten 70-30 Inerteen 100-42 Inertaen 5^201 A9 Inerteen 5^201 CF Inerteen *4201 CK Inerteen 5201 KA 5U2CIXJ AC-A AC-A Winter Grada A 200 P y d r a u l A 2 0 0 B * Pydraul P-9A Pydraul 135 150-XPydraul 1 3 5 A ^ Pydraul Pydraul 2 3 0 . Pydraul 2 3 OA Pydraul 312 Pydraul 312A Pydraul 540A Pydraul 5 4 0 8 Pydraul 2 5 A 1 ii, i i i i' ADM 007 1971 (Cont'd) > * y# inol`'l3 B3B Sintovac 1 Sir.tovac 2 Therminoi Therminoi Therminol Therminol Therminol FR-0 ?R - Low FR-1 FR-2 FR-3 / * Temp. Turbino1 153 * i %* Fom ad* OOTl^9 I MODUCTS CONTAINI?:g POLYCHLORH&TED BIFHgMYLS AMD/OR rOLYCHLCSII'ATSD TSRFH-MYLS ' ' SOLO IN 1972 I A roclor 1016 A ro clo r 1221 A ro clo r 1242 A roclor 1254 A ro clo r *432 A roclor 6037 Capacitor 21 * te Inerteen PPO Inerteen 70-30 Inerteen 100-42 Inerteen 54201 CM Inerteen 54201 KA Inerteen 54201 KJ Pydraul AC-A Pydraul AC-A Winter Grade Pydraul A-2C03 Pydraul ?-9A Pydraul 135A Pydraul 150A Pydraul 230A Pydraul 312A Pydraul 54C3 Pydra\il 62 SA Pyranol A l 3 B1 Pyranol A13 B3B Pyranol A13B 33-2 Santovac 2 f e r m i n o 1 FR-1 1t i I Fani ADM 007190 --nmiTTS CONTATTINO PQLYCHL0RINAT5D BIFHEMYLS AMD/Oa POLYC.VLORINATSD TSR5KENYL5 SOLO IN 1973 | A roclor 1016 A roclor 12^2 A roelor 1251* C a p a c ito r 21 Ir.erteen 70-30 In erteen 100-^2 In e rte e n 5^201 CM In e rte e n 5U201 KA rrie rte e n 5^201.JCJ MCS 1^89 pyranol A13B1 Pyranol Al33 33 Pyranol A133 33-2 Pyranol A133 33-3 \i i i ! VI f Fani T7A b ADM 007151 I A roclor 10l6 A roclor 12^2 A roclor 12,j* ' C a p a c i t o r 21 In e rte e n 70- jo I n e rte e n lOO--2 in e rte e n 5^201 G. In e rte e n 5**201 KA KCS 1"99 _ Pyranol Al 331 Pyranol A 133 |3-2 Pyranol Al33 -3-3 F n m `1 * 7 5 AOM 0 0 7 1 5 2 i FKDUCTS CONTASiI^G FOLYCKLCHINATSD BIPKSNYLS AHP/OR FOLYCHLCRINATSD TtHFHSMYES SOLO IN 1975 A ro clo r 101.6 A roclor 12*^ Capacito:* 21 Ir.e rte e n 70-30 .// Ir.erteen 100-^2 X re rte e n 5ii201..CM I r e r t e e n 5^201 /CA In e rte e n 5^201 KJ MCS 1^39 Parano1 A13B1 Pyrnol Al 33 33-3 F n m h ik 0 0 7 V51 A0* 1, f U f EXHIBIT C 4 1 1001077 DM n m M u faooucts comtaiwivc polychiomnateo BIPHEMYIS AMO/OR POIYCHLORIMATEP fERPHENYLS PROOOCTIOM (Thotuands of Pounds) Produrt Acoelor 1016 Aroclor 1221 Aroclor 1232 A r o c l o r 1 2 4 2 Aroelor 1248 Aroelor 1234 Aroelor 1260 Axoelcr 3060 A n e l o r 3432 Aroelor 3460 Montar 3 * 1971 6299 2781 237 23700 1139 6782 2479 387 6220 13983 4903 70912 197 2 22334 403 7228 - 9171 3 1272 68(1 1879 49131 197,3 1974 YfO Thru S P t . 1971 Foni 0o n * * *0* i * EXHIBIT D Fafti TM ADM 00715b * ir r, *FROOCJCTS C O N T A I M I N C P O L Y C H L O R I S A T E P IIPHENYLS ANO/OR POLYCHLORIMATED TERPHEHYLS PRODUCTION - ANNISTON, ALABAMA* (TAouaands of Poundt) Product Aroclor 1221 Aroclor 5060 Aroclor 5432 Aroclor 5460 Montar 5 1971 196 2 3,67 6220 13983 4909 1972 1272 61 1879 p r o d u c t i o n toroin a t a d in 1972 FoniP80 ADW 0 0 7 1 5 7 I EXHIBIT C 4 Fonici r *- ''(! I FWQPtKTS CONTAINING POLYCHLORINATED BIPHENYLS AND/OR POLYCHLORINATED T5RPKENYL5 SOLD IN 1971 Aroclor 1016- Aroclor 1221 Aroclor 1232 . Aroclor 1242* Aroclor T.24S * Aroclor 1254 Aroclor 1260 Aroclor 1262' Aroclor 4463 Aroclor 5060 Aroclor 5432 Aroclor ;4^2 Aroclor 5'^60 Aroclor 6037 Aroclor 6040 Aroclor 050 Aroclor 6062 .Aroclor 6070 Aroclor 6090 - Capacitor 21 Inerteen PPO 'Inerteen 70-30 Inerteen 100-42 `Inerteen 5^201 A9 Inerteen 5^201 CP Inerteen 5^201 CM Inerteen 5^201 KA ; 54201 K J Pydraul AC-A Pydraul AC-A Vinter Grade Pydraul A 200 -Pydraul A 200B Pydraul ?-9A Pydraul 135 Pydraul 1 3 5 A ^ Pydraul 150-A Pydraul 2 3 0 . Pydraul 230A Pydraul 312 Pydraul 312A Pydraul 5^0A Pydraul 540B. Pydraul 625A i Foni?R2 ADM 0 7 L ^ 8 1971 (Cont'd) 1 -. ,, pyrtnol' 13 B3H Sirtovac 1 Srtovac 2 i Therminol FR-0 ____ Therminoi FR - Lw T e m p * Therminol FR-1 Therminoi FR-2 Therminol FR-3 m-: T&rbinol 153 ... i n m ?R3 o o n ' '1' <k0* I' PRODUCTS C0?fTAI?fI?;5 POLYCHLCRIWATED BIPHSNYLS AWD/OR FOLYCHLCl'ATSD THR FHINYLS SOLD IN 1972 Aroclor 1016 Aroclor 1221 Aroclor 1242 Aroclor 12*4 Aroclor 5422 Aroclor 6037 . Capacitor 21 Inerteen PPO Inerteen 70-30 Inerteen 100-42 Inerteen 54201 CM Inerteen *4201 KA Inerteen 54201 KJ Pydraul AC-A . Pydraul AC-A Vinter Grade Pydraul A-2C03 Pydraul P-9A Pydraul 13*A Pydraul 1*0A Pydraul 230A Pydraul 312A Pydraul *403 Pydra^i 1 62 5 A Pyranol A l 3 B1 Pyranol A13 B3B Pyranol A13B 33-2 Santovac 2 Tierminol FR-1 AOM 007150 PRODUCTS CONTA Tf DIG POLYCHLORINATED BIPHENYLS AND/CR POLYCHLORINATED TZSPKSNYLS SOLD IN 1973 Aroclor 1016 Aroclor 12^2 Aroclor 1 2 5 U Capacitor 21 Ir.erteen 70-30 Ir.erteen lCO-^2 Inerteen 5^2C1 C'A Inerteen 3^201 KA Inert een 5^201.JCJ MCS 1^39 Pyranol A1331 Pyranol AI3 B 33 Pyranol A133 33-2 Pyranol A133 33-3 V001 Aroclor 10l6 A r o d e r l|j2 _ Aroclor 1 2 .^ Capacitor 21 Inerteen 70-j0 Inerteen Inerteen OA In e r te e n "42Q1 ka KCS 1^39 / * * pyranol A1331 Pyranol A13| 3-2 pyranol Al;3 33-3 2 t 1.0V ***> ADM 0 0 7 1 5 2 1\ EBOEUCTS CCTTAP.'IKg FOLYCHLCRir.'ATZD SIPHEffLS . and/ or f o l y c h l c r i a t p t z r f h s h y l s SOLD IN 1975 I A roclor 10V6 A roclor 12*=^ C apacitor 21 In ert een 70-30 Irerteen 100-^2 I n e r te en 52Q2._CM I r e r te e n 5U201 KA Irerteen 5^201 KJ MCS 1^39 Pyranol A13B1 pyranol Al 33 3B-3 i i r 0* f PRODUCTS CONTAINING POLYCHLORINATED 1 I' BIPHENYLS AND/OR POLYCHLORINATED "'t E R P H S N Y L S * PRODUCTION I (Thousands of Pounds) Product Aroclor 1016 Aroclor 1221 Aroclor 1232 A r o cl o r 1 2 4 2 Aroclor 1248 Aroclor 1254 Aroclor 1260 Aroclcr 5060 Aroclor S432 Aroclor 5460 Montar S * 1971 6299 2781 237 23700 1139 8782 2479 387 6220 13983 4905 70912 197 2 22334 403 - 7223 9171 3 1272 68 Cl 1879 49151 1973 1974 YfO Thru S^pt. 1975 q Q7 *0* ADM 00715b * * PRODUCTS CONTAINING POLYCHLORINATED !i BIPHENYLS AND/OR POLYCHLORINATED TERPHENYLS PRODUCTION - ANNISTON, ALABAMA* (Thousands of Pounds) Product Aroclor 1221 Aroclor 5060 Aroclor 5432 Aroelor 5460 Montar 5 1971 ( 1962 I 1 387 l 6220 [ 1 13983 j ' 4905 1972 - 1272 6861 1879 i r ri X * produc t i o n tarainatad in 1972 .I . ! *! . t F n n i ` 9 ADM 0 0 71 5 7 f * EXHIBIT E j Vaivi ADM OOTl^d PRODUCTS CONTAINING POLYCHLORINATED .B I P H E N Y L S A N D / O R P O L Y C H l d R I W a It E 0 TERPHEMYLS P r o d u c t i o n * S a u g e t , irl ino i1s (Thousands oC Pounds) i j Product A r o c l o r loie Aroelor 1221 Aroclor 1232 Aroclor 1242 Aroclor 1248 Aroclor 1251 Aroclor 1263 1971 6299 819 237 23700 1139 8782 2479 19 72 1973 22334 27159 ii 403 ' 52 _ - 7228 6039 - 64 9171 8864 3 1974 I 250 85 '! (79 69 25 8029 TTD Thru S e p t. 197 5 1 0 3 5 0 . i - - ?V 5120 6980 inm I I EXHIBIT E i J/ V a n -' " Q 2 aDH 00T156 P R O D U C T S C O N T A TW INC POLYCHLQft . B I P H E N Y L S A N D / O R P O L Y C H L Q r i m a 'ign TERFKEHYLS Production - Sauget, til ino! (Thousands of Pounds) Product A r o c l o r 101C Arocior 1221 A r o c l o r 12 32 Aroclor 1?42 Aroclor 1248 A r o c l o r 12 5 1 Aroclor 1263 1971 6299 819 2 37 23700 1139 8782 2479 1972 1973 22334 T 27159 i 4 0 3 j' 52 .1 - 7228 6039 - 64 9171 8864 3 19)74 r250 79 m 9 25 8029 TTO Thru Sspt. 1975 10350 ' 5120 6980 F a n i fioi iI A0M 007159 - - ---------- -- (/6 T T J VKTUD STATES DISTRICT COURT vofmsm district c f Illinois EASIER DIVISION xxnn> states c f ahtox& JCSIPH C. OXANDRA, >OKE230 L. KEFUNCZ*, PAUL L. KRIQT, and JAKES B. P1ANK, B llz. a ss' ViolationT" Title 18, ttnted Stat* Cbdef Sections 1001, 1341 and 134: The SPECIAL OCTCfgR 1980 AND JUK* chaises: i 11* At all tines material herein, Industrial Bio-Test Laboratories, Inc, (hereinafter referred to as IBT) did business in Northbrook, Illinois In the Northern District of Illinois and was a contract research laboratory vhich conducted animal studies on various drugs, pesticides, chsnicals, and other substances, for the sponsors of said substances, In order to determine the safety and effectiveness of the substances. 2. At all times material herein, JOSEPH C. CAIANDRA was President Of 1ST. 3. At all tines saterial herein, KJRQ L. l^LINGER was fenager of Ttadcology at IBT. 4 PAUL L. KRIdiT was Section Bead! for Bat Ttedcology at IBT z m appracimately Much, 1971 until September, 1972, at wiich tine he Jhnager of Ttocicology for the Department of Mfftidhe and BTvirc;rental Health at tbnsanto Corporaticn in St. Louis, Missouri1, fron apprcodimtely October, 1972 until the present 5. JAKSS B. PLANK was the Senior Group IivuVr far Jbt Ttsdoo at IBT until October of 1972, at Wiich tine he becartl the Assistant to the pnm MB* ^ - -1. , Homager off Toxicology at XBT f e n approdmately Dctober, 1972 ratil April, * 4 -i 1977. 6. JET conducted a two-year chronic coral tadclty study cn ' I Itrichlcrocarbanilide (TOC) in alhino rats, IBT Study K i t e B9575, far Monsanto Ctrpany (Monsanto). TOC is an antibacterial agent used in soaps. to or about toy 10, 1976, 2BT nailed its firal versioJ of the repeat of E] 1 I the study to tonsanto \to submitted the XBT study report to the Chited States Feed and Drug AffcdnistratiDn (HA) with a cover letter dated toy 11, 1976, for that agency's use in its evaluation of the safety of TOC. 7 IBT conducted a 22 month chronic oral tecicity study on Naprosyn in albino rats, IBT Study Norber B7922, fbr Syntec Corporation (Syntax). Naprosyn (also known as naproxen) is a drug used in the treatment of arthritis. On or about March 3. 1972, IBT called its report of the study to Syntax who submitted the IBT study report to FDfc, with a cover letter dated March 22, 1972, as part of its application for approval to test Naprosyn on humans and ultimately market the product. B. IBT inducted two carcinogenic studies on mice.(tests to determine whether a caTpound causes cancer) far Chemagro Corporation (Choragro). toe study was on Sencor, a herbicide, IBT Study Nixrber 9069, and one on Nmacur, a pesticide, IBT Study H n e r 9068. 1ST submitted the reports of the studies with a covex letter dated August 15, 1972 to toetagro, who siteittad the IBT study reports to the toited States finvizonnental Protection Agency CE>A), the Sencor study report fcy Beil cn torch 8 1973 and the Namcur sfcidy report by mail on October 15 1975. Both study reports were submitted as part of Chemagro1* application fbr approval to market these products for use on food crops. I n m <*05 -2- A pp>% ( I i i ..ft* Beriming in or bout 1970 and contiming until about July, 1977, in Northbrook, in the itarthem District of ZHiiois, Eastern Division, and elsewhere. JOSEPH C. CAIANDBA, HDI0 K. R E P U N Z R , Paul L. wrick, and, JArtS B. K/NK, defendants herein, together with co-fichesrs both tacjwi and unfoown to the grand jury, devised and intended to devise a achate to defraud 'clients and gcvenuent agercies by writing and distributing false and fraudulent study i i. reports and false and fraudulent explanations of studies and stuty reports, and by concealing the fraudulent nature of the study reports arid explanations of studies and study reports, all by scans of false and fraudulent reprc- Ji mentations and concealments, knowing and intending that the representations and concealments were false when cade. 10. Zt was a part of the scheie to defraud that the defendants wrote and distributed false and fraudulent animal study reports to clients i| ! who camissioned the studies, viiirfi study reports were submitted by the clients to goverixrent agencies that evaluate such reports as pert of their determination of the safety of those test snteriala. 11. St w s further p a t of tte aetatt to defend that the defendants provided FDA with false and fraudulent written submissions which [1 ; reaffirmed and m** new false and fraudulent statements as to BBterial facts, and concealments and emissions of material facts in, or pertaining to, the studies and study reports. | 12. Zt was further a part of the | schsae to defraud ! that the r* l p p fj *( original version of tie TOC stuty report was written and distributed by IBT to ffansanto on or stoat ftferdi 21, 1974. ZST submitted this version of tie TCCTreport to TJA on 12, 1976,t tfcich stuty report the ^fendants l o w to be false and fraudulent in that the study report: s. stated that the data reported were from animals that had been on the study for 24 norths, when defendants then Jmew that the report included data from a substantial rurber of animals that had been on the study for significantly lesser periods of tini; b. stated that 480 animals were in the study then I| defendants then fera/ that s substantially greater nzrber of animals were also part of the study? and . c. contained an Animal Mortality Talile (Table IV) thich defendants then knew to be false in that It substantially under-reported { tte zurher of aninels that were in the 6tudy n the rurber of animals that died during the study. 13. It was further a part of the cohere tb defraid that the final version of the TCC study report was written in April and toy, 1976, was dated feich 21, 1574, and was nailed to hfcnsarito by ZBT on or about May 10, 1976, suhnitted to FEA by tansantp under a oever letter dated Itey 11, 1976, and was foown by defendants to be false and fraudulent in that the study report: A. stated that the data reported were fron aninals that been on the study for 24 ncnths, When defendants then that the report iiduded data fron a substantial xuifeer of animals that had been on the stuty for significantly lesser periods of tine; * b. stated that 480 animals in the study then defendants -4 - ito m then Jtne^ that a substantially greater n r l g of snirals were part of the study; c. contained an Aninal totality Ttale (Table IV) which defendants then h e w t be false In that It substantially m3er-re$arta3 \ . jI the nztber of ansala that wwre part of the stilly and the ruHber of aniaals *\ that died during the study; d. stated that 250 extra animals were on the study for 24 ucnths and were an independent IBT "research" group separate fron the |1 animals reported In the TOC study when defendants then knew (1) that the so-called "research" group animals were rot anj independent "research" group but were used as a source of extin animals and animal tissues for the TOC study; (2) that the so-called' "research" aniiLls had been on study I 1for significantly lesser periods of tine than 24 senths; and (3) that a substantial amber of the extra animals were oocmingled into and reported as part of, the TOC stutygroup; j e. stated thatno histcpathologioal jeaminaticn (study of tissue characteristic of animal disease) was performed on the so-called "research" group animals, who* defendants then knew that tissues frem aery of tte so-called "research" group animals had been ad ecsained; ] f omitted and concealed the findings listed in a table of "Bistcpathological Changes in Testes -- Fos aortal Animals" when defendants then t o w that the table existed; g. stated that postmortem autolysis (chemical deterioration I I .of tissue after animal death} of testicular tissue precluded meaningful histopathologic evaluation of the testicular tissues of the poslaortan animals, defendants then knot that many J: those! tissues bad been so .X - 5 - F o n i ' o 32:) examined end graded; - | * *'" II h* stated that the XBT pathologist fir. Gcnovan Cbrdan, ecsoined the I iof `the study animals and that the tijriiags in the testes of the lowest dose level (T^) animals were indistinguishable \ I i| from the findings of the testes of the control group animals, then defendants ! 1 I 1then f a that fir. Gbrdcm's conclusion was that there were ICC related tocic effects in the testes of the aninals in the lowest dose level; and i. emitted and concealed, as defendants then fa, that * || Dr. William FiJbelin, a pathologist hired fcy Monsanto, lad ecsnined acne of lowest dose level showed TOC toataent-related tocic effects. 14. It was further a part of the echere to defraud that in response to IfiA questions concerning the TCC study, la written eplanation of the TOC stut^ i[ 1 report, dated December 12, 1976 was prepared and submitted to FEA by XBT on Decsiber 14, 1976, jwhidi 'explanation defendants then f a to be false and fraudulent in that the submission: stated that the data reported in the toy, 1976 report (dated Itarch 21 1974} frem animals that had been on the study for 24 smiths, then defendants then f a that the report included data fron a svbstantial xutber of aninals that had been on the study for significantly lesser periods of time; ! i b. concealed, as defendants thei fa, that the anisal sortality in the TCC study was substantially greater than reported in any version of the study report; | i c. stated that 250 extra animals were on the stuty for 24 1 ii eenths and were an independent XBT "research* grag>,1 -6- 1 n n ir'.n I animals n p orted in the TCC itu9yf tfen defendants then l a w (1) that the i" group eniraals were cot an rcn, ( but were used as a source of extra animal* and animal tissues for the ICC study; (2) that the ao~ealled research* animals had beai on study fa r + significantly lesser periods of time than 24 ncnths; and (3) that a sihstantial ranter of the ctra animals were conningled Into, and reported as part of, the TOC study roi? j d. concealed that histopathologic ecsninations were I i| performed on a substantial ranter of the so-called "research" animals, then cfefeiiants then kne>t that such eraminaticns had been pexfosned; and e. emitted and concealed, as defendants then taev, that Dr. William Ribelin, a pathologist hired by Rnsanto; had ocnined acre of the testicular tissues of the TOC study animals and had ccncluded in a written report that the lowest dose level showed TCC tieateeJt-related toxic effects. I II 15. It was farther a pert of the schsne to defraud that the final study report on Naprosyn, dated January 4, ! 1972, was [ written by 1ST and was received through the rail by Syntex fran 1ST on or about March 3, 1972, and I 'I submitted to the FEA by Syntex under cover letter dated Mardi 22, 1972, which I report defendants then knew to be false and fraudulent in that the report: I | a. contained individual animal and simmazy animal data i ~ :| allegedly h** on blood and urine tests perfbsned on or about the time of final sasifice of the study, then defendants than taiLr that no such tests hal been conducted and that the data was fabricated end false; and b. was sipleasnted by an Appendix Z thich was submitted to R A by Syntex cn April 9, 1974 vhich purported to represent, acong other things, fli the findings frera gross examination of the stu^y animals, when -7- Flirti400 f r f f . IO 1 0 0 <J '1 * I defendants then l o w that for a substantial portion of the gross firdings I 1 dor p o s t o r t m animals, no such awsinations were perfboned ard the firdings were fabricated and false. 7 \ i 16. It was fifftfcer a part of the scheme to ( i| that in response to FDA questions raised in Septeber, 1976 concerning the Naprosyn | ,1 study# a letter siyied by Joseph C. Chlftndra and, an $>lanation of the i Naprosyn study dated tomber 11# 1976 was written and submitted to RA# and a copy was mailed to Syntax under cover letter dated Novsnber 17, 1976. Defendants then knew that the Novenber 11# 1976 submission to the IDA was false and fraudulent In that the submission: j a. stated that the data reported for individual animal ;i and sunwry animal blood and urine values allegedly collected an or about . i - * -- 4 " " -:then defendants then tev that the data were fabricated and false; and b. stated that gross examinations were iperfoaicd on the postmortem animals and that the data from those examinations reported in i 'I Appendix ZZ were obtained from animal cage cards and animal disposition sheets, when defendants then knew that for a substantial number of the ! reported postnorten animal findings no gross toconinaticns were performed and the data were fabricated and false. U 17. Zt was further a part of the scheme to defraud that XBT i Iprepared and nailed to Checagro final reports far the Senear and Neriacur studies under cover letter dated August 15# 1972 to Osmagro. O e n g r o submitted the 1BT Sencor study report to CPA by nail on or about March 8# 1973# and submitted the 3BT Naramr study report to E>A hy sail on err abeut October 15# 1575# %hich reports defendants then S o w to be and -8- v o m a oi. io n 1! fraudulent In that each report: I 1, ` *" ` | ! a. stated that all the nice on thei study were fed the i1 studytest material for 16 months, then defendants Jciew that (1) the cnly * \ 1j ran for 14 conths; and (29 the mioe sacrificed and exandjvd at the end Ii of the study included a substantial raster of mice which had been fed the test material 14 souths or lass; !| b. contained a Mortality Table which defendants then taew substantially under-reported the raster of an&als that were on the study end the ranter of animals that died during the] stuSy'i ! I c. concealedthat a larger niter of ectra mice were to and were a part of the study; and d. stated that there was a third positive control group fed ben2edine, when the defendants then knew tiiat no such control group had been conducted with these studies. 16. It was further a part of the scheme tb defraud that 2BT K 4 -wrote an pAddendim Report to Cheragro" regarding the Sencor study report - u - u , o ~ > . - - - -- I iCheriagro marled to EPA on or about October 6, 1974, and which defendants knew to be false and fraudulent in that the x. x x . . - . . ^ . ^ as if the study had run for 18 sonths, when defej ndant!s| then Joiew that the mioe had been on the study for significantly lesser periods of time; 2. emitted and concealed that a substantially greater raster !! of mice were on the study than reported; and ! i 3. listed for the individual animals designated as FCXXI, their , 1! alleged raster of days on the study and gross pathological findings thich Font 4 0 2 - 9- k fP .t2 ~ JOimrV infoxsation defendant? taew t u false because no such positive control j| 9x04? had been conducted with this stud)/. 19. Xt %s further a part of the achare to defraud that an XBT audit was conducted on the eragro studies In April 1976 Wiich doonented that the studies were fal^e, as sperlfiad tm e in Paragraph 17a and that I the defendants concealed the results of this audit Iron Chowgro until July, 1977 20. | Xt was further a part of the achare to defraud that the Udted States m i l s and interstate wire ccnnunicaticns were used in furtherance of the echare. 21. to or abait fey 10, 1976, in the ferthem District of Illinois, Eastern Division, OOSEPH C. CALANDRA1, HDHENO L. XEPL3NCZR, PAUL L. WEIGH*, and JAMES B. PLANK, defendants herein, for the puposes of executing tte'aforesaid to defraud, and attainting to do so, taowingly did cause to be placed in the touted States nails the final version of the TCC stJty report, addressed to: j i| Daniel Jfcnan i* ; M ansanto Ctitpaiy ! ~ 800 Lindbergh Blvfl. St. toils, Missouri to b f aent and delivered by the tkiitad States Postal Service according to the directions thereon. In violation of Title 18, United States Code, Section 1341 ^i CEtKTTMO r t f i SPECIAL CCIQE&at 19B0 GRAND juror further 1- Paragraphs Che through T^renty of Count One of the indictment * are realleged herein. 2. On or about A,ugust 11, 1976, in ithe Noirthern District of i Illinois, eastern Division, i i JOSEPH C. CRIANDRA,| MDSNO L. KEPLXNGER, PAUL L. WRIGHT, and OWES 6. PLANK, defendants herein, for the purposes of executing the aforesaid achsae to i defraud, and attesting to do so, knowingly did anise to be placed in the Uiited States sails a letter fzan Joseph C. Chlarrira dated August 11, 1976, addressed to: Dr. Carl M. leventHal Deputy Director, Btireau of Drugs Department of Health, Education aid Welfare Public Health Service i[ FOod and Drug Adninistratim Rockville, Marylandt 2085i2 to be sent and delivered by the United States ]fcstal;Savice according to the directions thereon. j In violation of Title 18, ttoited States Oode, Section 1341. -11- F n m *nd BSSSEgESG 10033;j GOtKT W S The BECXAI# OCTCEER 1980 GRAND JURf further charges ij 1. " paragraphs Cue through Twenty of Count Che of this iniictmeit i are realleged herein. v | \ 1 2. to or about ttycnfcer 17, 1976, in the Narthem District of Illinois, Eastern Division, JOSEPH C. CALAMIRA# MDJSND L. K E P 1 H OE R , PAUL L. WEIGHT, and JAMES B. RANK, defendants herein, for the purposes of executing the aforesaid sctere to defraud, and attempting to do so, fcncvingly did cause to be placed in the .I I !United States rails a copy of the written submission by 2BT to the FDA regarding Naprosyn dated toverber 11, 1976, addressed to: Mr. Virgil Ttcnpscn' . Syntax Corporation I 3401 Hillvierf Avede Palo Alto, tolifonjia 94304 to be sent and delivered by the toitad States Itostal Service according to i the directions thereon. j In violation of Title IB, united States tode, Section 1341. -12- POiva <105 / W . / S ~ 1 0 0 3 3<>- I GCU7T POOR The SPECIAL CCTOECT 1580 V JURf further i 1, Paragraphs One through 5\ity of Count One of this iadictnent are realleged herein. * .| 1 2. In or about Octaher 1576 in the Northern District of Illinois Eastern Division JOSEPH C. CALANDRA, KKOEN0 L. JOEPIINOER PAUL L. KRZSTT and JAKZ5 fi. PLANK defendants herein for the purposes of executing the aforesaid scheme to defraud and attesting to do so tawingly did transmit and cause to be transmitted in interstate carreree, by neans of vire ecruunication certain signs signals and sounds, to wit: a long distance telephone call between I 'I 1ST and Dr. D.K. Lamb at Ghsragro in Kansas City Missouri. In violation of Title 18 United States Code, Section 1543. * 'I Cl -13- inni ftp -!< S 1 0 0oQ -`j> < carr w v e i T te SPECIAL OCTCBSt 1980 6 8ND JUfOf fu rth e r charges* 1. paragraphs (lie throjgh Six of Count One of this inUctoent ** are realleged herein. * i 2m At all tisoes material herein the Pcod 'and drug Adninistxation (FDA} was an agency of the ttiited States Qovernijent. 3. Oi or about Hay 10 1976 in NcrtftfceocJcj, in the Horthern district of Illinois, Eastern division and elsewhere, JCSIPH C. CALANDBA, DFD L. KEPUNCZR, PAUL L. WRIGHT, and ` JA>ES B. BLANK defendants herein, wilfully and knowingly did snake, and c&ise to be cade, false, fictitious and fraudulent statenents and representations as to i| material facts and concealed and covered up material facts, in a matter within the jurisdiction of PDA, to wits "Aeport to Hansanto Garpany, TWo-Year Quranic Oral Ttocicity Steady with TOC in Albino Bats, B7L 71*8, torch 21, 1974, XBI Ns. 9575," %hich study report vas submitted to FDA by Ksnsanto under c o w letter dated toy 11, 1976. The aforesaid false, 1 fictitious and fraudulent statscents and representations and gaissicns as to Bftterial facts ore listed in .Paragraph Thirteen of Gaunt One of this iixlictsent end are realleged herein. j In violation of Title 18, United States Code, Section 1001. -1 4 - m m Aon M P ./7 CC07T SIX i The SPECIAL GCTJHOt 1980 GRAND JITO farther 'charges: CtaJ1. Paragraphs die through Six of Cbunt and Paragraph Two [ [. of Cbint five of this indictment are realised termini 2 On or about Peoerfaer 12, 1976 in Northbrook, in the Northern District of Illinois Eastern Divisionj and i ek\lsewhere, JOSEPH C* CAIANDRA, *057*5 L. K ^ U N S R j PAUL L* W U C W , and` JAKES B* PLANK, defendants herein, wilfully and knowingly did teke, arid cause to be Bade, false, fictitious and fraudulent statarents and representations as to material facts and concealed and covered \%> neberial facts, in a tetter within the jurisdiction of the FDA, to wit: a Written explanation to tie j| FDA by 1BX regarding ZBT's "fteport to Monsanto Orrpany, TWo-Year . Qronie Oral Itccicity Study with TCC in Albino tots, ITL 71-6, torch 21, 1974, 1ST No. 9575.* The aforesaid false, fictitious and fraudulent atatsrents and representations and emissions as to material facts are listed in Paragraph Fburteen of Count Che of this indietuent and are realleged herein. l '] j" j In violation of Title 18, Diited States Ode, Section 1001. 15 - p n w aar /W P . / f inn C0Q7T SVEN The-SPECIAL OCTOBER 1980 GRAND JUW father charges: 1. ' Paragraphs Che through Six of Chint (he and Paragraph Two ' . 't of Cfcwnt Five of this indictment are realleged fcein, \f 2. On or about Dfesiher 12# 1976# in Northircok# in the Northern District of Illinois, Eastern Division] and elsewhere# JOSEPH C. CALANRA# HDKSND L. K7LZNCZR] PAUL L. WRIOir, and! JAMES B. PLANK# ! defendants herein# wilfully and fcxvingly did make# and cause to be made# false# fictitious and fraudulent stabarrents and representations as to i !! ceterial facts and concealed and covered up material facts# In a setter within the jurisdiction of the EDA# to wit: th original wrsion of the study report I il . "Report to Monsanto Qanpany, T^o-Year Chronic I ij Oral Ttadcity Study with TOC in Albino Rvts, 60 71--8i torch 21# 1974# 1ST No. 9575"# viiich was submitted along with the written alination of | |the YGC stuty to the EDA under cover letter dated Decenher 12# 1976 by XBT. She aforesaid false# fictitious and fraudulent statsnents and I 'i representations and emissions as to material facts are listed in Paragraph Twelve of Count die of this indie toent and are realleged herein* 1i In violation of Title 18# tftitad States code# Section 1001. ^* -16- vniv* **** ftP P . ii 1 0 0 I > : ) COWT EHKT T te SPECIAL OCTOBER 1980 AND JUK f u r tte r c te rg e s : 1 Paragraphs toe through Fi\* and Paragraph Seven of Count *\ I 'I Ore arri Paragraph Two of Count Fi\ of this indictment axe realleged herein. 2. (her about tovwber 11, 1976, iln Norithbro'ok, in the I 'I Northern District of Illirois, Eastern Division, and elsewhere. JOSEPH C. CALANDRA, MORDO L. KE7LZNZR, PAUL L. WRIQT, and' JAMS B. FLANK, | defendants herein, vilfully and taowingly did make, and cause to be xmde, i '| false, fictitious and fraudulent statements and representations as to material facts and corcealed and covered up material facts, in a matter i '[ within the jurisdiction of the IDA, to wit: a letterland written emanation * j ]| to the PDA prepared and submitted by IBT dated Novwfcer 11, 1976 regarding II the XBT study report on Naprosyn called: 'Report to Syntex Research, Division of Syntex corporation, 22-tonth Chronic Oral TOxicity Stariy with RS 3540 Albino Rats, Jamazy 4, 1972, IBT to. B7922". The aforesaid false, fictitious and fraudulent statements and representations and emissions as to material facts are listed in Paragraph Sixteen of Count toe of this i indictment and are realleged herein. ; In violation of Title 18, ttiited States Code, Section 1001. A T C E B IU t I kITED STAIZS A T T O R E -17- FORE P ER SON Fnm M O H i r T l T I1 I ~T1T~ \frfP. Z o I Monsanto Monsanto Company 800 N. Lindbergh Boulevard St. Louis, Missouri 63166 Phona: (314) 694-1000 September 15, 1982 ,d e p a r t m e n t o f m e d ic h ic a ENVIRONMENTAL HEALTH Mr. David P. Brown Assistant Chief Industrywide Studies Branch NIOSH 4676 Columbia Parkway Cincinnati, Ohio 45226 Dear Dave: j Enclosed is the Zack and Musch paper that ,we discussed over the telephone. Any final draft of this will differ in the background section but not in the numb'ers ,in the tables. Since.EPA has this draft, and since it was referred to in EPA's mini-symposium- I see no problem in s|ummarizing the results for Dr. Wade, but I would prefer that you not send him a copy just in case a slightly diffrent version gets published. Yours sincerely, aw Enclosure Vi P h . - D Manager, Epidemiology I Fonigli II A R e t r o s p e c t i v e M o r t a l i t y S t u d y o f P oI l y c h l io r i n a t e d Biphenyl Manufacturing Workers^- i Judith A. Zack, M.P.H.2 David C. Musch, M.P.H., Ph.D.3 > ^Monsanto Company Department of Medicine and Environmental Health ^Present address: 1751 .Legend Lane St. .Louis, MO 63141 ^Present address Department of Ophthalmology University of Michigan Medical School ST2512 Scott Turner Bldg., Box 004 1010 Wall Street Ann Arbor, MI 48109 i FnAi 100930 ii I ! : Ju d ith A. Zack /Pace 2 Abstract A retrospective cohort mortality study of workers exposed to polychlori- _` . i1 nated biphenyls (PCBs) during production of the compounds is reported. A total of 89 workers exposed to PCBs for a minimum of six months during the period I If r o m 1 9 4 5 t o 1 9 6 5 w e r e f o l l o w e d t h r o u g h 1 9 7 7 , a n d t h e i r v i t a l s t a t u s w a s d e t e r - mined. Comparison of this PCB-exposed cohort's mortality experience with age-, race-, and cause-specific mortality rates of the U.S. male population was performed. Observed deaths were not statistically greater than expected for any of the ca nc er sites examined. No deaths were observed for cancer of the i liver or malignant melanoma. A statistically significant) excess of circulatory disease deaths, exclusive of arteriosclerotic heart disease, was observed in white males. Cl 1009?T r I Ju d it h A . -Zack/Page 3 The term "polychlorinated biphenyls" (PCBs) describes a group of mixed iJ chlorinated biphenyls which vary in consistency from light, free-flowing *- ! l liquids to crystalline and non-crystalline solids, depending on the degree of chlorination. PCBs have been in commercial use since 1929. Their dielectric I ( properties, resistance to oxidation, acids, bases, and other chemicals, and ` iil thermal stability have made them useful for many applications, particularly 1n the production of capacitors and transformers, and in the insulation of elec- trie cables and wires. Reports of adverse health effects in man initia ted from several -incidents of a c c i d e n t a l h e a v y e x p o s u r e t o P C B s . A p r o c e s s c h a n g e inj a c h e m i c a l - p l a n t introduced an unspecified PCB conpound (Arochlor) into the work environment, i! |r e s u l t i n g i n e x p o s u r e o f 1 4 w o r k e r s t o e s t i m a t e d b r e a t h i n g z o n e P C B l e v e l s o f 0 . 1 m g /n w .l C h l o r a c n e d e v e l o p e d i n o n e - h a l f o f t h e e x p o s e d w o r k e r s , a n d l i v e r I1 function tests shewed a borderline abnormality in one of the seven affected workers. After 13 months of follow-up, the chloracne had disappeared, but the t liver function abnormality, although improved, remained. * Accidental ingestion of rice oil cont ami na te d wijth PCBs has re sulted in .i s e v e r a l o u t b r e a k s o f c o m m o n s y m p t o m a t o l o g y , r e p o r t e d (f r o m J a p a n ( " Y u s h o " d i s e a s e ) ^ a n d T a i w a n '( " Y u - C h e n g " d i s e a s e ) . 3 T h e m o s t c o m m o n a c u t e s y m p t o m s observed were hyperpigmentation and acne-like lesions , discharge from the eyes, neuroendocrine disturbances, emesis, and diarrhea. 1 ii There Was a dose-response relationship between the amount of oil ingested and the proportion of persons r e p o r t i n g s y m p t o m s . A f t e r s i x y e a r s , m a n y of t h e p a t i e n t s still r e p o r t e d s u c h ! symptoms as headache, stomach pain, numbness of the extremities, arthralgia, and respiratory synptoms.^ Although massive, ingestion of PCBs occurred in these incidents, analysis of the cooking oil in the Yusho episode showed that FniW 414 100932 I 1 1 Ju d ith A. Zack/Page 4 bi polychlorinated dibenzofuran$b and polychlorinated q u a t e r p h e n y l w e r e co- f i| contaminants. Analysis of blood samples from patients in both incidents, as w e l l a s l i v e r a n d ! ' a d i p o s e t i s s u e f r o m Y u s h o p a t i e n t s , s h ilo w e d t h e p r e s e n c e o f i1 1 1i these compounds along with PCBs.^* These co-contaminants obscure the rela- i tionship of PCBs to the symptoms resulting from ingestion of the contaminated rice oils. The Yusho incident served as a stimulus to a 1arge number of toxicologi- cal studies dealing with the health effects of PCBs Chronic toxicity studies of PCBs in mice and rats have shown hepatic effects ranging from hyperplasia to w e l l - d i f f e r e n t i a t e d h e p a t o c e l l u l a r c a r c i n o m a s 'f o l l o w i n g t h e i n g e s t i o n o f v a r i o u s 1 j| PCB-containing diets.9 > 10 Studies of human exposure toPCBs have shown that b o d y b u r d e n s a r e d i r e c t l y r e l a t e d t o t h e l e v e l o f e x p o s ui; e t o P C B s . 1 1 1 3 Morbidity-studies have focused on the effects of PCBs on the skin, liver, blood ch e m i s t r y , and o t h e r s y s t e m s . *6 C h lc rac ne , d e rm ati ti s, m i l d l i v e r func- tion abnormalities, and increased triglycerides levels we re reported with some consistency from these studies. Mortality studies of occupationally-exposed individuals have not yielded consistent results. A preliminary r e p o r t ^ addressed an (increase in deaths due to malignant melanoma (2 obs. vs. 0.C4 exp.), which occurred in a group of 51 research and de velopment and 41 refinery workers at a Hewj Jersey petrochemical plant. Another author commented on problems in defining exposures in this jj study.I S J n a s t u d y o f 2 5 6 7 c a p a c i t o r p l a n t w o r k e r s e x p o s e d t o P C B s , * 9 ! 1 excesses of liver and rectal cancer deaths, which were not statistically sig- |1 nificant, v/ere reported. Although few deaths were aval la th e for analysis by duration of exposure and latency, there was no trend by these measures for l i v e r c a n c e r d e a t h s , a n d a s l i g h t i n c r e a s e by l a t e n c y b u t n o t b y 1 e n g t h o f , inni ai 5 100933 Ju d ith A. Zack/Page 5 e x p o s u r e f o r r e c t a l c a n c e r d e a t h s . ' A n o t h e r s t u d y ofj 1 3 1 0 1w o r k e r s f r o m a c a p a c - itor-manufacturing-^)!ant with at least six months employment between 1945 and . l ii 1970 found statistically significant excess deaths from all cancers (in males) and all causes (in females)-20 Suggestive, but not statistically significant, 1 excesses were noted for deaths due to digestive systjem cancers (in males) and m a l i g n a n c i e s o f l y m p h a t i c a n d h e m a t o p o i e t i c t i s s u e (jin m a l e s a n d f e m a l e s ) . H o deaths were attributed to liver cancer or malignant melanoma. Due to the rela tively young age of this worker cohort and the resultant small number of deaths (n = 27), site-specific excesses were based on two or thrJe deaths; therefore, further study of this cohort was proposed by the authors. A t a b o u t t h e t i m e o f t h e i n i t i a l r e p o r t d e a l i n g w i t h !t h e m o r t a l i t y e x p e r i ence of an occupationally-exposed worker cohort, a prelimijiiary review of the mortality experience of Monsanto workers involved in!the production of PCBs was carried out. The present study represents a completed analysis of this worker cohort's mortality, with particular attention given to overall cancer, liver and pancreatic cancer, and malignant melanoma. Materials and Methods FnMAIfi During the period from 1936 to 1977, PCBs were manufactured at Monsanto I 'I Company's Sauget, Illinois plant. Throughout this p e 1r i o d , |t ii h e process of ma nu fac tu re remained relatively unchanged. This process, jn brief, involved the batch chlorination of biphenyls in the presence of iron and iron chloride' ij catalysts. The crude mixture produced in the chlorinators; was then aerated, d i s t i l l e d , e a r t h t r e a t e d , f i l t e r e d , a n d t r a n s f e r r e d tjo s t o r a g e t a n k s b e f o r e s h i p p i n g . W h i l e n o i n d u s t r i a l h y g i e n e m o n i t o r i n g d a t Ia w e r 1e a v a i l a b l e t o q u a n - tify the PCB-exposure levels during the stuay time, interviews with plant |i personnel established the fact that PCB exposure levels did not vary consider- ably within the PCB department. Therefore, all workers in; this department i r t /\ Ju d ith A . Zack/Page 6 were considered to have a common exposure to PCBs, as we 1 as other chemicals u s e d i n t h e d e p a r t m e n t , i n c l u d i n g h y d r o c h l o r i c a c i d ,, tri-i* a n d t e t r a c h l o r o b e n - zene, biphenyl, and chlorine gas. All male employees from the hourly roll who worked in the PCB department for at least six months between January 1, 1945 and December 31, 1965 were selected for the study. By use of the plant's computerized work history system, union records, and manual work history verificationj, 89 male, hourly employees m e t the criteria for inclusion in the study. The vital status of 98.9% (88) of t h e c o h o r t w a s d e t e r m i n e d a s o f D e c e m b e r 3 1 , 1 9 7 7 , u!s i n gi[ s t a n d a r d f o l l o w - u p t e c h n i q u e s . T a b l e 1 s u m m a r i z e s t h e r e s u l t s o f t h e vIi t a l i|s t a t u s t r a c i n g . A death c e r t i f i c a t e was ob t a i n e d f o r each person founc! to be deceased, and co di ng | !| . of the underlying cause of death was performed by an experienced nosologist, I i| using the International Classification of Diseases,'Aaaoted, Eighth Revision.21 U s i n g a c o m p u t e r p r o g r a m d e v e l o o e d f o r s u c h a n 1l a p p l i1e a t i o n , 2 2 t h e c o s e r v e d ii number of deaths among PCB workers was compared with those expected based on age-, race-, and cause-specific mortality rates of U.S. males. To compute ex p e ct ed numbers, pe rs on- ye ar s of o b s e r v a t i o n were alljocateil to fi ve -ye ar age a n d c a l e n d a r t i m e c a t e g o r i e s a n d n i l t i p i i e d b y c o r r e!s p o n d '!In g r a c e - a n d c a u s e - 1 specific death rates for U.S. males. The resulting quantities were summed Ii e v e r a l l a g e s and y e a r s i o o b t a i n t h e t o t a l e x p e c t e d n u m b e r s . R a t i o s o f o b served to expected number of deaths were expressed as standardized mortality ratios (SMRs). Significance testing of the SMRs was performed at the 5% level, assuming that the observed number of deaths follow a Poiss on di stributi on. Results Fornai? Of the 88 PCB workers for whom vital status tracing was successful, 58 were verified living and 30 were verified deceased. Death certificates were h n n m f' I Judith A. Zack/Page 7 obtained for each of the decedents. The person-years of observation contri- buted by the entir-e worker cohort are shown in Ta bV e 2. A total of 1800.1 *| person-years were observed at all ages, with the majority observed in the middle-age range (ages 35-60 yrs. contributed 74%, or 1333.1 person-years to the total). Cross-classification of PCB exposure duration with vital status { T a b l e 3 ) s h o w s t h a t t h e m a j o r i t y o f b o t h l i v i n g a n d1 d e c e!a s e d w o r k e r s w e r e exposed less than three years. The average length of exposure to PCBs for l i v i n g a n d d e c e a s e d w o r k e r s w a s s i m i l a r , w i t h d e c e a sIe d w 'o r'Ik e r s h a v i n g s l i g h t l y j| more exposure time (3.7 yrs. vs. 3.2 yrs., respectively).! Cause^spe^ific SMRs are listed in Tables 4 and 5 for the 60 white and 29 nonwhite male members of the PCB study cohort. Deaths due to malignant neo- |t p l a s m s , as i n d i c a t e d ' i n T a b l e 4, a c c o u n t e d for 2 7 % (3) o f t h e total nu mb er of j deaths. No cancer deaths were attributed to malignant neoplasms of the liver if or pancreas, or malignant melanoma. While many of the cancer-specific SMRs exceed 100, none are statistically significant. In white males, lung ca nc er accounted for 75% of the deaths due to malignant neo asms while no single cause predominates in nonwhite males. Table 5 presents a Drief summary of the eight career deaths in the PCB worker cohort. Among the non-nialignant causes of death (Table 6), diseases of the cir culatory system accounted for almost half of the deaths. For the category of IJ circulatory system disease, exclusive of arteriosclerotic heart disease, the SMRs for white males and for the total cohort were significantly greater than 1 '1 100. The excess in deaths due to this category is accounted for solely by the experience of the white males, since nonwhite males showed an SMR of 93. No f other causes of death in Table 6 showed observed deaths whi ch were statistically i : n m <xi 8 10003R I \ J u d i t'n A . Z a c k / ? a g e C greater than expected- The-overall SMR for malignant and non-malignant c a u s e s wa s 1 3 1 (3Q o b s e r v e d , 2 2 . 8 8 e x p e c t e d deaths}. Li tt le d i f f e r e n c e was found in this overall SMR by race (for whites, 133; for' nonwhites, 128). Di scussi on This investigation dealt with the mortality experience of a cohort of 89 \ naie workers involved for a least six months in th production of PCBs between J a n u a r y 1 , 1 9 4 5 a n d . D e c e m b e r 3 1 , 1 9 6 5 . T h e o n l y c aIu s e oIf m o r t a l i t y w h i c h l 1 showed a statistically significant excess in observed deaths was circulatory d i s e a s e s exclusive of ar te rio sc le rot ic heart disease. Tills excess was apparent only for white males. Circulatory diseases in this catee ory included deaths f r o m r h e u m a t i c h e a r t d i s e a s e , c e r e b r o v a s c u l a r di s e a :s e , a n d o t h e r f o r m s o f h e a r t > disease. I f t h i s e x c e s s c a u s e o f d e a t h i s n o t a n a r t i f a tc t , o n e w o u l d p o s t u l a t e t h a t there may also be a relation between risk factors of these circulatory diseases |a n d P C B e x p o s u r e . B l o o d p r e s s u r e , a r i s k f a c t o r ( w h e n e l e v a t e d ) o f c o r o n a r y heart disease (CHD) and cerebrovascular disease, has been1 related to blood PCB l e v e l s i n t w o s t u d i e s , w i t h c o n f l i c t i n g r e s u l t s . O nje s t u |d y 2 4 f o u n d t h a t serum PCB-levels made a statistically significant contribution to explaining the variability of diastolic (but not systolic) blood pressure measurements in multiple regression analyses of data from a community exposed to DDT and PCBs, w h i l e a n o t h e r study25 f o u n d n o s u c h a s s o c i a t i o n . S t u d i e s o f l i p i d s , w h i c h i have been associated with CHD and (with less consistency)! with cerebrovascular !1 disease, have considered total cholesterol, high density 1 ipoprotein (KDL), and t r i g l y c e r i d e l e v e l s i n r e l a t i o n t o b l o o d P C B l e v e l s . ji W h i li e n o c o n s i s t e n t association has been shown between blood PCBs and total cholesterol or HDL l e v e l s , m o s t , ^ , 1.6 t>u t n o t a l l , 2 4 s t u d i e s h a v e s h c w r i i n c r e a s e d t r i g l y c e r i d e F/im A19 100937 J u d i t h A . l a c k / P a g e 9, levels wi th increased blood PCB levels- Given the lack of su pp ort for an rI a s s o c i a t i o n b e t w e e n P C B s e x p o's u r e a n d n o n - A S H D c i r cfu l a t o r y s y s t e m d e a t h s f r o m -" * 1 |! previously reported mortality studies, and the inconclusive relation between ! c a r d i o v a s c u l a r risk factors and blood PCBs, this excess c a u s e of death irust be viewed as a preliminary finding, in need of support from other studies. While previous mortality studies as well as toxicological studies have implicated a variety of cancers - digestive system, liver, pancreas, malignant melanoma - as possible results of exposure to PCBs, the piresent study provides no support to such findings. In the Monsanto worker cohort, no deaths were I il attributed to liver or pancreatic cancer, nor were any malignant melanomas f o u n d . T h e o v e r a l l e x c e s s in c a n c e r d e a t h s , w h i l e riot s t a t i s t i c a l l y s i g n i f i cant (8 observed, 4.46 expected, SMR - 179), is mainly a result of respiratory i1 cancer deaths in workers for whom smoking habits were not! ascertained. i Although the present study's results do not support a carcinogenic effect ij a s s o c i a t e d w i t h P C B e x p o s u r e , t h e r e a r e s i g n i f i c a n t 1 i m i t a t i o n s t o t h e r e s u l t s . t \\ A principal limitation is^the size of the worker cohort,, y/hich prevents thei detection of increases in risk to deaths from rare diseases. A much larger I cohort followed for a longer period would be necessary to detect a two-fold !I increase, for example, in observed liver cancer deaths. In order to allow for a latency period, the study cohort was limited to those working at least six m o n t h s u n t i l D e c e m b e r , 1 9 6 5 . S i n c e P C B p r o d u c t i.o n 1c o n t i n u :eld u n t i l 1 9 7 7 , f u r t h e r li iI| follow-up of the mortality of Monsanto's PCB-exposed workers will have larger numbers,.as well as longer follow-up time. *i A n o t h e r l i m i t a t i o n c o m m o n t o r e t r o s p e c t i v e s t u d i e s of! o c c u p a t i o n a l c o h o r t s ii is lack of knowledge of exposures from other work-reljated activities. While p e r s o n a l , h a b i t s , s u c h a s s m o k i n g a n d d r i n k i n g , c a n s o m e t i m e s b e r o u g h l y ascer- i >( t a i n e d if c o - w o r k e r s or f a m i l y m e m b e r s ar e a v a i l a b l e for i n t e r v i e w , p r e v i o u s V i \ M' 2:0L 100938 I J u d i t h A . Z a c k / P a g e 10 exposures, or concurrent occupational exposures during follow-up, are often' impossible to assess. The connection of an effect to a previous PCB exposure must first consider other potential effect-related expo'sires. A useful comparison group in occupational mortalityfstudies is an unex- I' posed industrial cohort, from the same plant, if possible. Ascertainment of I m o r t a l i t y o f s u c h a c o h o r t a l l o w s f o r c o n p a r i s o n of| S M R s b e t w e e n e x p o s e d a n d unexposed cohorts, which reduces the possibility that an elevated cause of death in the exposed cohort is a result of a generally greater than expected cause-specific mortality in that area or industry. Such a comparison group would have been useful' in evaluating the elevated mortality due to non-ASHD circulatory system diseases found in this study. [ Given the size of the study cohort and the other limitations described above, the results of this analysis of PCB-exposed workers' mortality experi ence are not definitive, but rather contribute to the health-effects research i! c-n P C B s . A f u t u r e s t u d y o f t h i s c o h o r t c o u l d e v a l u a t e t h e m o r t a l i t y o f w o r k e r s involved from the initial through the final year of PCB production, and thus ,I have more power to detect any possible hazards of PCB exposure. mm 100930 I I Ju d it h A . Z a ck / P a g e 11 References - 1. Me ig s, J. W. , Vbpm, J.J.., Kartin, B.L. I !t I C h l o r a c n e f r o m an unusual expor- s u r e t o Ar oc hlo r. J. A. M.A . 1 5 4 : 1 4 1 7 - 1 4 1 8 , 1954,. 2. K u r a ts u n e , M . , Yoshimura, T., M a ts uza ka , J., Ya iaguchn, A. Ep id emi ol og y study on Yusho, a poisoning caused by ingestion of rite oil contaminated with a commercial brand of polychlorinated biphenyls.! Environ. Health Persp. 1:119-128, 1972. 3. Chang, K.J., Cheng, J.S. Huang, P.C., Tung, T.C. Study of patients with PCB p o i s o n i n g . J. Formosan Med. As so c. 79 :3 04- 31 3, IS 80. 4. Urabe, H., Koda, H . , Asahi, M. Present state of Yusho patients. Ann. N.Y. Acad. Sci. 320:273-276, 1979. 5. Nagayama, J., Kuratsune, M., Ma suda, Y. D e te rmi na ti on of - chi orinated dibenzofurans in Kanechlors and "Yusho oil." Bull. Environ. Contam. Toxicol. 15:9-13, 1976. 6. Kamps, L.R., Trotter, W.J., Young, S.J., Carson, L.J.,! Roach, J . A . G . , Sphon, J.A., Tanner, J.T., McMahon, B. Polychlorinated quaterphenyls i| M identified in rice oil associated with Japanese "YushOj' poisoning. Bull. Environ, Contam. Toxicol. 20:539-591, 1978. 7. Ka s h i mo t o , T . , Mi yata, H . , K u n i t a , N. T h e p r e s e n c e of p o l y c h l o r i n a t e d q u a t e r p h e n y l s in th e t i s s u e s c f Yusho vi ct ims . Fjood C o s m e t i c s Toxicol. 19:335-340, 1981. 8. Kashimoto, T . , Miyata, H . , Kunita, S., Tung, T.C., Hsu* S.T., Chang, K.J., Tang, S . Y . , Ohi, G., Nakagawa, J., Yamamoto, S. Role of polychlorinated dibenzofuran in Yusho (PCB poisoning). Arch. Environ.! Health 36:321- 326, 1981. 1009 id Kimbrough, R.D., Linder, "R.E., Gaines, T.B. ji ,)i O u d i t h A . Z a c k / P a g e 1 2 I! ' Morphological changes in I :| livers of rats-fed polychlorinated biphenyls. Arch. Tnviron. Health 25:354-364, 1972. Kimbrough, R.D., Squire, R.A., Linder, R.E.Stifandberg, 0.0., Montali, R. J., Burse, V.W. Induction of liver tunors in Sherman strain female 1 rats by'polychlorinateti biphenyl Arochlor 1260. 0. National Cancer Inst. 55:1453-1459, 1975. Ouw, H.K., Simpson, G.R., Siyali, D.S. Use and health effects of Arochlor I 1242, a polychlorinated biphenyl, in an electrical industry. Arch. Environ. Health 31:189-194, 1976. . M a r o n i , M . , C o l o m b i , A. , C a n t o n i , S. , Feri oli, E*., Fo, V. O c c u p a t i o n a l e x p o s u r e t o p o l y c h l o r i n a t e d b i p h e n y l s i n e l e c t r i c a l w o r k e r s . I. E n v i r o n m e n t a l a n d b l o o d p o l y c h l o r i n a t e d b i p h e n y l s c o n c e nI t r a t'i o n s . B r i t . 0 . Industr. Med.'38:49-54, 1931. C h a s e , K . H . , W o n g , 0., T h o m a s , D . , B e r n e y , B . W . , 1 S i m o n , R . K . C l i n i c a l a n d m e t a b o l i c a b n o r m a l i t i e s a s s o c i a t e d w i t h o c c u p a t i o n a l 'e x p o s u r e t o p o l y c h l o r - i nateti biphenyls (PCBs). J. Occup. Med. 24:109- 14, I S 82. Fischbein, A., Wolff, M.S., Lilis, R., Thornton, 0., Selikoff, I.J. Clin- ical findings among PCB-exposed capacitor manufacturing workers. Ann. N.Y. Acad. Sci. 320:703-715, 1979. Marcili, M . , C o l o m b i , A . , A r b o s t i , G. , C a n t o n i , Sj, Foa|, V. O c c u p a t i o n a l exposur e to polychlorinated biphenyls in electrical workers. II. Health effects. Brit. J. Industr. Med. 38:55-60, 1981. \ Baker, E.L., Jr., Landrigan, P . J . , Glueck, C.L., Zack, M . M . , J r . , Liddl e, J . A . , B u r s e , V . W . , H o u s e w o r t h , W . J . ,. N e e d h a m , L . L . M e t a b o l i c c o n s e q u e n c e s i| of e x p o s u r e to p o l y c h l o r i n a t e d biphenyl s '(PCB) in s e w a g e sludge. Am. J. Epidemiol. 112:553-563, 1930. ITnO I 1009 11 Judith A. Zack/Page 13 1 7 . B a h n , A . K . , R o s e n w a l k e / I . , H e r r m a n n , N . , G r o v e r , P; , S t e l l m a n , J . , O ' L e a r y , K. Me lanoma after ex posure to PCBs. N. Engl. 0. Med. 295:450, 1975. * i| 18. Lawrence, C; PCB? and melanoma. N. Engl. J. Med. 29 I 6 : 1 0 8 ,9 1 9 7 7 . 19. Brown, D.P., Jones, M. M o r t a l i t y a n d industri a! h y g i e n e study of wo rk ers exposed to polychlorinated biphenyls. Arch. Environ. Health 36:120-129, 1981. i I 20. Bertazzi, P.A., Zocchetti, C., Guercilena, S., Fogli a, M.D., Pesatori, A., Riboldi, L. Mortality study of male and female workers exposed to PCBs. Int. Symposium on Prev. of Occup. Cancer, He! sinki, Finland, April, 1981. 21. Eighth Revision, International Classification of Diseases, Adapted for Use in the United States. U.S. Department of Health, Education, and Welfare, I1 Public Health Service, PHS Publication Ho. 1693. Washington: U.S. Govern ment Printing Office, 1977. 22. Monson, R.R. Analysis of relative survival and propjortional mortality. Comput. Biomed., Res. 7:325-332, 1974. 23. Bailar, J.C., Ederer, F. Significance factors for the ratio of a Poisson variable to its expectation. Biometrics 20:639-643, 1964. 24. Kreiss, K . , Zack, M.M., Kimbrough, R.D:, Needham, L.L., Smrek, A.L., Jones, B.7. Association of blood pressure and polychlorinated biphenyl levels. J.A.M.A. 245:2505-2509, 1981. 25. Bumgarner, J.E., Hammer, D.I., Colucci, A.V., Creason, J.P., Finklea, J.F. Polychlorinated biphenyl residues in refuse workers Research Triangle Park, North Carolina, National Institute of Environmental Health- and S a f e t y , P u b l i c H e a l t h S e r v i c e , D e p a r t m e n t o f H e a l t h , .E d u c a t i o n ^ a n d W e i K o r n `M fare, 10 p p . , 1973. 100912 J u d it h A . Z a ck /Pag e 14 Table 1 F o l l o w - u p S t a t u s o f P o l y c h l o r i n a t e d B i p enyl Workers as of December 31, 1977 Follow-up Status Number Status known Verified alive Verified deceased Death certificate found Death certificate net found Status Unknown Total 89 FoniA95 100943 Ju d ith A. Z a c k / P a g e 1 5 Table 2 Person-years of Observation Contributed by Polychlorinated Biphenyl Workers' by Age Age in Years Person-years of Ob.servatii on 20-24 11.4 25-29 63.8 30-34 142.6 35-39 40-44 45-49 50-54 55-59 60-64 65+ 222.5 283.2 i 3i 2 5 . 3 21 9 4 . 5 1 2i 0 7 . 6 1| 3 4 . 0 ll5.2 'Total 1800.1 F an i to t; 100944 iII O u d i t h A . Z a c k / P a g e 1 6 1 ( Ii Table 3 Duration of Exposure to Polychlorinated Biphenyls by Vital Status Years of Exposure* <1 1-3 3-5 >5 L iv in g (n = 58) 20 20 6 12 Vital Status Deceased (N = 30) 5 12 4 9 U n k n b wn ( n =| i ) 1 1! \ c 1 Qj Total (n = 89) 26 -32 10. 21 Average Length of Exposure 3.2 yrs. 3.7 yrs. i 0.7' y r s . 3.3 yrs Lifetime exposure prior to 1-1-66 I I I FOrtl4 9 7 I ! I !i 100915 Ju d ith A. Z ack /w fe.'17 Table A Observed and Expected Deaths Due to Malignant Neoplasms by Race, PCB Worker Cohort I . C .D . N o . (Eighth Rev.)_ _ _ _ _ _ _ _ _ ` Cause of Death White jles 0 E SMR* Nonwhite Males 0 E SMR* T o 't'al 0 E SMR* 140-209 All Malignant neoplasms 4 2.70 148 4 1.76 227 8 4.46 179 140-149 Buccal cavity & pharynx 0 0.09 - 0 0.07 - 0 0.16' t 150-159 Digestive organs & peritoneum 0 0.75 - 1 0.58 172 1 1.33 75 155, 156 Liver 0 0.05 ' - 0 0.05 - 0 0.10 - 150-154, 157-159 160-1G3 162, 163 160, 161 -- lBb-189 200-209 164-104, 190-199 Other digestive organs Respiratory system Lung Other respiratory organs Genitourinary organs Lymphatic & hematopoietic tissue All ot he r sites 0 0.70 3 0.94 319 3 JJ.jiSL _ 337 0 0.05 0 0.28 - 1 0.53 189 1 1.23 81 1 0.59 169 4 1.53 261 1 -- 0-5.5-- 1 8 2 - - - -- 4 - - 1 t 4-4-- -2 7 8 - 0 0.04 - 0 0.09 - 1 0.23 435 1 0.51 196 0 0.28 1 0.36 -1 278 * 0 0.12 833 0.17 1 0.40 1 0.53 250 109 *No SMR was statistically si gn ifi ca nt (all p-values greater th a n 0.05) A9M 100916 Ju d ith A. ad rg e l Race Nonwhite Nonwhite Nonwhite White ? " *> i White White Nonwhite White MO o CO h-- Year of Birth 1909 1913 1909 1893 1912 1916 1907 1906 Table 5 Case Summaries of Cancer Deaths Among Polychlorinated Biphenyl Workers Y e a r of Fi r s t Exposure Year of Death PCB Exposure Duration (mo,) 1942 1959 13 1954 1965 85 1951 1968 1943 1963 1951 1968 1951 1977 1945 1964 1940 1957 28 34 28 33 8 79 Death Certificate C a u s e o f D e a t h ,(ICDj?) Carcinoma of colon (153.8) CarclnomatosisPrimary site, kidney (189.0). Carcinoma of lung (162.1) Carcinoma of right lung (162.1) Carcinoma of lung (162.1) Carcinoma of lung (162.1) Multiple myeloma (203.0) Metastatic carcinomacarcinomatosis (199.0) Ju d ith A. Z a c k / l^ c 19 Table 6 I.C.D. No. (Eighth Rev.) 390-458 410-413 390-409, 414-45B 460-519 *23 2 520-577 -- o 800-998 - Total O o CO 3 0 *p < 0.05 Observed and Expected Deaths Due to Non-mal1gnant Causes by Race, PCB Worker Cohort Cause of Death White Males ,0 E SMR Nonwhite Males 0 E SMR Total 0 E SMR Diseases of the circulatory system 11 6.82 161 5 4.35 115 16 11.17, 143, Arteriosclerotic heart di case 4 4.99 80 3 2.20 136 7 7.19 97 All other circulatory system 7 1.83 526* 2 2.15 93 9 3.90 226* Diseases of the respiratory system 0 0.73 - 1 0,54 185 1 1.27 79 Diseases of the digestive system __L_ 0 .7-5-- 133 1 -0.45--- 222-- 2 ~ lT 2 0 -- T 6 7 - - - - - External causes of death All other non-inalignant causes 0 1.43 . 2 1.10 182 1 0.95 105 __ 1 2.38 4_2_ _ _ _ 0 1.30 - 2 2.40 83 All causes, malignant & non-malignant 18 13.53 133 ' 12 9.35 128 30 22.88 131 I 1 I t PCBS: HUMAN AND E N V I R O N M E N T A L HAZARDS F. M. Chapter 20 D *1 tri, M. A. Kamrin 1 |, "The epidemiology ofj PCBs I! j Butterworth Publishers, Woburn, m a , 1983 007547 Knni a i i I I CHAPTER 20 THE EPIDEMIOLOGY OF PCBa William R. Gaffey Monsanto Company S c . L o u i s , M i s s o u r i 63 1 6 7 II INTRODUCTION I This evidence la a r e v i e w arid e v a l u a t i o n o f c o n c e r n i n g the r.ealtn effects t Iho e f e r e : x p :Jo e a s :oi ure o g : t c o p c l y c n l o r l n a t e d Diphenyls t'PCBsi, particularly at levels that do not cause acute toxic effects. A study is considered "epidemiologic evidence" if It measures, directly or indirectly, the differences in the risk of ill health among populations with different exposures tc PCBsJ In the p a s t s e v eral decades there have Deen manyj clin i c a l s t u d i e s o f the e f f e c t s of heavy e x p o s u r e s tol PCfis ;e.g., Vo n Weael et al., 19*3; Schwartz, 1936). Sucn studies are extremely \ useful in identifying the kinds of effectsj that snould De investigated. However, they do not address the question of the r i s k o f i n c u r r i n g s u c h e f f e c t s a n d a r e , t h e r e f o r e , r.c: i n c l u d e d in this review. ( The studies reviewed here fall into three categories. First, there are studies of accidental heavy exposures and the r e s u l t i n g acute and chronic effects. In each case the study w a s p r o m p t e d by an, o u t b r e a k of i l l n e s s or t n e | o c c u r r e n c e of a d e a t h in an e x p o s e d population, a f ter which tne population was studied. Second, there are studies of the relationship between .expo sure to PCBa and the resulting body burden of PCBa :njserum or adipose tissue. Strictly speaking, these are not epidemiologic studies since they do not deal with health effects. jHowever, if a relationship between level of exposure and body burden cannot be verified, the interpretation of epidemiologic studies b e c o m e s diffi c u l t if not impossible. f i 007548 FoniAfi2 J i J PC l i . H jfiidt n J tn v ^ ro /i )L 'iiC .* J Th third category i populations in question w* to PCfis, r a t h e r than b e c a u s e been observed first. idles that were done because the vnown or suspeeted to be eiposed s untoward health oulc( had M a n y p u b l i s h e d r e p o r t s c o m b i n e jo o r a l l o f t h e s e t y p e s of investigations. In the sections that follow, we consider first the studies of accidental over exposure; second, the studies of PCS exposure versus body burden; and third, the e p l d e a j o i c g i c s t u d i e s o f e x p o s e d p o p u l a t i o n s . Ir. t h * l a t t e r section, the d i s c u s s i o n will be o r g a nised with respect to the health effects that were investigated. These are: (1) d e1r m a t o l o g i c s y a p t o e s , ( 2) o l c h e w l e a l a l t e r a t i o n s , (3) o t h e r s y m p t o m s a n d i l l n e s s e s , () c a r c i n o g e n i c i t y . ACCIDENTAL HEAVY EXPOSURE Two epidemiologic studies of accidental exposure have been reported. The| first (Helgs et a K , 195*) described an outbreak of chloracne in a plant In which a process change had Introduced an unspecified PCB coapound Into the work environaent. Breathing tone lavals of PCB were stated to be 0.1 ag/a^. Seven o f 1* e x p o s e d w o r k e r s d e v e l o p e d c h l o r a c n e , b u t l i v e r f u n c t i o n t a e b s n t o s r m a w l e i r t e i e s n o iIn il the In six of these, with soox borderline seventh. The chloracne disappeared after treatment, and the single borderline liver function abnormality l a p r o v e d , b u t d i d n o t d i s a p p e a r a f t a r 13 a o n t h a . l a p r o v e d process control prevented any recurrence. Although the estlaated PCB level aust be accepted with reservation b e c a u s e o f the state o f the art at that tlae, it is clear that the c h loracne res u l t e d free the PCB exposure, Given the lack of oontrols and the small rata of abnormal liver function, it Is unlikely that the PCB exposure had any connection with the liver function findings. The second Incident is the now faaous Yusho Incident in 1966 w h i c h h a s ! b e e n d o c u m e n t e d i n m a n y r e p o r t s U u r a t s u n e e t al., 1972; Urabe et al., 1979) in which some thousand Japanese became ill after eating cooking oil which had been contaainated with C ane chi or, 900, a P C S c o a p o u n d o f Japanese aanufacture. T h e c o s t et acute syapt observed were hyperplgaen- tatlon and acne-llke lesions, discharge froe the eyes, central nervous systea| syaptoas, and voaltlng and dlirmea. There was a dose-response relationship between the aacunt of oil ingested vr o A I r V i\ r.*)c t.: . j-- . a.- III II and the p r o p o r t i o n of persons reporting symptoms. Three years later a b o u t , h a l f U>e p a t i e n t s had improved, but] still has syapjtoas. Six years later oany patients still reported such symptoms as headache, stomach pain, nuaonesj of the itrmitles. Joint pain, and respiratory syaptoas. . | 1 [l Out of ten live births to uoaen affected by Tusno, nine shoved hyperpigaentstlan end aost had increased eye discharges. These sy a p t o a s later disappeared. Although there] have beer r e p o r t s o f p r e a a t u r e e r u p t i o n o f t e e t h (2 | c n i l d r e r o u t o f s e r i e s o f 13) a n d u n u s a l l y v i d e f o n t a n e l l e s a p d s a g i t t a l s u t u r e s .3 o u t o f 1 3 ) it, i s h o t a t a l l c l e a r t n a t t h e s e f i n d i n g s r e p r e s e n t a n y a o r e t h a n t h e n o r m a l v a r i a t i o n to be] e x p e c t e d , since no control observations were made (Funatsu et al ., 1972). In g e n e r a l , l a boratory t e s t s o f the Tusho victims s h o w s : elevated serum triglyceride levels, low serua cholesterol serious cases, and elevated serua glutaaic-cxaloacet:: -.-arsaeinase (SCOT) and serua glatasic-pyruvlc trarvsaslnase 5 C P T i l e v e l s i n s e r i o u s c a s e s ( H i g u c r i , 1976). As of the end of 1977, fifty-one. deaths among Tushc patients had been identified. The percentage of cancer death: ; 35. u e x c e e d e d t h a t o f t h e p r e f e c t u r e I n ' w h i c h t h e d e a t h s occurred (21.1). However, the figures do not appear to be very useful for several reasons. First, after the original']incidem. the criteria for diagnosis of Yusho had been| changed, so that :t is i m p o s s i b l e to d e t e r m i n e the d e n o a l n a t o r which1 p r o d u c e d this nuaber. The coapleteness of ascertainment of the deaths is u n k n o w n . In a d d i t i o n , n o a d j u s t a e n t for] aee a p p e a r e d tc h a v e b e e n m a d e i n t h e a b o v e c o m p a r i s o n . F i n a l l y , trie a v e r a g e e l a p s e d t i m e f r o m e x p o s u r e to d e a t h was less^ than ten vears. and cannot be calculated p r e c i s e l y because the dates] of death are not provided. This aay well be too short a period for cancers resulting free the exposure to show up. A l t h o u g h t h e T u s h c i n c i d e n t r e p r e s e n t e d a' m a s s i v e ingestion o f PCBs, recent reanalysis of the eoofcliv oil and of tne estimated intake by the patients shows that the |exposure ts p o l y c h l o r i n a t e d d l b e n z o f u r a h s (PCDFs) and[ p o l y c h lorinated quaterphenyls (PCQs) was about equal to the exposure] to PCBs. a n d c u r r e n t d e t e r m i n a t i o n s o f P C Q s in b l o o d a'nd o t h e r t i s s u e s o f Yusho p a t i e n t s h s v a t o w n l e v e l s s i a l l a r jto that- o t - P C B s (It l a b r o u g h , i 9 6 0 ) . I t I s , t h e r e f o r e , d o u b t f u l w n e t h e r a n y generalisation can be aide from this incident to lower level environmental or occupational exposures to PCBs. 1 1i `C U H t j i K i i * i . j L t t v 11 j o m ,'d ^ , i j* ENVIRONMENTAL LEVELE AND BODY BURDENS T wo studies of the relationship between w e s t ion of PCBs and b l o o d l e v e l s o f PCBs h a v e been reported (NLPII, 1075; Kreiss 1 1 * . I'ifltJ. In e a c h c a s e the s t u d y w a s c o n c e r n e d w i t h ingestion of fish known to contain relatively high levels of PCBs. In the first, an association was found between blood PCBs and exposure level as estimated hy the aaount of Lake M i chigan s p o r t fish consumed. In the second, the relationship b e t w e e n b l o o d P C B s and a c o m p l e x of factors was e s s o i n e d in a p o p u l a t i o n 11 n a n a r e a w i t h h l g n l e v e l s o f t n v i r o n m e n t a 1 contamination. Age. sax, and fish consumption, in that order o f i m p o r t a n c e , w e r e a s s o c i a t e d vltft b l o o d l e v e l s o f P CBs. To tne extent that fish consumption measures ingestion of PCBs, these studies confirm that blood PCBs arc a function of I n g e s t i o n o(j P C B s as veil a s o f age a n d s e x . O t h e r a s s o c i a t e d v a r i a b l e s w e r e e x a a i n e d I n K r e i s s e t a l . ( 1961) b u t w i l l b e discussed In the following section. |i A number of studies of blood PCBs and exposure to PCBs have b e e n made, most of them In conjunction with studies of health ef f e cts. The portions of the studies relevant to this section are reviewed here. There are three types of studies. The first compares groups which have has different exposure levels as estimated from process considerations or environmental measurements. F o r 1 c o n v e n i e n c e , s u c h a s t u d y d e s i g n w i l l b e c a l l e d T y p e A . The | second, trtuch we will d e s i g n a t e Type B, measures the change o v e r t i m e inj a s i n g l e g r o u p a f t e r P C B s h i v e b e e n r e m o v e d f r o m the environment (or after the group has left the environment). The third, T y p e C, compares groups that have had different durations of| exposure. Often the same report will c o n t a i n more than one type of study. For example, an exposed greup may be compared w i t h an unexposed g r o u p (Type A) and within the exposed ,group lon g - t e rm exposed workers may be compared with short-term workers (Type C). The m e a s u r e of body burden has in most cases been a single nimiber re p r e s e n t i n g , depending on the study, blood PCBs, plasma PCBs, s e r u m PCBs (all of which are called "blood" PCBs tn tnic review), or level of PCBs tn adipose tissue. Analytic methods lava varied over time and among investigators. More recently, eeasurea o f body burden have sought to determine separately the l e v e l s o f h i g h e r c n l o r i n a t e d b i p h e n y l s (5 o r m o r e c h l o r i n e a t o m s per molecule) and lower chlorinated biphenyls. T a b l e 1 l i s t s the s t u d i e s c o n s i d e r e d in tr.is s e c t i o n , wi t n the type of design and wnether or net separate determinations of h i g h e r anld lower c h l o r i n a t e d b i p h e n y l s were m a d e . All of t h e s t u d i e s e x c e p t B a t c e r e t a l . ( 19601 a r e o c c u p a t i o n a l . r/lcr Lf : J l'Pij bJoyy of PCSs .`S J TABLE 1 !i i` I I Studies of Environmental Levels and Body Burden o f P C B s t>y T y p e o f B o d y B u r d e n M e a s u r e * Study * Baker et a l., i960 Bumgarner et al., 1973 Chase et a 1., 1982 Hara et al., 19TM. 1975 Hasegava et al.. 1972 Inoue et a]., 1975 Karnpanen and Xelho. '973 Kitamura et a_., 1973 Haroni et al.. I9fiia Ouv et a i . , Smith et al.. 1982 Study Type3 A W A.C B.C A.B.C A.C A 5 A.C A ,2 a .: ! iUar. and Low 1 Cr lorlnatea PCBs 1i Adipose PCBs No No No No No No Ne No Ten Tes1 Yes ; No No 1 Yes ; No , No 1 No Yes No No No No *A s Comparisons of groups with diffrer: exposure levels B = Evaluation of results of decreasing or removing' exposure C : Comparisons of groups with diffrer.: durations of exposure A l l o f the T y p e A s t u d i e s a g r e e In s n o w i n g a h i g h e r b o d y bu r d e n o f PCBs in populations with r u s h e r envir o n m e n t s 1 e x p o s u r e , e x c e p t for one a n o m a l y in B a k e r el al.| (19fl0)j. T h ere, persons exposed to sludge containing PCss had slightly lower blood levels than the controls, on the average* However, the s l u d g e - e x p o s e d p e r s o n s a n d t h e c o n t r o l s w e r e fn o t m a t c h e d f o r a g e , w h i c h K r e i s s e t a l . ( 198D s h o w e d t e b e t h e m o s t i m p o r t a n t fac t o r a s s o c i a t e d with blood PCS level. It, t h e r e fore 1 appears unequivocal that higher exposure to PCBs Beans a higher body b u r d e n , a l l o t h e r t h i n g s b e i n g e q u a* l . l[ The Type B studies appear at first glance to be Bore equivocal (Table 21. Two studies show a recrease when exposure ceased or decreased and two do not. However, the|studies showing no decrease reaeasured their study groups within a aonth or two after exposure changed. The ones snowing s decrease remeasured after three aontns and one year. * The fact that Ouv et al. (1976) fc.nd no decrease after :wc m o n t h s while Kitamura et ai. (1973) f:-nd o ver a 50 percent 007550 Fnm v js-J K'bs: JuA-.-, snd t'fU'i ron^-neji lu^jr t. TABLE 2 Studies of Blood PCB Levels Before and After Exposure Levels Che need, and Interval from Exposure Change to Remeasurenent Study Exposure Change Hara et a 1., 197" , '975 a s e g a w a e t a ! . . i?72 K i t a m u r a et a !.. '9 ? 3 Cuw et al., 1975 Ceased Ceased Ceased Decreased Interval tc fiemea- srement (montns i Decrease in Blood PC6 Level (p e r c e n t ) 12 c * 7 5 1 Hone 3 50 2 None decrease after three months g i v e r rise to sore uneasiness. However, in the former study exposure was decreased but still present, w m l e in the latter s t u d y PCS use had ceased. Cuw et al. ' (1 9 7 6 1 allac suggest t h a t a f t e r exp o s u r e s in the i r s t u d y plant had decreased, workers did not wear gloves as recommended, s o t h a t t h e b l oJ o d P C s l e v e l s m a y h a v e r e s u l t e d f r o e s k i n c o n t a c t . Table 3 shows the fin d i n g s for the Type C studies other t h a n M a r o n i et! a l . ( 1 9 8 1 a ) a n d S m i t h e t a l . ( 1 9 8 2 ) t h a t i s , f o r those that compared duration of exposure with a single measurement of Blood PCB level. The results are not consistent. The s t u d y o f B u m g a r n e r et a_i. ( 1 9 7 3 ) found v erv low l e v e l s (average 4 ug/.kg) in exposed w o r k e r s , which ray hnve accounted for their failure tc find a r e l a t i o n s h i p with duration. On the o t h e r h a n d , trie e x p o s e d w o r k e r s i n H a s e g a w a et al.. ( 1 9 7 7 ) h a d a n a v e r a g e l e v j e l o f 370 u g / k g a n d s t i l l s n o w e d n c r e l a t i o n s h i p with duration.' T h e s t u d i e s o f M a r o n i e t a l . ( 1 ? 8 l a ) a n d S m i 't h e t a _ l . i 1982) s u g g e s t a p o s s i b l e e x p l a n a t i o n . H a r o n i e t a l . (1 < 5 8 l a 1 m a d e s e p a r a t e jc o m p a r i s o n s o f h i g h c h l o r i n a t e d PCB s a n d lo; c h l o r i n a t e d FjCBa between w o r k e r s witn present and past exposures. They found diff e r e n c e s in the low chlorinated PCEs but n o t in the m e n c h l o r i n a t e d c o m p o u n d s . Ever, t h o u g h their a n a l y s i s did not adjust f o r age, it surrests that the relationship oetween blood PCB levels ano duration and recency sf exposure nay be a function o f the level of chlorination of the PCBs. Smith et M . (1982), however, in an e l e t o n t c una lysis I TABLE 1 II Studies of PCB Levels by Dure cion of Eititur* Be lat:c r a m p of r.oc : PCfl to Study Cu"aticr of Exposure Rac* Bumgarner et al-, '973 Chase et al.. 1982 Hara et al.. 197*. 7 5 Maserawa et al., 1972 Inoue ec al., i975 No Si No Yes its -Yes -- -- No -- -- Yes - | f o f n i g h a n d 1: w c r . c - i r . a t c d b l o o d P C B s v e r a u s j p - e s e r : a n d p a s t exposure, found no "evidence either to sup?:-*, cr refute d i f f e r e m a c c u m u l a t i o n k i n e t i c s in h u m a n s f o r *.re t o w e r a n d h i g h e r c h l o r i n a t e s t i p n e n y l s " . N e v e r t h e l e s s , cr.ey| f o u n d a significant correlation between current personal a:- levels and low c n l o n n a t e c blood PCBs, but no significant correlation with hign cnlonnatec blood PCBs- In summary, body burdens of PCBs are clearly related to the level of exposure to environmental PCBs. | Observations of a d e c r e a s e in the b u r d e n o f P C B s a f t e r e x p o s u r e is e l i m i n a t e d o r d e c r e a s e d a r e n e t c o n s i s t e n t . T h e l a c k of| c o n s i s t e n c y m a y be due to the short periods of observa tion jof soce of the studies, or possibly to differences in the average chlorination of the PCBs involved. Studies of the r e l a t i o n s m p of PCB burden ts duration of exposure again are not consistent. There is a suggestion that this may be due to the confounding effects of axe and sex, or tc differences m tne mctabclisr cfi|mgh and lew chlorinated PCBs, with the higher PCBs being mire likely to accumulate in ad ipose tissue. EPIDEMIOLOGIC STUDIES OF PCBs AND HEALTH Excluding mortality studies, there are enologie s t u d i e s of h e a l t h e f f e c t s r e l a t e d to P Cs e x p o s u r e . Tre' a c c i d e n t r e p o r t o f M e i g s rt a_I. < 1 9 5 ^ i is i n c l u d e d s i n c e ifI d i d n o t I \t 07551 inni A38 i 2 o PCJ * . Hum*,,1 end f n v j to n m c n t l H*zur*J* d i f f e r i n d e s i g n from t n y o f t h e s t u d i e s t h a t w e r e n o t m o t i v a t e d by accident report. These studies are listed In Table with a s u m a r y of the f i n d i n g s b y m a j o r c a t e g o r y . F i v e o f trie r e p o r t s a r e in J a p a n e s e (hara et al., 197. 1975; Hasegawa et al., 1972; Inoue et al., 1 9 7 5 ; K i t a m u r a e t a l .. 197 3 ) . T h e d e t a i l s o f t h o s e s t u d i e s a r e taken from the NIOSH criteria document for PCBs (WIOSH, 1977). T w o o f t h e s t Iu d i e s M C a a p p a n Je n a n d K o l h o , 1 9 7 3 ; S C D H , 1 9 7 0 ) a r e not s p e c i f i c as to health e f f e c t s . The first of these is a comparison of |groups with different work exposures and d i f f e r e n t b l o o d PCS levels ( 7 - i 9 0 0 u g / k g In the 12 persons with the g r eatest exposure) In which the authors simply state t h a t all p e r s o n s s t u d i e d were In g o o d h e a l t h . T h e se c o n d Is a s t u d y o f 3 2 w o r k e r s i n a c a p a c i t o r p l a n t , 10 o f w h o a w e r e e x p o s e d r e g u l a r l y to PCBs.| T h e a u t hors s t a t e that there is "no evidence of physical harm jesultmg from workinc with PCBs". T h e r e m a i n i n g 16 s t u d i e s i n T a t l e a r e r e v i e w e d b e l o w with respect to their findings in each major category of health effects. T he stu dies are con s i d e r e d in the order of their population. Dermatologic Effects T h e r e a r e 12 s t u d i e s o f d e r m a t o l o g i c e f f e c t s a s s o c i a t e d w i t h P C S e x p o s u r e . The. first Is M e i g s et al. (195) described in the above section on accidental heavy exposure, wno found that 7 o f 1 e x p o s e d workers got chloracne where the PCS concentration in their breathing zones averaged 0.1 ag/a^. H a s e g a w a et a l . ( 1 9 7 2 ) 1r e p o r t e d a n u n s t a t e d n u m b e r o f ea s e s of h y p e r p l g s e n t a t i o n of the hands, and acne-llke lesions of the Jaw, back, and thi'xns in exposed workers. The average blood PCBs in the workers was 370 ug/kg. However, the authors state that skin complaints were unrelated to blood PCB levels and a p p e a r e d to be duej to skin contact. Kltamura et al. (1973) r e p o r t e d a r a n g e o f s k i n d i s o r d e r s I n 1 0 o f 13 e x p o s e d w o r k e r s with an average blood level of 020 ug/kg. The disorders occurred on parts of the body not normally In direct contact with PCBs. Hara et al. (197, 1975) reported that about 5 percent of 118 capacitor workers complained of blackheads and other acne-llke symptoms while working with PCBs. The complaints were not related to blood levels of PCBs, and virtually disappeared within a year afttfj exposure had ceased. Inoue et al. (ji975) reported one case of chloracne In an exposed worked whose blood PCBs were in the 190 to 21C ug/kg range, but no s y m p t o m s in the rest o f a small work force whose ! 00,17552 TAIH.t: >i . PCB Epidemiology Studies (Other Than Mortality) and Sumiary or Findings** S tu d y D erm atologic Findings P h y s io lo g ic a l I'm ran* l e r a Sytnpl nos n i l Illn e s s A l v a r a s e t a l . , 1977 -- Y B a k e r e a l . f 1900 NY H B u m g a rn e r e t a l . , 1973 -- N C hase 1 i l . f 1902 yYY F l s c h b e i n e | a l . , 1979 Y N Y lia r s e l m l . , 1979, 197S t Y -- lla a e g a w a e t a l . , 1972 y Y -- ln o u e e t a l . , 1975 7-- K a a p p a n e n and K o lh o , 1973 -- -- -- K it a m u r a e l a | . , 1973 Y N -- K r e i s s e t a l . , 191 --Y N M aroni e l a ^ .t 1 ?8 lb Y Y Y M e ig s e t a . , 1959 YY Y MDPH, 1975 N -- N Oiiw e l a l . , 197f> Y N -- S 1 I h - e t - a l . - , -- 1962--------- ---------- . -- | t Y SCDH, 1978 -- -- U a rs h a w e l a l . , 1979 --Y Y *Y * Findings associated with exposure N z No Findings associated with exposure Ho entry * No data presented Other ** __ N N -_ N Y [ n f ' O J Q i t v * r t d 33 V J "J 298 : /Jwrur, w nj m*; f o n n tn c j i b l o o d P C B s r b r ( e d f r o 13 0 t o 5 2 0 u g / k g . T h e M i c h i g a n D e p a r t m e n t of Public Health (1975) reported no relationship of any Tusho symptoms to consumption of Tish with high levels of PCBs. Ouw gt al. ( 1 9 7 6 ) |r e p o r t e d 1 c a s e s of der m a t i t i s . eye Irrita t i o n , or burning sensations on tne skin out of 3* exposed workers, w h e r e a i r l e v e l s o f P C B s r a n g e d f r o m 0 . 3 2 t o 2.22 m g / m ^ . T h e c o a p l a i n t s a p p e a r e d to o c c u r s o r e o f t e n in tr.cse w i t h m g n m r blood PCB levels. Fiscnbein et al> (>979) reported that about 50 p e r c e n t of| 3 2 6 c a p a c i t o r m a n u f a c t u r i n g w o r v e r s r e p o r t e d a history of dermatological symptoms, the most common symptom being a rash. Those with symptoms had higher blood Levels of high c h l o r i n a t e d PCBs. B a wer et a K (I5cr* reported no c h l o r a c n e m >8 e x p o s e d w o r k e r s ( a v e r a g e b l o o d P C S s 7 5 . 1 u g / k g ) o r 1 9 m e m b e r s o f t h e i r f a m i l i e s ( a v e r a g e b l o o d P C B s 33*6 u g / k g ) . M a r o n i e t a 1 C 196 l b ) r e p o r t e d 10 c a s e s o f d e r m a t i t i s ( 5 diagnosed as active or past chloracne) out of 80 exposed w o r k e r s . T h e a v e r a g e b l o o d P C B l e v e l in the s t u d y w a s 3**2 ug/kg. Chase et al. (1982) observed chloracne and an increase i n o t h e r d e r m a t o l o g i c a l f i n d i n g s i n 86 e x p o s e d m a l e r a i l r o a d workers, but the findings were not significantly associated with blood or fat PCB levels. Smith et al. (1982) found no c h l o r a c n e i n a s t u d y p o p u l a t i o n o f 32*< e x p o s e d w o r k e r s i n ' capacitor manu f a c t u n n g and transformer repair, whose average blood PCBs ranged from 38 to 5 6 ug/kg. However, there was a significant association of skin rash or dermatitis with blood levels of high chlorinated PCBa. Interpretation of this mass of data is complicated by the difficulty of diagnosing chloracne, tne uncertainties of blood PCB d e t e r m i n a t ions, and the changing technology for making such determinations^ Nevertheless, the data suggest strongly that when PCB blood levels exceed about 150 to 200 ug/kg, chloracne can occur. However, most studies have shown that the occurrence of c h l o racne is not further associated with blood PCB levels. This s u g g e s t s 'that (a) personal idiosyncratic factors m ay be involved and/orj (b) that the high blood levels are an indicator of the existence of environmental contamination which actually produces chloracne by skin contact. The reports of dermatitis other than chloracne suffer from an a d d i t i o n a l c o m p l i c a t i o n . A c c o r d i n g tc the N a t i o n a l Health Survey, 'about one-third of all Americans of working age have at least jone c u rrent s k i n condition serious 'enough to warrant evaluation by a physician (NCHS, 1979). Clearly, substantially more than one-third must have either a current condition o r a (history of such a condition In tne past. The prevalence figures reported by Haronl et al. (1981b) and F i s c f i b e l n e t all. ( 1979) a r e , t h e r e f o r e , n o t i n t h e m s e l v e s r e m a r k a b l e , but! the a g r e e m e n t o f F i s c h b e i n et al. (1979) and Smith et al. ( 1962) on the relationship between dermatitis and > \ 1 rfwr tpi I Ptli* .j high chlorinated blood PCBs suggests that th is association may Mml. Liver Function T e n s t u d i e s e x a m i n e d l i v e r f u n c t i o n . M e i g s et all. C 1 9 5 ^ ' f o u n d o n e b o r d e r l i n e a b n o r m a l l i v e r f u n c t i o n in Hi e x p o s e d w o r k e r s . H a s e g a w a et al. (1972) f o u n d aild d i s t u r b a n c e s in exposed workers (increase! SCOT, SGPT, SAP, decreased serum cholninesterase) which they did not consider to be clinically s i g n i f i c a n t . K i t a m u r a e: al. ( 1 9 7 3 ) . O u w et a_.. ( 1 9 7 6 ) , F i s c h b e l n e t a l . ( 1 9 7 9 ), a n d B a k e r e t a l i (i960, ) ( a n o n occupational study) found no abnormalities jassociated with e x p o s u r e , e x c e p t t h a t '3iw et a_l. ( 1 9 7 6 ) f o u n d a h i g h BSP retention In four out of seven w o r k e r s with bipod levels above 500 ug/kg. Maroni et a l . ( i?c 'b found 16 out of SO worxers with a b n o r m a l i t i e s in GOT, OCT. and t r a n s a m i n a s e s . Their blood PCB levels were higner than cse in the workers with normal liver function. Kreiss et al. 1 9 3 1 K n o n - o c c u p a t tonal study.) found no relation between liver alconcl consumption were function and taken into blood accoun t P . C B s C w h r a e s ne'i age et and al. l 1 9 8 2 ) f o u n d a m o n g e x p o s e ! r a i l r o a d w o r k e r s !a s t a t i s t i c a l l y s i g n i f i c a n t c o r r e l a t i o n :b e t w e e n b l o o d P C B s { a n d S C O T a f t e r adjusting for age. Smitr. e al. ( 1 9 S 2 ) found elevates'SCOT and CCT levels in persons with higner blood PCB levels. In sunrtary, six studies of the ten found seme mild liver function abnormalities, none of which were associates with any measurable adverse h e a l t h .effects. The two rnn-occupational s t u d i e s . B a k e r e t a l . ( I 9 6 0 ) a n d K r e i s s e t a l 1. ( l $ S l ) , f o u n d no abnormalities associates with blood PCB leve. Fischbein et al. ( 1979) in their study bf c a p a c i t o r manufacturing workers, noted that "there was a paucity o f abnormal results in the biochemical studies." F i n a l l y , A l v a r e s e t a l . ( 1 9 7 7 ) r e p o r t e d t h a t !i n f i v e w o r k e r s o c c u p a t i o n a l l y e x p o s e d to PCBs, thej rate o f drug m e t a b o l i s m was s i g n i f i c a n t l y h i g h e r than in a group of controls natened for age, sex, and smoking and drinkingIhacttsJ Fat Metabolism j J Six studies considered c h o l e s t e r o l levels. | One <Bumgarner 1973) found no relationship between cnolesterol level and b l o o d P C B l e v e l . - O n e o f t h e r e m a i n i n g f i v e 1H a s e g a w a e t al., 1972) found a decrease in cholesterol, glycerides, 0Q l ^ fnnia a 290 P iJs.- Jfuiun and Cnvironwk.ntJi rtuxards phospholipids* and beta-lipoprotein in exposed workers. Three of the ether four studies found no relationship sf cholesterol to b lood PCBs (Baker et al., i960; Chase et al.. i?82; Smith ' *t 1- 1962) while one found increased cholestersl at hither b l o o d l e v e l s o f P C B s ( K r c l s s e t a l . , 1961). t r e ; s s e t a . )196U a n d S m i j t h e t a l . ( 1962) a l s o present r r - . r r a d i e t o r y findings with rjespeet to HDL cholesterol levels; tne former found no relationship to blood PCBs, but the latter round an Inverse relationship. Five studies examined triglyceride levels. Four found an i n c r e a s e w i t h i n c r e a s e d b l o o d P C B s ( H a r t e t al., >97ti, 1975; B a k e r e t al., 1|980; C h ase et al., 1962; S m i t h et al., 1962) while one found no relationship when cholesterol level was taken into account (Kreiss et al., 1961). In suotary, most studies, including one ncn-occupatlonal study, have associated increased triglycerides with PCB exposure. The data on cholesterol show no relationship in three studies, and an jincrease and decrease in one study each. HDL cholesterol either decreased or was unchanged (one study each). Even i f PCB e x p o s u r e has some effect on fat metabolism, it appears to be without any apparent clinical significance. Blood and Blood Pressure There are five studies of blood chemistry: Bumgarner et al. ( 1973). Kitamura',et al. (1973), F i s c h b e i n et al. (1979), Baker et al. ( 1 9 8 0 , and Haronl et al. (1961b). Kone of them report any relationship of blood chemistry to PCS levels. B u m g a r n e r et al. (1973) and, K r c l s s et al. (1961) mea s u r e d blood pressure in exposed persons. Bumga r n e r et al. (1973) found no association with PCBs, but Kreiss et al. (1981) found a statistically significant association between diastolic blood pressure and blood PCBs. Since there was no control group and s i n c e K r c l s s et a|l. ( 1 9 8 1 ) a r e t h e o n l y i n v e s t i g a t o r s to r e p o r t this finding, its significance is not clear at this time. Symptoms, Illness, and Othar Conditions E i g h t s t u d i els i n v e s t i g a t e d s y m p t o m s , I l l n e s s , a n d o t h e r c o n d i t i o n in persons exposed to PCBs. None of the three nonoccupatlonal studies reported any abnormalities. The first of these ( M D P H , 197,5) c o m p a r e d the i n c i d e n c e o f 19 c o n d i t i o n s , most o f w h i c h were reported In Tusho disease, in consumers of sports fish containing PCBs and in controls. The second (Baker et al., I960) found none of the following conditions were associated with blood PCB levels in a community study; fever, 3 i f ( Vi n 1 ) ) C) The CpJdrffj0J*-, #or rct% .'9J weight loss, anorexia, fatigue, headaehe, eye irritation, cough, shortness of breath, nausea, vomit lr; diarrhea, abdominal pain, arthralgia, and persistent rash.j The third study (Kreiss et al., 1961) reported the `sase thing for prevalence of illness or weight loss in the (preceding year; use of eedication, use of sedical cere, history of heart disease. and percentage of pregnancies ending in sisearriage. stillbirth/ or infant death. Or the occupational studies, Chase et al. (1982) reported nc evidence of organ toxicity from the sedical histories or physical examinations of 86 exposed railroad workers. Three s t u d i e s r e p o r t e d v a r i o u s s y e p t o s a . F i s c h o e l n e t 1 si.'. (1-979) r e p o r t e d a h i s t o r y of g a s t r o i n t e s t i n a l symp t o m s in 18 pe r c e n t of 326 capacitor manufacturing "workers, a prevalence of from 3 . 0 t o 1 5 * 2 p e r c e n t o f v a r i o u s m u s c u l o s k e l e t a l s y m p t o m s , a n d a. prevalence of from b.S to 27.8 of various neurjologlcajl symptoms. These were, however, unrelated to duration of employment or to l e v e l o f b l o o d P C B s . K a r o n i et al', ( 1 9 8 1 b ) r e p o r t e d e i g h t c a s e s of gastrointestinal complaints in 80 exposed workers, with no indication of wnether there was a relationship to duration of employment. They also reportad two bleeding haemangiomas and one case of chronic myelocytic leukemia. These findings do not appear to have any significance, since they apparently are unrelated to the circumstances of exposure. Smith et al. (1982) reported an increased prevalence of general malaise and possibly altered peripheral sensation with increased blood PCB levels among occupationally exposed workers, but found no clinical abnormalities on1 physical examination. I Finally, one study of pulmonary function (Warshaw et a l . , 1979) reported decreased vital capacity In 2^3 '^capacitor w o r k e r s . H o w e v e r , t h e p u l m o n a r y f u n c t i o n v a l u e s i n ;'the s t u d y population, most of whom were current or ex-smokers, were compared with a standard population of non-smokers, so that the effect of smoking was not taken Into account.j The weight of evidence, as Smith et al. (1982) conclude, is that no studies to date "have s h o w n that occupational e x p o s u r e to P C B s is associated with any a d v e r s e health'] out come, to be distinguished from demonstrable subcllnleal biochemical alterations." | There associated studied In appear to be no significant clinical effects with the occupational or environmental exposures these reports. 1 007554 n'4j iVfli v Juffuri Lav i row*.in*i Carcinogenicity It la g e n e r a l l y agreed that e p i d e m i o l o g i c e v i d e n c e for carcinogenlcijty should fulfill certain requirements in order to be acceptable. These requirements, presented below, seat with the study design, the logic of the observed pattern, and the repeatability of the results (Doll, 1981). (1) P o s i t i v e as s o c i a t i o n s in g r o u p s o f i n d i v i d u a l s witr. k n o w n e x p o s u r e ( c a s e - c o n t r o l o r c o h o r t s t u d l e s ). . (2) That are not explained by bias In recording or detection. (3) That are not explained by confounding. ( M That are not explained by chance. (5.) T h a t v a r y a p p r o p r i a t e l y w i t h d o s e . (6) That vary appropriately with period of exposure. (7) That are observed repeatedly In different c i r c u m stances . There are four studies directed solely or primarily to the question of the carcinogenicity of PCBs. Table 6 lists the studies and their findings. They are reviewed here k e e p i n g in mind Doll's requirements. The most o b v i o u s feature in T a b l e 5 is that no s t u d y agrees with any other. That is, the r equirement o f repeatability, is not met. The first study by Bahn at al. (1976, 1977) o b s e r v e d three m e l a n o m a s i n a| g r o u p o f 9 2 r e s e a r c h a n d d e v e l o p m e n t a n d r e f i n e r y workers. These workers had an unknown caposure to other possible carcinogens, so that there could have been confounding. In any case, the study was withdrawn for revision in the definition of the eiposed population, and has not yet been released (NIOSH, 1977). I # Mjsch (1982) studied 89 Honsanto workers exposed ror at least six months between 19*5 and 1966 inclusive. There w e r e n o d e a t h s f r o m c a n c e r o f t he l i v e r o r c i r r h o s i s . Tlie excess in respiratory cancer was baaed on four deaths and was not statistically significant. As with Bahn et a|. (197b, t977), there wks confounding because of other chemical exposure at the plant and, In this case, possibly cigarette saoKing. T}h.1 CpiJ c f l u o i j , IJ : ,'y i TABLE 5 * Inconsistencies In Studies or PC8 Exposed Populations With Cancer in Find toes 1 I , i Study Number Studied a Findings Bahn et al.. 1976; '977 Zack and Husch, '9c Brown and Jones, *9z: B e r t a z z i e t a l . , 1961 92 89 2.567 1.3-10 Melanoma4 Lung ! Liver 1 Rectum Digest:veb , Lymphatic, and hematopoietic S i g n i f i c a n t at 1 percent level Significant at 5 percent level B r o w n a n d J o n e s ( 198 W s t u d i e s 2 , 5 6 7 w o r k e r s i n a c a p a c i t o r p l a n t . A b o u t h a l f t h e J c o h o r t h a d a l a t e n c y p e r i o d 0' f 2 0 y r s or aore., A l t h o u g h there was an excess of liverj cancerjj deaths, it was inversely related to duration and latency of exposure, wnich does not support an occupational explanation. There was also an excess of rectal cancer. However, the two plants studied are,located in an area whose mortality froa rectal cancer is greater than the U.S. average (Mason et al., 1975). Since U.5. population rates were used as a basis for comparison, the rectal cancer excess is at least partly an artifact. I B e r t a z z i e t a l . ( 1 9 8 1 ) s t u d i e d 1 , 3 1 0 w o r k e r 's w i t h a t l e a s t s i x m o n t h s e m p l o y m e n t i n c a p a c i t o r m a n u f a c t u r i n g b e t w e e n 19^6 and 1970. Althouch excess digestive cancer was observed, there were no liver cancer deaths. The total numberj or oeatns was s m a l l ( 2 7 1 a n d t h e e x c e s s c a n c e r o b s e r v e d w a s b a s e d or, t w o o r three deaths for each of the two major sites involved!) There is no indication of the duration or latency of exposurejjfof the cancer deaths. The authors state that there were! no other major exposures at the plant, and propose to continue the study with a larger cohort. In spite of the statistical significance of t h e e x c e s s e s f r o m a l l c a n c e r s , t h i s s t u d y m u s t tic c o n s i d e r e d a p r e l i m i n a r y r e p o r t , p a r t i c u l a r l y s i n c e it s n a r e s j w i t r . trie o t h e r studies a failure to agree on any particular pattern of aortality. I 1 I i ;o o i* 5 iFniifi 1 11 1 294 PCBm : Nu m h sn d t'n vi ronm rnc^l * x s r d s The existing mortality studies of occupational exposure do not show the agreement that would load on to infer an excess risk of cancerJ Much of the conflict Inc findings can ho a t t r i b u t e d t o thji p o a a l b l t e f f e c t o f c o n f o u n d Inc e x p o s u r e s , a n d to tha "noise level" of aporadlc excesses which would bo oxpcld in the abaonc of any occupational hazard. SUttURT AND CONCLUSIONS The eptdeoijoloclc studies of exposure to PCBs show that the body burden in exposed persons, whether the exposure is by lncestlon, Inhalation, or skin contact, is related to the environmental levels and distribution of PCS. The relation of body burden to d uration of exposure is less clear, and appaars to differ depending on the decree of chlorination of the PC8s. Nev e r t h e l e s s , the evidence is clear that higher exposures mean higher blood PCB levels, and that persons with occupational exposures have bipod PCB levels that nay be an order of aaxnitude g r e a t e r than that of e n v i r o n m e n t a l l y (that la, n o n occupationally) exposed persons. O c c u p a t i o n a l exposure to PCBs at high levels has been associated wlth| the occurrence of chloracne, but the relationship la not straightforward, suggesting that the actual risk of c h l o racne Is also a function of Individual susceptibility and personal work habits, as wall as possible exposure to other contaalnants. Dermatologic problems other than chloracne are associated with occupational! exposure, and pay be related to exposure to h i g h chlorinated .PCBs. Alterations | of liver function and fat metabolism associated with PCB exposure have bean observed In spveral studies, but are characterised by investigators as mild and of no clinical significance. Tha one fact on tdilch a ll occupational studies of health e f fe c ts agree is that there baa been no c lin ic a l I lln e s s associated with PjC8 exposure other than dermatitis. Studies o f non-occupatlonally exposed populations have found neither derm atitis nor other c lin ic a l evidence ,of exposure-related e f f e c t s , with the| exception of s sin g le study which suggests that d ia s to lic blood pressure say be related to blood lev el o f PCS*. I Mortality studies concerned primarily with cancer present p r o b l e m s o f i n terpretation due to the small saaple size of som e o f the studies, and to the confounding effect of other FOniOA?', V ( f l ( t i Monsanto Monsanto Company 800 N. Lindbargh Boulsvard. St. Louis, Missouri 83167 Phone: (314! 694-1000 February 27\ 1985 .DEPARTM EN T OP MEDICINE a ENVIRONMENTAL HEALTH David P. Brown National Institute for Occupational Safety and Health Robert A. Taft Laboratories 4676 Columbia Parkway Cincinnati, Ohio. 45226 M A R :D Dear David: Enclosed is a photocopy of the report "Mortality of PCB Workers at the Monsanto Plant in Sauget, Illinois" by Judith 2ack and David Musch. As far as I know, this is the final reportjl, although the report Was never published in the scientific 'literature. !i It was good hearing from you yesterday. I will be1 attending the t NI0SH Dioxin Registry meeting in Cincinnati oh March 14-15, 1985, and I am looking forward to seeing the old crew that is still working at NIOSH. Sincerely, Enclosure cc: -W.R. Gaffey f -'.fr' P L A l N T I F F 'S i Knni/\R 1 o n o in I ) ( IN THE CIRCUIT COURT OF THE CITY OF ST. LOUIS STATE OF MISSOURI GLENN BROWN, et al, Plaintiffs, vs. MONSANTO COMPANY, Defendant. Cause Noi 862-00694 AFFIDAVIT IN SUPPORT OF MOTION !,TO SEVER THOMAS M. BISTLINE, being first duly sworn, on his oath states : 1. I am Litigation Counsel for onsanto Company. I make this Affidavit m support of Monsanto Company's Motion to Sever. 2. The information set forth in Ithis 'AIffidavit was compiled at my direction from historical sales summaries of iI Monsanto Company which were prepared anInuallyI in t'he ordinary course of Monsanto Company's business, The matters set forth herein are true to the best of my knowledge,! information, and belief. 3. Monsanto Company sold the following products containing polychlorinated biphenyls to Westinghouse Electric Corporation at its plant in Bloomington, Indiana: 1957-1967 Aroclor Aroclor Aroclor 1242 1286 (Less than 6,000 lb./yr.) 1254 (Less than 100 Ilb.//yy r .) Vlfil ' 259 1968-1970 Aroclor ' 1242 Aroclor 1232 (Less than 1,5(00 lb./yr.) Aroclor 1254 (Less than 200| lb./iyr.) Transformer Inerteen PPO (Less thah 1,000 lb./yr.) 1971-1977 Aroclor 1242 Aroclor 1016 Inerteen 54201 CF Inerteen 54201 A9 Inerteen 542C1 KJ Capacitor 21 Capacitor Aroclor 1489 I ; (Less than 100 lb.) i| 4. Monsanto Company sold the following products containing I !| polychlorinated biphenyls to Westinghouke Electric Corporation at its plant.in Muncie, Indiana: 1964-1970 Therminol FR-2 1971 Therminol FR-1 1972-1977 No sales 5. Monsanto Company sold the. following products containing i 11 polychlorinated biphenyls to Westinghouse Electric Corporation at its-plant in Cincinnati, Ohio: 1959-1968 Transformer Inerteen PPO 1969-1972 Transformer Inerteen PPO Transformer Inerteen 100-42 (Less than 1,000 lb./yr,) 260 1973-1976 Inerteen 70-30 y // THOMAS M. BISTLINE COUNTY OF ST. LOUIS ) ) STATE OF MISSOURI ) SS. ^Subscribed and sworn to before me, a Notary Public, this ** day of March, 1987. /38 JAIn H J M Notar f ^ u b i i c SHI31&Y j. NOTAnY P3LIC. STATE Or V.i_-iOUR| MY COMViSS>ON ^EXPIRES 74i7 ST. LOU'S COUNTY HUSCH, EPPENBERGER, DONOHUE, CORNFELD JENKINS ^ s jj < /< U > Charles E. Merrjill -, #27238 100 North Broadway-I 4th Floor St. Louis, MO 163102' (314) 421-4800 Attorneys for Defendant Monsanto Company Fr.ni **;i 261 i IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISITRICT!l OF TEXAS BEAUMONT D VISION CECIL SCOTT, ET AL VS. MONSANTO COMPANY CIVI L ACTION NO. B-84-1103-CA ***** September 3, 1987 Volume XIV BEFORE THE HONORABLE JOE J. FISHER UNITED STATES DISTRICT JUDGE, jlAND A JURY Reported by: C. Frank McMillan! Federal Court Reporting Co. P. O. BOX 2664 Beaumont, Texas 770 06 (409) 839-2518 inm t P L A N T I F F 'S tevffW EXHIBIT I \ 1 A ??A RA NC S 2 3 ATTORNEYS FOR PLAINTIFFS: 4 MR. DAVID .M. LACEY MR. MICHAEL A. POHL 5 MS. SUSAN BAKER'I GILPIN, POHL & BENNETT 6 1300 POST OAK BOULEVARD HOUSTON, TEXAS '.177056 7 MR. THOMAS |HENDERSON 8 MR. ANTONIO PYLE HENDERSON GOLDBERG 9 1030 FIFTH AVENUE PITTSBURGH, PENNSYLVANIA 15219 10 MR. BENTON MUSSLEWHITE 11 609 FANNIN,jSUITE 517 HOUSTON, TEXAS 77002 12 13 ATTORNEYS FOR DEFENDANT1: I1 14 MR. ROBERT A. HALL MR. ROBERT A. JONES 15 MR. JONATHAN SHOEBOTHAM WOODARD, HALL & IjRIMM 16 4700 TEXAS COMMERCE TOWER HOUSTON, TEXAS 7|7002 17 MR. TANNER T. HU14T, JR. 18 MS. CHERYL D*. OLESEN MR. WALTER CRAWFORD 19 MR. MARK FREEMAN | WELLS, PEYTON, BEARD, GREENBERG, 20 HUNT & CRAWFORD P. O. BOX 3708 21 BEAUMONT, TEXAS 77056 22 ALSO PRESENT: j 23 l I MR. WILLIAM PAPAGEORGE, CORPORATE 24 REPRESENTATIVE OR THE MONSANTO CHEMICAL COMPANY. 25` I ^ I R i m /*?* I 1 INDE* 2 3 WITNESS DR. PAUL WRIGHT 4 READING FROM DEPOSITION 5 PAGE .2176 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Fnm i i 1 still true today, is it not? 2 Y*es, as much as it can be, you know, 1 i \ 3 900 miles apart 4 5 MR. CRAWFORD: Thank you. Your Hor \ 6 we have a few exhibits to offer if we 7 We have got 2811C, which are the 8 records of D r . Spence r . We have got 382 9 which are the Bloomington Hospital reoor 10 We have got 2827A, which i!s a report fro j ij 11 the National Jewish Hospital on April 13 12 and then we would also offer these three 13 exhibits which we have just made refer II 14 to and that's 2397A, 3 and C. 15 i THE COURT: All right'1. Any fucth e t 16 quest ion s? 17 MR. CRAWFORD: Thank you. 18 MR. POHL: No# Your Honor. 19 THE COURT: All right, Mr. Toon, 1 20 may stand down. .21 Ladies and gentlemen, jthe Court is 22 going to instruct the jury 'in regard to I, 23 testimony by video depositions and 24 depositions of Dr. Wright, Dr. Paul Writ 25 i! The Court made a rulingyesterday a i i| n l f 1 the plaintiffs had attempted to o ff e: t! 2 deposition of Dr. Paul Wf ight over the 3 objections of the defenda nt that it \Ijou 4 admitted. 5 Then during the offe ring of the 6 deposition it appeared that Dr. Wrigh t ' 7 taking what is known las the Fif th Amendi 8 that he refused to give testimony. 9 So, the Court could not see any 10 in continuing that deposit ion after 11 inquiring of counsel if hi s ans wer to a. 12 the questions that they ha!d asked, wh.LCl i13 some s i x or seven or eight q u e s t i o n s , 14 don't remember how many it was, may be I. 15 than that, but several questions. 16 The Court then rIevers1ed his rulir 17 said that we would sustain the defendan' 18 objections to the offering! of this test 19 by Dr. Wright and would grant their re|qi 20 to suppress the deposition^ 21 Out of an abundance of fairness, I 122 Court has been advised that there was s< . 1i J 23 testimony given by the, witness to which 24 did not assert a Fifth! Amendment right i 25 gave some testimony 10(114 1 The Court feels that although the 2 deposit io n ".ay not be of too much 3 s i g n i f i c a n c e , that tjhe jury sho uld b; at ,4 to weigh and conside r the d e p o s i t i o n for 5 whatever it might be [wordh in regard to .6 c a s e . 7 And the deposition a's the Court 8 understands offered by the plaintiffs v 9 the objections of the defendant for t he 10 purpose of showing Dr. W r i g h t 's relation 1 11 to Monsanto and the knowledge that Moisa 11 12 had as to the test, wdrk which Dr. Wright 13 d o n e . 14 So, we are gotiongpermit the i 15 plaintiffs to reoffer or Jffer such 16 deposition testimony of Dril Wright by 17 or question and answer as they wish to 18 o f f e r . 19 And we will also permit coun sel to 20 state the number of questions that they 21 asked Dr. Wright and the questions. 22 You may read the quest ions to whidt i1 23 asserted his constitutional, right of no 24 a n s w e r i n g . l 25 All right. You may proceed. Fool I I 1 The record will re 1 1'ect that the 2 defendant has made obj ect ions to this 3 testimony and they have a| ru nn i ng obj ec t i tt l 4 All right. 5 MR. M U S S L E W H I T E :i You<\ r Honor, to s a \ Ii 6 time, I'm simply going to'say that we wi ] Ij 7 not rerun the video portion that we r& n 8 yesterday. The jury las a l r e a d y seen i t 9 about his background, when he went with 10 Monsanto then went with Ib |t and then pack 11 with Monsanto. 1 2 There's no reason to repeat that anc 13 are just going to ask two q u e s t i o n s an 3 r 14 the answers and that's i t , 'Your H o n o r . 15 THE COURT: All right:' 16 17 MR. MUSSLEWHITE: "QUESTION: You kr iil 18 at the time you were a mana'ger of toxicol 19 at Monsanto that Monsanto was con ti nu ing 20 use the IBT test results that pertained 21 Monsanto's Aroclor products! in an effor : 22 Monsanto to forestall various government: 23 regulations designed to limit the dischc .i . 24 of PCBs into the environment'!? 25 1 I' "ANSWER: On my attorney's advice, FOOT TTdZ 1 hereby i n v c < e t h e rightsj s ec ur ed to me by '. \i 2 the Fifth and Fourteenth; A m e ndment s to the 'f 3 U.S. Con sti tu tio n and r e s p e c t f u l l y refuse to 4 answer that question on the grounds that any 5 information I give in respon se may tend to 6 incriminate me. 7 "QUESTION: Dr. Wright, when you had an 8 interchange with the EPA* j'about cau s i ng them 1 '1 9 to forestall their regulations limiting the i 1 10 discharge of PCBs into the environment, you ti 11 knew at that time that the IBT A ro cl or !I 12 studies both understated and' mis represen ted 13 the toxic effects of IPCBs'! on r o d e n t s ; isn't 14 that true? 15 "ANSWER: On my att orn ey's advice, X 16 hereby invoke the rig its Siecured to me by 17 the Fifth and Fourteenth A m e n d m e n t s to the 18 U.S. Constitution and r e s pec tf ull y refuse to 19 answer that question on-the gro und s that any 20 information I give in response may tend to 21 incriminate me." 22 23 MR. MUSSLEWHITE: j That con cludes it, 24 Your H o n o r . 25 THE COURT: All r ig h t What else do Mm T T ST 1 you have? Do you have sc me thing to add? I; 2 * MR. JONES : Yes I sir Your Honor. 3 THE COURT ; All right, M r . J o n e s . 4 MR. JONES: Your Honor, in light of the 5 Court's ruling, I wouIl d li5ke to read at I 6 least a small portion of Paul Wright's 7 depos ition. That portion w h ic h be'gins on Page 18, ji 9 line 20. And this was an o b j e c t i o n that I 10 made as counsel for Monsan'to, prior to, 11 right after the first invocation of the II 12 Fifth Amendment by Paul Wright. 13 MR. MUSSLEWHITE: Excuse me, .Your 14 Honor. May I interpose this? He's about to 15 read an objection, not a qt e s t i o n . And we 16 object to him reading his objections. I J! 17 don't mind him making the ob j e c t i o n to His 18 Honor; but to read it f rom the dep osition 19 seems superfluous. 20 THE COURT: I think that's appropriate. 21 No need of you reading yourj o b j e c t i o n . 2 2 MR. JONES: Your H o n o r 1, the only thing 23 iI that I was going to state in connection with 24 I '1 that deposition was that 1 as counsel for 25 Monsanto requested Dr. 1WrigIhI t to truthfully T o m a fin TTF7 1 and honestly and completely answer all ' 2 questions that Hr. Pohi or I may ask at the 3 deposition because so fa r as M o n s a n t o was 4 aware, there was -5 THE COURT : The Court will accept that 6 statement. 7 HR. JONES: Okay Triank you, Your 8 Honor. 9 Your Honor, I would 1jike to read one I 10 other additional portion a|nd that's on Page ii 11 63 where X asked the question: Page 63, 12 line 10. 13 14 "QUESTION: Dr. Wright, for the past 15 hour and a half, you have been ass e r t i n g 1i 15 your Fifth Amendment pri vileg e against 17 s e l f - i n c r imination in the C o n s t i t u t i o n of 18 the United States. i 19 I. "Do you intend to c o n tin ue to assert 20 your Fifth Amendment p r*i'viiljege to the i i 21 questions that I may ask concerning the 22 subject matter of this |laws'uit?" 23 24 MR. JONES; Wherein Hr. Wri gh t's 25 counsel said: "Assuming that your questions Fnni T T ST J1 intend to as< Dr. Wri ght that as to each and 2 every question you pose that would touch 3 upon the same subject mattIer .as Mr. Pohl's ! I 4 q u e s t i o n s to which Dr . Viright has invoked 5 his constitutional rights on behalf of D r . 6 Wright, I would state that , yes, he intends 7 to invoke the same rights !>he invok ed all 8 along during Mr. Pohl' s qiies t ions ." 9 At that point, I did not ask any 10 further questions and pass the witness. 11 12 THE COURT: All right]1. What do you 13 have next? 14 MR. POHL: We cail Phil Smith as our 15 next witness. 16 THE COURT: Have a seat in the w i tnes s 17 chair. You may proceed 18 19 20 21 22 23 24 25 Fnm 2184 1 PHILLIP S.i SMITiH, 2 HAVING BEEN DULY CAUTIONED AND| S W O R N TO TELL T HE 3 TRUTH, THE WHOLE TRUTH AND NOTHI NG BUT THEil TRUTH, 4 TESTIFIED AS FOLLOWS: 5 6 7 DIRECT EXAMINATION 8 BY MR. P O H L : 9 Q Would you state your full name? 10 A Phillip, niadle initial "S," Smith. 11 Q And where do you livep 12 A Barrington, Illinois. 13 Q Are you a former employee of Ind ust ri al 14 Biotest Laboratories, Inc.? 15 A Yes, I am. 16 Q Now, prior to your testimony here before the 1| j 17 Court today, have you visited with anyone from 18 Monsanto in your home in recent mont hs? 19 A Y e s , I have. 2 0 Q Who was that ? 21 A A Mr . Tim P e c k . 22 Q A n d , very, very 23 substance of that v i: the nature of the 24 visit? 25 A Mr . Peck wanted F n mA r o d or compounds i I i B .b 1 and what my involvement might hjave been with 2 them. 3 Q How was it that he came td your house?' II T 4 A He came to the front door jand said that he i 5 was passing through the neighborhood and thought I : 6 he would stop in and chat with me. 1 7 Q Where do you live in r e l at io n sh ip to 8 Chicago, Illinois? 9 A About 40 miles northwest of Chicago. 10 Q 1 ' Did he indicate anythijng to you about your ^j 11 personal liability if you s'ay anything against 12 Aroclor products? i 13 A Mr. Peck asked me if I had con sulte d a i 14 private attorney regarding my liability in 15 speaking to anybody about Aroclor products. |] | 16 Q Are you still willing to testify here before 17 this jury? 18 A Yes, I am. 19 Q All right. Tell us briefly what your job 20 was at IBT? 21 A For most of my time at IBT I was an 22 assistant toxicologist. \ 23 0 When were you first employee 24 A January, 1971. 25 Q When did your employment conclude? TTtT 1 A June of 1977. 2 Q And in addition, let tme ask you this: With `3 regard to the Monsanto rodent Aroclor studies, i 4 did you personally work on Monsanto's Aroclor 5 stud ies? 6 A Yes, I did 7 Q Did you per sonally help pr'epare the reports 1> 8 of the conclusions on Monsanto's Aroclor studies? 9 A Y e s , I did. 10 Q In addition to your p er so nal ly having worked !i - !* 11 on their studies, was there a point in time.at Ii I 12 IBT when the parent company of IBT conducted an 13 audit of what had gone on in recent years at that 14 lab oratory? 15 A They had conducted an inhouse investigation. 16 Q What was your role in th a t inves t iga tion? 17 A I had testified in that investigation. 18 Q Well, I'm not talking about that. With 19 regard to the actual looking at !the d o c u m e n t s , .. . 1i 20 auditing the work that had been done and so , I1 21 forth, did you have a role in that? I' 22 A I audited studies, yesl 23 Q. And for what period of time did you go back 24 and audit prior studies? 25 A I spent, with a .number of people, m m i 2187 .I ap pro ximat ely nir.e mcnthsj time looking at studies 2 that had been done from 19 7 0 , through 1976. 3 Q Who was Otis Tranche r? 4 A Otis Tranche: `was ma nager of the laboratory 5 when I started there. 6 Q Who is Paul Wright? 7 A Paul Wright was hired as section head of 8 toxicology about two mont is after I star te d at. ;i 9 the laboratory and he was in charge of the, rat 10 and dog toxicity areas and I was an e mp lo ye e in 11 the rat toxicity 12 In connection with Mo( nsarii'to's Aroclo r ij 13 studies, did you personally work with Paul L. 14 Wright? 15 A Y e s . j I' 16 Q Who was Mannie Reyna? i i; 17 A Mannie Reyna was, an employee in the rat 18 toxicity department. 19 Are you familiar with th care and handling 20 of the rodents used in regards to Mon sa n to 1s 21 Aroclor chronic oral toxicity studies? 22 A Yes, I am. 23 Q Are you familiar with the electronic 24 weighing machine at IBT? 25 Y e s , l a m . TTHT 1 Let me ask you very brief ly about a few .t 2 documents that Dr. Cal and ra pro ved up and that we \\ 3 have taken the liberty of b l o wi ng up. I 4 Regarding the Aroclor study, whose initials i 5 appear at the top left-hand corner of this 6 document, "P.L.W." 7 Do you recognize those initials? 8 A Paul L. Wright. 9 Q It also is add re ss e d |to a m a n named " M .L .K ." 10 Who is that? 11 A Marino L. Keplinger. 12 Q Who was he? 13 A Manager of the laboratory.'! 14 Q With regard to the Aroclor! studies, one 15 comment is: Unless survival can be improved, I'm 16 concerned that all of your rat ca rc ino ge ni c 17 studies will be judged to be inadequate. 18 Was there a p r obl em wi th the survi vability 19 of the rodents on Monsanto* s Aroclor study? 20 A Yes . i :21 Q On the second page, the document goes on to 22 say: The tumor incidents in females with 1254 is 23 bothersome, 82 percent at 10 par ts per million 24 and 100 percent at a 100 parts per million. With 25 regard to the tumors in the animals and with Fnm I 2TST 1 regard' to mor tality of the a n i ma ls during the 2 course of the study, was there a small or a large 3 percentage of th animals tha d d ied during the 4 course of the study? 5 There was a -- 6 7 MR. JONES: Your Honor, I would like to 8 interpose an obj ectiJn at jt h is point, if I 9 may . 10 Your Honor, I would object that the ji 11 proper predicate has not been laid to show 12 that this witness has personal knowledge of 13 those facts that he's abou't to testify to. 14 In fact, I anticipate his answer based upon 15 the deposition which showed that he does not 16 have personal knowldge, but it's based on 17 h e a r s a y . 18 THE COURT: Obj ec tio n o v e r r u l e d . 19 20 BY MR. POHL 21 Oo you have personal knowledge- of 22 deficiencies with regard to Monsanto's Aroclor 23 studies? 24 A Yes, I do. 25 Q Let me just -- let me just Jump ahead for a T T T tr 1 moment and cover seme things generally and then 2 we will come back and detail i,t . 3 Do you have personal know-ledge that the raw 4 data with regard to Monsanto's! Aroclor studies 5 was either falsified or fabricat ed? [j || 6 A The report of the raw data was falsified. 7 Q You know that personal1y ? j 8 A Yes. 9 Q Did you actually sign reports that contained 10 false data? 11 A I signed two reports that contained false 12 data, yes. 13 Q In addition, did someone forge your name to 14 one of the other Aroclor studies? 15 A Yes, they did. 16 0 Now, let me ask you one other question: 17 What do the initials TBD mean in regard to the 18 M o n sa nto Aroclor studies? 19 A In the necroses logs the TB D means "too 20 badly decomposed." 21 Q I'm going to show you 22 23 MR. POHL: May I app ro ach the witness? 24 THE COURT: Yes. 25 F n m -i k *} 'zry r 1 BY HR. P O H L : 2 -- a document marked Plaintiffs' 2916, whidh 3 is a p a r t of the Monsanto Aroc or r e p o r t s . It's 4 entitled "Hi s t o p a t h o l o g i c '1 Histopath Logistic 5 Sheet." Are you familiar with! that docu ment? 6 A Yes, I am. 7 Q It contains in its text, a tab ul ati on with ! 8 regard to rats used on Monsanto's Aroclors 9 studies, does it hot? 10 A Yes, it does. 11 Q And in regards to the information listed 1 2 with some of these rats -- and! I 'm just flipping 13 through some of the pages -- do you see the 14 initials TBD, and TBA? 15 Yes . 16 And again, what do trise initials mean when 1.7 used together? j\ 18 It means that the ahi:mal was too badly 19 de com posed and the technician dis pos ed of the 20 animal. 21 When an animal is too badly dec om posed and 22 is destroyed or thrown awa;y, what happens to the ij 23 ability of the pathologist to use that animal to 24 determine whether it died f rom cancer, whether it 25 died from tumors or other thingls? r n m Aia TT9T 1 The pathologist neverj gets a chance to look 2 at any tissues from the animal' beca us e the 3 technician has thrown it a way 4 With regard to the Monsanto' Arocl or studies, I 5 have you looked at the t a b u l ati on s regarding the Ii 6 histopathology to det ermine a p p r o x i m a t e l y what ii ;( 7 pe rce nta ge of the animals on this study were just Ii 8 thrown away and no one wili ever know what it was 9 that killed them? 10 Approxim ately 70 perce nt o'r more of the ii 11 11 animals that died during the coiurse of the study, i' i! 12 that are reported in the h i s t o p a t h log sheet were 13 too badly d e c o m p o s e d . 14 Now, another document jthat1 we have had blown Ji I 15 up, and I will just go to the second page of it, 16 is a statement by the man ou have identified as 17 11 Dr. Francher. He says "I'm ashjamed to publish 18 the work done on these studies.!" 19 With regard to the -- "I am asham ed to 20 publish the work done on these studies," with 21 \ 'I regard to the Monsanto rodent studies, would you 22 be ashamed of the work that was! done on the 23 rodent studies? 1 24 A Yes, I would. 25 Q There is another document that refers to the F n m 471 2193 1 papers being submitted to M o n s a n t o ' s lawyers 2 before they could be published'. And aga in I will 3 just go to the secona. sh. eeit. 4 "I hope to get copies of all the studies in 5 th'e hands of Bill Papageoige, 'Scott Tuc ker and l 6 the lawyers next week. I do not anticipate a lot i i I i|7 of changes from them and hope that the attorneys 8 agree that we can go ahead with publication.*' Ii 9 Was there any other client of IBT besides ! .! 10 Mo n san to that wanted its paper's reviewe d by tJ 11 lawyers before they could jbe put in final form? 12 A Not that I know of. Q13 Are you familiar with the; "swamp'*? 14 A Yes, I am 15 Q Are you familiar with the other rooms at IBT i 16 where the rodents were housed? 17 A Yes, 1 am. Q18 In as brief a manner as you pos sib ly c a n , 19 can you describe generally the con dit ions of the 20 animals in those rooms anc how they were cared 21 for and housed? 22 The animals in most riodent: studies were 23 1! housed in a small cage; and depending on what 24 room they were in, there w,ere either water 25 i! bottles or an automatic watering mechanism that "2T9 4 1 was supposed to supply water to the animals, 2 feed, pans und erneath the cages to catch urine, 'i 3 feces, food that was kicked out- 4 The conditions in most rooms were g e n eral ly 5 poor, there were many loose animals. i 1 6 Did Dr. Wright have knowledge of what you i! 7 have described as generally poo(r con dit ions with 8 regard to the housing and care of the animals? 9 A Yes, he did. 10 Q During the course of tjhese! studies, were i 11 there visits by representatives of Mon sa nto to 12 IBT? 13 During ray employment there, there were tI 14 visits from Monsan to personnel to IBT. 15 Without going into any, detail, can you just 16 identify some of the names for t'he jury of some 17 of the people from Monsanto who came to the 18 premises of IBT while you were employed there? .! I 19 Dc. Hunt, a Dr. L e v m s k s a s ; a Dr. Sharph, 20 iI possibly a Dr. Wheeler and Dr. Paul Wright had I| 21 worked at Monsanto before he came to work at IBT Ii 22 and he went back to Monsanto aftjer app ro ximately 23 18 months. And after that, he would come and 24 .. visit at IBT. i i 25 If any of the gentlemenI thajt you have F n m tn.i TT9T 1 identified fron Monsanto had gone to any of the 2 rooms where the rocents wet e being housed that 3 were.on Monsanto studies, would they have been 4 able to observe these deficient, con di t i o n s that 5 have been described to this jury? 6 A Yes. 7 Q How would they have -- how. would even a t casual observer been able to note those 9 condi tions? 10 The smell in the roomsl was terrible, and 11 just looking at the general cono i t ions of the 12 cleanliness of the r o o m s . 13 Now -- and for how long die Paul Wright I 14 continue to come back to IBfT after he returned to 15 employment at Monsanto? 16 As far as I know, up until the time I left 17 the employment of IBT -- 18 Q He was still -- 19 A -- Industrial Biotest 20 Q He was still interacting and working with I '! 21 IBT regarding the Monsanto studies? 22 Y e s . 23 24 MR. POHL: May I approach the witness? 25 mm : 2196 1 BY MR. POHb: 2 Let me show you Document, 2881, which has 3 p re v io u sl y been identified and'. is one of the IBT 4 records which we obtained, Do you know what that 5 document is? 6 Yes, I do. 7 Q What is it? B A T h e y 're graphs of body we light data for the 9 control and test groups of the three Aroclor 10 mater ia ls in the two-year study on Arocl or that 11 Biotest did. 12 You are talking about the, M o n s a n t o - s p o n s o r e d 1 3 Aroclor studies? 14 A Yes. -I 15 Q And was this data -- do e s 1 it perta in to the 16 body weight of the animals? 17 A Yes, it does. | 18 Q Was this data a part of the Mo ns ant o 19 Aroclor -- the IBT Aroclor report? 20 A Yes. 21 Q All right. Is the data contained on Page 1 22 of that report, for examplel falsified? r ]| 1 2 3 Yes, it is. A majority of .the data is j 2 4 falsified. |1 i F n w m2 5 O-n every page?, ' Ij I1 ! 1! 2 197 1 A Yes. 2 Q Who falsified the data with regard to the -- 3 that part of the data with regard to the Aroclor 4 study? 5 A Paul L. Wright. 6 Q Do you have any personal knowledge 7 whatsoever that Paul L. Wright fabricated the 8 data on the Arcclcr study? 9 A I observed him fabricate the body weight 10 data that is on this exhibit in front of me. 11 Q W e r e y o u i n t n e roomwith him when he 12 fabricated the body weight data for the rodents 13 used on Monsanto's Aroclor studies? I A A Yes, I was. 15 Q After Paul Wright returned to Monsanto and 16 after he made his trips back to IBT, did he ever 17 request that the study be redone or any curative 18 measure whatsoever be conducted so that an 19 accurate study can be made? 20 A Not to ray knowledge. 21 cfZDlS ,, 'lA Iq I i M 22 MR. POHL: May I approach the witness, 23 aga in? 24 THE COURT: Surely. In m 25 L BY M R . POHL; 1 i li TITS' 2Q I w i 11 *try tc be brie f about this, but there I 3 are three sets of reports bn the Aroclor studies, 4 are there not? 5 A Yes. 6 Q The first group concludes that the effect .1l 7 was normal, correct? 8 A Yes. 9 Q- The second group concludes! that all had a 10 slightly tumocigenic effect? 11 A Yes. 12 Q And thefinal set concluded that the product 1 3 does not causecancer? 14 A Yes. 15 All right. Does your signature appear on I! 16 the conclusion page or a pu r por Bed copy of your 17 signature appear on the conclusion page of the 18 first three Aroclors reports dat ed November 12, Ij 19 i 20 These are the three reports that found 21 nothing wrong. 22 Okay. These are the first reports that were i 2 3 done, dated November of *71? 24 A Y e s . Forti A *77 25 Q Let me show you very briefly just one of f 2199 1 those, which is the report on Aroclor 1254; and 2 turn to the signature page. 3 It says, "report prepared' b y ," and then has 4 a signature line for Phil S. Smith, assistant t| 5 toxicologist- Do you see t h a t ? 6 A Yes, I do. 7Q Is that your signature? A N o , it is n e t . 9 Q Did you sign the report? 10 A N o , I did not. 11 Q Who forged your signature? 12 A Paul Wright. 13 Q With regard to the actual care, feeding, Ij 14 housing of the animals, were Mons a n t o ' s rodents I 1 5 treated -- the rodents bn Monsanto's studies 16 ! 'I treated differently than the other rodents? 17 A No, they were not. 16 Q With regard to Monsanto's paper work, the 19 reports of its conclusions and so forth, did 20 Monsanto receive any special treatment different 21 from other customers of IBT 22 A Yes, they did. I 23 Q After Paul Wright returned' to Monsanto, did 24 he ever return to IBT and personally' dictate 25 changes to reports of products for M o n ^ ^ j ^ T J ^ ^ T2TT" 1 A Y es, he d id . 2 Q A f t e r - - w e l l l e t me a p p r o a c h i t t h i s w a y . 3 T h e r e h a s b e e n t e s t i m b n y by a man named Dr .I ! 4 L e v i n s k s a s th a t he v a l i d a t e d ttje IB T A r o c l o r 5 s t u d ie s and he found them to be p r o p e r and v a l i d , i |l 6 a n d h e w r o t e t h a t i n a r e p o r t ' tih a t h e p r e p a r e d . i 7 L e t me a s k y o u f r o m - y o u r ' p e r s p e c t i v e a s a n S a s s i s t a n t t o x i c o l o g i s t and [one who a c t u a l l y 9 worked on th e se s t u d i e s and was' t h e r e e v e ry d a y 10 w h e n t h e w o r k w a s b e i n g d o n e : C o u l d o n e v a l i d a t e 11 t h e I B T A r o c l o r s t u d i e s w i t h o u t m a k i n g a n y 12 i n v e s t i g a t i o n o r d r a w i n g a n y c o n c l u s i o n s a s t o 13 t h e h o u s i n g o f t h e r o d e n t s , ! t h e f e e d i n g o f t h e 14 r o d e n t s , t h e d o s a g e o f t h e i r o d e n t s , t h e w a t e r i n g 15 o f t h e r o d e n t s , t h e s u r v i v a b i l i t: y o f t h e r o d e n t s , 16 o r t h e s u b t l e t i e s o f t h e h a n d l i n g o f t h e r o d e n t s ? | 17 A No, th e y c o u l d n o t . j fa 18 Q B a s e d u p o n w h a t y o u o b s e r v e d w i t h t h e l !!19 a n i m a l s t h a t w e r e f e d t h e A r o c l o . r p r o d u c t s w h i l e 20 y o u w e r e a n e m p l o y e e o f M o n s a n t o ! a n d b a s e d u p o n 21 w h a t y o u l e a r n e d a s o n e t h e '\a u t h o r s o f t h e I 22 M o n s a n t o - s p o n s o r e d A r o c l o r s t u d i e s , i f s o m e o n e 23 : ' :i came to you today and s a i d th a t A r o c l o r s w here as 24 h a r m l e s s a s c o m m o n t a b l e s a l t , h o w w o u l d y o u 25 r e s p o n d ? Fom 1 2 3 4 5 6 7 a1 9 io ii 12 13 14 15 16 17 18 19 20 21 22 23 24 25 2 20 1 Number one, thoughjt you] said that while I was an employee of Monsanto Q I mean, an employee of IBjT. il A I never worked for M o n s a n 'to. Q I'm sorry. HR. JCivES: Your Honor, may I interpose an objection. I would object to th]e witness answering any opinion questions along that line. There has been no predicate laid that he is I qualified tc give such opinions. In fact, if the Court will permit me to take him on voir dire, I could establish that. THE COURT: I don *t l<now whether i1 counsel insists on the question or not. I think the objection will Je -- |i MR. POHL: I wiljl just withdraw the quest ion. Pass the witness for cross examination. THE COURT You wish to cross examine him? HR. JONES: Yes,iYour H o n o r . F o n t 48 0 i 1 2 3 4* 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 it won't take but ju; minute TTJT REDIRECT EXAM: 3N BY MR. P O H L : Without being a certi f ied t o x i c o l o g i s t , without being a certified pathologist, are you i able to recognize the falsification of data when you see it? A I feel that I am able to do that, yes. Q Why would you have signed jthose two reports and possibly signed the third back in 1971, but f not today? ! it In 1971# when these reports were being done, i| I was just starting to learn about writing laboratory reports at IBT, 'and ,I had prepared a small section of these repojrts. j And D r . Paul Wright and Mr. Jim Plank had prepared many sections# and they told me that I was going to i have to sign the report. j You talked about the swamp with Mr. Jones. Were the other the swamp? The other rooms -- how^did ,they compare i | ii the other rooms were not -- to were not wet like the swamp w a s , but there were more loose animals in the ot her rooms that would F o n i /ifti 2234 I get upvon the cage racks and chew animals' feet 2 and toes. And in the swamp, there weren't as 3 many -- the loose animals wouldn't get up in 4 there . 5 Q Did you complain to anyone at IBT about the 6 falsification of data that you saw going on or 7 the conditions that you observed? 8 A Yes, I did. 9 Q On few or many occasions did you complain to 10 the management -- can you hear me? 11 A I c a n h e a r y c u . 12 Q On few or many occasions did you complain to 13 the management of IBT about either the 14 falsification of data or the horrid conditions 15 that the animals were living in? 16 A I di dn't -- I still didn't -- the microphone 17 distorted the first word in your question. 18 Q On few or many occasions did you complain to 19 the management about the conditions at IBT or the 20 falsification of data? 21 A I complained about it on manyoccasions. 22 Q Did you complainto Paul Wright, for 23 examp1e ? 24 A Yes, I did. 25 Q There were some questions asked about the m m * fta T2T5" 1 job ttvat you had, after IBT and you were fired for 2 sleeping' on the job. 3 Yes. 4 With regard to that particular incident -- |i ,t 5 won't take but a second -y do -you have a p r o b l e m 6 with your -- did you have at that time a p r o b l e m 7 with your eyes? 8 A Yes, I did and. I still dot 9 Q Did it require surgery? 10 A Yes, it did. II Q Did it appear as if you were sleeping when 12 you were not? 13 A Yes, it did. 14 Q Can you explain that in 1C words or less to 15 the jury. 16 I have a convergence >. deficiency that causes 17 my left eye to drift out; and iwhen I am tired and 18 reading a lot, it will drift ou t and 1 have f 'll19 double vision so that I will cover my left eye 20 with my hand so I can continue' reading and not 21 have double vision. 22 Is that what you were doing at the other job 23 when they saw you and thought you were sleeping? 24 A Y e s . 25 Q Did other people -- were other people called FoniAftU 2 23 1 to testify before the grand jury and to assist 2 the government and give iestirnony besides 3 you rse1f? 4 A Yes, they were. 5 Q All right. Have you asked to be paid or is 6 anybody paying for your t ime i n connection with 7 the d e p osition you gave or your testimony in this 8 trial? 9 A No, I have not. 10 Q Has any offer to payjyou seen made for your 11 testimony? 12 Other than reimbursing my, expenses for being 13 here, there has been no offer for paying for my 14 testimony. 15 Does that include your direct o ut-of-pocket 16 expenses only such as the plane fare to get here 17 and the plane fare when you leave today to go 18 home? 19 That's correct. 2 0 THE COURT: I think it's unnecessary to 21 go into that. 22 HR. P O H L : Pass the witness. 23 THE COURT: Hr. `Jones , anything else? 24 MR. JONES: Your Hono r, I only have 25 about two questions, and ,that will be it. F n m 3R& t TT3T 1 RECROSS EXAMINATION 2 BY MR. JONES: ! 3 Q You testified about t h e s e a l leged 4 deficiencies today at IBT. Did you tell the 5 United States Government o'f those de f i c i e n c i e s in 6 1971? 7 I did not tell anybody other than IBT I I1 8 employees in 1971 about the def i c i e n c i e s . 9 And you also then, based upon that, did not i; 10 bring that to the attention of the people out at 11 the Monsanto Company? 12 I had -- was not in a 1,po s i t i o n to bring that >' '1 13 to the attention of the M o n s a n t o Company. 14 15 MR. JONES: That is a'll I have. Your 16 Honor. j 17 MR. POHL: One q u e s t i o n about that. 18 19 20 REDIRECT EXAMINATION 21 BY MR. POHL: 22 The data which you sayj was falsified and the 23 data with regard to the 70 percent of the animals \1 |i 24 that were too badly decomposed t-o even determine 25 what caused their death, was tha t data part of a Foni 585 2 238 1 group of data that was su omi 11 ed to the M o n s a n t o 2 Company for its review? 3 It's part of the raw data for the study file 'i 4 4 that Monsanto would have received at some point 5 in time. 6 So, if Monsanto had read that study file, 7 would they have seen and could have drawn some of 8 of the same conclusions tiat you were able to 9 draw from these documents? 10 They would have been a b l e 1 to see the d a t a , 11 yes 12 13 MR. P O H L : Thank y o u !L 14 THE COURT: All right. I believe this 15 concludes your testimony, And you may be 16 excused. And you may leave. 17 THE WITNESS: Thank you, Your Honor. 18 THE COURT: Ladi es and gentlemen of the 19 jury, we have a hearing in another matter, 20 which is probably going to take 15 minutes 21 or so. And we need to have a recess. 22 So, we are going to excuse you for 30 23 minutes. Please return to you r places in 3 0 2 4 minutes. That will be ten minutes before 25 1 1 : 0 0 . IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAsI BEAUMONT DIVISION ! CECIL S C O T T , et. al. vs. MONSANTO COMPANY ) ) C. A. NO. 84-1103-CA ) TESTIMONY OF PHILLIP S. SMITH September 3, 1987 i ABSTRACT OF TESTIMONY t i My name i s . P h i l l i p S . S m ith an d I l i v e B a rrin g to n , Illin o is . I am a f o n n e r e m p lo y e e In d u s t r ia l B io t e s t L a b o ra to rie s , In c . [2184 in of I v i s i t e d w i t h M r. P e ck o f M o n sa n to in my home t o d is c u s s A r o c lo r co m p o u n d s a n d w h a t my in v o lv e m e n t m ig h t h a v e b e e n w it h th e m . ^ e c k a s k e d me i f I h a d c o n s u lt e d a p r iv a t e a t t o rn e y r e g a r d in g my l i a b i l i t y in s p e a k in g to anybody about A ro c lo r p ro d u c ts . [2 18 4 -2 18 5] I was f i r s t e m p lo y e d .a t IB T in J a n u a ry 19 71, as an a s s is t a n t t o x i c o l o g is t a n d c o n c lu d e d my e m p lo y m e n t in June 1977. I w o rk e d o n M o n s a n to 's A r o c lo r [s t u d ie s and h e lp e d p re p a re th e r e p o r t s . - I a u d ite d s t u d ie s .; I spent a p p ro x im a te ly n in e m onths lo o k in g 1970 thro ugh 1976. [2 1 8 5 -2 1 8 6 ] a t s tu d ie s *| i done fro m O t is F ra n c h e r w as m anager o f t h e | l a b when I s t a r t e d t h e r e . P a u l W r ig h t w a s h i r e d a s [a s e c t i o n h e a d o f t o x i c o l o g y a b o u t tw o m o n th s a f t e r I s t a r t e d at! t h e la b a n d h e w a s i n c h a r g e o f t h e r a t a n d d o g t o x i l c i t y ]| a r e a s a n d I w as an e m p lo y e e in r a t t o x i c i t y a n d w o rk e d w it h W rig h t in M o n s a n t o 1s jA r o c l o r s t u d i e s . M a n n ie R eyn a w as a n e m p lo y e e in th e ra t t o x ic it y d ep artm en t. I am f a m i l i a r w i t h t h e c a re and h a n d lin g o f th e ro d e n ts u sed in ' re g a rd s to M o n s a n to 's A r o c lo r c h r o n ic o r a l t o x i c i t y s t u d ie s . [ 2 1 8 7 ] The in it ia ls A ro c lo r stu d y , PiL.W . a d d re s s e d to M a rin o L . la b o ra to ry . [2188] on th a t docum ent re g a rd in g i s P a u l L . W rig h t J and i t K e p l i n g e r w ho i;s m a n a g e r o f th e is . th e T h e re w as a p ro b le m w ith th e 's u r v ijv a b ilit y o f th e ro d e n t s on M o n s a n to 's A r o c lo r stu d y ]. The docum ent says th e ' tum or in c id e n t s in fe m a le s w ith 1254 is b o th e rs o m e , 82 p e r c e n t a t 10 p a r t s p e r m i l l i o n and 100 p e rce n t a t a 100 p a rts p e r m illio n . [2188] I h a ve p e r s o n a l k n o w le d g e o f d e f ic ie n c i e s w it h r e g a r d to M o n s a n to 's A r o c lo r s t u d ie s . The r e p o r t o f raw A ro c lo r s tu d ie s was f a ls if ie d . I sig n e d ) tw o r e p o r t s th a t c o n t a in e d f a ls e in fo r m a t io n an d som eone fo r g e ii my name to one o f t ie o th e r s tu d ie s ^ [2 1 8 9 -2 1 9 0 ] TBD m eans " t o o b a d y d e co m p o se d ", When t h e s e i n i t i a l s a p p e a r in a r e p o r t i t m eans t h a t th e a n im a l w as to o b a d ly decom posed and th e te c h n ic ia n ! d is p o s e d o f th e a n im a l. The p a t h o lo g is t n e v e r g e t s a ch a n ce l] to lo o k a t t i s s u e b e c a u s e t h e t e c h n i c i a n h a s t h e 1a n i m a l t h r o w n aw ay* 70% o r m ore o f th e a n im a ls t h a t d ie d d u r in g th e c o u r s e o f th e stu d y w ere to o b a d ly d ecom posed. [ 2 1 9 0 - 2 1 9 2 ] i -2- F O f V * i I In th e d o p ume n t sta te m e n t by D r. F ra n c h e r. w o rk done on th e se s t u d i e s . " [2192] t h a t I am l o o k i n g a t i s a " I am a s h a m e d t o p u b l i s h t h e I , t o o , w o u ld 'b e a sh a m e d . I know o f no o t h e r c l i e n t ( o f 'IB T b e s id e s M on santo t h a t w anted i t s p a p e rs re v ie w e d by la w y e rs b e fo re th e y c o u ld be p u t in f i n a l form . [2 1 9 3 ] i i In m ost ro d e n t s t u d i e s , th e a n im a ls w ere h o used in a s m a ll c a g e an d d e p e n d in g on w h at ropm t h e y w e re in , th e re w ere e it h e r w a te r b o t t l e s o r an a u to m a tic w a te rin g m e ch a n ism t h a t w as s u p p o s e d to s u p p ly w a t e r t o th e a n im a ls , fe e d , p an s u n d e rn e a th th e ca g e s to c a t c h u rin e , f e c e s , fo o d th a t w as k ic k e d o u t. The Ic o n d it io n s w ere p o o r , t h e r e w e r e m a n y l o o s e a n i m a l s . ' I D r . || W r i g h t h a d k n o w le d g e o f th e c o n d it io n s . [ 2 1 9 4 ] i The v i s i t s o f M onsanto p e rs o n n e l to IB T in c lu d e d D r. H unt, D r. S h a rp h , D r, L e v in s k s a s ,! p o s s ib ly a D r. W h e e le r and D r. P a u l W rig h t. [ 2 1 9 4 ] Had a n y o f th e s e p e r s o n n e l v i s i t e d t h e r o d e n t ' s ro o m s, t h e y w o uljd h a v e s e e n the d e f ic ie n t c o n d itio n s . [2 19 5] j i P a u l W rig h t c o n t in u e d to com e b a ck t o IB T a f t e r he r e t u r n e d to M o n sa n to u n t i l th e tim e l| l e f t th e e m p lo y m e n t o f IB T a n d he w as s t i l l in e r a q t in g w ith IB T in M onsanto s t u d ie s . [2 1 9 5 ] i I am l o o k i n g a t g r a p h s o f b o d y w e ig h jt d a t a f o r th e c o n t ro l and t e s t g ro u p s o f the th re e A ro c lo r m a te ria ls i n t h e t w o - y e a r s t u d y o n A r o c l o r t h a t B i o t e s `,t d i d . A m a j o r i t y o f th e d a ta i s f a l s i f i e d . [2 1 9 6 ]! P a u l L . W rig h t f a l s i f i e d th e p a rt o f th e d a ta w ith re g a rd l to A r o c lo r s . I o b s e rv e d h im f a b r i c a t e th e b o d y w e ig h t! d a t a f o r th e ro d e n t s u se d on M o n s a n to 's A r o c lo r s t u d ie s , He n e v e r re q u e ste d th a t the stu d y be red o n e. [2 1 9 7 ]! CR O SS- EX A M IN A TIO N W ith r e s p e c t t o th e t h re e s e t s ! o f r e p o r t s on A r o c lo r , th e f i r s t g ro u p c o n c lu d e s t h a t'th e e f f e c t w as n o rm a l. The se co n d g ro u p c o n c lu d e s th a t a l l had a s li g h t ly tu m o rig e n ic e f f e c t and th e f in a l s e t | c o n c lu d e d th a t the p ro d u ct does no t cau se ca n ce r, These a re the f i r s t re p o rt s th a t w ere done d a te d Novem ber o f '|71. [2 19 8 ] On th e s ig n a t u r e pag e on th e re p o rt o f A r o c lo r l|2 5 4 , P a u l W rig h t fo rg e d my s ig n a t u r e . [2 1 9 9 ] -3- Kornt 8M I M onsanto r e c e i v e d s p e c ia l treatm en t' from o th e r cu sto m e rs o f IB T . A f t e r P a u l W rig h t re tu rn e d to M onsanto he p e rs o n a lly d ic ta te d ch ang es to re p o rts o f p ro d u cts fo r M onsanto. [2199] I know te s tim o n y h a s been g iv e n b y D r . L e v in s k s a s th a t he fo u n d th e se re p o rts v a li)d . No one [ ]c o u l d v a l i d a t e t h e A r o c l o r s t u d i e s w i t h o u t i m a k i n g a n y in v e s t ig a t io n s . 2200 I n e v e r w orked f o r . M o n san to . [ 2201] REDIRECT EXAMINATION In 1 9 71 , th e n th e se re p o rt s w ere b e in g d o n e, I w as j u s t s t a r t in g to le a r n a b o u t w r it in g |la b r e p o r t s and I p re p a re d a s m a ll s e c t io n . D r . P a u l W rig tit a n d J im P la n k p r e p a r e d m a n y s e c t i o n s a n d t h e y t o l d me I w a 's g o i n g t o have to s ig n the r e p o r t . [2 2 3 3 ] I c o m p la in e d to P a u l W rig h t f a ls if ic a t io n th a t I o b served . [2234] | about th e I had a p ro b le m w it h my e y e s and s t i l l d o , w h ic h r e q u ir e d s u r g e r y . I t a p p e a re d to o t h e r s as; i f w as s le e p in g on th e jo b when I was n o t. [2 2 3 5 ] I h a ve n o t a sk e d to be p a id ::o r c o n n e c tio n w ith t h is te s tim o n y . I am re im b u rse d f o r e x p e n se s. [2 2 3 6 ] my tim e in o n ly b e in g RECROSS EXAMINATION I d id n o t t e l l an yb o d y o th e r th a n IB T in 1971 about the d e f ic ie n c ie s . [2 2 3 7 ] I e m p lo y e e s F noi r m 1 UNITED STATES DISTRICT COURT 2 EASTERN DISTRICT OF TEXAS 3 O F F I C I A L R E P O R T E R 'S CERT IFICATE 4 5 6 I, FRANK MCMILLAN, OFFICIAL! C O URT RE P O R T E R FOR 7 THE DISTRICT COURT OF THE UNITED STATES FOR THE EASTERN 8 DISTRICT OF TEXAS, DO HEREBY CERTIFY THAT THE ABOVE AND 9 FOREGOING PAGES CONSTITUTE A TRUE, CORRECT AND COMPLETE 10 T R A N S C R I P T OF THE PROCEEDINGS IN THE ABOVE STYLED AND 11 NUMBERED CAUSE. 12 WITNESS MY OFFICIAL SIGNATURE IN.THE CITY OF 13 BEAUMONT, TEXAS, ON THE 14 15 16 17 C : FRANfc m CMILL'AN------------- 18 O F F I C I A L COURT REPOR T E R UNITED STATES DISTRICT COURT 19 EASTER*N DI SiT R I C T OF TEXAS 20 I 21 22 23 24 25 r n m ' Q i IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS BEAUMONT DIVISION CECIL SCOTT, ET AL VS. MONSANTO COMPANY CIVIL ACTION NO. B-84-1103-CA SEPTEMBER 2, 1987 VOLUME XIIII * * * * *!* * BEFORE THE HONORABLE JOE J FISHER UNITED STATES DISTRICT JUDGE, AND A JURY WITNESS 1 DR. PAUL L. WRIGHT l ! 11 '1 r I| SHOWING OF VIDEO DEPOSITION | READING FROM VIDEO D!EPOSIITION! PAGE 1983 1992 REPORTED BY: C. FRANK MCMILLAN FEDERAL COURT REPORTING CO. P. O. BOX 2664 BEAUMONT, TEXAS 770106 F n f t V ^ (409) 839-2518 i\ 1 A PPEA RA N C ES i 2I i 3 ATTORNEYS FOR PL<AINTI "FS: 4 MR. DAVID M. LACEY HR. MICHAEL A.jpOHL 5 MS. SUSAN (BAKER GILPIN, PORL & Sb ENNETT 6 1300 POST OAK BOULEVARD HOUSTON, TEXAS 77056 7. HR. THOMAS HENDERSON 8 HR. ANTONIO PYLE HENDERSON i GOLDBERG 9 1030 FIFTH AVENUE PITTSBURGH, PENNSYLVANIA 15219 10 MR. BENTON MUSSLEWHITE 11 609 FANNIN. SUITE 517 !, HOUSTON, TEXAS 77002 12 13 ATTORNEYS FOR DEFENDANT 14 MR. ROBERT A. HALL MR. ROBERT A. J'n ES 15 MR. JONATHAN SHOEBOTHAM WOODARD, HALL & PRIMM 16 4700 TEXAS COMMERCE TOWER HOUSTON, TEXAS 77002 17 ! II MR. TANNER T. HUNT, JR. 18 MS. CHERYL D. OLESEN MR. WALTER CRAWFORD 19 MR. MARK FREEMAN WELLS, PEYTON, BEARD, GREENBERG, 20 HUNT l CRAWFORD1 P. O. BOX 3708 21 BEAUMONT, TEXAS 7.7056 22 F n m Q a ALSO PRESENT: 23 HR. WILLIAM IfAPACEORGE, CORPORATE 24 REPRESENTATIVE OR THE MONSANTO CHEMICAL COMPANY,. 25 \ I I I r 11 INDEX 2 3 4 WITNESS DR. PAUL L. WRIGHT 5 SHOWING OF VIDEO DEPOSITION READING FROM VIDEO DEPOSITION 6 7 8 WITNESS DR. WARD R. RICHTER I I 9 I SHOWING OF VIDEO DEPOSITION READING FROM. VIDEO DEPOSITION 10 1 11 12 13 14 15 16 17 18 19 2 21 22 23 24 25 PAGE 19 8 3 1992 PAGE 2032 2047 1 2 3, 4 5 6 7 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 T78 of Dr. George J. Levisksas. THE COURT: Who do you have next? I HR. JONES: Your Honor, the defen d a n t | will make its offer in its case in chief. j| THE COURT: Thank you. Who do you have next? HR. P O H L : With t h a t ,, Your Honor, at this time ue call Dr. Paul L. Wright by video deposition. THE COURT: Do you have additional objections to make or do you make the same . . . ! objections? :'i. ;i HR. JONES: Yes, Your Honor, we do. Yesterday you stajted, jYour Honor, that if we had additional objections other than ( those running objections to make them at the appropriate time and this is one of those times,-Your Honor. We would object to the testimony of Paul Wright to the extJnt that he seeks or ] .. seeks to invoke his Fifth Amendment rights under the constitution of the United States !\ on the ground that suchlte s timony is irrelevant, it's immaterial,|it*s F n m ' Q 5 inflammatory and its prejudice outweighs its l 6 ' ! i 1 ( i iI 197!: 1 probative value. 1 2 3 reason that there is no adverse inference 4 that can be drawn from such inv o c a t i o n of i| S the Fifth Amendment, rights to the Defendant I 6 Monsanto. And, therefore, the test i m o n y is 7 irrelevant. 1 i' 1; 8 No adverse inference can be drawn for a I! 9 couple of reasons, Your Honor. Number one, I1 10 the. witness was not an employee of M o n s a n t o iI 11 at the time of the deposition. M o n s a n t o did '` I j 12 notcontrol'or influence nim or could 13 influence him in any 1way.! j He was 14 represented by counsel at jthe deposition. IS And, in fact, I as cojinsel for M o n s a n t o 16 Company specifically objected to his taking \ 17 the Fifth' Amendment and requested that he 18 answer the questions 19 THE COURT: L e t 's notllargue your 20 objections. Just make them. 21 MR. JONES All rig h t ; Your H o n o r . 22 That's the first objection. Your H o n o r . 23 The second objection that we have to 24 the testimony is that there; is noF0fl1<*96 25 substantial independent evidence to support 1 the inference w h i c h - t h e plaintiffs seek to 2 draw; that being, that the invocation of the 3 Fifth Amendment by Pjaul Wright, which they I: 4 are seeking to draw, is not that he may have ! ;i 5 committed a crime but the! fact that Monsanto 16 knew that he committed a crime or alleged or it 7 knew of the alleged deficiencies of IBT. I :| . 1 8 Your Honor, si.n1ce thi]ere is no 1 T, 9 independent corroborating'levidence on that 10 point under the authority of the United 11 States versu_s___J_a__m_e_s_, jthat *'testimony should 12 be excluded. \ i 13 But even if they-did ,have corroborating 14 evidence. Your Honor, they, have got to also 15 show that the inference that they draw is I16 \ more probable than any^ other inference and 17 that they haven't done'. 18 We would also object tjo the testimony 19 on the ground that Paul Wri'cght's knowledge 20 whatever it may be, cannot be imputed to ii 21 Monsanto because if, in fact, there were 22 deficiencies at IBT and if, in fact, he knew 23 of those deficiencies, he di dn't tell them 2 4 to Monsanto. And under* case law, You.f n n i497 25 Honor, if an employee acts a'H 1981 1 interest of its employer)-- 2 THE COURT: Lei's nit argue. I I3' HR. JONES: Okay, Your Honor. 4 Your Honor, w e 'd also in that case, 11 : 5 what we would like to do 'is just refer to III 6 the Court the brief that we filed in support 7 of the motion in limine which contains many 8 of these objections. Andjwe would request 9 that the deposition testimony be excluded. 1 IO MS. BAKER: Could I b'e heard just for 11 the record? 12 THE COURT: Yes. 13 MS. BAKER: And rlely for our part on I! 14 our briefs filed with the Court and on the 15 fact that a lot of cases represented by 16 United States versus James has been 17 overruled by the United States Supreme 18 Court. Thank you. 19 THE COURT: The Court overrules the I 120 additional objections as weljl as the 21 original objections and gives counsel a !i 22 running objection to all o f these matters 23 and deny the request. 24 All right. Let's proceed. F(\011 25 MR. JONES: Your Honor, |may I state on3 1902 I1 1 additional thing and then we can go on with 2 the deposition. 3 May we request an instruction from the 4 Court to the jury that no1 adverse inference 5 may be drawn against Monsanto Company as a 6 result of this testimony for the reasons I1 7 that we stated earlier? 8 MR. POHL: Your |Honoir, I would like to 9 be heard on that. 10 TH COURT: Yes. 11 MR. POHL: Your onor , I don *t want to !l 12 engage in argument, but the fact, the I '! 13 evidence already shows from Monsanto's 14 witnesses that Dr. Wright Was hired back by 15 Monsanto at Monsanto's reques t 16 He came back in a high management 17 position, that after he came back, he 18 continued to coordinate wit| I B T * We have 19 read to the jury this very morning documents I 20 that Paul Wright had knowledge of and even Ii 21 Manual Rhame, one of MoInsant1o's current 1 .; 22 employees, testified that he1 personally told 11 23 Dr. Weight about these deficiencies that 24 we're going to detail a 11i 1 1 1e bit later in itn n i 25 this case. 1 1 THE COURT: All r i g h t . 2 instruct the jury that this t 3 being offered for the purpose 4 knowledge, if any, on the pa r 5 And Monsanto, being a CO i 6 course, it acts through agent S\ 7 employees. And the jury may 1 8 circumstantial weight or valu II . 9 evidence as they consider it \ 10 Now, on the question o4f knowl 11 Monsanto. 12 All right. You m'ay prjoc i 13 MR. POHL: We are,ready 14 Your Honor. 15 THE COURT: All right. 16 17 (WHEREUPON THE FOLLOWING PORTIONS 18 VIDEO DEPOSITION WERE SHOWN TO THE 19 20 Raise your right hand. [Do yjo 21 swear that the testimony you are a 22 will be the truth, the wholejtruth \\ .23 but the truth so help you God? 24 A I do. Ii 25 Q Dr. Wright, my name is Mike P il TM T 1 have just heard, I'm onejof the attorneys for the 1 2 plaintiffs; that is, the parties who have brought 3 this civil lawsuit 4 We are here today to askyou a number of 5 questions. Before we start those questions, let 6 me say first that the plaintiffs are calling you 7 as an adverse witness in that you were employed 8 by both by IBT and Monsanto 9 Let me begin your deposition by asking you 10 to state for the Court and jury your full name, 11 A I am Paul Lee Wright. 12 Q If at any time during the course of the 13 deposition you don't u n d e r s t a n d 1one of my I 'i 14 questions because I speak too softly, because I'm 1I s IS not careful in the way I wordedthe question; 16 because it is somehow confusing to you or because i 1? there is some distraction in the room, I woul'd 18 appreciate your stopping me and asking me to ; 19 repeat the question or to rephrase the questibn iii 20 so that we can be very clear that you understand iI !l 21 each and every question. ( i 22 Can we have that agreement? t 23 A I will do my best. | 24 Q And you understand, Dr. Wright, that this! 2 S deposition, even though we are here in rather l r 4 i c J 1 2 34 5 6 7 6 9 10 11 12 13 14 15 16 17 18 19* 20 21 22 23 24 25 "1TST informal proceedings, can be used at the time of trial; that is, we can show thilis videotape or read the question and answers or any part thereof to the Court and jury? A That's my understanding*' Q And you understand thLt you have just been sworn by the court reporter? A Yes, I do. Q And you understand that that means that you I1 have been sworn to tell the truth and the whole truth just as. if you were sworn on the witness i stand in the courtroom before the jury? A 1 understand that. Q And in response to each of 'my questions, I would like you to give me the full and complete and. truthful answer to each question, okay? A All right. Q And in what year did you obtain your Ph.D.? A In 1961. Q When were you first employee by Monsanto? A In 1965. jj i Q When were you first employed1 by Industrial Biotest Laboratories, Inc.? A In 1971. Q When you were II w.. * F o n - TF87 1 job title? 2 A I believe it was manager of toxicology 3 Q And when did your employment with IBT 4 terminate? i 5 A In November of 1972.1 i 6 Q Did you then return jto employment with 7 Monsanto? 6 A Yes, I did. 9 Q And what was the first da^ that you 10 recommenced your employment with Monsanto? 11 A I believe it was N o v efim b e r 1, i 1972. 12 Q What was your job title at Monsanto when you 13 became re-employed by Monsanto?, 14 A rIt,again-,was manager o1f tAoxicol. ogy,. S' 15 Q And you worked here in St., Louis in the 1 16 offices ofMonsanto? I! l!I 1 17 A Yes, I did. | 18 Q You were criminally iJdicted; is that 19 correct? S I 1 20 A That's correct. j t 21 Q All right. And do you) recall when you were i( 22 indicted? 1 iov i 23 A No, I don't. I believe it was in 1982. 24 Q After the indictment wJs han'Ided down, you ij 25 ultimately went through a crjiminall trial, did vm i I! 1T8T 1 not? 2 A Yes, I did. 3 Q And did you have anattorney representing 4 you in that criminal trial}I? ' 5 A Y e s , I did. 6 Q What was that lawyer's name? i '1 7 A The lead lawyer was Mr. James Robertson of 8 1 ' !l the Wilmer, Cutler i Pickering firm. I1 9 Q How many other attorneys, if any, assisted 10 in your representation durijng tlie course of those 11 criminal proceedings? 12 A There were two. 13 Q W e r e a l l t h r e e o f those lawyers with the !1 14 Wilmer, Cutler & Pickering law firm? i; 15 A Yes, they were, as far las l!know. 16 Q And you understood thatj law'firm to be out 17 of Washington, D.C.? 18 A Yes, it was. 19 Q The criminal trial took place in Chicago 20 did it not? 21 A Yes, it did. 22 Q Did you also have local 'attorneys iM 23 representing you in Chicago? I ii l( 24 A Well, there was a firm Hapfin & Hapfin and 25 apparently was involved in the firm but they did 1 not represent me personally, a's far as I know. 2Q How long did the trial last? 3 A I believe about seven months. 4Q And you were tried along with Dr. Keplinger 5 and a man named James Plan ,t? 6 A That's correct. 7 Q And a Dr. Joe Keplinger di d not complete the 8 trial because of physical illness; is that 9 correct? 10 A T h a t 's c o r r e c t . 11 Q And so far as you understand, the trial as 12 to Dr. Keplinger has never |been completed; is i 13 that correct? 14 A I have no knowledge. 15 Q At the conclusion of the trjial, were you 16 convicted? 17 A Yes, 1 was. 18 Q And were you sentenced by the judge? 19 A Yes, I was. 20 0 Did you take an appeal tfrom that conviction? 21 A Yes, I did. j 22 0 And was the conviction (affirmed? 23 A Y e s , it was. 24 Q I want to show you a document which 1 have 25 obtained from the district courts of Chicago t \I TTE 1 which is your indictment and ask you first, if 2 you have ever before looked at the grand j u r y ls 3 indictment as it pertains to- you, have you? 4 5 (Whereupon the video deposition was interrupted.) 6 7 THE COURT: Dot you 'need to go into this 8 much detail? 9 10 (Video r e s u m e d .) i 11 Yes, I have seen the1indictment. I don't 12 know the document you have. 13 14 (Whereupon the video deposition was interrupted.) 15 16 THE COURT: Is it necessary to go into 17 this much detail? 18 HR. MUSSLEWHITE: We can stop, Your 19 Honor -- 20 THE COURT: Can yjou offer the rest of 21 it by Q4A? 2 2 MR. MUSSLEWHITE: Just;| want to go over 23 (one question, Your Honor. liniYir nf> 24 MR. PQHL: If we can have about two 25 more minutes then we are going to o f f e r *- f 1990 1 by Q&A. 2 THE COURT: All right. Hake it roll 3 then. 4 ' 5 (Video deposition resumed.) 6 Q Let' me show this to yjou arid your lawyer 7 This is a certified copy which Jwe obtained from 8 the United States District; the Northern District 9 of Illinois and pass it to y o u .; Take a moment to 10 look at it and just identify it for the record as 11 to whether or not it's the ind ictment? 12 Does that appear to be the in d i c t m e n t ? 13 It appears to be, but -C cannot -- am not 14 totally certain that that's the document at this 15 point in t irae. j I 16 But to the best of your knowledge today, 17 that appears to you to be a true and accurate 18 copy of the indictment that you were faced with? 19 A That is ay assumption. 20 I want to ask you a few questions, Dr 21 Wright, about the attorneys' fees associated with 2 2 your criminal trial -- 23 24 (Whereupon the video depos itionI was i n t e r r u p t e d . ) 25 THE COURT: L e t 's don't- u --' \ T9TT 1 that. Let's don't go back into the attorney 2 fees. Just go into 1details that are just, 3 thread .bare, you've just L o r n it thread I. ! 4 bare. Get to the testimony that you want to !' ( 5 ask hia about concerning his test, I suppose 6 and -- see if you caJ do that. i3 7 HR. MUSSLEWHITE:! Can you do it to the 8 first question on there -- okay 9 10 (Video deposition r e s u m e d .) 11 12 There was a manager of toxicology for IBT IIi 13 and also there is a manager} for toxicology for 14 Monsanto at a later point in tim,e. You knew that 15 the United States Government an d 5 possibly others 16 might receive copies of the conclusions of the 17 studies that were being conducted at IBT, on 18 Monsanto's Aroclor products, did 'you not? 19 On my attorney's advice , I hereby invoke the 20 right secured to me by the Fifth 'and Fourteenth 21 Amendments to the U.S. Constitution and j '\ 22 respectively refuse to answer that question on 23 the grounds that any inf orma tiion , FrtiY * n N 24 1 25 (Whereupon the video deposition was concluded.! T9'9 r 1 THE COURT: What is the necessity of 2 offering this? 3 MR. MUSSLEWHITE: Yo6r Honor, there's 'I ;j 4 about only eight questions that we have that 5 go into the -- 6 THE COURT: Well , let's get to the 7 eight questions then. 8 MR. MUSSLEWHITE: We will stop that and 9 read them. 10 THE COURT: All right.1 11 MR. P O H L : If you will turn to Page 31, 12 line 19, I will ask the question. You can 13 give the answer. 14 MR. HUSSLEWHITE: Okay 15 16 (Reading from video deposition) 17 Dr. Weight, is it true that the result of 18 IBT's high mortality rate injconnect ion with 19 Monsanto's Aroclor study and!the practice of 20 substituting animals during the course of such 21 studies cause the toxic effects of Monsanto's 22 Aroclor studies to be serious ly understated? 23 On my a t t orney's advice,| I hereby invoke the 24 rights secured to me by the Fifth and Fourteenth 25 Amendments to the U.S. Constitution T WTI 1 respectfully refuse to answer 'that question on 2 the grounds that any information I give in Ii II 3 response may tend to incriminate me. 4 (End of reading) 5 6 MR. POHL Page 33, ine 12. 7 8 (Reading from video deposition) 9 Dr. Wright, is it true that the reports of 10 the conclusions reached in connection with the 11 IBT Aroclor studies were altered several times at 12 Monsanto's request? .t 13 A On my attorney's advice I hereby invoke the 14 rights secured to me by the Fifth and the -i 15 (End of reading) 16 17 THE COURT: If he is going to invoke !i 18 the Fifth Amendment, all ofi these will -- 19 ! '1 there's no need of offering: them. i; 20 MR. MUSSLEWHITE: jYour1 Honor, our 21 purpose, if I may say so, is to show the i| 22 ll questions -- the information we tried to get 23 from this witness and if you will -- I 'll -2 4 we'll stop reading the Fifth Amendment and 25 just read the questions';. T 9 "9 T 1 THE COURT: Did' you not get the 2 information from other wi!tnesses? 3 HR. POHL: our Honor, this is the 4 witness that has the most'; direct knowledge I i ii 5 both from the point of view of IBT and I 6 Monsanto. 1 7 THE COURT: Don'|t you think the Court 8 knows that? It's absolute ly a waste of time 9 to ask a question and then1, to have him 10 invoke his Fifth Amendment right. That 11 doesn't add anything t-o the t e s t i m o n y . 12 MR. POHL: We want to show the jury, 13 Your Honor, that we attempt*ed to go to the i 14 one person from both Monsari to and IBT who 15 had the ost -- i i 16 THE COURT: The Court is reversing its 1 17 rulings. We will sustain the defendant's if 18 objection and we will grantjhis request to 19 suppress this deposition of Mr. Wright's 20 All right. 21 MR. JONES: Your Honor,; in light of the 22 iCourt's recent ruling here, we would request \23 that the jury be instruc'[ted to disregard the 24 previous testimony. inm 1 \ 25 THE COURT: Yes, the Court will request Tsry 5 1 the jury to disregard any portion of Mr. 2 Wright's testimony that hjas been read. All 3 right. 4 MR. POHL: Your |Honofr, at this time we 5 would -- 6 THE COURT: Do not give it any !j 7 consideration or affe'ct to Dr. Wright's I: | 'I 8 deposition in regard to your deliberation as I 9* a jury in this case. Do riot give it any .i 10 affect or consideration inj your rulings 11 All right. 12 MR. POHL: Your Honor , we would read i 13 from the deposition an|d offer a summary of i 14 Dan R. Bishop taken June 29j, 1987 . And Ii i . 15 will read a summary and there are some 16 questions and answers and I would ask Mr 17 Husslewhite to respond to the questions. 18 THE COURT: All right.1. What witness is 19 this? 20 MR. HUSSLEWHITE: This is the last one 21 that I mentioned to Your Honor of the last 22 witness we have that was Monsanto's -- 23 public relations man. It's, a short offer. :j 24 THE COURT: You may proceed. r o w r'1 ^ 25 MR. POHL: Your H n t i n r IN THE SUPERIOR COURT OF THE STATE; OF DELAWARE IN AND FOR NEW CASTLE COUNTY ! 1I MONSANTO COMPANY, a corporation ) of the State of Delaware, ) Plaintiff, ) ) v. ) C.A. o. AETNA CASUALTY AND SURETY COMPANY; ALLSTATE INSURANCE ) I 'I ) NON ARBITRATION CASE ) iI COMPANY (as successor to ) NORTHBROOK. EXCESS AND SURPLUS ) COMPANY, formerly NORTHBROOK INSURANCE COMPANY); AMERICAN ) ) !' J CENTENNIAL INSURANCE COMPANY; ) AMERICAN HOME ASSURANCE COMPANY; ) AMFRTCAN MANUFACTU^TMg ^tttihj ) rrr^i^ aTjr r n_M? APPALACHIAN ) INSURANCE COMPANY; ASSOCIATED ) I II i, 89. I INTERNATIONAL INSURANCE COMPANY; ) BIRMINGHAM FIRE INSURANCE ) COMPANY OF PENNSYLVANIA; ) CALIFORNIA UNION INSURANCE ) COMPANY; C.E. HEATH COMPENSA- ) "zCc i o 33 o & n m TION AND LIABILITY INSURANCE ) cr COMPANY; CERTAIN UNDERWRITERS ) > -o a -jJ AT LLOYD'S, LONDON, AND LONDON ) --< O n MARKET INSURANCE COMPANIES; ) OJ t COLUMBIA CASUALTY COMPANY; CONTINENTAL CASUALTY COMPANY; ) ) FIREMAN'S FUND INSURANCE ) COMPANY; FIRST STATE INSURANCE ) COMPANY; GRANITE STATE ) INSURANCE COMPANY; HARTFORD ) ACCIDENT AND INDEMNITY COMPANY; ) THE HOME INSURANCE COMPANY; ) 1 HUDSON INSURANCE COMPANY; ) INSURANCE COMPANY OF NORTH ) AMERICA; INSURANCE COMPANY OF ) THE STATE OF PENNSYLVANIA; ) INTERNATIONAL INSURANCE COMPANY; ) LEXINGTON INSURANCE COMPANY; ) LIBERTY MUTUAL INSURANCE ) COMPANY; NATIONAL CASUALTY ) COMPANY; NATIONAL UNION FIRE ) INSURANCE COMPANY OF PITTSBURGH; ) NEW ENGLAND INSURANCE COMPANY; ) 1 \ I. * NORTH STAR REINSURANCE CORPORATIO N ; NORTHWESTERN NATIONAL INSURANCE COMPANY; P A C IF IC EMPLOYERS INSURANCE COMPANY; PRO TECTIV E NATIONAL INSURANCE COMPANY OF OMAHA; ROYAL INDEMN IT Y COMPANY; ST. PAUL SURPLUS L IN E S INSURANCE COMPANY; TRAVELERS IN D EM N ITY COMPANY; UNIGARD SECU RITY INSURANCE COMPANY; U NITED STATES F IR E IN S U R A N C E COMPANY; a n d WAUSAU UNDERWRITERS INSURANCE COMPANY, D efendants. ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) COMPLAINT Plaintiff, Monsanto Company ("Monsanto"), by its attorneys, complaining of the defendants, a l l e g e s : THE PARTIES 1. Plaintiff Monsanto Is a corporation organized in 1933 under the laws of the State of Delaware,.with an aggregate sales volume in Delaware of at least $50,000,000 annually. Monsanto has maintained an office in Delaware, 'and its registered agent in Delaware presently is located at 1209 Orange Street, Wilmington, Delaware 19801. 2. The full name, state of inco rporation, principal place'of business, and other jurisdictional Information regarding each defendant is set forth in the Appendix of Jurisdictional Information, attached heretL as; Appendix A, and is incorporated herein by reference. t 3. The defendant Insurance companies,are, and at all relevant times mentioned herein were, engaged in the business of writing (a) primary or excess general liability insurance -2- irnni ^ d I o o lic ie s , a n d /o r (b ) e n v iro n m e n ta l im p airm en t 'o r p o llu t io n y ! `I l i a b i l i t y in su ra n ce p o lic ie s . || l1 4. In c o n s id e r a t io n o f prem ium s p a id by M onsanto, the defendants i s s u e d l i a b i l i t y i n s u r a n c e p o l i c i e s ' c o v e r i n g 1! M onsanto, the p o lic y numbers and p o lic y p e rio d s o f w hich a re ii jI lis t e d in the attach ed appendices B (g e n e ra l l i a b i l i t y p o lic ie s ) and C (e n v iro n m e n ta l im pairm ent and p o llu t io n l i a b i l i t y p o lic ie s ) h e re to , w h ich hereby a re in c o rp o ra t e ! by re fe re n c e . The re fe re n c e s to d e fe n d a n ts' p o lic ie s h e re a ft e r in th is co m p la in t a re re fe re n c e s , in p a rt , to thei s p e c if ic D o lic ie s ! lis t e d in thee x h ib its attached h e re to . | I 5 . In a d d it io n to th e in s u r a n c e co m p a n ie s named as ! 1. d e fe n d a n ts, E xcess In s u ra n c e Company (" E x c e s s " ), In t e g r it y || In s u r a n c e Company ( " I n t e g r i t y " ) , M id la n d In s u r a n c e Company 1J (" M id la n d " ), M is s io n In s u ra n c e Company ( " M is s io n " ) , M utual F ir e , ; :J M a rin e and In la n d In s u ra n c e Company ("M u tu a l F i r e " ) , and T r a n s it ! 'I C a s u a lt y Company ( " T r a n s it " ) a ls o s o ld e x c e ss l i a b i l i t y in su ra n ce p o lic ie s to M onsanto. E x c e ss, In t e g r it y , M id land , i ij,, M is sio n , M utual F ir e , and T r a n s it , how ever, c u r r e n t ly a re the su b je ct o f liq u id a t io n p ro cee d in g s. ! 6. In each o f the le a d u m b re lla p o lic ie s , c o v e rin g the p e rio d from O cto b er 1, 1959, to A p r i l ! 1, 1986, (th e "Lead U m b re lla p o l i c i e s " ) , L lo y d 's and the London Com panies co n se n te d to subm it, at the re q u e st o f the in s u r e d ,,t o tJe j u r is d ic t io n o f any co u rt o f com petent j u r is d ic t io n w ith in the U nited S ta te s, to c o m p l y w i t h a l l r e q u i r e m e n t s n e c e s s a r y t o i g i v e 1s u c h c o u r t -3- i I jurisdiction, and to have all matters arising under their policies determined in accordance with ttie lav and practice of such court. 7 . Each of the excess general jliabillity policies issued bv ACIC adopts and follows the form of [the Lead Umbrella r policies, including those provisions relaxing '[to jurisdiction and choice of law described in paragraph 6. 8. Each of the excess general liability policies issued bv Aetna adopts and follows the form of! the Lead Umbrella |i policies, including those provisions relating to jurisdiction and choice of law described in paragraph 6. 9. Each of the excess general liability policies Issued by American Hone adopts and follows the form of the Lead- Umbrella policies, including those provisions relating to i :| u . jurisdiction and choice of law described m paragraph b. I . 1. 10. Each of the excess general liability policies ji Issued by American Manufacturers adopts and follows the form of che Lead Umbrella policies, including those provisions relating Co j u r i s d i c t i o n a n d c h o i c e o f l a w d e s c r i b e d i n paragraph 6. j 11. Each of the excess general l'iabiL;ity policies I| issued by Appalachian adopts and follows the form of the Lead Umbrella policies, including those provisions relating to jurisdiction and choice of law described in paragraph 6. i iI ; 12. Each of the excess general liability policies issued by Associated International adopts and follows the fora Che Lead Umbrella policies, including those p1rovisions -a- r e la t in g to j u r i s d i c t i o n .and c h o ic e o f law d e s c rib e d in p arag rap h 6. 13. Each o f the e x ce ss g e n e ra l l i a b i l i t y p o lic ie s is s u e d by Birm ingham ad o p ts and fo llo w s the form o f the Lead U m b rella p o lic ie s , in c lu d in g those p ro v i s io n s r e la t in g to j u r i s d i c t i o n and c h o ic e o f law d e s c rib e d in p a ra g ra p h 6. 14. Each o f the ex cess g e n e ra l l i a b i l i t y p o lic ie s is s u e d by C a lif o r n ia U nion ad opts and fo llo w s) the form o f the Lead U m b rella p o lic ie s , in c lu d in g those p ro v is io n s re la t in g to j u r i s d i c t i o n -and c h o ic e o f law d e s c rib e d in p ra g ra h 6. ij 15. Each o f the excess g e n e ra l l i a b i l i t y p o lic ie s is s u e d b y CNA a d o p ts and f o llo w s th e fo rm o f t'he L e ad U m b r e lla p o lic ie s , in clu d in g those p ro v isio n s re la tin g to ju r is d ic t io n a n d c h o i c e o f l a w d e s c r i b e d i n p a r a g r a p h 6. 1 6 . The e x c e s s g e n e r a l l i a b i l i t y p o l:i c y is s u e d by C o lu m b ia a d o p ts and fo llo w s the form of. th e u n d e r ly in g Lead U m brella p o lic y , in c lu d in g those p ro v is io n s re la t in g to j u r i s d i c t i o n and c h o ic e o f law d e s c rib e d in p a ra g ra p h 6. i1 1 7 . E a c h o f t h e e x c e s s g e n e r a l `l i a b i l i t y p o l i c i e s is s u e d by E m p lo y ers' S u rp lu s ad opts and fo llo w s the form o f i ;l Lead U m b rella p o lic ie s , in c lu d in g those p ro v is io n s re la t in g - 1 \ j u r i s d i c t i o n and c h o ic e o f law d e s c rib e d in p a ra g ra p h 6. ~e 1J 18. Each o f the exce ss g e n e ra l l i a b i l i t y p o lic ie s the to Issu e d by F ire m a n 's Fund adopts and fo llo w s the form o f the Lead U m brella p o lic ie s , in c lu d in g those p ro v is io n s re la t in g to j u r i s d i c t i o n and c h o ic e o f law d e s c rib e d in p a ra g ra p h 6. -5- 19. Each of Che excess general liability policies issued bv First State adopts and follows 'the form of the Lead U m b rella p o lic ie s , in c lu d in g those p ro v is io n s r e la t in g to !1 jurisdiction and choice of law described in paragraph 6. I ' 20. Each of the excess general liability policies issued by Granite State adopts and follows! \ the|fora of the Lead 1 Umbrella policies, including those provisions relating to i i| j u r i s d i c t i o n and c h o ic e o f law d e s c rib e d in p a ra g ra p h 6. 21. Each of the excess general liability policies issued by Hartford adopts and follows the form of the Lead Umbrella policies, including those provisions Relating to iurisdiction and choice of law described in paragraph 6. r Ir . 22. Each of the excess general liability policies issued by Home adopts and follows the form! of the Lead Umbrella !1 policies, including those provisions relating to jurisdiction and choice of law described in paragraph 6 .! 23. Each of the excess general liability policies issued by Hudson adopts and follows the form of the Lead Umbrella policies, including those provisions relating to jurisdiction and choice of law described in paragraph 6. 24. Each of the excess general liability policies issued by INA adopts and follows the form of th Lead Umbrella l< policies, including those provisions relating to jurisdiction ! and choice of law described in paragraph 6.i 1 i I 25. Each-of the excess general liability policies -ssued by International adopts and follows the form of the Lead -6- 1 II Umbrella policies, including those provisions relating to jurisdiction and choice of law described i!n paragraph 6. 26. Each of the excess general liabil ity policies issued by ISOP adopts and follows the form of t ne Lead Umbrella l policies, including those provisions relatjing to jurisdiction r and choice of law described in paragraph 6. , j 27. Each of the excess general liability policies i s s u e d b y L e x i n g t o n a d o p t s a n d f o l l o w s t h e f o r m ' of the Lead U m b rella p o lic ie s , in c lu d in g tho se p r o v is io n s r e la t in g to j u r i s d i c t i o n and c h o ic e o f law d e s c rib e d in p a ra g ra p h 6. 28. Each of the excess general liability policies issued by Liberty Mutual adopts and follows the form of the Lead Umbrella policies, including those provisions relating to Jurisdiction and choice of law described in paragraph 6. . . .'I 29. Each of the excess general liability policies issued by Lloyd's and the London Companies, that provides coverage in excess of a Lead Umbrella policy, adopts and follows -L . i . 'I' the form of the Lead Umbrella policies, including those provisions relating to jurisdiction and choice o:: law described 6 .in paragraph j 30. The .excess general liability policy issued by National Casualty adopts and follows the form of the underlying Lead Umbrella policy, including those provisions'1relating to Jurisdiction and choice of law described in paragraph 6. T1 j * | j 1. Each of the excess general liability policies *.ssued by National Union adopts and follows the form of the Lead F n m wfk -7- l] Umbrella policies, including chose provisions1r e l a t i n g t o j u r i s d i c t i o n and c h o ic e o f la v d e s c rib e d jin p a ra g ra p h 6. 3 2 . Each of the excess general 'liabi lity policies i s s u e d by New E n g la n d a d o p ts and f o l lo w s th e fo rm o f th e Lead Umbrella policies, including those provisions relating to j u r i s d i c t i o n and c h o ic e o f law d e s c rib e d in p a ra g ra p h 6. 33. Each o f the excess g e n e ra l l i a b i l i t y p o lic ie s is s u e d by N o rth S ta r adopts and fo llo w s the form o f the Lead iJ U m b rella p o lic ie s , in c lu d in g those p r o v is io n s r e la t in g to >\ j u r i s d i c t i o n and c h o ic e o f law d e s c rib e d in p a ra g ra p h 6. 34. Each o f the excess g e n e ra l lJ i a b ilit \ y p o lic ie s is s u e d by N o rth b ro o k adopts and fo llo w s t ie form o f the Lead U m brella ! p o lic ie s , in clu d in g those p ro v is io n s i ii r e la t in g to j u r i s d i c t i o n and c h o ic e o f law d e s c rib e d in p a ra g ra p h 6. 35. Each o f the excess g e n e ra l l i a b i l i t y p o lic ie s iI is s u e d by N o rth w e ste rn N a tio n a l ad o p ts and fo llo w s the form o f the Lead U m b rella p o lic ie s , in c lu d in g those p ro v is io n s re la t in g to J u r i s d i c t i o n and c h o ic e o f law d e s c r ib e d in p a ra g ra p h 6. '1 36. Each o f the excess g e n e ra l l i a b i l i t y p o lic ie s !1 is s u e d by P a c i f i c E m p lo y e rs a d o p ts and f o l lo w s ,the fo rm o f th e !1 L e a d Umbrella p o l i c i e s , i n c l u d i n g t h o s e p r o v i s i o n s r e l a t i n g to Jurisdiction and c h o i c e o f la w d e s c r i b e d i n p a r a g r a p h 6. -_ I ]l J / . Each o f the excess g e n e ra l l i a b i l i t y p o lic ie s i ssued by P r o t e c t iv e N a tio n a l adopts and fo llo w s the form o f the i! L^ad U m b re lla p o lic ie s , in c lu d in g th o se p r o v is io n s r e la t in g to J r s d ic t * o n and c h o ic e o f law d e s c r ib e d in p a ra g ra p h 6. -8- i ram I 38. Each of Che excess general liability policies II issued by Royal adopts and follows the form of the Lead Umbrella [| policies, including those provisions relating Go jurisdiction and choice of law described in paragraph 6. i 39. Each of the excess general liability policies it issued by St. Paul adopts and follows the form of the Lead \ Umbrella policies, including those provisions Relating to iurisdiction and choice of law described in paragraph 6. I il 40. Each of the excess general liability policies issued by Travelers adopts and follows the torn of the Lead Umbrella policies, including those provisions relating to I II jurisdiction and choice of law described in paragraph 6. 41. Each of the excess general liability policies I1 issued by Unigard adopts and follows the form of the Lead i 'Umbrella policies, including those provisions reflating to |i jurisdiction and choice of law described in paragraph 6. 42. Each of the excess general liability policies issued by U.S. Fire adopts and follows the form of the Lead Umbrella policies, including those provisions relating to jurisdiction and choice of law described ini paragraph 6. II 43. The excess general liability policy issued by Wausau Underwriters adopts and follows the form of the underlying .Lead Umbrella policy, including those provisions relating to jurisdiction and choice of law descri bed in paragraph'6. ' Fnm m -9- i 44. Each o f the ex ce ss g e n e ra l l i a b i l i t y p o lic ie s 11 issued b y A m b a s s a d o r , E x c e s s , I n t e g r i t y , M i d l a n d ^ M i s s i o n , i| M utual F i r e , N o rt h e a s t e rn , and T r a n s it ad o p ts and fo llo w s the form o f the Lead U m b re lla p o l i c i e s , in c lu d in g th o se p r o v is io n s r e la t in g to j u r i s d i c t i o n and c h o ic e o f law o e s c r i bed in p a ra g ra p h 6. NATURE OF ACTIO N 45. T h is is an a c tio n fo r a d e c la ra t o r y jud g m en t, ' > , Ii b ro u g h t p u rs u a n t to 10 D e l. C. 6501 e t s e q ., th a t defendant's a re o b lig a t e d to pay in f u l l the c o s t s o f d e fe n se o f j u d i c i a l and a d m in is t r a t iv e a c t io n s b ro u g h t a g a in s t M onsanto se e k in g damages f o r p e rs o n a l o r b o d ily in j u r y and p r o p e r t y damage I i. a lle g e d ly caused by ch e m ica ls p ro d u ce d , g e n e ra te d , o r d isp o sed o f b y M o n s a n t o ( t h e " e n v i r o n m e n t a l a c t i o n s 1' ) . M o n s a n t o a l s o seeks damages fo r b re a ch o f c o n t ra c t on t h e (b a s is Chat d e f e n d a n t s a r e o b l i g a t e d Co p a y i n f u l l t h e l i a b i l i t y t h a t h a s , I i[ b e e n , and may b e, im posed on M onsanto i n th o s e ac t io n s by se ttle m e n t o r judgm ent, and d efen d a n ts a re o b lig a ted to pay in f u l l the sums M onsanto expends to a v o id l i a b i l i t y to t h ir d p a rtie s. I! BACKGROUND OF THE ENVIRONMENTAL! ACTIONS %6. S in c e at le a s t 1915, c e r t a in m a t e r ia ls co n n ected [i with Monsanto's business allegedly have contaminated the I Igroundw ater an d /o r caused a ir p o llu tio n at v a rio u s lo ca tio n s - 10- r o m ^92 I iI a c r o s s Che c o u n t r y , g iv in g r i s e 'to a c t u a l and p o t e n t ia l I '[ l i a b i l i t y fo r a lle g e d b o d ily o r p e rso n a l in ju r y and p ro p erty damage. II |i 47. Monsanto has been, and is, a defendant in various j u d ic ia l a c tio n s a cro ss the co u n try a lle g in g b o d ily in ju ry o r p ro p e rty damage caused by e n v iro n m e n ta l c o n ta m in a tio n . M onsanto Is b has been d esig n a ted as a re sp o n d in g p a rty in v a rio u s adm i n i s t r a t i v e a c t i o n s a c r o s s th e c o u n t r y w r iic h a l l e g e t h a t i t ii i s o r may be r e s p o n s i b l e f o r dam ages r e s u l t i n g fijom en viro n m en tal hazard s a lle g e d ly e x is t in g at v a rio u s s it e s t h r o u g h o u t t h e U n i t e d S t a t e s . T h e s e a l l e g e d dam a ges result from a l l e g e d p e r s o n a l o r b o d i l y i n j u r y a n d / o r p r o p e r t y damage which a lle g e d ly o ccu rre d as a r e s u lt o f exp o su re to ch e m ica ls at v a rio u s lo c a t io n s o r in the su rro u n d in g en viro n m en t. !: 4 8 . I n c a s e s w h e r e t h e r e h a v e b e e ni a c c i d[e n t s r e s u l t i n g l, in p o t e n t ia l b o d ily in j u r y , p e rs o n a l i n j u r y , 1 o r p r o p e rt y damage '' l . to t h ir d p a r t ie s , M onsanto has expended, and c o n tin u e s to expend, sums to in v e s t ig a t e a n d ' re m e d ia te the a c t u a l o r \! threatened migration of contaminants onto the properties of S third parties. Hereinafter, references to environmental actions ` j1 i n c l u d e M o n s a n t o 1s r e m e d i a l a t t e m p t s t o a v o i d l i a 'b i l i t y t o t h i r d p a r t i e s ajt t h e s e l o c a t i o n s . ;i 49. The allegations asserted against Mdnsanto in the environmental actions, the damages that are sought therein, and the sums expended to avert liability, are within jthe coverages of the insurance policies that the defendants solji to -u- I I> Monsanto and are not excepted or excluded therefrom. Thus, t{ i|defendants are obligated to pay in full thp costs and expenses of defense of those actions and to indemnify Monsanto in full for liability arising from those actions as a result of settlements or judgments. Defendants also are obligated to pav in full the sums Monsanto has expended, and continues to expend, i! in remedial actions to avoid liability arising from the migration of hazardous chemicals onto the properties of third parties. !> i; 50. Monsanto has incurred millions of, dollars in costs iii and exo*enses of defense and liability as ajiresul t of the environmental actions. | JURISDICTION 1i 51. Defendants t'r :aten to breacn, and have breached, Insurance contr. acts with Monsanto and dutieiis of good faith and fair dealing owed to Mpnsanto, causing great and incalculable damage to Monsanto's lawful interests. Defendants threaten to i violate, and have violated, their fiduciarjj duties to Monsanto. 52. Monsanto . brings this action tIIo secare a declaratory judgment respecting rights of contract and legal I relations between Monsanto and defendants, 'including the I i| obligation to defend Monsanto in all further proceedings in the nvironnent;a| actions -and to indemnify MonsLnto lior all future 1^ab i1 " ^ L ity and costs in the environmental actions. Monsanto also -12- i i I?nm I seeks to obtain the fullest legal relief possible, including aoney damages, for defendants' breaches of contract and other wrongs. allegations relating to all defendants 53. All of the defendant insurance companies named i| I[ herein are, and at all times relevant to this action were, engaged in the business of writing liability insurance policies. I1 54. The detendant insurance companies sold Monsanto various primary, excess, and environmental impairment liability insurance policies which cover at least from the late 1930's, to and including April 1, 1986. A partial schedule of the primary and excess general liability policies currently at issue in this i 'I litigation is contained in Appendix B, attached hereto, schedule of the environmental impairment ancl pollution liability policies is attached hereto as Appendix C. i ! ;! 55. The general liability coverage in each policy period is organized into a primary policy and successive layers ! of excess coverage above that primary policy. 1 ii ' 56. The primary and excess general liability coverage sold by defendant Liberty Mutual, covering at least the period from the late 1930's, to and including March 1, 1971, provides coverage for all sums which Monsanto becomes legally obligated i :| to pay as damages because of bodily injury or property damage. Liberty claims chat the applicable policy limits m its post- October 1, 1965 primary and excess liability policies are || exhausted, and chose policies are not included in this complaint. -13- Fnm I 57. Defendant Liberty Mutual sole Mons anco at lease one insurance policy which provides coverage for pollution or contamination, covering periods prior to arid inc luding March 1, | 1971 ("Liberty Pollution Policy"). A schedule o f thac policy is contained in Appendix C, attached hereto. 58. The policy sold by Liberty Mutual, described in the preceding paragraph, provides coverage for all sums that Monsanto becomes legally obligated to pay a's a result of bodily injury or property damage caused by "exposure to' pollution or contamination,, resulting in injury or damage." 59. The primary general lcioavbeirlaigtey sold bv I defendant Travelers, covering at least the period March 1, 1971, to and including April 1, 1978, provides coverage for all sums which Monsanto becomes legally obligated to pay as damages because of bodily injury or property damage 60. The primary general lcioavbeirlaigtey sold by defendant INA, covering at least the period April 1, 1978, to and including April 1, 1987, provides coverage for all sums !| which Monsanto becomes legally obligated to pay as damages because of bodily injury or property damage 61. The Lead Umbrella general liability policies provide coverage for "ultimate net loss," wlich is defined 1 I broadly in most, if not all, of those policies to include payments both for indemnity and legal fees, charges and other costs and expenses of defense. Vnm -14- p o lic ie s 6 2 . E a c h of Che L e a d U m b r e l l a g e n e r a l l i a b i l i t y I .co n ta in s Che same o r s u b s t a n t ia l l y s im i l a r la n g u a g e and p ro vid es coverage fo r: Che Local sum which the Assured, or his Underlying Insurers as scheduled, or bo^th, become obligated Co pay by-reason [of personal injuries, property damage or advertising liability claims, either through adjudication or compromise, and shall also incljude j hospital, medical and funeral charges and all sums paid as salaries, wages, corapjensat'ion, fees, charges and law costs, premiums o' attachment or appeal bonds, interest, expenses for doctors, lawyers, nurses and investigators and other persons, and for litigation, settlement, adjustment! and j[ investigation of claims and suits [which a r e paid as a consequence of any occurrence covered hereunder, excluding only the j salaries of the Assured's or of any j underlying insurer's permanent employees 63. Most, i f not a l l , o f the exce ss l i a b i l i t y p o lic ie s i| that are excess of the Lead Umbrella policies, adopt and follow the form of the Lead Umbrella policies' provision relating to j :j the scope o f in su ra n c e co ve ra g e quoted in pjaragraph 62. 64. D efen d an t I n t e r n a t io n a l s o ld M onsanto a t le a s t two e n v i r o n m e n t a l i m p a i r m e n t l i a b i l i t y ( " E I L " ) j p o l i c 'i e s , c o v e r i n g a t le a s t th e p e r io d J u l y 1 5 , 1982 th ro u g h J u ly j 15 <1985. A s c h e d u le o f th o se p o l i c i e s i s c o n ta in e d in Appendix C, a tta ch e d h e re to . 6 5 . T h e E I L p o l i c i e s s o l d b y d e f e n d a n t International p r o v i d e c o v e r a g e f o r s u m s w h i c h M o n s a n t o b e c o m e s legally o b lig a te d to pay as a r e s u lt o f, in t e r a lia the emission, discharge, dispersal), disposal, seepage, release or escape of any liquid, -15- t solid, gaseous or thermal irritant, contaminant or pollutant into or upon land, the atmosphere or any watercourse or body of water. 66. Monsanto currently is seeking coverage under the primary or excess general liability insurance policies and the Libertv pollution policy for environmental actions in connection with the following location and possibly others: (1) Martinez, CA; (2) Long Beach, CA;' (3) Santa Clara, CA;j (4) Sauget, II; (5) Seymour, IN (6) Alvin., TX; (7) Bridgewater, MA; aijnd sate 11ite sites in Nashua, NH; Londonderry, NH; and PI ymouth, MA; (8) Everett, HA; (9) Springfield, MA; (10) Woburn, M ( I D St. Peters, HO; (12) Bridgeport, NJ; (13) Kearney , NJ; (14) Oswego, NY; and eight satellite sites; (15) Colum 3ia, TN; (16) Friendswood, TX; (17) La Marque, TX; and (18) Texas City, TX; (19) Arlington, TN; (20) Bayou Sorrel, LA; (-21) slartz Creek, MI; (22) Hamilton, OH; (23) Livingston Parish, LA:j (24) I 1 Kankakee, XL; (25) Oakland, CA; (26) Galloway, TN, (27) SIickerville, N J ; (28) Edison, N J ; (29) Pittstown! N J ; (30) Coventry, RI; (31) Rock Creek, OH; (32) Soda Springs, ID; (33) Times Beach, MO; (34) East St. Louis, IL; (35) Houston, TX; (36) Bear Creek, WI; (37) Columbia City, IN; (38) Burri! 11vi lie, RI. 67. Monsanto also currently is seeking coverage under the EIL insurance policies sold by defendant International for environmental actions in connection with locations and possibly others at (1) Sauget, Illinois; (2) Bridgewater, Massachusetts; , I; and sites in Nashua, New Hampshire; Londonderry, New Hampshire; and Plymouth, Massachusetts; (3) Everett, Masisachusetts; (4) -16- i ' I r v J' Br id g e p o rC , New J e r s e y ; (5 ) F rie n d s w o o d , T e x a s ; (6 ) T e x a s C it y , | 1 T exas; and (7 ) e ig h t s a t e l l i t e s it e s in c o n n e c tio n w ith Oswego, New Y o r k . 68. ..I M onsanto expended s u b s t a n t ia l prem ium s to p u rch a se the l i a b i l i t y in s u ra n c e p o lic ie s so ld by the d e fe n d a n ts and e it h e r has com plied w ith a l l c o n d itio n s p reced e n t, under those p o lic ie s or those co n d itio n s are not a p p lic a b le . A lle g a t io n s R e la t in g to the In t e n t o f the In s u ra n c e In d u s t ry R e g a rd in g C o vera g e for. P o llu tio n L ia b ilit ie s I1 69. Documents w rit t e n bv re p r e s e n t a t iv e s o f the I in s u ra n c e in d u s t r y a t th e tim e o r the r e v is io n o f 't h e sta n d a rd co m p reh e n sive g e n e ra l l i a b i l i t y ("C G L ") p o lic y form in 1966 d em o n strate th a t the in su ra n c e com panies s p e c i f i c a l l y in ten d ed to and d id , c o v e r p o llu t io n l i a b i l i t i e s . The p r o v is io n s o f the In su ra n ce p o lic ie s at issu e in th is a c tio n are v ir t u a lly id e n t ic a l to the s ta n d a rd CGL p o lic y as a d o p te d . 70. In 1965, G .L. B e a n ,.A ss ista n t S e cre ta ry , L ib e rty M u tu a l In s u r a n c e Company, d e liv e r e d a p a p e r e n t i t l e d "New C om preh ensive G e n e ra l and A u to m o b ile Program , The E f f e c t on M an u factu rin g R is k s " at the M utual In su ra n c e T e c h n ic a l C o n fe re n c e . A c c o rd in g to M r. B ean, u n d e r the new p o l i c y , " i t i s c^e va ste d is p o s a l area th a t a m a n u fa c tu re r's b a s ic p re m is e s -o p e ra tio n s co verage is lib e r a liz e d mLst s u b s t a n t ia lly . " (em phasis in o r ig in a l) 71. A ls o in 1965, Lyman J . B a ld w in , J r . , S e c r e t a r y - Und e P * r it in g o f the In s u ra n c e Company o f N o rth A m e rica , ^ r essed the A m erican S o c ie ty o f In s u ra n c e Management. I t f ^ edd 1 e s s * Mr. B a ld w in c i t e d " s lo w in g e s t io n o f f o r e ig n s u b s t a n c e s -17- ^ U or inhalation of noxious fumes" as examples of covered 1;abilities. He also stated that the new CG'^ policy would provide coverage for property damage resulting from the'emission of '''noxious fumes" from a chemical manufacturing plant. 72. In 1966, Mr. Bean prepared a "Summary of Broadened Coverage Under New CGL Policies With Necessary Limitations To Make This Broadening Possible." This document was' circulated by cover memorandum dated July 18, 1966. In his summary, Mr. Bean stated that coverage was provided for "gradual B I ,or gradual PD resulting over a period of time from exposure to the insured's waste disposal. 1 Examples would be gradual adverse^ effect of smoke, fumes, air or stream pollution, contamination of water supply or vegetation." (emphasis in original-) 73. In 1966, WLllard J. Obrist of the Ge'neral Accident .L.' Group wrote a "New Comprehensive General Liability Insurance Policy-A Coverage Analysis." Mr. Obrist offered as an example of coverage, the "inhalation of noxious fumes." 74. Starting in 1970, some of the general liability | policies sold by the defendant insurance companies exclude coverage .for liability for bodily or personal injury or property damage arising out of the discharge, dispersal, release or. escape of smoke, vapors, soot, fumes, acids, i alkalis, toxic chemicals, liquids or. gases, waste materials or other irritants, j | contaminants or pollutants into or upon land, but this exclusion does not apply ifj suchj discharge, dispersal, release or escape is sudden or accidental r COnCaia similar language. -18- Fnni I 75. When the insurance industry was seeking approval of the aforesaid pollution exclusion in 1970, it 'I represented to various state insurance commissioners and departments that the exclusion was merely a clarification of the Ineith'eI r expected nor intended" language in the definition of "occurjrence." 76. For examole, on July 30, 1970, the Mutual II Insurance Rating Bureau, an insurance trade association v/hich petitioned-states to accept the pollution exclusion, told the West Virginia Commissioner ot Insurance: i ; i This endorsement [pollution exclusion] is actually a clarification of the j| original intent, in that the definition of occurrence excludes damages that can be said to be expectedor intended, j [I 77. On August 3, 1970, Travelers wrote to the West i Virginia Commissioner of Insurance: j "The idea behind these endorsements is that the insurance industry does not consider | intentional pollution to be insurable, anc the industry wishes to makeits position \ clear to the insured." i '! Travelers uses the term "if expected or intended" in its pollution exclusion instead of "sudden and accidental" but has stated that "the results of the two phrases ar1e th'eI same." 78. In view of these representations, the West Virginia Insurance Commissioner issued an order approving the pollution exclusion and stating in part: 1) The said companies [INA, Travelers,' j American Horae, St. Paul and AmericanJStates] and rating organizations have represented jto the Insurance Commissioner, orally and in i writing, that the proposed exclusions ... are Fnm ^ -19- m erely c la r if ic a t io n s o f e x is t in g co ve rag e as d e fin e d and lim it e d in the d e f in it io n s o f the term 'o c c u rre n c e ,' co n ta in ed in thej |[ r e s p e c t iv e p o l ic ie s to w h ich s a id e x c lu s io n s w ould be a tta c h e d ; j i 2) To the e x te n t th a t s a id e x c lu s io n s re m e r e c l a r i f i c a t i o n s o f e x i s t i n g c o v e r a g e 1] t h e I n s u r a n c e C o m m is sio n e r f i n d s t h a t t h e r e is-- no o b je c t io n to the a p p ro v a l o f su ch e x c l u s i o n s . 79. Upon in fo rm a tio n and b e l i e f , s im il a r re p r e s e n t a t io n s w ere made bv in s u ra n c e in d u s t r y tra d e g ro u p s to in s u ra n c e \ I! co m m issio n e rs in v ir t u a lly every s t a t e , in c lu d in g D elaw are. 80. The g e n e ra l l i a b i l i t y p o lic ie s s o ld b y the I d e fe n d a n t in s u ra n c e com panies p ro v id e co v e ra g e fo r an o c c u r re n c e , d e fin e d as an a c cid e n t, in c lu d in g co n tin u o u s o r repe ated e x p o su re to c o n d it io n s , w h ich r e s u lt s in ! b o d ily in ju r y o r p ro p e rt y damage n e it h e r ex p ecte d nor in te n d e d from the stane p o in t o f the in su re d o r c o n ta in s im ila r language. 81. Statem ents by re p re s e n ta tiv e s o f th in su ra n ce I '! i n d u s t r y a l s o d e m o n s t r a t e t h a t t h e i r i n t e n t w a s to; p r o v i d e c o v e r a g e t o a p o l i c y h o l d e r who in t e n d e d to e m it p o j'llu t a n t s i f 1 il t h e p o l i c y h o l d e r d i d n o t e x p e c t o r i n t e n d the* r e s u l t i n g s p e c i f i c dam age. 8 2 . F o r e x a m p l e , M r . B a l d wiinn 1w9r6o5t e t h a t t h e r e was co v e ra g e fo r a p o lic y h o ld e r whose p la n t e m itte d n o x io u s fum es th a t damaged the p a in t on n e ig h b o rin g b u ild in g s " u n t i l s u c h tim e a s th e in s u re d became aw are t h a t th e damage was b e in g d o n e." FnO1 -20- 9 I 83. In 1966, Mr. Obrist noted that coverage would be denied only if the resulting injury was "clearly foreseeable or intended." Mr. Obrist also specifically wrote that there would be coverage for unintended damages caused by intentional acts. il. Further, instances arise when the injury is ah unintended result of an intentional act. The two situations, an absence of intent or an unexpected result, would be covered uncler either the 'accident' or 'occurrence definition. FIRST CLAIM FOR RELIEF 84. Monsanto realleges paragraphs 1 through 83, as if fully set forth herein. 85. The primary and excess general liability insurance policies sold by all of the defendant insurance companies and the Liberty pollution policy provide Monsantoj with! insurance [L coverage for liability arising from personal or bodily injury I iI and property damage, including damages arising out| of the environmental actions described in paragraph 66 above. 86. The defendant insurance companies have refused, or threaten to refuse, to accept their legal obligations to pay in full the total sum that Monsanto legally is obligated to pay, including damages and costs and expenses of defense, as a result of some or all of the environmental actions descriled in paragraph 66 above. 87. All of the defendant insurance companies are obligated under their liability insurance policies to pay in full the total sum that Monsanto became or will become obligated -21- r 9j k to pay, Including damages and costs and expenses' of defense of some or all of the environmental actions described in paragraph 66 above. 88. As a result of the foarnegaocitnuga,l and justiciable controversy presently exists between''Monsanto and all of the defendant insurance companies regarding the I ' il defendants' obligation to pay in full the total sums that ii Monsanto became or will become legally obligated `to pay as a II result of some or all of the environmental actions described in paragraph 66 above. SECOND CLAIM FOR RELIEF .89. Monsanto realleges paragraphs 1 through. 88, as if |i fully set forth herein. 1 k j! 90. As a result of some or all of th environmental ! actions described in paragraph 66 above, Monsanto has incurred, ! !.. and will continue to incur, substantial legal liability and costs and expenses of defense. 91. Each of the defendant insurance companies has L J I '! breached, or will breach, its obligations setj forth in its primary or, excess general liability policies or i'nI the Liberty pollution policy, which it sold to Monsanto, by its failure and !| refusal to pay in full, within its policy limits, the total sura that Monsanto became obligated to pay by reason of!, legal liability and costs and expenses of defense of the environmental actions described in paragraph 66 above. -22- 9 2. As a d ir e c t and p ro x im a te r e s u lt ' o f t h e ir b re a ch e s o f c o n t ra c t , the defendant in su ra n c e com pan ies1have d e p riv e d M onsanto o f the b e n e fit o f the in s u ra n c e co v e ra g e from a t le a s t' li from the la t e 19 30 's , to A p r il 1, 1986, fo r w h ich Monsanto has p a id s u b s t a n t ia l prem ium s. | THIRD CLAIM FOR RELIEF fu lly 93. Monsanto re a lle g e s set fo rth h e re in . p a ra g ra p h s 1 through 92, as i f i j 9 4 . T h e E I L i n s u r a n c e p o l i c i e s s o l d b'y d e f e n d a n t I n t e r n a t i o n a l p r o v i d e M o n s a n t o w i t h i n s u r a !n c e cilo v e r a g e f o r - 1 l i a b i l i t y a r is in g from p e rs o n a l o r b o d ily in ju r y and p ro p e rty d a m a g e , i n c l u d i n g d a m a g e s a r i s i n g o u t o f t (l e e n v i r o n m e n t a l a c t io n s d e s c rib e d in p a ra g ra p h 67 above. 95. Defendant In t e rn a t io n a l has 'fa ile d , o r w ill f a il , !1 to a c c e p t i t s le g a l o b lig a t io n s to pay in f u l l a l l sums th a t M onsanto le g a lly i s o b lig a t e d to pay, in c lu d in g damages and c o s ts and expenses o f d e fe n s e , as a r e s u lt o f the en viro n m en tal a c t io n s d e s c rib e d in p a ra g ra p h 67 ab o ve. 96. Defendant In t e rn a t io n a l is o b lig a te d under it s E IL j: in s u r a n c e p o l i c i e s to pay a l l sums th a t M onsanto i s , o r w i l l b e, o b lig a t e d to pay, in c lu d in g damages and c o s ts and expenses o f d e fe n s e o f the e n v iro n m e n ta l a c t io n s d e s c r ib e d in p a ra g ra p h 67 above. i | i 97. As a r e s u l t o f the fo re g o in g ,' an a c t u a l and j1 j u s t i c i a b l e c o n tro v e rs y p r e s e n t ly e x is t s between; M onsanto and defendant In t e r n a t io n a l re g a rd in g In t e r n a t io n a l's o b lig a t io n to -23- i fn m * s t II pay in full all suras that Monsanto became, or will becorae, legally obligated to pay as a result of the environmental actions described in paragraph 67 above. FOURTH CLAIM FOR RELIEF 98. Monsanto realleges paragraphs 1 through 97, as if fully set forth herein. \! j 99. As a result of the environmental ac tions described in paragraph 67 above, Monsanto has incurred , and will continue to incur, substantial legal liability and costs and expenses of defense. 100. Defendant International has breachedttil,7 or will breach, its obligations set forth in its EIL insurance policies, which it sold to Monsanto, by its failure and refsal to pay in full,7 within its *oolicyJ limits,1 all suras thatt Monsianto became obligated to pay by reason of legal liability and costs and expenses of defense of the environmental actions cescribed in | paragraph 67 above. j 101. As a direct and proximate result of its breaches of contract, defendant International has deprived Monsanto of the benefit of the insurance coverage from at leas t July 15, . " |! 1982 to July 15, 1985, for which Monsanto has paidt substantial premiums. | WHEREFORE, plaintiff Monsanto requests judgment: !i i!1 1. On the First Claim for Relief, !that this Court declare that the defendant insurance companies, all of which :I sold primary or excess general liability insurance. policies to -2i- Foni Monsanto, are obligated (i) to pay in full Monsanto's legal liability for damages arising out of the environmental actions | described in paragraph 66 above, and (ii) to pay in full the fees, charges, law costs, and expenses for lawyer s and for litigation for defense of the environmental actions described in paragraph 66 above, both incurred, and to be incurred, by Monsanto. 2. On the Second Claim for Relief tor Monsanto 1s damages. 3. On the Third Claim forthRaetlitehfi,s Court declare that defendant International, which sola EIL insurance policies to Monsanto, is obligated (i) to payI .in 1full Monsanto s i 1 legal liability for carnages arising out of the environmental II (ii)'.to pay in full i the costs and expenses for defense of the environmental actions !I described in paragraph 67 above, both incurred, and to be incurred, by Monsanto. j 4. damages. On the Fourth Claim for Relief,'i for 'Monsanto1s I; r' 1 5. That this Court declare that defendants have I violated their fiduciary duties to Monsanto. !L Tom *s -25- 6. That Monsanto further recover: a . Attorneys 1 fees, costs , and expenses incurred in this action, and interest. i b. Such other and further relief as is just and proper. OF COUNSEL: Jerold Osh-insky Stephan G. Wielgoz Patricia A'. Van Dyke David M. Halbreich Susan P. Scharfstein ANDERSON BAKER KILL St OLICK 1800 K Street, N.W. Suite 700 Washington, D.C. 20006 (202) 466-7921 - and - John H. Gross ANDERSON RUSSELL KILL St OLICK, 666 Third Avenue New York, New York 10017 (212) 850-0700 Dated: January 20, 1988 -26- FnniFvH APPENDIX A. JURISDICTIONAL INFORMATICA The following paragraphs sec forth the name, the state of incorporation, the principal place of bus! ness, and other jurisdictional information regarding each defendant: 1. Upon information and belief defendant Aetna Casualty and Surety Company ("^ecna") is a corporation organized under the jlaws of the State of Connecticut, with its principal place of business at 151 Farmington Avenue, Hartford, Connecticut 06156, Ii and is licensed to do business, and is doing and transacting business, in Delaware, 2. Upon information and belief, defendant Allstate 1h Insurance Company ("Allstate") is the successor by mercer to Northbrook Excess andSurolus Insurance Comany, formerlv known Ii as NorthbrookInsurance Company("Northbrook"). Uponinformation and belief, Allstate is a coro- oration orI gani,jzed under the laws of the State of Illinois, with its principal place of business at Allstate Plaza AS, Northbrook, Illinois 60062, and is licensed to do business, and is doing and transacting business, in Delaware. 3. Upon information and belief, [defendant American Centennial Insurance Company ("ACIC" ) is a corporation organized !i under the laws of the State of Delaware!, with its principal place of business at 400 Beneficial Center, Peapaci, New Jersey 07977, and is licensed to do business, and is cloing and transacting business, in Delaware. 'I 1i Ij 4, Upon information and belief, defendant'American Heme Assurance Company ("American Home") is I a. corpIoration organized I 9 K' S>,,f' 4 i i n 1 e) 1 1 2I i it under the laws of fcthe State of New York, with its principal place of business at 70 Pine Street, New Yore, Nel York 10270, and is i| licensed to do business, and is doing and transacting business, in Delaware. 5. Upon information and belief, defendant American i Manufacturers M.utual Insurance Company ("American Manufacturers") is a corporation organized under the laws of, the State of Illinois, with its principal place of business at Long Grove, .` 1 1 Illinois ,60049 , and is licensed to do business, and is doing and transacting business, in Delaware. 6. Upon information and belief, defendant Appalachian Insurance Company ("Appalachian") is a corporation organized ' ` t ` : under the laws or the State of Rhode Island, with its principal I; place of business at Allendale Park, P.Oi Box ;7500, Johnston, !) Rhode Island 02919, and is doing and transacting business in Delaware. 7. Upon information and belief, defendant Associated I ;l International Insurance Company ("Associated International") is a corporation organized under the laws of the .State of California, with its principal place of business at 3450 Willshire 3oulevard, i\ Los Angeles, California90010, and is doing and transacting business in Delaware. i' j ` 8. Upon informationand belief, defendant! Birmingham Fire 1 Insurance Company of Pennsylvania ("3irmingham" is a corporation \ organized under the laws of the State of Pennsylvania, with its principal place of business at 70 Pine Street, New York, New York 3 10270, and is licensed to do business, and is doing and transacting business, in Delaware. 9. Upon information and belief, de fen cant California Union Insurance Company ("California Union" corporation organized 1 uncer the laws of the State of California, with its Drincioal olace of business at 1600 Arch Street, Philadelphia, Pennsylvania 19103, and is doing and transacting business in Delaware. 10. Upon information and belief, defendant C.E. Heath Compensation and Liability Insurance Company , formerly known as Employers' Surplus Lines Insurance Company ("^mDlovers' Surplus"), is a corporation organized under the laws of the State of Delaware, with its orincioal d a c e oLf business at 1799 Old Says ho re Highway, Suite 136, 5ur lir.came', California 94010, and is licensed to do business in Delaware. 11. Upon information and belief, diefencants Certain Underwriters at Lloyd's, London ("Lloyd1s") a1re individuals, all or most of whom are residents and subjects of the United Kincdom. UDon information and belief, defendants London Market Insurance 1 i| Companies ("the London Companies") are corporations, all or most of which are organized and existing under the,laws of the United ii ' Kingdom. In the policies which they sold to Monsanto, Lloyd's t1 and- the London Companies agreed to submit, at ithe request of the insured, to the jurisdiction of any courJ of competent ...... i ;1 jurisdiction within the United States, and to comply with all 'I requirements necessary to give such court! jurisdiction. 12. Unon information and belief, defendant Columbia ! 1 Casualty Company ("Columbia") is a corporation lorganized under Fiini i I ( 4 the laws of the State of Illinois, with its principal d a c e of i] business at CNA Plaza, Chicago, Illinois 60685, and is doing and transacting business in Delaware. II 13. Coen information and belief- , defendant Continental Casualty Company ("CNA") is a corporaltion organized under the laws of the State of Illinois, with its princiDal place of 1 1 business at CNA Plaza, Chicago, Illinois 60685, ana is licensed !1 to do business, and is doing and transacting business, in Delaware. 14. Coon information and belief,' defendant Fireman's Fund 1 Insurance Company ("Fireman's Fund") i|s a corporation organized under the laws of the State of California, with its principal II ' place of business at 777 San Marin Drive, Novato, California IJ 94998, and is licensed to do business, [and is a o m c and transacting business, in Delaware. 15. Goon information and belief, defendant First State \\ . Insurance Company ("First State") is a corporation organized under the laws of the State of Delaware , with its principal place of business at 60 Batterymarch Street, Boston, Massachusetts I II 02110, and is licensed to do business, and is doing and transacting business, in Delaware. 1 t ' i| 16. Upon information and belief, defendant Granite State 1 i| Insurance Comoany ("Granite State") is a corporation organized I1 under the laws of the State of New Hampshire,! with its principal place of business at 1750 Elm Street, P.O. Box 960, Manchester, !\ New Hampshire 03107, and is licensed to do business, and is doing II and transacting business, in Delaware. I I I \ \\ 5 17. Upon information and belief, defendant Hartford Accident and Indemnity Company ("Hartford") is a corporation organized under the laws of the State of Connecticut, wirh its principal place of business at Hartford Plaza, Hartford, Connecticut 06115, and is licensed to do business, and is doing and transacting business, in Delaware, 18. Upon information and belief,, defendant The Home Insurance Company ("Home") is a corporation' orGanized under the laws of the State of New Hampshire, wi th its or incicaI olace o; business at 59 Maiden Lane, New York, New York 10038, and is licensed to do business, and is doing and transacting business, in Delaware. 19. Uoon information and belief, defendant Hudson Insurance i1 Company ("Hudson") is a corporation organized under the laws of \ the State of Delaware, with its principal place of business at 280 Park Avenue, New York, New York 100'17I, Land..is licensed to do ! . ;1 business, and is doing and transacting [business, in Delaware. I 'I 20. Uoon information and belief, defendant Insurance ] Company of North America ("INA") is a corporation organized under the laws of the State of Pennsylvania, with its principal place of business at 1600 Arch Street, Philadelphia, Pennsylvania 19103, and is licensed to do business, and is doing and transacting business, in Delaware. 21. Upon information and belief, defendant Insurance Company of the State of Pennsylvania ("ijSOP")\ is a corporation organized under the laws of the State ofj Pennsylvania, with its principal place of business at 70 Pine Street1, New York, New York finivi 3 w I >r V3 .-I rI V I.' n t1 -6- 10270, and is licensed to do business, and is doing and transacting business, in Delaware. 22. - Upon information and belief, cefs|.dant International Insurance Company (''International") is a corporation organized under the laws of the State of Illinois, with its principal place of business at 200 South Wacker Drive, Chicago, Illinois 60606, and is licensed to do business, and is doing and transacting business, in Delaware. 23. Upon information and belief, defendant Lexington Insurance Company ("Lexington") is a corporation organized under the laws of the State of Delaware, with its principal place of business at 100 Summer Street, 3ostcn, Mass'a1chusects 02110, and is licensed to do business, and is doing and transacting business, in Delaware. 24. Ucon information and belief, defendant Liberty Mutual Insurance Company ("Liberty Mutual") is a corporation organized under the laws of the State of Massachusetts , with its principal place of business at 175 Berkeley Street, Boston, Massachusetts 02117, and is licensed to do business, and is doing and transacting business, in Delaware. `I 25. Upon information and belief, defendant National Casualty Company ("National Casualty") is a corporation organized under the laws of the State of Michigan , with its principal place of business at 4242 Lindell Boulevard, St. Louis, Missouri 63108, and is licensed to do business, and is doing and transacting business, in'Delaware. pom i FF , ' i i; r I 7 26. Upon information and belief, defendant National Union Fire Insurance Company of Pittsburgh ('[National Union") is a corporation organized under the laws of t h ;State of Pennsylvania, with its principal place of business at 70 Pine ti Street, New York, New York 10270, and is licensed to do business, ( and is doing and transacting business, in be laware. 27. Upon information and belief,! defendant New England Insurance Company ("New England" ) is a corootation orcanized under the laws of the State of Massachu setts , with its principal place of business at 60 Batterymarch Street, Boston, Massachusetts 02110, and is licensed to do .business, and is doing and transacting business, in Delaware. 23. Upon information and belief, defendant North Star II Reinsurance Corporation ("North Star") is a corporation organized under the laws of the State of Delaware1, with its principal place of business at Ten Stamford Forum, P.O. Box 10009, Stamford, Connecticut, and is licensed to do business>r and is doinc and transacting business, in Delaware. 29. Upon information and belief, defendant Northwestern .i National Insurance Company ("Northwestern Nati|ional") is a corporation organized under the laws of the'State of Wisconsin, with its principal place of business at 731 North Jackson Street, Milwaukee, Wisconsin 53202, and is licensed'o do business, and is doing and transacting business, in Delaware. 30. Upon information and belief, defendant Pacific Employers Insurance Company ("Pacific Employers") is a corporation orcanized under the laws of the .State of California, FYWVI -fl with its principal place of business at 1600 Arch Street, PhiladelDhia/ Pennsylvania 19103, and is licensed to do business I i. and is doing and transacting business, in'Delaware. II 31. UDon information and belief, defendant Protective I II National Insurance Comoany of Omaha ("Protective National") is a ,| corporation orcanized under the laws|of the State of Nebraska, i lj with its principal place of business |at 5 South 17th Street, Omaha, Nebraska 68102, and is licensed to Ido business, and is doing and transacting business, m. Delawar*1e. 32. Upon information and belief, defendant Royal Indemnity Company ("Royal") is a corporation orcanized under the laws of the State of Delaware, with its principal place of business at 9300 Arrcwooint Boulevard, Charlotte, North Carolina 28210, and is licensed to do business, and is doing and transacting I business, in' Delaware. | I 33. Upon information and belies, defendant St. Paul Surplus Lines Insurance Company ("St. Paul" ) is a corporation organized under the laws of the State of Delaware, with its princioal place of business at 445 Minnesota Street, Suite 900, I il St. Paul, Minnesota 5^101, and is licensed to do business, and is doing "and transacting business, in Delaware, - 1I 34. Upon information and belief*, defendant TravelersI 'I Indemnity Company ("Travelers") is a corporation organized under the laws of the State of Connecticut, iith its principal place of business at One Tower Square, Hartford,! Connecticut 06183, and is licensed to do business, and is doing and transacting business, in Delaware. ITftfYl fi'' ^ 9 35. -Upon information and belief, defendant Unigard Security Insurance Company, formerly Unigard Mutual Insurance 1 Company ("Unigard"), is a corporation organized under the laws o; 11 the State of Washington, with its orincioal d a c e of business at I 'l ' 1215 Fourth Avenue, Seattle, Washington 98161-1096 and is licensed to do business-, and is doing1 and\(transacting business, in Delaware. 36. Upon information and belief, defendant United States Fire Insurance Company ("U.S. Fire") is a corporation organized under,the laws of the State of New York, w'ith its principal place of business at 305 Madison Avenue, cJ 193J, Morristown, New I 1I Jersey 07960, and is licensed to, do business, and is doing and transacting business, in Delaware.. 37. Uoon information and belief, defendant Wausau I 11 Underwriters Insurance Company ("Wausau Underwriters"), formerly known as Wausau Insurance Company, is a corporation organized under the laws of the State of Wisconsin, with its princiDal place of business at 2000 Westwood Drive, Wausau, Wisconsin 54401, and is licensed to do business, and is doing and transacting business, in Delaware. t o m ^**7 Insurance Company ACIC Aetna American Home American Manufacturers DDalachian Associated International Birmingham California Union APPENDIX g Policy Number CC002371 CC002366 ; Policy j Per icd ' 4/1/82-4/1/83 1 4/1/82-4/1/83 Q6XN32WCA Q6XN565SCA 06XN566SCA \ ! 4/1/79-4/1/80 4/1/85-4/1/86 ' 4/1/85-4/1/86 CE352711 CE357373 CE2692052 C23380986 CE3380986 CE3380733 CE3380722 OCT10005 3SG002001 33G002001 7/6/67-10/1/70 10/1/70-10/1/73 10/1/71-4/1/75 I 10/1/73-4/1/76 : 10/1/73-4/1/76 : 4/1/76-4/1/77 ! 4/13/76-4/1/77 i : 10/1/70-10/1/73 : 10/1/73-4/1/76 10/1/73-4/1/75 XL70329 XL70330 XL70659 XS110S68 ; 10/1/69-10/1/71 , 10/1/69-10/1/70 . 3/1/71-10/1/73 l : 4/1/85-4/1/86 SE6073353 SE6073500 SE607361Q ZCX003219 ZCX003565 ZCX004Q38' ZCX004438 ZCX006191 ZCX006508 ZCX007095 ZCX007914 ZCX007868 ZCX007869 ' 4/1/78-4/1/79 ; 4/1/79-4/1/80 14/1/80-4/1/81 I :4/1/78-4/1/79 4/1/79-4/1/80 4/1/80-4/1/81 :4/1/81-4/1/82 14/1/82-4/1/83 4/1/83-4/1/84 ,4/1/84-4/1/85 4/1/8S-4/1/86 4/1/85-4/1/86 4/1/85-4/1/86 CNA Columbia Employers' Surplus Fireman's Fund First State Granite State Hartford Home Hudson -2- j i RDX9566963 RDX9567017 \ RDX9681809 I 4/10/61-12/19/62 8/2S/61-1/7/63 1/7/63-10/1/65 RDX-1864000 ! 4/1/76-4/1/77 S-10274 S-16-00 208 S-16-00209 S-16-04445 S-16-10516 ! I i i SN7034 ! SN1941 | XL-1006264 XLX-1053669 j XLX-1204544 ! XLX-1203152 XLX-12Q3184 XLX-1363821 XLX-1362287 il 920412 920602 920603 921901 11/3/59-12/19/62 1/7/63-10/1/65 1/7/63-10/1/65 7/10/67-10/1/70 10/1/70-10/1/73 9/28/61-1/7/63 j 1/7/63-10/1/65 6/30/67-10/1/70 10/1/70-10/1/73 : 10/1/73-4/1/76 4/1/76-4/1/77 | 4/1/77-4/1/78 4/1/78-4/1/79 4/1/79-4/1/80 l 11/1/71-4/1/72 4/1/72-4/1/75 4/1/72-4/1/75 4/1/75-4/1/73 6178-0227 6181-2964 ' 4/1/78-4/1/79 j 4/1/81-4/1/82 08XS100202 | 4/1/76-4/1/77 HEC9540020 HEC9543285 HEC9304837 HEC4165765 HEC9006835 HC00207 HC00863 9/28/61-1/7/63 : 1/7/63-10/1/65 10/1/68-10/1/71 10/1/71-4/1/75 4/13/76-4/1/77 4/1/82-4/1/83 4/1/83-4/1/84 I INA International ISO? Lexington Liberty Mutual Lloyd's and the London Companies -3 ISG 1107 XCP143 24 I 4/1/78-4/1/87 4/1/78-4/1/79 5220551124 4/1/85-4/1/86 41714172-5264 4171-5264 4 1 7 6 - 6818 4177- 7688 5888 ! ! I I i 10/1/71-4/1/72 4/1/72-4/1/75 4/1/72-4/1/75 4/1/76-4/1/77 4/1/77-4/1/78 GC402964 GC4Q3113 GC403236 GC402556 GC403983 GC5501415 CZ5505649 5510304 5510303 5513782 5513880 5522588 10/1/70-10/1/73 ! 10/1/71-4/1/75 1 4/1/72-4/1/75 ! 10/1/73-4/1/76 ; 10/1/73-4/1/76 ! 4/13/76-4/1/77 ; 4/1/77-4/1/78 ; 4/1/78-4/1/79 ! 4/1/78-4/1/79 1 4/1/79-4/1/80 4/1/79-4/1/80 I 4/1/81-4/1/82 LP-60 41-903024 RK-6041-903025 ; LP1-641-004287-080 RK1-6 41-00 4287-11,0 LP1-641-00 4287-08'l LP1-6 41-0 04 287-08.2 RK1-641-004287-11;!l RXl-300-007520-017 10/1/59-10/1/60 10/1/59-10/1/60 10/1/60-10/1/61 10/1/60-10/1/61 10/1/61-10/1/62 10/1/62-10/1/65 10/1/61-10/1/65 7/28/67-10/1/70 Unknown 509-60DD-2309 509-60DD-2310 SD2080/K57299 SD2084/K57300 SD2123/K5852.9 SD4Q59/K6821'0 SD5133/K7S15'4 SD5134/CU253|7 SD5135/CU2538 SDS136/CU2539 SD5137/K7 6155 SD7104/K79731 SD8141/K12689 SD8142/CU6086 SD8143/CU6087 i 1959-8/5/60 8/5/60-12/19/62 8/5/60-12/19/62 7/26/59-12/19/62 9/15/59-12/19/62 11/3/59-12/19/62 2/15/61-12/19/62 12/19/62-10/1/65 12/19/62-10/1/65 12/19/62-10/1/65 12/19/62-10/1/65 ! 1/7/63-10/1/65 ; 10/1/64-10/1/68 , 10/1/65-10/1/68 1 10/1/65-10/1/68 i 10/1/65-10/1/68 M ill R 5 0 i National Casualty National Union New England North Star Northbrook Northwestern National Pacific Employers Protective National Royal St. Paul -5 XU000098 1168336 1232248 1232082 9600273 NE000Q 49 NSX-8870 NSX-9634 NSX-8869 NSX-11727 NSX-13389 NSX-15327 63-004-352 63-005-599 63-006-609 63-007-890 63-007-916 XLP401125 XLP401141 XLP401873 XLP403537 XCC012907 XCC013046 XCC013134 XCC013135 XUB1806982 XU81807032 RED102440 REO102442 CC05508338 CC055Q8337 4/1/84-4/1/85 4/1/75-4/1/78 4/1/78-4/1/79 4/1/79-4/1/80 4/1/81-4/1/82 4/1/84-4/1/85 10/1/70-10/1/73 5/8/71-10/1/71 i 10/1/70-10/1/71 I 10/1/73-4/1/76 I 4/1/76-4/1/77 4/1/77-4/1/78 . : 4/1/78-4/1/79 4/1/79-4/1/80 I 4/1/80-4/1/81 I 4/1/81-4/1/82 ! 4/1/81-4/1/82 I 10/1/70-10/1/73 3/1/71-10/1/71 10/1/73-4/1/76 I 4/1/76-4/1/77 4/1/83-4/1/84 ! 4/1/84-4/1/85 I 4/1/85-4/1/86 1 4/1/85-4/1/86 4/1/82-4/1/83 4/1/83-4/1/84 4/1/83-4/1/84 4/1/83-4/1/84 ! ! 4/1/84-4/1/85 I 4/1/84-4/1/85 F a n i sfii i Travelers Unigard CJ.S. Fire Wausau. Underwriters -6- TR- NS L-9512 02-7,1 3/1/71-4/1/74 TR-NSL-9 51[202--714 4/1/74-4/1/77 TR-NSL-14 4(T924-/4-77 4/1/77-4/1/78 GL26-9 6S1 1-1487 10/1/72-10/1/73 10/1/73-4/1/76 5220221789 4/1/77-4/1/78 573600102711 4/1/85-4/1/86 /r f F fiM 5 5 2 Insurance C'snoanv International Liberty Mutual 1I APPEn d i y r Policy Number * i 560-000-09,0 560-000-268 ; ; Policy Period 7/15/82-7/15/83 7/15/83-7/15/84 LG1-641-00 4287--790 1 0 / 1 / 7 0 - 3 / 1 / 7 1 lI fJ { 1I\ ij 1 I I I J1 I i 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 28 1 there, both of them. I. 2 Q Who, to your knowledge, sir, formulated the ! :| 3 company's PCB policy with respect to identifying, and then 4 deciding whether to replace, retrofill or detoxify, PCB or i 5 PCB-contaminated equipment? 6 A I'd say Mr. McCarthy, probably Mr. Fabbi and 7 Mr. Ryan. And they took it to Mr. Ryan but I would think 8 that Mr. Fabbi or Mr. McCarthy were responsible. 9 Q And it was submitted to Mr. Ryan, as the 10 Chief Executive Officer? 11 A I would think so, yeah. {At that time he was i '* t1 12 their superior. ! i 13 Q Is it your tinderstanding {that prior to 1978, i> 14 there was no individual within the company who was 15 responsible for investigating or determining whether there 16 were any potential EPA regulations which would govern PCB or 17 PCB-contaminated equipment? 18 A Prior to 1978? 19 Q Yes, sir. 20 A There was absolutely nobody, and probably l1 21 sometime subsequent to 1978, before anybody became involved 22 on it on a direct basis. 23 Q Prior to 1978, who, if anyone within Nevada i 24 Power, was responsible for monitoring rules and regulations 25 of governmental entities with respect to any matter that MARIJANE SIMON, C.S.R. r 29 1 night impact your business? 2 A Nobody. 3 Q Has there any procedure at all :jthat was in 4 place for monitoring proposed regulations in any field 5 related to the utilities business? I 6 A There was no formal procedure, I 7 The only thing that vas done vais, the Vice 8 President of Generation and Construction at that time vas 9 responsible for making sure that Nevada over complied vith 10 clean air, things of that nature. 11 Q Who vas that individual? 12 A At that time? 13 Q Yes, sir. 14 A . James Zornes. 15 Q James vho? 16 A Zornes,.Z-O-R-N-E-S. 17 Q Is Mr. Zornes still vith the company? 18 A NO. 19 Q Is he retired? 20 A 21 Q 22 Vegas rea? 23 A 24 Q 25 him? Yes. Do you know whether he still lives in the Las I think he does. As far as I knov, he does. Do you knov hov to contact or get ahold of MARIJANE SIMON, C.S.R. 82 1 As I indicated, I don't think they had 2 briefing books until maybe the last five years. 3 Prior to that time, they had loose pieces of 4 paper that were put there when an item came up, or when 5 their agenda was passed out. 6 Q Prior to the time that these briefing books 7 were prepared, were those loose documents retained? 8 A No. Not that I know of. 9 Q Would there be any record, such as an 10 index -- that would have been prepared -- that would 11 indicate what loose documents were given to individual board 12 members? 13 A No. 14 Q Mr. Matteucci, since December 18th -- or 15 excuse me -- October 18th or 19th, 1989, have you had any 16 discussions with Don Fabbi? 17 A That's a week ago, approximately? 18 Q Yes, sir. 19 A No. 20 Q Haveyou discussed with Mr. Fabbihis 21 deposition testimony? 22 A No. 23 Q Has Nevada Powereverparticipated in any 24 lobbying activities at the national level regarding PCB's or 25 PCB regulations? MAKIJANE SIMON, C . S . K . Fnni ^ H 7 83 \1 A Not to my knowledge. I 2 Q Has Nevada Power ever participated, through i 3 any of its trade association memberships,; in lobbying on PCB 4 regulations? 5 A Not directly. 6 Q Has it participated in indirect lobbying 7 efforts through its trade associations? 8 A Well, I don't know. ! i 9 They belong to EEI. If EEI; did, I have no 10 idea. 11 Nevada Power never directly became involved 12 in anything. 13 Q Do you know of any requests' made of Nevada j! 14 Power by any of its trade association! members to become .. i 1. 15 actively involved m any PCB regulation lobbying efforts? 16 A No. . 17 Q Who would know? 18 A Whoever was the EEO -- CEO at the time the 19 request was made. 20 Q So going back to 1978 to pick a date, it 21 might be Mr. Allen or Mr. Pearson? 22 A (The witness nodded his head affirmatively.) 23 Q Mr. Ryan, or now Mr. Lenzie?! 24 A Yes. Yes. 25 Q Are you aware of any lobbying efforts that MARIJANE SIMON, C.S.R. FftfVi'Wl ! J 1 1 UNITED STATES DISTRICT COURT D I S T R I C T OE N E V A D A . 2 --- o Oo NEVADA POWER COMPANY, a ; *) 3 Nevada corporation, ) ) 4 P i a in t i f f , ) 5 vs . ) ) Case No. )C V - S - 8 9 - 5 5 5 - L D G 6) MONSANTO COMPANY, a foreign i 7 corporation; GENERAL ELECTRIC ) )` C O M P A N Y , a f o r e i g n c o r p o r a t i|on ; ) 8 WESTINGHOUSE ELECTRIC CORPORATION, ) a foreign corporation; and DOES ) 9 I through XXV, inclusive, | i i 10 Defendants. ! 11 I 12 BE IT R E M E M B E R E D that, pursuant to Subpo e n a , 13 and on M o n d a y , N o v e m b e r 13, 1989^ c o m m e n c i n g at the 14 hour of 1 0 : 0 5 a.m., at the Ljaw O f f i c e s of W i l s o n , 15 Sonsini, G o o d r i c h & Rosati, Two Palo Alto Square, 16 Palo, C a l i f o r n i a , b e f o r e me,I L U A N A R E G A N , a I 17 C ertified Shorthand Reporteri, License No. 4971 , a ii i 18 N o t a r y P u b l i c in and for the' C o u n t y of San M a t e o , I 19 State of C a l i f o r n i a , p e r s o n a l l y a p p e a r e d 1i 20 G I L B E R T ADDlI S , *l 21 who was called as a witness by the d e f e n d a n t I 22 W e s t i n g h o u s e E l e c t r i c C o r p o r a t i o n . 23 24 O B U J E N & M c C U T C H E O N Certified Reporters & Notaries 25 2555 Park B o u l e v a r d Palo Alto, California! 94306 26 ( 4 1 5 ) 3 2 6 - 9 9 2 0 Fnm 26 1 A . Trade magazines, Electrical World, 4 Electric Light and Power. 3 Q. Do you recall when it was that Electric 4 World and Electric Light and Power began publishing 5 stories on the subject of proposed regulations? 6 A . No . 7 Q. You also indicated that you received 8 copies of the Federal Register on subjects related 9 to regulations of P C B s ; is that correct? 10 A. Sporadically. I didn't subscribe to it. 11 These just got to me in various ways, which I don't 12 r e c a l l . 13 Q. Have you ever personally pa z i p cipated in 14 any lobby effort -- 15 A . No . m T 16 Q. - - on any subject related to PCBs? 17 A . No . 18 Q. Have you been asked to provide any 19 technical input from those who h a v e done lobbying on 20 the subject of PCBs and the utility industry? 21 MS. BRIEANT: In your question, do you mean 22 anybody who has done lobbying, or do you mean people 23 within EPRI? 24 MS . LEEN: Anyone who has done lobbying. 25 MS . BRIEANT: Anywhere in the country? 26 MS . LEEN: Yes. pYliVl *^11 CBUJEN & McCUTCHEON C E R T I F I E D SHORTHAND REPORTERS Ml BRIEANT: Okay. 27 2 THE W I T N E S S : I have not: b e e n a s ked to p r o v i d e i 3 it. I d o n ' t kn o w w h e t h e r it might) h a v e b e e n u s e d , A information EPRI developed. 5 MS. LEEN: Q. Y o u p e r s o n a l l y h a v e n ' t 6 p a r t i c i p a t e d in p r o v i d i n g any t e c h n i c a l input into 7 l o b b y i n g e f f o r t s , at l e a s t to your k n o w l e d g e ? 8 MR. KOTOSKE: Objection, Vague. The problem 9 is, and I' m g o i n g to s t a t e for the r e c o r d my 10 o b j c t i o n , he is h a v i n g a hard time d r a w i n g a 11 d i s t i n c t i o n b e t w e e n his effort's, and t h ose of E P R I ' s | 12 d i r e c t l y and the fact that s o m e b o d y e l s e m i g h t use I il 13 s o m e t h i n g that was p u b l i s h e d by this c o m p a n y that he I :l 14 d o e s n ' t k n o w about. T h a t ' s the b a s i s for my 15 o b j e c t i o n . U n t i l that d e m a r c a t i o n is d r a w n , he's 16 going to have a ve r y d i f f i c u l t time a n s w e r i n g that 17 quest i o n . 18 THE W I T N E S S : C o r r e c t . 19 MS. LEEN: Q. I was a s k i n g if you p e r s o n a l l y 20 p a r t i c i p a t e d , and now I' m g o i n g to go to the n e x t 21 step, w h i c h is to ask, to your k n o w l e d g e , has EPRI 22 p a r t i c i p a t e d in l o b b y i n g e f f o r t s in the e l e c t r i c a l ; ii 23 industry w i t h re s p e c t to p r o p o s e d r e g u l a t i o n s on the 24 subject of P C B s ? 25 A . No . VitfVi * * 1 2 Q. D you have any p e r s o n a l k n o w l e d g e , sir, ^3UJEN & McCUTCHEON - C E R T IF IE D SHORTHAND REPO RTERS rj 1 w h e t h e r _ ^ RI has p r o v i d e d t e c h n i c a l i n put to 28 i i ! 2 individuals an; the industry which have been used by 1 1 3 the i ndustry to lobby on the s u b j e c t of PCBs? 4 A. No. 5 Q. D o e s your o r g a n i z a t i o n m a k e any i 6 p a r t i c u l a r e f f o r t to m o n i t o r , t h a t . i s , to k e e p on 7 top of d e v e l o p m e n t s in p r o p o s e d r e g u l a t i o n s that 8 affect the electrical industry? 9 A. Not that I ' m a w a r e of. T h e r e c o u l d very 10 well be, but I ' m not a w a r e of it. 11 Q. Wh o w i t h i n EP R I w o uld be k n o w l e d g e a b l e on 12 that sub j ec t? 13 A . I d o n ' t k n o w . 14 Q. W h a t e f f o r t s , if any, has EPRI m a d e over j| 15 the years s i n c e you have b e e n emplo yed w i t h them, ! 16 s i n c e 1978, to i n f o r m its m e m b e r s 6 f p r o p o s e d \i 17 r e g u l a t i o n s on the s u b j e c t of PCBsrj 18 A. I'm not a w a r e of any. I have not. 19 Q. Ar e t h ose s u b j e c t m a t t e r s c o n t a i n e d in 20 any of the PCB s e m i n a r m a t e r i a l s tirat EPRI has put 21 OH over the y e a r s ? | 22 A Y e s , 23 Q. So, at l e a s t w i t h resp e c t to i 24 d i s s e m i n a t i n g that i n f o r m a t i o n , tha t is d o n e in 25 seminars; c o r r e c t ? 26 A . Y e s . O BUJEN & McCUTCHEON - C E R T IF IE D SHORTHAND. REPORTERS F f 'L U 29 Q. A s i d e f r o m d i s s e m i n a t i n g the i n f o r m a t i o n i 1 ' in the s e m i n a r p r o c e s s , d o e s EPRI 'prepare t e c h n i c a l 3 b r i e f s that refer to p r o p o s e d EFA jjregulations on the 1 s u b j e c t of P C B s ? 5 A. No. 1 I 6 Q Has any of the research: whi c h EPRI has I 7 been doing since 1978, when you became employed with 8 EPRI, d e a l t w i t h the s u b j e c t of r e s e a r c h r e l a t e d to 9 the impact of pro p o s e d rgult lon s ! on the subject of 10 PCBs? 11 A. All of it w o u l d n ' t be d o n e if the It 12 r e g u l a t i o n s w e r e n ' t there. 13 Q. Is one of the r e a s o n s t h a t EPRI do e s th 14 r e s e a r c h in the f i r s t p l a c e is b e c a u s e p r o p o s e d 15 r e g u l a t i o n is l i k e l y to have an i m p a c t in the 16 e l e c t r i c u t i l i t y i n d u s t r y ? 17 MS. B R I E A N T : I'll o b j e c t to the fo r m of the 18 q u e s t i o n . I think it's c o n f u s i n g . 19 MS. LEEN: Fair e n o u g h . If i t 1s not 20 u n d e r s t a n d a b l e , let me w i t h d r a w iti and try it a 21 d.if f e r en t way . 22 Q. I'm trying to find out w'hy EPRI does 23 r e s e a r c h on the s u b j e c t of PCBs at all , a n d , from 24 what I've g l e a n e d , I t h i n k y o u ' r e i n d i c a t i n g to me j| 25 that EPRI w o u l d n ' t do the r e s e a r c h jon PCBs u n l e s s 26 there were r e g u l a t i o n s that i m p a c t e d the e l e c t r i c a l ! F n m =63 O B U JE N & McCUTCHEON - C E R T I F I E D .SHORTHAND R E P O R T E R S I v\1 J-? '!>f * V--> v :-.^ U 'i-r U .. 1 UNITED STATES DISTRICT COURT i *1 ' -! I 2 DISTRICT O FI NEVADA I 3 4 5 NEVADA POWER COMPANY, a Nevada C o r p o r at ion, I 6! Plaintiff, 7 vs . 8 MONSANTO COMPANY, a foreign j 9 corporation; GENERAL ELECTRIC] COMPANY, a foreign corporation; 10 W E S T I N G H O U S E E L E C T R I C C O R P O R A T I O N / a foreign corporation; and DOES 11 I t h r o u g h X X V , inclusive, Case N o . CV-S-89-555-LDG LRL 12 Defendants.'*i 13 14 15 D E P O S I T I O N OE M A R K H. R E D D A W A Y 16 T a k e n on Mon d a y , D e c e m b e r 4, 1989 17 At ten ojclocj c a m i 18 At 1100 East: B r i d g e r A v e n u e 19 Las Vegas, Nevada 20 21 22 23 24 25 Rep o r t e d by: Barbara Shavalier, I A S S O C IA T E D R E P O R T E R S OF NEVADA! - 7 0 2 / 3 8 2 - 8 7 7 8 13.3 1 Q . n the last y e a r orj two! ha v e you 2 rece i v e d any new h ealth or any new kno w l e d g e 3 c o n c e r n i n g the h u m a n h e a l t h effects of e x p o s u r e to 4 PCBs? 5 A . Probably. 6 Q. Has there b e e n any s i g n i f i c a n t 7 k n o w l e d g e in this r e g a r d that you h a v e o b t a i n e d in 8 .the last two y e a r s ? ii 9 A. Not in my e s t i m a t i o n . I 10 Q. The i n f o r m a t i o n you' h a v e l e a r n e d in the |i 11 last two years, is it p r e t t y much| g o i n g over g r o u n d 12 that y o u a l r e a d y k n e w about p o s s i b l y e i g h t y e a r s a g o ? 13 A . N o . I think as opposed' to r e p l o w i n g ii. 14 old g r o u n d it ha s a t e n d e n c y to m i n i m i z e some of the 15 work that was done earlier. In o'ther1 words, to 16 d e e m p h a s i z e the t o x i c i t y d a t a that was p r e s e n t e d in 17 the late s e v e n t i e s and e arly eighties-, and if 1i 18 a n ything, it does t h a t . !i j 19 Q. In y o u r first two yjea r sj of w o r k i n g at 20 N e vada Power, approximately how much of your time 21 w o u l d h a v e been devoted towards work: c o n c e r n i n g PCBs ;I 22 at N e v a d a Power? 1| 1i 23 A. T h e m a j o r i t y of my jtime was s p ent w i t h 24 that problem. i 25 Q. T h a t -was true e a rly on and s t i l l t o d a y ? 108 1 A. Yeah. Th a t was essentia'l|ly, I think 2 e v e r y o n e was in a g r e e m e n t that the reas.on that t h o s e 3 r e c o r d s were p r o m u l g a t e d were for hose two reasons, 4 Q. And n o t w i t h s t a n d i n g that, o v e r the 5 y e a r s the E P A has c h a n g e d what it is r.elqu i r in g 6 u t i l i t i e s to do. W h a t if a n y t h i n g h a v e y o u l e a r n e d 7 in 1 9 8 8 th a t you d id not know about: PCB s and their 8 reports of human health effects and environmental 9 e f f e c t s in 1982? 10 A. Oh, t h ere is all m a n n e r o'f things. il N u m b e r one, and I can only s p e a k f r o m 12 my o w n e x p e r i.e n c e i.n this regard, I1 thisink that m 13 1982 that p e o p l e h a d a m u c h - - h o w s h all :I say i t - - i t i14 was a k n e e - j e r k r e a c t i o n m my esti m a t i o n , a n d I'm 15 not a bi t c e r t a i n to this day that PCBs c a u s e the 16 p r o b l e m s that h a v e b e e n a l l e g e d to h a v e b e e n 17 a s s o c i a t e d w i t h that chemical. I I j 18 I think in 1982 that the !p r e s s h a d a 19 l a r g e p a r t to do w i t h f a n n i n g the winds of p u b l i c 20 o p i n i o n s , so to speak, w i t h re s p e c t to this c h e m i c a l , 21 a n d s i n c e that time I think e v e r y o n e that h a s h a d an y 22 s u b s t a n t i v e dealings with that c hemical h a v e come to II I: 23 a c o m m o n a g r e e m e n t at least on the Is u r f a c e , that it 24 i sn't nearly as bad as they thought itjwas o r i g i n a l l y i 25 So, yes, our p e r c e p t i o n s have- changed, 1 think, a A S S O C IA T E D R E P O R T E R S OF NEVADA! - 7 0 2 / 3 8 2 - 8 7 7 8 109 U great deal. Q. If I understand- what you h a v e just told me, the w a y in w h i c h your p e r c e p t i o n ha s c h a n g e d in m o r e r e c e n t ye a r s is to b e l i e v e that POBs are not as 5 h a r m f u l as the e a r l i e r r e p o r t s s u g g e s t e d ; is that 6 correct? 7 A. I d o n 't think that I e v e r t h o u g h t that 8 they w e r e that bad. But I may have bee n in the 9 m i n o r i t y in that case. ! 10 Q. But you c e r t a i n l y r e a d -- : 11 i ! A. A n d the b o d y of the infor n a t i o n now 12 t e n d s to s u p p o r t that o p i n i o n , in my es t i m a t i o n . X 13 I 1 i i .I Q. Y o u had, h o w e v e r , c e r t a i n l y r e a d the : 14 r e p o r t s that s a i d PCBs w e r e h o r r i b l e s u b s t a n c e s , did i 15 you not? 16 A. I ha d read b o t h . I h a v e r e a d r e p o r t s 17 that say they are h o r r i b l e , I h a v e r e a d r e p o r t s that Hi 'ai;* :C V. . f& 18 sa y that th e r e is n o t h i n g to t h a t . A n d b a s e d u p o n I 19 t h a t I th i n k that even e a r l y on in my d e a l i n g w i t h 20 th a t c h e m i c a l I never t h o u g h t it was as bad as some 21 p e o p l e t h o u g h t it was 22 Q. Now, you p r e v i o u s l y testi f i ed , sir. r 23 t h a t si n c e you h a v e been w i t h N e v a d a P o wer in the 24 s a f e t y s e r v i c e s depa r t m e n t , the s a f e t y services 25 d e p a r t m e n t has kept files on rules and regulations Fnnm j;7 146 1 Q. Do you r e c a l l that the s t u d y r e p o r t s o n i 2 other studies observing reproductive effects from 3 exposure toPCBs? 4 A. I do not r e c a l l that. I 5 Q. Do you r e c a l l reports 1 i n k i n g PCBs to 6 b i r t h d e fects in lab a n i m a l s ? 7 A. Yes. 8 Q. Do y o u r e c a l l studies 1 inking, s t u d i e s 9 r e p o r t e d in the Drill, Freiss study r epor t ing |i 10 o b s e r v e d tumors in l a b o r a t o r y animals 7 11 1I A. If I can c l a r i f y this, p l e a s e . Y o u are 12 t a l k i n g about the r e p o r t s that are re f e r r e d to in 13 this report; is that c o r r e c t ? ! k j i 14 Q. Yes. I'm r e f e r r i n g to: the s t u d i e s that 15 are s u m m a r i z e d in the Drill, Freiss s tudy ? 16 A. C o u l d I h a v e the q u e s t i o n a g a i n p l e a s e ? 17 Q. Do you r e c a l l the D r i l l , F r e i s s s t u d y iI 18 r e p o r t i n g other studies that observed tumors in 19 l a b o r a t o r y a n i m a l s ? 20 A. Y e s . 21 Q. Wa s it y o u r c o n c l u s i o n that those 22 t u m o r s i n d i c a t e d that PC B s may be pot: e n t i a l l y 2 3 carcinogenic? i 24 A. No. I I; 25 Q. W h a t is the basis for that FnMW A S S O C IA T E D R E P O R T E R S OF NEVADA - i7 0 2 / 38 2-8 7 7 8 147 1 interpretation? ! ii 2 A. B a s e d upon not only this l i t e r a t u r e but ,i 3 other literature that I have read and studied that 4 the l evels of i n t o x i c a t i o n , if y o u will, in o r d e r to | 1| 5 a c h i e v e the d e s i r e d r e s u l t s in t h e s e a n i m a l s is 6 several orders of magnitude larger than what we could I 7 e x p e c t to see in the g e n e r a l p o p u l a t i o n or even, for 8 that matter in ut i l i t y wo r k e r s e x p o s e d to PCBs. iI 9 I suppose if you c o u l d put e n o u g h i 10 orange juice into a laboratory animal you might be i; 11 a b l e to i n d u c e an o range juice tumor in them, but i1 12 that does not mean to say orange juice causes tumors i 13 in l a b o r a t o r y anima l s , a n d 1 am not sure ^that in this, 14 or in any other studies to this day I'm not c o n v i n c e d 15 that PCB c a u s e d tumors in l a b o r a t o r y animals that in i if 16 a q u a n t i t y tha t w o u l d o r d i n a r i l y be je x p e c t e d to be 1 ; 17 o b s e r v e d in the general p o p u l a t i o n or in the 18 o c c u p a t i o n a l p o p u l a t i o n . 19 Q. B u t you are aware a l s o that t h e r e are 20 studies that have made that linkage between observed 21 t u m o r s in l a b o r a t o r y a n i m a l s and the p o t e n t i a l l y 22 c a r c i n o g e n i c a f f e c t s e x p o s e d to P C B s ? 23 A- Yes . ,I 24 Q, Th a t is a l s o the b a s i s for E P A 25 r e g u l a t i o n o f P C B s ? Fnni*33) r 1i 1 shou l d p r o b a b l y explain that. I have seen some of 2 t h e s e st u d i e s in o t h e r forms. I don't recall 3 n e c e s s a r i l y h a v i n g seen it in this part icular c o n t e x t , 4 in o t h e r w o r d s w i t h this l e t t e r a t t a c h e d to it or I'm 5 a w a r e of some of t h e s e s t u d i e s and have] read some of 6 them. t ! 7I I Q . W h i c h ones are you able to identify as 8 ;i r e p o r t s 1 or studies . which you have actuakly i i| I 'I read which 9 ! are c o n t a i n e d as an att a c h m e n t to that letter? 10 A. The p r e s e n t s t ate of Y U S H 0 Y - u - s - h - o 11 pati ent s . 1 2 Q. W h a t is the date of that; study, s i r ' 13 A. It d o e s n ' t h a v e a datje. t looks l i k e 14 it c o u l d be 1979.- T h e r e is a code at the bottom, but 15 I c a n ' t tell. Let me look do w n he r 16 Q. 17 s tud ie s ? What do you recall ab out the YUSHO -I ( 18 A. Do y o u want to k n o w e v e r y t h i n g I k n o w 19 a b o u t the Y U S H O s t u d y ? 2 0 Q. If y o u can reca l l at this p o i n t in time, 21 y e s , sir. 22 A. Well, to the best of my r e c o l l e c t i o n ! 23 s o m e t i m e in the 1970's a rice oil m a n u f a c t u r i n g p l a n t t 24 in J a p a n h a d a p r o b l e m with tthe h e a t e x c h a n g e r that 25 c o n t a i n e d PCBs. The he a t e x c h a n g e r leak! ed and A S S O C IA T E D R E P O R T E R S OF NEVADA i 7 n W ^ fl')- p 7 7 D 9S 1 c o n t a m i n a t e d the o i l ' that was being m a n u f a c t u r e d for ii 1 2 human consumption. j 3 The oil subsequently was sold and I' ; 4 h u n d r e d s upon h u n d r e d s of J a p a n e s e p e o p l e b o u g h t it, 5 they u s e d it to cook t h eir rice, they b e c a m e ill as a 6 result of that and e x h i b i t e d various and s u n d r y 7 clinical m a n i f e s t a t i o n s 1 not the 1eas t! of which were 8 meibomian discharge, liver dysfunction, hyper 9 p igmentation of the skin. There were problems with 10 d e c r e a s e d fetal b i r t h w e i g h t in some of the p r e g n a n t 11 women, I .even think a few pe o p l e died as a r e s u l t of 12 it, a l t h o u g h I d o n ' t k n o w from what s p e c i f i c c a u s e 13 that o c c u r r e d . 14 Subsequent to that there has been a 15 h o s t of s t u d i e s d o n e t r y i n g to d e t e r m i n e w h e t h e r or | 16 not it was the i n g e s t i o n of the PCB itself or some 17 c h e m i c a l that w a s g e n e r a t e d as a r e s u l t of h e a t i n g it i 18 that c a u s e d the p r o b l e m to occur, And I 1m no t 19 c e r t a i n that t h a t ' s ever b e e n r e s o l v e d to t h i s date. j j| 20 T h o s e s t u d i e s a r e still ongoing, jand the p e o p l e that 21 are s t i l l a l i v e and h a v e b e e n s u b j e c t e d to t h a t are 22 s t i l l be i n g s t u d i e d to this day. ^ In a n u t s h e l l . / 23 that 's it. 24 Q. W e r e you a w a r e of the Y U S H O i n c i d e n t 25 and the st u d i e s that h a v e r e p o r t e d the Y UJSSH O inncciiident |Qft17/l K H O n T i m Pfc An it nt n.1 * 1 Q . Have you ever been asked to put ' ! i. 2 together a complete list of all PC3 equipment which 3 has been changed out? 4 A. No- 5 Q. Is Nevada Power still changing out any 6 PCB equipment? 7 A . Yes. 8 Q. What is it changing out at the present 9 time? i 1 0 A. Transformers. And to a lesser extent I 11 voltage regulators, those kinds of things as they are 12 discovered on the system 13 Q. Do you recall how many transformers are 14 left on the system? 15 A . No i d e a . 16 Q. Are those listed in Mr. ;F a b b i `s records? 17 A. How many transformers ar,e left on the 18 system? 19 Q Y e s , sir. 20 A. As far as I know, no. 21 Q. Have you investigated whether Nevada I il 2 2 Power has inadvertently contaminated electrical 23 equipment with PCB fluid? 24 A. I have looked into that problem, y e s . ii 25 Q. When did you first look into that FnMK72 ASSOCIATED REPORTERS OF NEVADA - 702/382-8778 CU ct-ropt... Jl NAVAd?,. X . J 1 p ro b lem? 2 A. Probably shortly after ;I came to work 3 there. 4 Q . What caused you to look into that 5 problem? 6 A. Probably what prompted; it was the idea 7 of simply the way that Nevada Power w orks on its 8 transformers. We bring them to a cen trai location, 9 we take the oil out of them and dump them in a common i 10 container, and then when we have work ed on the ! 11 transformer, we put the fluid back in to the 12 transformer. 13 Sometime after I becameiiI aware of that 14 process, it occurred to me that we mijght j ! 15 inadvertently be dumping PCB transfor mer oil into I 16 that common tank thereby contaminated the oil and 17 then .dumping it back into a large number of i 18 transformers and exacerbating the problem 19 Q. Did you attempt to quariti fy the extent 20 to which Nevada Power was contaminate ng its own 21 equipment through this method? 22 A. Well, I was never certa in that that was 23 the case. As I said, I looked into tihe. problem, but i 24 you are in a situation where as you:dump PCB fluid 25 into a large volume tank, it tends to dilute that Ihni!773 ASSOCIATED REPORTERS OF NEVADA - 702/382-8778 C l i l p i . . v t > { n V h V i C fc ^ i-i n v T a e U a r t a . M P a r\ a P Q 1 fl1 1 material and you will almost in every case get some 2 readin g of PCBs'. What we are looking fo r essentially | : 3 is oil that's less than 50 parts per mil lion when you 4 are all done. I'm not certain that I ever f o u n d .it 5 to be over that in any of those instance's. (6 Q. Did you start a testi.n!g program to iI i 7 determin e whether the common oil tha.t was used to i 8 refill transformer equipment was PC|B contaminated? 9 A. Yes . 10 Q. When did that start? 11 A. Oh, let me see. Prob'ably--well, I 12 can't even say that with any accuracy, several years 13 ago 14 We bought a tester that we use in-house, 15 a n d it's a p r o c e s s t h a t ' s d o n e by what'Is c a l l e d ion 16 specific electrode which measures total chlorine ion 17 content in the oil. In other words, it does not 18 discr imina te between chlorine that that exists in 19 PCBs f r o m chlorine that exists in jtrichlorobenzene or i 20 in a n y of the solvents that might be used to clean 21 transformers. 22 So essentially what (you nave is what we 23 consider to be a fairly safe test for the presence of 24 PCBs, because we are counting all of t ie chlorine, 25 not just that which is present in PCBs . ioni FT74 a c c n n T z i ' P F n b f p d r t p . R S OF NEVADA - 702/382-8778 1 A. Just in general terms the discussion 2 was on P C B s . 3 Q. Have you ever provided commentary to 4 EEI on the subject of PCBs? 5 A. No. 6 Q. Have you participated ini any I ! 7 preparation of commentary to EEI on th,e subject of 8 PCBs while at Nevada Power? 9 A. Not that I'm aware o.f. 1 0 Q. Have you provided any commentary to 11 EPRI on the subject of PCBs? 12 A. No. 13 Q . And have you par tic ipate:d in any 14 commentary while an employee of Nevada1 Power? 15 That is, have you been consulted for 16 the preparation of something, even if you didn't 'I 1 17 actually offer the commentary yourself 18 A. Not that I'm aware o f . 19 Q. One of the articles which is contained 2 0 in Exhibit 45 is a May and June issue, 1981 from the 21 Archives of Environmental Health e|ntit:iled Mortality 22 in Industrial Hygiene, Study of Worker s Exposed to 23 Polychlorinated Biphenyls. 24 Do you recall reading th at article, s i r ' 25 A. Not specifically, no. F n iH H 7 5 A S S O C I A T E D R E P O R T E R S OF N E V A D A - 7|0 2 / 3 8 2 - 8 7 7 8 1 You indicated shortly aw hile ago that 2 you attended a General Electric semina r at the 3 Tropi cana. 4 A . Yes. 5 Q. And are you able to reca 11 6, approximate ly how long ago that was? j 7 A. It seems like it was two or three years 8 ago but that's about as close as can come on it. 9 Q . What was the general top ic of that 10 seminar? 11 A. I PCBs. I'm sure that's what it' was. 12 Q. So the whole seminar was about, PCBs ? 13 A. As far as I recall. yes 14 Q. 15 semi nar ? And did you get any mate rials at that t 16 A. I don't remember if I di d or not. 17 Q. If you would have gotten a n y , would you 18 have put them in your files at Nevada Power ? 19 A . Undoubtedly. 2 0 Q. Do you recall any of the| individuals 21 who spoke at that -seminar? 22 A. If memory serves, and I--this is a 23 problem for me because the guy I that I i1think was i 24 involved with this seminar has worked !for two 25 different companies during this, roughly-the same [ F,nnif?76 A S S O C IA T E D R EPO RTERS OF NEVADA - 7(02/382-8778 W'-LH i 1 UNITED STATE'S DISTRICT COURT 2 DISTRICT OF NEVADA 3 4 5 NEVADA POWER COMPANY, a Nevada Corpora tion, 6 ) Plaintiff, ) 7) vs . ) Case N o . 8 ) CV-S-89-555-LDC MONSANTO COMPANY, a foreign ) LRL 9 corporation; GENERAL ELECTR IC ) COMPANY, a foreign corporat ion ; ) 10 WESTINGHOUSE ELECTRIC CORPORATION, )) a foreign corporation; and DOES' ) 11 I through XXV, inclusive, 1 ) ) 12 Defendant's. ) )` 13 14 1 5 DEPOSITION OF DA N IEL P. CROTTA 16 Taken on Monday, December 11, 1989 17 At 10:05 a .m . 18 At 1100 East Bridger Avenue i 19 Las yegas, Nevada 20 21 22 23 24 25 Reported by: Margaret M Harmon', RPR, C S R #2,74 inmCT ASSOCIATED REPORTERS O f |n EVa1d A - 702/382-8778 516 So u t h El ah l-h Strofi- - T.ac a K t a i r a ^ a Q 1A 1 1 Nevada Power's practices when it serviced and j 2 maintained existing equipment to use recycled oil 3 whether .it was PCB or non-PCB? 4 A. No. The transformers returned from the 5 field were recycled through our shop. That oil was 6 kept separately because it was a different type. I'm 7 talking about PCB oils. So I -- tp my recollection, 8 there was not an intermingling of ihe two oils. 9 Q. Do you recall Mri . Reddaway suggesting * i t 10 implementation of the policy tjo make sure that there 11 was no intermingling of oil? 12 A. I believe so, uh-huh!. 13 Q. Do you know.what it was that 14 prec ipitated his suggestion to implement that policy? 1 c A. I assume it was from the EPA or OSHA. 16 I don't really recall 17 Q. Did Mr. Reddaway discuss with you at i! 18 the time he made his suggestion the fact that he was ! i 19 concerned about the two types of oils becoming 20 intermingled? 21 A. I believe so, uh-huh. 22 Q. Did you conduct; any investigation as a 23 result of his expressing his concern as to whether or 24 not that had actually happened? 25 A. I believe so, but, .again, I don't Fnm578 I i i 1 A . ` I really don't recall whether that was 2 the 3 (Witness review! ng d o c u m e n t .) !1 4 I believe so. 5 Q. Mr. Fabbi indicates in the memo which 6 is marked as Defendant's JJJJ that 'Nevada Power had ri i 7 some PCB absorbent pillows in stock' i 8 Can you tell me what ithose were, sir? |I 9 A- I was wondering that |myself when I read 10 that. I don't k n o w . I don't recal 1. We used 11 pillows, oil pillows, for example, !when we take oil 12 out of a transformer, even a substation transformer, 13 to house the oil temporarily, and I assume these were 14 smaller pillows of that natureJ They're shaped like i 1 C a pillow. Actually, it's a bag, a ;[leak-proof bag. 16 Q. In 1976 when Mr. F a b b i f i r s t a d v i s e d 17 you through his memo that there was Askarel which was l 18 a name for PCBs, was there any [procedure in place to ir 19 insure that oil from PCB equipment was not i 20 intermingled with oil that was Inonm'ineral or some 21 other substance? 22 A. I don't recall when that came about. 2 3 Q . When what came aliout, s i r ? 24 A. Where we have -- (obtained special 25 equipment to handle PCB oil that we kept separate inni 5 7 9 38 from equipment that handled good oil. Q. Was the practice before a new policy came out to intermingle PCB oil with other types of oil? A- . Before we were aware of a problem, we used the same equipment, uh-huh,, iii Q . And did you use oil from a common tank or container to top off existing equi ipraent when oil was requ ired? A. Well, we have a couple' sources of oil; One is brand-new oil, and one is recycled oil. We wouldn't put a recycled oil into a n'ew unit for topping. Q. Why is that, sir? 1 D A. Because we had brand-new oil and wanted to keep new and new together. j j! Q. Would you use recycled oil to service exListing equipment? A. Ye s . O. Do you recall ther e coming a point in time in which M r Reddaway sugges ted; implementing a procedure to insure that recycle d oil was non-PCB oil? ,| A. Yes. I don't reca 11 when. Q. . Prior to the time that Mr. Reddaway made the suggestion to implement a new p q 1ic s it i I .I 1 Nevada Power's practices when it serviced and 39 2 maintained existing' equipment to use recycled oil 3 whether .it was PCB or non-PCB? 4 A. No. the transformers returned from the 5 field were recycled through our shop . That oil was 6 kept separately because it was a dif ferent t y p e . I'm 7 talking about PCB oils. So I -j* to -my recollection, 8 there was not an intermingling of th e two oils, 9 Q. Do you recall Mr. Redd away suggesting 10 implementation of the policy to make sure that there 'll was no intermingling of oil? 12 A. Z believe so, uh-huh. :l 13 Q . Do you know.what it wa s that 14 preci pitat ed his suggestion to implement that policy? 1 C A. I assume it was from the EPA or OSHA. 16 I don't really recall. 17 Q. Did Mr. Reddaway discu ss with you at 18 the time he made his suggestion the :fact that he was 19 concerned about the two types of oils becoming 20 intermingled? 21 A. I believe so, uh-huh.; i 22 Q. Did you conduct any investigation as a 23 result of his expressing his concern as to whether or 24 not that had actually happened? | ; 25 A. I believe so, butj aga'an, I don't F,nni58l 1,1 N atio i-- Elactrical M anufacturers Association 1; 2101 L Str&e. N W Suite 2C0 Wasnington. 0 C. 20037, (202)457-34C0 April 5, 1983 Mr. Donald G. Fabbi Safety Director Nevada Power Company, Station #5 6226 West Sahara Avenue Las Vegas, Nevada 89151 Dear Mr. Fabbi: Enclosed please find a copy of the NEMA publication on human health effects of PCBs as recently announced in the March issue of the Electric Light and Power magazine, The second publication that was announced in that issue, PCB Conference Notebook, featuring a speech byj William Gunter of EPA can be obtained thru the publishing, company in New York and sells for $75.00. If you would like to obtain the Notebook please write or call the following company: I *j Executive Enterprises Publication o ., Inc. 33 Wst 60th Street New York, NY 10023 (212) 489-2680 Should you have any questions, pleasie feeil1 free to call me at .(202)457-1964. Sincerjely, ; /rah Enclosure cc: R. G. Hansen Rebecca Hirsch Secretary to R; Hansen ivJ 0 6 738 ynni^M used In electrical equipment ded & unique com binatlon^f e ;vand Are safety" But in^Qie^eai Ired a reputation as posing aserio l. Recent information,'shoi not the serious threat they wers l>elleY 9 public In identifying reapc5i5& aj cation on hum an health effegts of PC JT this] Issue in perspective!' tfis Nation V lfanufacturers Association (NEMA) h Jh la booklet. -.5^ Vvm3 . 'is the principal national trade association cal m anufacturing Industry. NEMA me products used in the generate amission, distribution, control an d ' end-use ty^mcluding^-traiiaioEmers.and^large. caps Certain of these were once designed to use PC an insulatingjfluid. While FCB electrical produc ye not been m anufactured since about 1978,'max still in use and have many years of' ` >r^ tec "T ri m itci e <I* lfe. K B s (polychlorinated biphenyls) are a'family of ovi 200 chemical compounds, ranging from light, ol fluids to heavy oils to greases and waxes.' They-ha^ been valuable because they are Are resistant, hai excellentj electrical Insulation qualities and are chen cally and thermally stable. _ Production of PCBs started around 1930, whan the were used in a.number of Industrial appUcatior Their chemical and therm al stability resulted in wld spread use as a heat transfer fluid. They also becam valuable In the .paper industry, as plasticizers fc various materials and as components for inks, dye dust-settling agents, die-casting lubricants, paint pesticides and adhesives. But their major use was i the electrical Industry, where they became'ah insula lng liquid for capacitors and transformers. Here PC5 replaced jxmbustible Insulating fluids and reducei the risk of fire in office buildings, hospitals, school and factories. |. * /'ii * - * . * -vr" - 40 years of widespread Industrial u* to question whether the benefits resu might he offset by adverse environme an' 'around 1966 when, environments Sweden showed some buildup bfPCBs u uent studies indicated that their rate o was very slow and th a t n atu ral forces a long time to remove PCBs from the t. , lj <; i;: *. ; hum an poisoning incident in;Japan was .buted to PCBs and prom pted concern health effects. Then In 1974 a govern >t reported th at PCBs caused cancer in a Of r a t . 'I :if to prompted Congress to single out PCBs tlon In the Toxic Substances Control Act 1976. Section 6(e) of the Act: Zfei'- -- the U.S.-Environmental protection Agency `'prescribe PCB m arking''and disposal re ts; 1 * - s \continued PCB use except in selected situ s ajgland j * '| . j j T FCBmanufacture, processing, an d 'd istrib u JJdp5*ceptln selected situations.'* .. t'JjJnterestlng to note, however, th a t while produc ~and sale 'of FCBslhave also been discontinued in me other countries] their manufacture and use con of B u r o p ^ _ v ,, poeeihie FuB' hum an health effects have used the most public concern, the health Issue has n examined in great detail --both in the U.S. and ... .| " i^In the Japanese poisoning incident, Japanese-ir lectured PCBs Were tlie heat transfer fluid In exchanger used to heat rice o il The heat ex .developed a leak, causing some of its fluid v nate the oil. The rice oil was then package used as a cooking oil. In what is how > -3Usho incident] about 1,300 people b eating food cooked witlijthe oil. ^ There were many different effecb tlon to acne-like skin conditions ' victims also experienced feel!' lng of the upper eyelids, darkening of the'nails and individual effects. In sc passed on to newborn c j, FnoiSfls The irony of tlie sb ` 1 has presented stror 1 j| blame. In fact, the ht*, :! nated the rice oil contah. j combination of high tempt* 0.6 / v\* 'y. V -. changed about oftheorlglr jnateri&ls called qua1 henyls, who 'facts are uhknowi&;?^j* ijm prtantly, about 280Q parte per milllc 1 ^ 4 percent, of the original PG5 fluid hi fe te d Ito polychlorinated dibenzofurai SteS&Is with a reportai animal toxic! ffp B a . Later tovestjg&fcforis by the ja] jlf ie Ttish `symptoms tSfchePDF conte: >ml, notto the PCBs themselves.* By the tin ibecame.generally Log* a ^howevgr, tl y 'believed th at PCBs/were extrema THE U.S. SITUATIOI DO PCBfeCAUSE CANCER IN HUMANS? ifcton In :tha United States Is quite diffr: ''which resulted In the T^sho incident. Fin =*~it'exchangers containing 60 ppm or moi i*banned in the manufacture, or.proce* drugs, or oogmecs^Booni^'thgre is n ' "iDFs are genaratea.'the Operation c 1 products. Third,* he SPA"rigidly co istorage and disposal of PCBs. And finally, th itionel Safety and Health.' Admlnlstratlo: ial exposure to PCBs. -- if the PCDF concentratiqiof U.S. electrics Be rangs from 0 to 2 ppm.'hairdly the 250 __/tin Japanese heat tta n sfer fluid. About th possible pathw ay for hum an,exposure to PCDF. is through eating fish from'certain bodies o r;lffc^th tI& K iSri& to a w f f ^ h a r a ms&sur&bft ititlea of PCBs. Assuming th a t the fish contain th< it Food and Drug Administra tion xnaxlmuix of 6 ppm PCBs and th at the PCBs oontaln 2 ppn )Fb, our fish eater would have to eat about 1 pounc per day for over 150 years to acquire the lumlPCDF dose th a t caused Illness In the Jape tTsho incident. W- ; 1 1i j -vyiv- .* le concern about PCBs as a cause of cancer stemmed ldpally from a| government experiment reporting it PCBs caused cancer in a certain type of rat. This >rt has since been questioned by other scientists addition, another study by the National Cancer ^Institute failed to |show that PCBs caused cancer In jurats. But the real question Is not whether PCBs cause icer in animals ,fb u t w hether they cause cancer in ,,humans. The evidence strongly suggests th at they do "not. If PCBs were hum an carcinogens, signs of cancer should have shown up by now in the most highly exposed electrical| workers. 'Hie exposure of same & -began almost 40 years ago. Signs of cancer attributed S ./to PCB exposure have not been Identified In these -.w o rk ers. J *'.The most Important study of PB exposed workers N * _ ^,. .'- v`"* *j ' ''frr *.... Reported in|1961. It was a mortality study by jqnflllCLBtitute for Occupational Safety andH sa it$dut*2800 workers employed by iw ocapael . . i. Exposure in one plant began as ea: 5;|the other by 1946. The conclusion? Nosta 'Significant excesses of cancer werejobeen there was no apparent relationship betwe rearing lengths of employment m'PCB-expce sa n d !the risk of death due to cancerr&rdlovas 'disease, neurological manifestations or,from a ' Tills Is particularly n o tew o rp y sir iof the 2500employees In the study were expos 3for more th an 17 years. Some were exposed 40 years I DO PCBs CAUSE OTHER ILLNESSES IN HUMANS? . ..--filfaK* leal studies of workers occupationally exposed _ 3 have been performed by the South'CarolL jpartment of Health and Environmental Control, 1 M ount Sinai School of Medicine andLby]othe Hone of these studies revealed any serlqus' heall ( problems related to PCB exposure. t.':0 th e r studies by the M ichigan D epartm ent i [alth and the Connecticut Department of Heal! ices examined fishermen who have consume ge quantities] of PCB-containing fish. Again r leant clinical effects were observed, if - - A comprehensive and scientifically evaluated PC tur study was conducted in 1981 and reporte 1988 by the highly respected-toxicology censultir of Drill, Friess, Hays, Loomis & Shaffer. I 8eymourL. Friese, president of the firm, summarize findings in these words: .. At hum an exposure levels as high as those prei encountered In occupational settings, PCBs c& cause chloracne jand Increases in one or more live enzymes.[ Neither effect represents a serious or Hi threatening problem. From present evidence, no tirr associations can be made between PCB exposure ant ^ any other hum an health effects, even after long-tern ^occupational exposures." .*v**~- 1 Dr. Frise went on to say th at since the risk fron even high-level occupational PCB exposure Is lov ' PCBs in the n atu ral environment do not present sl{ - nlflcant human health risks. In Mayjof 1982, the U.S. Environmental Protectior `; Agency sponsored a symposium on PCB health effecu In his report to the EPA, p art of which was quoted in . the May 29, 1982, Issue of SCIENCE NEWS, the sym * poslum chairm an stated that, *... it is evident... after 50 years of industrial production (th a t)... no algnlfl f cant clinical disease or clear epidemiological crrela FoW*^ tions have been obser/ed in occupationally exposed persons. Considering the lower and declining expo j: sure to PCBs via the environment, It seems unlikely ! i >! .0 6 2 3 ~ T Tfc- - -C X * - injury will be observed from^5nvii _ to P C B a." ere is no reason to believe that futi ; result In any surprising new Infon Eeoontinue. Presently the National In ' ~,.patlonal Safety and Health,jn b rta l ^ j extended, m anufacturers'^ oontl obTexposed employees and some'states a *&eir own research on human* health regulations require the early rep la PC5 capacitors and transform ers, a] use of the remaining u n its to the end lives -- subject to periodic Inspection ,ers for leaks. ' V&y^*; 'A regulations deal effectively w ith the d gBs. These disposal regulations J S rm it1 R ln'hlgh tem perature Incinerators p rln hi* boilers. Such m ethods have been th< tested and approved by the SPA, and are vei PUTTING PCBs IN PERSPECTIVE ''Jr- r*! V >.:;i " r 'I the recent favorable information on PCB t health effects, the Federal Government cc Its strict regulation of FCBs. The regulator 4eigaed to, gqjm i^the jc o n j^ u e d _ Q ^ ^ 9 q iij ' equipment without excessive exposui um ans to PCBs and without excessive leakage < into the environment. Additionally, Federal st< and regulations, put In place since 1976, prohlb ^manufacture of PCBs. Although they dialntegrat slojwly In the environment, they will eventual! removed by natural processes. v--- v * - Bo, to|put the)PCB Issue Into perspective, PCBs ai t the hazard to hum an health once thought. Thl conclusion Is fairly drawn from a considerable bod; of objective study, examination and evaluation on th ' part of many scientists and medical personnel. At th pame time, government regulations and "Indus tr. actlces have been designed to minimize the escap PCBs from electrical equipment Into the envlroi ment and to control the storage and disposal of PCBs a e endiof their service Ufa. The evidence and thesi Safeguards should eliminate the fear of PCBs an< . establish that PCBs do not pose a serious threat to ouj 'Uvea and health! PAY INCREASE EFFECTIVE FEBRUARY 27 "THE SMOKY MOUNTAIN ARTS & CRAFTS FESTIVAL" i -- --T --- , 1 A c o s t- o f - liv in g pay ra is e has been announced, e ffe c tiv e F e b ru a ry 2 7 , f o r a l l W estinghouse ABB em ployees e l i g i b l e to r e c e iv e such an in c re ase . |j !1 H ourly em ployees w i l l re c e iv e a pay b o o st o f 14 c e n ts an h o u r, w hilt e l i g i b l e non-exem pt s a l a r i e d p e rs o n n e l w i l l r e c e iv e 24.27 p e r montl The b a s is f o r th is ad ju stm en t i s th e change in th e consumer p ric e index fo r urban vage e a rn e rs and c l e r i c a l w orkers from June 1988 to December 1988. **I* C om plim entary t i c k e t s to THE SMOKY |MOUNTAIN ARTS AND CRAFTS FESTIVAL, b e in g h e ld a t THE INDIANA CONVENTION CENTER, MARCH 9-12 a re a v a i l a b l e in Human R eso u rc e s on a f i r s t come b a s i s . THE SMOKY MOUNTAIN ARTS AND CRAFTS FESTIVAL f e a t u r e s " J u r ie d c r a f t e r s from many s t a t e s w ith hand made, c r a f t s in c lu d in g American F o lk A rt Wood C arv in g s (N o rth C a r o lin a ) , C ountry Wood F u r n itu r e (G eorgia), Tole P ainted Tin Punch (T exas), Country Ceramics (Alabama), S o ft Sculptured D olls (F lo rid a ), Jew elry (In d ia n a ), C allig rap h y (O hio), C lothing (T ennessee)] Folk A rt & C arousel Horses (A labam a), C lay'O rnam ents ( I l l i n o i s ) , Melfal S c u lp tu re (S outh C a ro lin a ), P e rso n a liz e d C h ild ren s Books (T en n essee), Q u ilts & P o tp o u r r i (A lab am a), Toys (T e n n e s s e e ) , Wood Item s (W isco n sin & K entucky), ju s t to mention a .fe w . I J EMPLOYEE PETITION run. r u n nr^uuxh EVALUATION To A ll E m ployees: Muucie taauagciaeut LcCeiitly LcCcived a p e titio n re q u e s tin g a h e a lth e v a lu a tio n f o r PCB e x p o s u re . I t I s our a ss e ss m e n t t h a t th e r e n ev er h a s b e e n , n o r I s th e r e now, any s i g n i f i c a n t o r h a rm fu l r i s k to human h e a lt h a t th e W estlnghouse ABB Muncle P l a n t . !| In th is re g a rd , re c e n t re se a rc h In the H ealth and Environment D igest A u gust, 1988, by R enate D. Kimbrough, c o n c lu d e s t h a t " . . . d e s p ite p o s itiv e la b o ra to ry anim al d ata and except fo r chloracne (a skin r a s h ) , exposure to PCB's has le d to no co n v in cin g c l i n i c a l l y dem onstrable, ch ro n ic h e a lth e f f e c ts in liumans." In a d d itio n , a l l e v a lu a tio n s by s t a t e and f e d e r a l a g e n c ie s r e l a t e d to PCB*s have fount th e Muncle P la n t in com pliance w ith r e g u la to ry re q u ire m e n ts. T h e re fo re , we a re n o t aw are o f a n y |m e d ic a l n e c e s s ity f o r em ployees tc have a h e a l t h e v a lu a tio n f o r PCB e x p o s u re . P le a se be a s s u re d ve w i l l c o n tin u e , a s we have in th e p a s t, to a p o lic y commitment fo r the p ro te c tio n of our employees a g a in s t the harm ful e f f e c ts of any hazardous su b sta n c e. *** feature ! II PCB's-prevalent and persistent Intensified research is needed to minimize their dangers i Carl Qa Gustafson, Federal Water Quality Administration, Athens,\Ga. I d uring the past three years, a special class of compounds, called polychlorinated biphenyls (? c 's), has claimed the attention of ecologists and pesticide analysts in this country. These compounds were not discovered in the environment until 1966 in Sweden and 1967 in the U.S., despite the fact that they have been available com mercially for 40 yean. Interest in pcb's has arisen because they are frequently found in fish, bird, water, sediment, and other environmental samples when such samples are examined for chlori nated pesticide residues. That a wide variety of samples containing pcb's has been collected from England, Scandi navia, The Netherlands, Antarctica, Central America, and many different parts of the U.S. makes them truly ubiquitous pollutants. Potychlorobiphenyls are made by substituting chlorine atoms for one or more of the hydrogen atoms at the The Monsanto Co. stated recently in a letter to Congressman William F, Ryan of New York that as of August 30, it would no longer sell ecu's to , customers for use in general plasticizer operations where disposal o f the endproducts cannot he controlled. After some lag period' .(he time it takes to eventually dispose o f the products made from pc'j and currently in processor's inventories---the quantity of ecu's getting into the environment may be substantially reduced. I f Monsanto's former customers look for pcb substitutes, rather than purchasing pcb'i from manufacturers in Japan and Europe, the projected decrease could become a reality. Carl G. Gustafson numbered positions of the biphenyl structure. | I Aroclor. pcb's are also manufactured in Europe and Japan, under trade names such as Phenochlor and CIophen. The various Aroclors are dif ferentiated by a four-digit number, with the last two digits indicating the percentage of chlorine in the mixture. Properties In the process of replacing hydrogen atoms with chlorine atoms, a | large number of substitution combinations arise. For example, three monochloro- biphenyl isomen are possible, 12 di- chlorobiphenyl isomen, 21 trichloro- biphenyl isomen, and so on. Theoreti- cally, 210 compounds can be prepared by this substitution process; a typical example would be 2,4,6,2'4*-penta- chlorobipbenyl. | Whenever aromatic hydrocarbons such as biphenyls are chlorinated, the product is a mixture of compounds, in cluding isomen. It is quite difficult to synthesize single, specific chloro biphenyl compounds in the laboratory unless involved procedures are em ployed. Consequently few of the indi vidual compounds have been prepared in the pure form for study. | In the commercial process for^ pcb manufacture, biphenyl is chlorinated with anhydrous chlorine in tall cy lindrical towen with either iron fllinp or ferric chloride as the catalyst, jThe by-product is hydrogen chloride; the product is a mixture of several pcb's. The degree of chlorination .is deter mined by measuring the specific gravity of the mixture or, when the product is more viscous, the balf-and-ring soft ening-point test is used. The whole pro cess calces from 12 to 36 hours. I in the U.S., the sole manufacturer of pcb's is the Monsanto Co., which markets them under the trade name The three most important physical j properties of the pcb's are low vapor pressures (they have high boiling points), low water solubility, and high dielectric constants. They are miscible with most organic solvents and compatible with many types of poly ' mers. Although some individual polychlorobiphenyl compounds are crys talline, the Aroclor mixtures are either liquids or resins. iI The chemical properties that make ' pcb's desirable industrial materials are their excellent thermal stability, their strong resistance to both acidic and basic hydrolysis, and their general in ertness. They are quite resistant to pxidation. Monsanto reports, in a tech nical bulletin on pcb's, that they can be heated to 140 C. under 260 p.s.i. of oxygen pressure "without showing any evidence of oxidation as judged by de velopment of acidity or formation of 1 sludge." ] The physiological properties of the pcb's make them potentially significant contaminants of the environment. For any pollutant, two factors are involved: acute toxicity, which is immediately evident because of a high death rate or other maiming effect; and chronic tox icity, which is the result of a slow ac cumulation of the poison in the body and is a sublethal effect. Whenever acute toxicity is high, a pollutant will be readily recognized and appropriate remedial actions will be introduced. If, on the other hand, acute toxicity is low, . i I ' a Dk 0 ^ the physiological effects will go un noticed until the chronic effects make themselves evident When this happens the problem may have advanced be yond immediate or $asy correction. Acute taxkJty All studies of KS'J in animals indi cate that acute toxicity is not a signifi cant factor. Their acute toxidties are on the order of those of other chlori nated aromatic compounds. Monsanto has sponsored two investigations of the acute toxicities of Aroclor mix tures. In the first, at the Kettering Laboratory at the University of Cin cinnati. Dr. J. F. Treon and his coworkers investigated the toxicity of Aroclor vapors for guinea p ip . mice rabbits, and rats. All animals survived a 24-day exposure to 0.83 p.p.m. of Aroclor 1242 for 7 hours per day on 17 of those days. Even after more pro longed tests, there were no severe ef fects from Aroclor 1242. In the second investigation, still in process, three groups of beagles are fed Aroclor 1242, 1254. and 1260. respectively, at a rate of 100 p.p.m. in their diets'. After three months* no significant abnormalities have been noted. Similar studies on fish have been per formed in several laboratories. Dr. Richard Schoettger of the Sport Fish eries and Wildlife Fish-Pesticide Re search Laboratory in Columbia. Mo., reports that 96 hour-Tt.30 toxicities of the Arodors to trout range from 1.17 to 60 p.p.m. Compared to dot, whose 96 haur-TL-,,, toxicity is 0.002 to 0.009 p:p.m. for trout, the pcb's have a rela tively low acute toxicity. With the more sensitive bluegill, the 96 hour-TLjo for Aroclor 1248 is 0.273 p.p.m.t while that of dot is 0.008 p.p.m. Aroclor tox icities appear to be inversely propor tional to the chlorine content of the mixture. Shellfish, o p t and shrimp are more sensitive to pci's. Dr. Tom Duke, at the Sorexu of Commercial Fisheries Pesticide Field Station, re ports 100% mortality of juvenile pink shrimp exposed to 0.10 p.p.m. of Aro clor 1254 in water for 48 hours. This concentration of Aroclor 1254 will cause a 100% decrease in shell growth of oysters after 96 hours. To achieve the same effects with dot in these ex periments, only 0.0006 p.p.m. and 0.01 p.p.m.. respectively, were required. There is very tittle evidence that pea's are toxic to insects. Studies to date show that they are less toxic than dieldrin or dot. Ai with fish, their tox eroscopically tbe kidneys showed icity appears to be inversely jpropor- I marked tubular dilation and numerous tional to the chlorine content of the j casts." mixture. | | Another chronic effect of p c i's is Based on the above data, it is tin- 1 related in wildfowl. The accumulation derstandable why the polychlorobi- of high concentrations of chlorinated phenyls, commercially available for hydrocarbons in birds resulted in dis A0 years, have only recently attracted ruption of normal breeding behavior attention aa toxic environmental con- j and in the formation of thin-shelled taminints, | eggs. A dramatic example of this effect dShrente texldty J has been observed in the case of the brown pelican. On the Anacapa Islands The chronic toxicities of pcb's pre- ` off the California coast, no young were sent a more disturbing situation; [several ( hatched last year from 300 pairs of chtronic effects have been obser|ved. It > nesting birds. The shells of most eggs was discovered, quite by accident, that . laid were so thin that a dent occurred pea's have a toxic effect on chickens. when the egg was picked up. Professor E. L. McCune and his a> . There are two possible causes for workers at the University of Missouri the laying of thin-shelled eggs by wild found their chickens dying after they 1 fowl. One is a low calcium reserve in were placed in a feeding house, parts | the bird; the other is the inability of of which had been freshly painted with ; the bird to deliver the needed calcium an epoxy paint. Careful investigation 1 to its oviduct, where the eggshell is revealed that the toxic factor was Aro forming. The calcium level in the avian clor 1242, a binder in the paint|W hen i biosystem and the calcium reserve in Aroclor 1242 was fed to the chicks it i the secondary bone structure or medul produced tbe same characteristic`effects lary bone, found only in female birds as chick edema factor. McCune re- i when they are breeding, are controllai ported: "Cross pathology included hy by the hormone estrogen. A high es dropericardium, hydroperitonium, en trogen level is associated with the for larged heart, liver, and kidneys, and mation of this calcium reserve. Chlo hemorrhage of internal organs. Mi- rinated hydrocarbons, sucb as nor, r I-- V I chlordane, dieldrin. and p c i's, activate enzymes in the liver which transform _ estrogen into a more water-soluble compound that is readily eliminated from the bird's body. This means that when estroge* levels are tow, calcium reserves will also be low, and there fore very Kttie~caic^m will be avail able for strong eggshell production. Dieldrin and pcb's are more effective than ddt in this type of enzyme-induc* tion activity. Aroclor 1262 has an es-; tradiol degrading potential four to five * times that of p.p1' ode or technical ' grade dot. The ability of the female bird to deliver calcium to her oviduct during the last 20 hours, when the eggshell is being formed, is related to the func tioning of the enzyme carbonic anhydrase. When birds that have ex hibited the ability to lay normal eggs are injected with a metabolite of ddt ( dde) just prior to the formation of the eggshell, they will lay thin-shelled eggs. This indicates that dot also in hibits the activity of carbonic anhydrase. the enzyme that controls the flow of calcium from the blood stream of the bird into its oviduct. Since dieldrin seems to have no effect on carbonic anhydrase, we may assume that neither do the pcb's. How ever, these compounds delay breeding time significantly. Many ornithologists feel that late breeding has a stronger influence on the reduction of bird populations than does the laying of thin-shelled eggs. If this is true, pcb's are a more potent threat than dot to our declining bird populations, es pecially for predatory birds that ac cumulate fairly high levels of pcb's be cause they eat smaller animals that al ready have concentrated pcb's in their own tissues. Other investigators have produced evidence to show that pcb's are simi lar to ooT in their activity. Dr. Joseph Street a t Utah Stats University has shown that when pcb's accumulate in the liver, they induce microsomal en zyme activity by bringing about more rapid metabolism of drugs, insecticides, and other foreign compounds. He fed rats a diet containing 50 p.p.m. of Aroclor 1254 or Aroclor 1260. After 10 days on this diet, the test animals were administered hexobarbitol at a dose of 100 p.p.m. to induce sleep. In comparison with a control group, the sleeping time for these rats was reduced by 65 to 80% . Street also found that Aroclor, when fed at the i same level, will reduce dieldrin stor age in adipose tissue by 90 to 95% ; in crease aniline oxidation by 200 to 300%; and increase epn dtoxication by 430 to 470%, In addition, the pcb's cause activation of organothiophosphate compounds, which adversely affeet the system. This latter effect coun terbalances the detoxification of diel drin. \ ;! Normally, when a substrate activates an enzyme, it is converted to a watersoluble form that will be eliminated from the system; however, this is not the case with pcb's. Because they re main in the system for prolonged periods of time, their enzyme ^induction activity is always present. In* this way. the normal concentration of important body chemicals may be lowered ^o the) ( t i Eaifroacnmtal Sri-- * TedMiecr i point of bringing about malfunctions in the system. For example. Street be lieves that the pcb's bring about steroid degradation, which can lead to altered endocrine relationships. The chronic toxicity to man is ai follows: Like the chlorinated naphthalenes, the chlorinated diphenyls have two distinct actions on the body, namely, a skin effect and a toxic action on the liver. The lesion produced in the liver is an acute yellow atrophy. This hepato-toxic action of the chlorinated di phenyls appears to be increased if there is exposure to carbon tetrachloride at the same time. The higher the chlorine content of the diphenyl compound, the more toxic it is liable to be. Oxides of aated diphenyls are more ADM 002^0* I I toxic than the unoxidized ma terials. The skin lesion is known as chioracne, and consists of small pimples and disk pigmentation of the exposed areas, initially. Later, comedones and pustules develop. In persons - who have suffered systemic intoxication, the usual signs and symptoms are nausea, vomiting, loss of weight, jaundice, edema, and abdominal pain. Where the liver damage has been severe, the patient may pass into coma and die. Sax. ,V. Irving, "Dangerous Prop erties o f Industrial M a t e r ia l s , " 3rd ed-. V a n N o s tra n d -R e in h o ld , N e w Y ork, 1968. The ubiquity of pcs's is related to the wide spectrum of applications that have been found for them. The largest single use of pcb's is related to their electrical properties-- as coolant-insulation fluids in transformers. For this purpose the Aroclors are also sold under such trade names as Chlorextol (AlUs-Chalmers Mfg. C o.), Dykanol (Federal Pacific Electric C o.), Inerteen (Westinghouse Electric Co.), Noflamol (Wagner Electric Co.). Pyranol (General Electric Co.), and Therminot (Monsanto Co.). Other uses of pea's include formula* tion into ballasts for fluorescent fix* tures; impregnation of cotton and as* bestos for braided insulation of elec trical wiring; a plasticizer in wire and cable coatings; capacitors and askareltype transformen; and plasticizen of vinyl ch'oride polymer films. Because of their thermal stability and fire re sistance. the Pea's also find application in high-pressure hydraulic fluids, spe cialized lubricants and gasket scalen, heat transfer agents, and machine tool cutting oils. Miscellaneous uses in clude: formulation into some epoxy paints; protective coatinp for wood, metal, and concrete; adhesives; and in carbonless rep red u tisf paper. One of the primary manufacturers of carbon less reproducing paper also sells Aroclors in an encapsulated form. Generally the kinds of applications described above mean that the pcb's will be in many types of products that eventually find their way to the domes tic market. When used In manufacture of ballasts for fluorescent fixtures they will be found in kitchens, bathrooms, stores, and offices throughout the coun try. Wherever office forms are used that do not use carbon paper, one may find pcb's formulated into the micro capsules of dye that comprise the re- Oat chromatogram A is of a standard pesticide mixture, S ii typical of Aroelor 1254. and A + 8 is tha chromatogram [of a 50 : 50 mixture of both. Tha concentration of Aroelor 1254 is approximately 10 times those of tha pesticides in A, hence it is un- derstandable why PCS's ware not readily!recognized in pesticide chromatograms. Gas ehromatograph (Packard 7620) conditions: gas flow 80 ml./min. nitrogen: tern* peraturas oven. 210* C.. inlet) 230* C..jdetactor. 218* C.; Ni* electron capture detector S' x Vi" glass column packed with 87 SE-30 on Chromosorb Q 80-90 mesh. I FfUMTOd producing layer of the business! form, pea's have also been found on the transparent receipts used in credit card charge forms. As plasticizers they can be expected to appear in many con sumer plastics. t Since the chronic toxicities are so significant, it becomes important to know just how extensively the j pcb's are distributed in the ecosystem, and just how they find their way into ; the environment. Rainwater in En* ' gland, brown seals off the coast of j Scotland, white-tailed eagles in Swe, den, cod in the Baltic Sea. mussels in The Netherlands, adelie penguin eggs ! in the Antarctica, brown pelican eggs in Panama. Arctic terns, shrimp in Florida, river water in Japan, waten | in the Great Lakes, human hair, and human adipose tissue--samples of all \ these have been found to contain pcb's. VdltfMi Mti in n . I rthus m iking them a class of widely dispersed pollutants. H-- dilyafcM rts* The properties of pea's that make them industrially -useful are the same properties that cause them to persist in the euvirotunenL These in clude thermal stability, resistance to oxidation and hydrolysis, solubility in a wide range of organic solvents, water insolubility, high dielectric constant, and compatibility with many types of macromolecules. Their resistance to oxidation and hydrolysis also makes pea's more stable and persistent than ddt. Consequently, they could even tually accumulate to a higher concen tration than ddt, especially if the use of ddt is sharply curtailed in the U-S. The solubility of pcb's in nonpolar solvents explains why they are readily absorbed into fatty tissue and into the liver. Their resistance to oxidation or other types of chemical degradation explains iheir persistence in the en vironment and accumulation in animal tissue. The latter effect is enhanced both by their insolubility in water and solubility in organic solvents. Their chemical inertness and resistance to metabolism account for their low acute toxicity. But as they slowly build up in a living system their con centration approaches toxicity levels, at which point chronic effects make themselves evident It has been established that fish-eat ing birds will accumulate large concentiations of pea's, as in the case of the white-tailed eagle, which has been found to have as much as 14,000 p.p.m. of pcb's. Peregrine falcons, taken off the coast of California, were found to have as much as 2000 p.p.m. in their lipid tissue. When shrimp were exposed to 10 p.p.b. of Aroclor 1254 for 48 hours, they accumulated 1300 p.p.b. of pcb's, which represents a 130-fold con centration ia a very short time. Oysters, exposed to tfl identical concentration of Aroclor 1254 for 96 hours and then placed in pea-free water for four days, still had a concentration of 33,000 p.p.b. of pcb's, which constitutes a 3300-fold concentration. This means that even though the concentrations of pcb's are in the parts-per-billion range in the environment, their high lipid solubility causes them to collect in fatty tissues of lower animals and marine life. Therefore, species at the top of a food chain will also accumulate p c i's in their bodies, particularly in their lipid tissue and liver, in much the same SIS Eaiiftm--Ml Snm n * Tvrtviilny ii way as they accumulate dot and other ! gators find that the concentration of chlorinated pesticides. | pcb's in the environment is as high as Because of the low solubility of pcb's that of dot. in water, when a solution or dispersion There are several ways by which of them is discharged into a river or pcb's get into the ecosystem. One of lake, they will accumulate on the sedi these is by incineration. Products con ment in relatively high concentrations. taining pcb's, such as carbonless re Subsequently, they will redissolvc very producing paper in business forms, slowly in the water as conditions plastics (especially polymer film and change. Therefore, it will usually take sheeting that contain pcb's as plasti a long time to flush out a contaminated cizers). spent ballasts from fluorescent area. light fixtures, and objects coated with Act!dental eccurrenee pcB-formuIated coatings, all find their way to the city dump or incinerator The reason that pcb's have not been for burning. The pcb's do not bum but found in the ecosystem as extensively \ are vaporized. They are then carried as dot, and are not present in environ- | into the atmosphere, where they collect mental samples at as high a concen- on particulate matter and are subse tration as dot, is that pcb's find their : quently returned to the surface of the way into the environment accidentally. J earth, into the rivers, lakes, and oceans. ddt is deliberately spread because this | In this way they become widely dis is the only way its insecticidal proper- I tributed throughout the global environ ties can be utilized, pcb's arejnot in- ment. Another source is probably land tended to get into the environment, but , run-off from industrial wastes and they do because their unique chemical dumps. A third source is the point of properties prevent them from being de manufacture and the plants where stroyed by our usual waste disposal \ pcs's are processed into other products. methods. Thus, they inadvertently es- ' They can escape through the plant ven cape and become widely dispersed. tilation and exhaust systems into the In Sweden, where the use [of dot atmosphere and through its waste treat has been banned, and where the main ! ment system into sewen or directly into power source is hydroelectric, [investi- j II ADM Q02A6 I It is interesting to note that the inci dence of p c i's in environmental sim ples is highest in industrialized and ur banized areas. Birds whose primary habitat is the San Francisco Bay area have a larger'Concentration of pca s per unit of body weight than those lo cated in Baja, Calif., which is com pletely rural. Aquatic life in the Archi pelago of Stockholm, the most indus trialized area of Sweden, were found to have a higher concentration of pcb's than fish samples taken from the west ern coast of Sweden, a less developed area. Sediment samples taken from -outhern portions of Lake Michigan nave a higher concentration of pen's than those from other parts of the lake. Monsanto states that until a recent change in marketing policy (see inset, page 814), sales of Aroclors were in creasing at the rate of 8% per year While this increase does not seem sig nificant, it may be important if the in:reased consumption was in consumer products and thus would find their way into our normal solid waste disposal *ystems. Such an occurrence would mean a definite increase of pcb residues m the environment, and therefore a marked increase in their chronic tox icity effects. Detect!art pcb's were not discovered in environ mental samples until very recently for several reasons. First, as indicated above, they have not been deliberately distributed about the ecosystem. Sec ondly, because of their relatively low acute toxicities, their presence was not immediately evident. Finally, they are difficult to detect analytically. The pcb's were first detected as in terfering peaks in the gas chromato graphic analysis (OC) of environmental samples being analysed for chlorinated pesticide m id i-- When p e t's are pres ent in a sample they give a pattern of several gc peaks, whose retention times are similar to thosa of dieldrro, o ar. doe, sldrin, and heptachlor oxide. Be cause the peaks were not large or sharp, investigators tended to ignore them until S. Jensen, in Sweden, and R. Risebrough, at the University of California at Berkeley, identified them as corresponding to common constitu ents of environmental samples being analyzed for persistent pesticides. The problem of the interferences of pc i's with the analysis of other chlori nated pesticides has been largely over come by prior treatment of the sam ple. Several investigators have used column chromatography to separate pcb's from chlorinated pesticides. At a' recent meeting, sponsored ] by the' fwqa's National Water Quality Lab-, oratory, Duluth, Minn., a general pro-< cedure was recommended for spara-! *tion of pea's from pesticides! In this, 'procedure for biosamples, the sample \s extracted with hexane as in regular j pesticide analysis. It is then partitioned wjth acetonitrile to remove fats, the cleaned-up extract is passed through a i Fluorisil column and then through a silicic acid column. Finally, the sam ple! is analyzed by gas chromatography, with a chloride-specific detector. In this way the pesticides are retained on the 1 silicic acid column for later elution and identification. Research To assess fully the significance of pcb's as environmental pollutants, ad ditional research is needed. No one really knows the extent of thejchronic effects of these chlorinated hydrocar bons. Some problems that need to be considered are: j Although pcb's are known to ac cumulate in human organs wej do not know at what concentration they will begin to exhibit toxic effects. Will these chronic effects be similar to those shown in animals-- microsomal en zyme activity, calcium metabolism in hibition, and so on? What ate other possible chronic effects? | Which of the many re s com pounds in the commercially available mixtures are responsible for their tox icity? Can commercial PCS mixtures be modified to eliminate the toxic com ponents? Pure samples are required to answer these questions. At the present time work is continuing at the Vwqa's Southeast Water Laboratory to sep arate each of the A rodor mixtures into its many components, and to identify each component. | We need to know all the uses for the pcb's. What is the annual produc tion of pcb's? Our knowledge of these facts is limited and needs to [be ex panded. These facts should be [known if we are to accurately determine how they get into the environment; and take steps to prevent further environmental contamination by them. In view of the complexity of the isolation and accurate quantitative analysis of fob's in chlorinated resi dues. a straightforward, unambiguous measurement of them needs to be de veloped. What is the fate of fob's in nat ural waters? More needs to be known of their partition coefficients between bottom sediments and water. This is vital if we are to estimate how loag it will take for a river bed to clean itself of contamination. It will also be useful when assessing the effecti of pcb's an marine life that feed on the bottoms of lakes, riven, and estuaries. We should also learn more about pcb solubility in water of various ionic strengths. Are present waste treatment sys tems adequate to handle p c i's? Do spe cial measures need to be taken when pcb's are part of the waste effluent be ing treated? By trying to get some of these an swers now, we may find that we are in a position to control (he escape of pen's into the environment before ad ditional damage is done. So frequently, action is taken only after it is evident that massive damage has resulted from a particular pollutant. In the case of the pcb's we may have an opportunity ro resolve the situation before that happens. AdditionalReading Hubbard. H. L, "Chlorinated Biphenyt and Related Compounds." Encyclo pedia of Chemical Technology, 2nd ed.. 9, Interscience Pubi., New York, N.Y.. 1964. pp. 289-298. Reynolds. L. M.. Bull. Environ. Content. Toxicol. 4.128 (1969). Risebrough, R. N., et. af., Nature 220 (1968). Fani tog d\ a Cari G. Gustafson, chairman of th Department of Chemistry of King's College. Briareliff Manor. N .Y., re ceived a Ph.D. in organic chemistry from the University of Delaware in 1937. During the 1969-70 academie year, he was on leave at the rwQ* Southeast Water Laboratory in Athens, Ga.. where he studied trace organic analysis in waste effluents. As a mem ber of the National Water Contami nants Characterization Research Pro gram. he worked with pcs'jt and pulp and paper mill effluents. I I I I II ! IN -THE SUPERIOR COURT OF THE STATE OF DELAWARE IN AND FOR NEW CASTLE COUNTY MONSANTO COMPANY, a corporation of the State of Delaware, Plaintiff, v. C.A. No. AETNA CASUALTY AND SURETY COMPANY; ALLSTATE INSURANCE ) ) NON ARBITl RATION CASE COMPANY (as successor to ) J NORTHBROOK. EXCESS AND SURPLUS ) I COMPANY, formerly NORTHBROOK ) INSURANCE COMPANY); AMERICAN ) CENTENNIAL INSURANCE COMPANY; ) AMERICAN HOME ASSURANCE COMPANY; ) I AMERICAN MANUFACTURERS MUTUAL ) INSURANCE COMPANY; APPALACHIAN ) J INSURANCE COMPANY; ASSOCIATED ) INTERNATIONAL INSURANCE COMPANY; ) BIRMINGHAM FIRE INSURANCE COMPANY OF PENNSYLVANIA; CALIFORNIA UNION INSURANCE ) ) ) i j COMPANY; C.E. HEATH COMPENSA- ) TION AND LIABILITY INSURANCE COMPANY; CERTAIN UNDERWRITERS ) ) I AT LLOYD'S, LONDON, AND LONDON ) MARKET INSURANCE COMPANIES; ) j COLUMBIA CASUALTY COMPANY; ) CONTINENTAL CASUALTY COMPANY; ) I FIREMAN'S FUND INSURANCE ) COMPANY; FIRST STATE INSURANCE ) COMPANY; GRANITE STATE ) INSURANCE COMPANY; HARTFORD ) ACCIDENT AND INDEMNITY COMPANY; ) 1 THE HOME INSURANCE COMPANY; HUDSON INSURANCE COMPANY; ) ) I INSURANCE COMPANY OF NORTH ) AMERICA; INSURANCE COMPANY OF ) THE STATE OF PENNSYLVANIA; ) INTERNATIONAL INSURANCE COMPANY; ) LEXINGTON INSURANCE COMPANY; ) "i LIBERTY MUTUAL INSURANCE ) COMPANY; NATIONAL CASUALTY ) COMPANY; NATIONAL UNION FIRE ) "T INSURANCE COMPANY OF PITTSBURGH; ) NEW ENGLAND INSURANCE COMPANY; ) i; NORTH STAR REINSURANCE CORPORATIO N ; NORTHWESTERN NATIONAL INSURANCE COMPANY; PA CIFIC EMPLOYERS INSURANCE COMPANY; PROTECTIVE NATIONAL INSURANCE COMPANY OF OMAHA; ROYAL INDEMNITY COMPANY; S T . PAUL SURPLUS LINES INSURANCE COMPANY; TRAVELERS INDEMNITY COMPANY; UNIGARD SECURITY INSURANCE COMPANY; UNITED STATES FIRE INSURANCE COMPANY; a n d WAUSAU UNDERWRITERS INSURANCE COMPANY, Defendants. ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) CERTIFICATE OF NON-ARBITRATION I , RICHARD E . POOLE, ESQUIRE, a t t o r n e y f o r p l a i n t i f f , h e r e b y c e r t i f y i n g o o d f a i t h a t t h i s t i m e , i h ' my o p i n i o n , t h a t !i . this is a declaratory judgment action where the claim is substantially non-monetary and damages are in excess of fifty thousand dollars ($50,000.00), exclusive of costs and interest, ! and that this action is therefore excepted from compulsory arbitration pursuant to Superior Court Civil Rule 16(c)(1). ( POTTER ANDERSON & CORROON 350 Delaware Trust Building PiO. Box 951 Wilmington, DE 19899 i (302):658-6771 I ,] Attorneys for Plaintiff, Monsanto Company (j 1 I ! Fnmw OF COUNSEL: Jerold Oshinsky, Esquire Anderson Baker Kill Si Olick 1800 K Street, N.W. Suite 700 Washington, D.C. 20006 (202) 466-7921 - and- John H. Gross, Esquire Anderson Russell Kill St Olick, P.C. 666 Third Avenue New York, NY 10017 (212) 850-0700 Datedr January^?),' 1988 ! iI | i -3- FiWil *Q8 -- _ ------ -------------- tKTHD S M E S DISTRICT; court! NORTHS DISTRICT CF H U N D I S EASTS DIVISION ttTED STAS CF AK3ICA JCSOT C. OMANDRA, KMSNO L. K P U N S * , FAUL L. WUCHT, and JA>ES B. FLANK, ta. S j c / Z & s - ___________ Violations Title 16, tfuted Stlt CcdeJ Sections 1001, 1341 and 134 The SPECIAL C 1CEER 1980 GOND JUKf charges: 1. At all times material herein, Industrial Bio-Test laboratories, II Inc. (hereinafter referred to as 2BT} did business in Northbrook, Illinois in I 'I the Northern District of U H r o i s and was a .contract research laboratory thich || ccn&jctad animal studies on various drugs, pesticides, chsnicals, end other pjbstvoes, for * jx3Bsor 0 told w l s u n e s , In' order to determine the safety and effectiveness of the s^stances. j . 2. At all times material herein, XEEFH C CALANSRA v&s President Of IBT. I 3 At all times material herein, MEMO L. ror&XETi v&s Stager of Ttodcology at 1ST. 4. FAUL L* KRICZfT was Section Bead for tat Toxicology at IST fron approcisetely Huch, 1971 until Septenber, 1972, at Wiich tine he beugte I; tahtgar of Ttodcology for the Department of Hadiclhe and ttrviiornental Health I il at ftasanto Corporation in St. Zouis, Missouri, f r m approdnetely October, 1972 until the present. | 5. J N S B. FLANK ves the Senior roup Inafler fee tat Ttodm l ogy at IBT until October of 1972, at %hich time he bac& L the Assistant to the A ??* 4 y fenager cf todcology et XBT ficcn eRrodmitel^ October, 1972 ratil April, 1977. - -'* - || ' I .1 .' ZET conijrtrd a too-year chrmic oral todcity study on TrkhloEOcaitanilide (TOC) In albino rats,, XBT 'Study :fitter B9575, for ) i Itonsanto tepefy (tonsanto). TCC is an antibacterial agent used in soaps. Os or about toy 10, 1976, XBT nailed its final {version of the report of i j] the study to tonsento *too submitted the IBT'study report to the United States Food and Etug Adninistration (FIA) with js ccpver letter dated Hay 11, I 'i 1976, far that agency's use in its evaluation of the safety of TCC. 7. XBT ccndicted a 22 sonth chronic oral toxicity study on Naprosyn in albino rats, XHT ,'Study Porter B7922, for Syntec Corporation (Syntax). Naprosyn (also known as naproxen) is a drug used in the treatment of arthritis, to or about March 3. 1972, XBT mailed jits'report of the study to Syntex who submitted the XBT study report to FIA, -with a cover letter dated torch 22, 1972, as part of its application for approval to test Naprosyn on hmans and ultimately market the pso&ctj! (Charegro) Ore study was on Sencor, a herbicide, XBT Study ttrrber 9069, and one on N m c u r , a pesticide, XBT Study Hser 9060. XBT sufanittad the report* of the studies With a cover letter dated August 15, 1972 to ttenagro, |* who mittad the XBT study reports to the united States Brrvixcfmtal Protection Agency QBJO , the Sensor study report by sail on torch 8, 1973 ! 1 end the Honcir study report by n i l on CLrtoher 15, 1975 Both study reports were submitted as part of tosaagco's application for approval to urket these products for use on food Inm 600 ,9. Begiming In or about 1970 and leontiming m t il about July, 1977# in Northbrook, in the Northern District 'of zulinois, Eastern Divisto i* aid e l A e re , c.ocsEPU calandra, VCS3X) X. XETUGDt, PAUL L. WRXSfT, and OAKS B. PUNK I defendants herein together with co-achmers both Io o a end vsOoswn t o the IH grand jury devised end intended to devise e i d e e to defraud clients and i| govwnment agencies by writing and distributing false and fraudulent study [| reports end false and fraudulent emanations !of studies and stiaty reports, , ! l| and by concealing the fraudulent nature of the study reports and eplanattos of studies and study reports, all by nans of |false and fraudulent rcpie- i* I sentattos and concealments, knowing and intending that the representations !\ and conoealnents were false when code. ! ,i 10. Zt was a part of the achere to defraud that the defendants wrote and distt'ibuted false and fraudulent animal study reports to clients who caimissicnad the studies, *&ich study reports were admitted by the clients to government agencies that evaluate |such reports as pert of their detexainaticn of the safety of those test aaterlalsi , *" | U . it was further a part of the schsne to dffrwri that the deforients provided ItA with false and freuAilent written sutznissiens which reaffirmed and made new false and freudulent statsnents as to seterlal facts, and concealments airi emissions of material facts in] or pertaining to# the i studies and study reports. j 12. Zt was further a part of the achaae to defraud that the -3- Fomiti '/L0P original version o f the ICC otuty report m s v ritte i n j d iatrib rtal ty JBT to M nunts on or about Iferdi 21, 1974. SET auhsittaS thi* v en lo i of tic TO^report to FDft on Decailm 12, 1976, iich ataty report tie | . ;| defendants feiew to be false and fraudulent In that the study report: s. stated that the data' reported were fren aninals that had been on the study for 24 norths, then defendants then Jmew tint the | !| report Included data froa a substantial ninber of erdnals that ted been on the study for significantly lesser periods of tine; b. stated that 460 aniiMls were in the study then defoliants then foa; that a substantially greater oxter of animals were also part of the stu^; and c. contained an Aniiral tortality Table (Table IV) thich I 'I defexJants then taiev to be false in that it substantially under-reported the ranter of aninals that were in the study and the nzrtex of animals that died during the stud(y. 13. It was further a part of the adhere tb defraud ttet the fi version of the TCC study report was written in Aps'^xj and fey, 1976 was dated Kirch 21, 1974, and was nailed to fensanto fcylBT on or about fey 10, 1976, was submitted to FDA by fensanto under a cover letter dated fey 11, 1976, and was foown by tefendants to be false and fraudulent in that the study reports a. stated that the data reported froa aninals that had batn on the study for 24 tenths, when defendants then IM that the repeat included data ficp a substantial oxter of animals that had been on Ii the study for significantly lesser periods of Itioe; \ b. stated that 480 aninals in the study then defendants - 4- r a n i cn*2 f t P f i .-7 100 jo n then taaw that A substantially greater Of the Study; 1 of animals text l c. contained an Animal totality Table (Table IV) Wi i * defendants then taaw to be false in that it substantially wrier-iapartad the ru rte s of animals that w r e part of the study and the nxrter of animals l that died dtoing the sb^y,* j i d. stated that 250 extra animals were on the stody for 24 months and were an Independent IBT "research" groupi separate fron the animals reported in the TCC study, W^en defendants then taew (1) that the so-called "research" group animals were not ah independent "research* croup, but were used as a source of extra animals and animal for I . !| the TCC sbi3y; (2) that the so-called "research" animals had 'been on stody i .'i for significantly lesser periods of tine than 24 scnths; and (3) that a substantial lurtier of the ectra animals were ocrmingled into, and reported as pert of, the TOC study gioip>; i e. stated that no histcpathDl^oal:amination (sbidy of tissue characteristic of animal disease) was performed on the lied "research" group animals, whsi defendants then b w that tissues from many i| of the ao-called "research" groip animals had laeen so easnined; f. omitted and concealed the ladings listed in a table of "Histopathological Ganges in Testes -- Poslaorteal Animals", W a n defendants then l o w that the table edsted; i g . stated that postmortem autolysis;(chemical deterioration of tissue after animal death) of testicular tissue precluded meaningful histopathologic evaluation of the tostinilar tissues of the posirorta n animals, W a n defendants then Y x& that many of those tissues had been ao Fnniisna a -5- W f.t 1 0 0 ' j `] \) ecznined and gradadj . . . * ~ h. stated that the 2BT pathologist, Dr. Ccrovan Ctete, cxaoined the tisvi.ys of the study aninals arid coneliried toat t* tirdlngs l1 . in the testes of the lowest dose levt, (T^) anin&ls were indistinguishable fran the findings of the testes of the control group anisis then defendants then ) w that Or. Gorton's conclusion vas that there were ICC related toxic | I effects in the testes of the anmls in the louest!dose level; and i. omitted and ccnoealed, as defendants then k r& t, that Or. Williacn Ribelin, a pathologist hired by Hsosant, had examined acne of the testicular tissues of the TCC study animals and had concluded that the I! lowest dose level showed TOC treataent-related toxic effects. I II 14. It was further a part of the schere to defraud that in response to FEA questions concerning the TCC study,1a written eeplanaticn i . !l of the TCC study and report# dated Decerber 12, 1976 was prepared and subnittad to FDA. by JBT on Ba a t er 14, 1976, whidv emanation defendants then b w to be false and fraudulent in that the sutiaissim; I !l a. stated that the data reported in the Itay, 1976 report (dated torch 21, 1974) were f a n aninals that had been on the study for 24 sonths# When defendants then b w that toe report Included data tore a substantial zurber of aniiuls that bad been on the itoty for aignifiantly i l e t ear periods of tine; b. concealed, as defendants then Jow, that the anisel sortality in the TOC study was substantially greater than reported in any i version of the rtajSy report; " * c. stated that 250 metre anioals were an the stuty for 24 sontos and were an independent 1ST "research* grxpj separats fraa toe Faaicna - 6- 100330 animals reparted in the TOC study/ when defendants then te*w (D that tte >" animals ^ z e rot an independent "research" gtbip, but ufe! u a of extra animals and anlzoal tissues for tie ice study; (2) that the -called "research" animals had been on study far significantly lesser periods of tine than 24 Barthsand (3} that a | i] substantial nrber of the extra animals Mere cominglad Into, aid as part of, the TCCstudy group; l| | I T |d. concealed that histopathologic ecsniiMtlons were performed on. a substantial nxrber of the ao-called "research" animals, Uien defendants thenb w that sudi nominations had beei performed; and i || e, omitted and concealed, as defendants t h & taew, that Or. William Ribelin, a pathologist hired by Hansanto, had eomiried of the testicular tissues of the TOC study aninals and had carloVd in a written li report that the lowest dose level shoved TCC treatment-related toxic effects. 15. It was further a part of the schism to defraud that the final i; study report on Kaprosyn, dated January 4, 1972, was written by 2FT and was - i| received through the nail by Syntex froa 1ST on' or about Kferch 3, 1972, and submitted to the FIA by Syntax under cover letter dated Mardi 22, 1972, which report defendants then ) m to be false and fraudulent In that the report: a. contained individual animal and sixmary animal data or about the time of final aasifice of the study, %tei defendants than Smew that no audi tests had b a n conducted and that the data was fabricated and false; and b. was supplanted *n Appendix S %4dch was submitted to FDA by Syntac cn April 9, 1974 %*iich purport*sd to represent, econg other things, all the findings frers gross examination of thJ stuify anicels, when - 7~ FfiillfcAS 1 A rff.iO 1 0 0 `j 'J T defffdAnts then knew that for e substantial portion of tte gross fiiriings for postmortem animals, so such oarainatims were performed and tbs fiMiies ware fabricated and false. 1$; Zt was further a part of the achrc to' that in j response to FDA questions raised in Septecber, 1976 concerning tte Naprosyn study, a letter si^md by Joseph C. Cfclandra and an plAMticn of the Naprosyn study dated November 11, 1976 m s written and submitted to FXA, and a copy wls mailed to Syntax inder cover letter dated Nbvsrber 17, 1976. Defendants then knew that the No/erb a t 11, 1976 submission to the H A was false and fraudulent In that the submission: { i a. stated that the data reported for individual aninal and siTmeiry aninal blood and urine values allegedly collected cn or about the tine of final sacrifice of the study tere accurate, +hen defendants t; then toew that the data were fabricated and false; aid b. stated that gross examinations were performed cn tha ;| postmortem animals and that the data from those examinations reported In Appendix ZZ w r e obtained iron animal cage cards and animal disposition *i sheets, when defendants then J e w that for a substantial Timber of the I repor ted postnorteni animal findings no gross ecaminations were perfoared and the data were fabricated and false. 17. Zt was further a part of the setene to defraud that 3BT ;| prepared and mailed to Checagio final reports far the Sejoar and Nonacur submitted the XBT Sencor study report to EPA by m i l on or about Jbrch 8, 1971, and submittal the XBT Naracur study 1 report to C A I by mil on o r about ! ,| October 15, 1975, **ich reports defendants then knew to be false and - S- 11 i oo j j +' K I < fraudulent la that each report* iI | ~ a* stated that all the mice on the study were fed the t- i1 ' test material for 18 months, %hen defendants' taew that (1) tte study only ran'for 14 xronths; and (2) the mice sacrificed andlexamined at the erri 1 1 of the study included a substantial ranter of mice which had been fed the test material 14 months or less; ' i 1 i b. contained a Mortality Table tfiich defendants then taew substantially under-reported the nrrber of animals that were on tte study and the rasrfcer of animals that died during the stu3y,; | >| ! c. concealed that a larger ramber of ectra mice jwere **3*3 to and were a part of the study; and | d. stated that there was a third positive control group I1 ! fed benzedine, when the defendants then ta that no such control igroup had ! been conducted with these studies. 18. It was further s part of the scheme tb defraud that S T I ;l | wrote an "Addendum Report to Csnagro" regarding the Senoor study report l ;i | and railed it to Cheiagro on or about December 21, 1973, which addendum I !| | Chemagro mailed to S>A on or about October 8, 1974, and which defendants knew to be false and fraudulent in that the addeiSms 1. listed the nrrber of days that each mouse was on the soady l i as if tile study had run for 18 scnths, when defendants then l o w that the mice had bean on the study for significantly lesser periods',of tine; 2. emitted and concealed that a<substantially greater rarber -of mice were on the study than reported; and j j i 3. listed for the Individual animals designated as PQII, their ii alleged nunier of days on the study and gxoss pathological findings thidt Fnni infannaticn defendants taew %nj false br m < |no aich positive ccriLcul *i ! it gro> had been e m i t t e d with this tto. * " ! 19* Zt %es further a part of the echone to defraud that an ZBT Ii aixlit vas conducted on the O w a g r o studies In April* 1976 Wiich deososated II that the studies were false, as spfrififd above in Paragraph 17a, and that i :l the defendants concealed the results of this audit fran Chmegro until July, 1977. 20. !; I Zt %as further a part of the schm e to defraud that the United States palls and interstate wire caanrJicatiens were used in furtherance of the schore. ! 21. On or abort ftiy 10, 1976, in the Northern District! of Illinois, Eastern Division, JOSEPH C. CAXAKSR&, HDJSNO L. K7UNCER, PAUL L. W R I G W , and OWES 8 . FIAKK, \ defendants herein, for the purposes of executing the aforesaid defraud, and atterpting to do so, taowingly did cause to be placed in the I1 Uiited States sells the final version of the TOC tuiy report, addressed to: Daniel Itoaan Rsnsanto Oorpany 800 Lindbergh Blvd. St. louis, Missouri to bo sen t and delivered by the thitad States Postal Service according to the directions therecn. In violation of Title 18, Uiited States Code, Section 1341. - 10 - Mini K08 A f P .iS I 1 0 0 'JT i L. y i\ \J r -------- " CCXKT1W *,w SPECIAL'6C3QCR 1980 ( 5 W JUFSf further charge't 1_ Paragraphs Cne through twenty of Count Che of the lndlcbeit are realleged hseln. 2. On or about August 11, 1976, In the Northern District of Illinois, Astern Division, J0OEPH C. OU^DRA, M7FENO L. KOTJNOER, PAUL L. HPJffiT, and JAMES B. FLANK, | <tefendants herein, for the purposes of aecuting the aforesaid schste to defraud, and attarpting to do so, torvingly did oausej to be placed in the Uutad States sails a letter frexn Joseph C. Calandra dated August 11, 1976, addressed to: 1 Dr. Carl M. LeventHal Deputy Director, Bureau of Drugs Dpartirent of Health, Education and Welfare Public Health Service j Ftod and Drug Adainistxatlifln Bockville, Maryland 20852 to be seit arri delivered by the united States Postal Service according to the directions thereon. In violation of Title 18, tfritad States Ode, Section 1141. o - 11 - M P .IH i 10033.7 LJ c a m ihfee ll Th* SPECIAL OCTCEER 1980 GRAND JURf tether charges* 1. Paragraphs One through Twenty of tamt Cfce of this lndictmeit are realleged herein. 2. Cn or about Itovenber 17, 1976, in' the ttorthem District of Illinois, festero Division, | JOSEPH C. CAXANDRA, HDffMD L. FEPLINCIR, PAUL L. vmiffiT, and JAKES B. PLANK, defendants herein, for the purposes of ecuting the aforesaid chore to defraud, and attesting to do so, knowingly did cause to be placed in the Ii ttiited States nails a copy of the written suhraissicn by 3BT to the PDA regarding Naprosyn dated Nwaiter 11, 1976, addressed to: Mr. Virgil 7tai|jsan Syntax Corporation 3401 Hillview Avenue Palo Alto, California 94304 to be sent and delivered by the ttiited States Postal Service according to the directions thereon. ! In violat i m of Title IS, ttiited States Code, Section 1341. - 13- 1001610 i o o y j 'o - -----* - O< cnwro *. 13 SPECIAL OCmtfTt 1580 GRAND JCBtf further charges: - I ; 2. Paragraphs One through Twenty of Count ft of this lnUctsrant are realleged herein* 2* In or about October 1576 in the Northern District of Illinois Eastern Division JOSEPH C. CALANDRA HDK^O L. KEPUNGDt, PAUL L. KRISfT, anil JAMES fi* FLANK j defendants herein for the purposes of eocuting the aforesaid schere to defr&al, and attesting to do so, tervingly did transmit and cause to be i transmitted in interstate ccirceroe, by nans of %dre,conmmicatim, certain signs, signals and sounds, to vit: a long distance telephone call between 2BT and Dr. D.W. Lsrb at Chsragro in Kansas City, Missouri* In violation of Title 18, United States Code, Section 2343* X1 J inniRll -2 3 - aasossa flpp.ns 10033i cxyrnvg 19ft SPECIAL O O C B O i960 B A N D JUPST further charges: 1*. Paragraphs Cbe through Six of Gaunt fre of this indicteent ere realleged herein. 2. At ell tijrtts saterial herein, the Ptcd end Drug Adninistretion CHAO ves en agency of the toited States Gbvenwsnt. I 3. On or about Itay 10, 1976, in Northbrook; in the Northern District of Illinois, Eastern Division, end elsewhere,! JCSSPH C. CAIANDRA, eras l . i m s x z r, PAUL L. H R I W T , end J S S. P1ANK, defendants herein, wilfully end taowingly did make, end cause to be cede, false, fictitious and fraudulent etat&ents end representations as to eaterial facts and concealed and covered up material fasts, in a matter within the jurisdiction of IDA, to wit: "Aeport to Ifcnsanto Cbrtgeny, Two-Year Qironic Oral Ttodrity Study with TOC in JObiitf Bats, SOL 71-8, 11 m x c h 21, 1974, ZBT tb. 9575," W d c h study re .w s euhaittaS to IDA by !I Itensanto rnfer cover letter dated ftey 11, 1976. |The aforesaid false, fictitious eid fraudulent statsoents and representations end emissions as to eaterial facts ere listed in Peregnph thirteen of Gaunt One of this b d i e t n t end ere realleged herein. In violation of Title 18, ttiitad States Gods,1Section 1001. -14 - FOOl 12 MP.r? 1 as ^ C ttK T SIX the SPECIAL 000331 1980 OttND JUStf furtter! 1 / Paragraphs Che through Six of Count Che and Paragraph Two ! of Cant Five of this indieLient are realleged herein'. 2. Ch or about Decerber 12 1976 in ItortlibrooJc, in the Northern District of Illinois, Eastern Bivisicnl and elsewhere, JOSEPH C. QLANDRA, yam # l . kepunceh; PAUL L. WRIGiT, and JAMSS B. RANK, defendants herein, Wilfully and taowingly did sake, aro cause to be cade, false, fictitious and fraudulent statalents and rejceaentations as to I ceterial farts and concealed and covered tp material,facts, in a natter i> within the jurisdiction of the FDA, to wit: a written explanation to the __ __ l '1 FDA by -XETT regarding pi's "ffeport to Monsanto topany,, ttoYear . Chronic Cfral TCodcity SOjdy with TCC in Albino Pats, BTL 71-6, March 21, 1974, 1BT No. 9575.* the aforesaid false, fictitiois and frau&ilent statorents and representations and emissions as [to oetexial facts are- listed in Paragraph Fourteen of Count O * of this indietaent and are realleged herein. Xn violation of Title 18, Biited States &de'. Section 1001. - 15- M. /f v3 3 CCWT SEVEN The SPECIAL CCTCBD* 1980 GRAND J I K tether 1*; Paragraphs One through Six of ramt Che and Paragraph Two i1 of t o n t rive of this indictment are realleged herein! |] 2 On or about Droarhpr 12 1976, in Northfccotfc, in the i1 Northern District of Illinois, Eastern Division^ and elsewhere, D CSIPH C . CAIANDRA, MDKENO L. KEPUHCERi Pa u l l . WHiarr, and JAM ES B . PLANK, defendants herein, wilfully and taowingly did make, arid cause to be made, false, fictitious and fraudulent statements and represent*tims as to material facts and concealed and covered up aaterial facts, in a matter within the jurisdiction of the IDA, to wit: thej original version of the study report "Report to Monsanto tapany,} Two-Year Oironic Oral Ttodcity Study with TCC in Albino fots, BnJ 71-8, March 21, 1974, (| i 2BT to. 9575", wiuch was submitted along with the written es?lanaticn of the TCC rbjdy to the PDA under ocver letter dated Deoertber 12, 1976 by 2BT. The aforesaid fal, fictitious and fraudulent statements and replantations and emissions as to material facts are listed in Paragraph Twelve of C a n t (be of this indictment and are realleged herein. Zn violation of Title 16, Diitad States GodeJ Section 1001. e inm m 4 -1 6 - fffP.fi I* . .> 1 0 0 'j, coot c o t the SPEQAL OCTCTER 1980 GlAND JUKf further charges: I 1 1* Paragraphs One through Five and Paragraph Seven of Gaunt One and Paragraph Two of Count Five of this indictment are realleged herein. 2 On or about Itovwber 11, 1976,1 in Itorthhrooic, In the Northern District of Illinois, Eastern Division, and elswhere, JOSEPH C. CALANDBA, K O F Q O L. KEFLXNCZR, PAUL L. WRIOT, and J W S B. FUNK, defendants herein, vil fully and taowingly did make, and cause to be vede, I 'I false, fictitious and fraudulent statorents and representations as to material facts and ooroealed and covered up material1facts, in a matter within the jurisdiction of the FDA, to wit: a letter and written e^lanation to the FDA prepared and submitted by XBT dated Itovenber 11, 1976 regarding the XBT stucty report on Naprosyn called: Report tD'ISyntoc Research, Division of Syntax Corporation, 22-itonth ttxonic Oral Toxicity SOxfy with BS 3540 Albino Pats, Jaruazy 4, 1972, XBT Ns. B7922"J The aforesaid false, fictitious and fraudulent statarents and lcpiesentatlcns and emissions as to Mterial facts are listed In Paragraph Sixteen of Count Coe of this indiefeent and are realleged herein. Xn violation of Title IB, ttiitad Statles code, Section 1001. 1 A T R BILL: ii* . \1i `!1 1 F, O H E T T r T o ST 1 1l F a n i l s IW ililfSlA IES A X iair -1 7 - 14 f P . 2 . 0 r C /i ! A Retrospective Mortality Study of Polychlbrin ated Biphenyl Manufacturing Workers^* Judith A . 'Zack,. M.P.H.2 David C. Msch, M . P . H . , P h -0,3 ^ M o n s a n t o C o m p a n y D e p a r t m e n t o f M e d i c i -ine and Environmental Health ^Present address: 1751 legend Lane , St. Louis, MO 63141 3P$ent address: Department of Ophthalmology University of Michigan Medical School S T 2 5 1 2 S c o t t T u r n e r B1 d g . , B o x 0 0 4 1010 Wall Street Ann Arbor, MI 48109 FOMK1K 100930 Ou d i cn A. Z a c k / ? ' " j 2 Abstract A r e t r o s p e c t i v e c o h o r t m o r t a l i t y study of w o r k e r s e'xpo.sed t o , p o l y c h l o r i - jL. | F n a t e d b i p h e n y l s ( P C B s ) d u r i n g p r o d u c t i o n o f t h e c o m p o u n d s i;s r e p o r t e d . A t o t a l of 89 workers exposed to PCBs for a minimum of six months during the period from 1945 to 1965 were followed through 1977, and their vital status was deter mined. Comparison of this PCB-exposed cohort's mortality experience with age-, ra ce -, and c a u s e - s p e c i f i c m o r t a l i t y rates of t h e U. S..male p o p u l a t i o n was performed. Observed deaths were not statistically greater than expected for any of the cancer sites examined. Mo deaths were observed for cancer of the liver or malignant melanoma. A statistically significant] excess of circulatory disease deaths, exclusive of arteriosclerotic heart disease, was observed in white males. Fonifii*7 J u d it h A . -Zack/Page 3 The term "polychlorinated biphenyls" (PCBs) describes a group of mixed c h l o r i n a t e d b i p h e n y l s w h i c h tfary in c o n s i s t e n c y f r o m l i g h t , f r e e - f l o w i n g liquids to crystalline and non-crystalline solids, depending on the degree of iI chlorination. PCBs have been in commercial use since 1929. Their dielectric properties, resistance to oxidation, acids, bases, and other chemicals, and j thermal stability have made them useful for many appflicati ons, particularly 1n i t h e p r o d u c t i o n o f c a p a c i t o r s a n d t r a n s f o r m e r s , a n d i n t h e 'i n s u l a t i o n o f e l e c - trie cables and wires. R e p o r t s o f a d v e r s e h e a l t h e f f e c t s i n m a n i n i t i a t e d f r o m s e v e r a l `- i n c i d e n t s o f a c c i d e n t a l h e a v y e x p o s u r e t o P C B s . A p r o c e s s c h a n g e ini a ch em ica l- p l a n t introduced an unspecified PCB compound (Arochlor) into the work environment, resulting in exposure of 14 workers to estimated breathing zone PCB levels of 0.1 mg/m^.l Chloracne developed in one-half of the exposed workers, and liver function tests shoved a borderline abnormality in one of the seven affected iI workers. After 13 months of follow-up, the chloracne had disappeared, but the j liver function abnormality, although improved, remained. Accidental ingestion of rice oil contaminated wi th PCBs has resulted in several outbreaks of common symptomatology, reported .from u apan ("Yusho" disease)^ and Taiwan '("Yu-Cheog" disease).3 The most commdn acute symptoms <j observed were hyperpigmentation and acne-like lesions , discharge from the eyes, neuroendocrine disturbances, emesis, and diarrhea. There was a dose-response i i relationship between the amount of oil ingested and the proportion of persons t\ reporting symptoms. After six years, many of the patpentS' still i l symptoms as headache, stomach pain, numbness of the extremi ies, i reported such arthralgia, and respiratory symptoms.^ Although massive ingestion of P CBs occurred in these incidents, analysis of the cooking oil in the Yusho episode shewed that Knni 818 1 009-?2 kJ': n J u d i t h A. Zack/rage A ti polychlorinated dibenzafurans5 and p o l y c h l o r i n a t e d j q u a t e r p h e n y l w e r e co- i "* c o n t a m i n a n t s . A n a l y s i s o f b l o o d s a m p l e s f r o m p a t i e n t s i,n b o t h i n c i d e n t s , a s well as liver and Adipose tissue from Yusho patients, snowed the presence of these compounds along with PCBs.? 8 These co-contaminants obscure the rela. t i o n s h i p o f P C B s t o t h e s y m p t o m s r e s u l t i n g f r o m i n gI e s t i o 1n o f t h e c o n t a m i n a t e d rice oils. The Yusho incident served as a stimulus to a 1arge number of toxicolcgi- cal studies dealing with, the health effects of PCBs. Chjonic toxicity studies of PCBs in mice and rats have shown hepatic effects ranging from hyperplasia to w e l l - d i f f e r e n t i a t e d h e p a t o c e l l u l a r c a r c i n o m a s f o i l oIw i n g , `It h e i n g e s t i o n o f v a r i o u s PCB-containing diets.9 10 Studies of human exposure to* PCBs have shown that body burdens are directly related to the level of etposur e to PCBs.11. 13 !i Korbidity-studies have focused on the effects or PCBs on! the skin, liver, blood . ' | chemistry', an d o t h e r s y s t e m s . 1- 1 Ch l c r a c n e , d e rm ati ti s, m i l d l i v e r func- tion abnormalities, and increased triglycerides levels weVe reported with some consistency from these studies. I i M o r t a l i t y s t u d i e s o f o c c u p a t i o n a l l y - e x p o s e d i n 'd i v i d u l a l s h a v e n o t y i e l d e d i ` 1 co nsisten t results. A preliminary r e p o r t ^ addressed an increase in deaths due !' tp malignant melanoma (2 obs. vs. 0.04 exp.), which occurred in a group of 51 research and development and 41 refinery workers at a Hew Jersey petrochemical plant. Another author commented on problems in defining Exposures in this | ; ij st ud y.13 in a study of 2567 ca pacitor plant workers exposed to PC Bs ,!9 l >1 excesses of liver and rectal cancer deaths, which were not statistically sig- ! 1I nificant, were reported. Although few deaths were available for analysis by i 1 duration of exposure and latency, there was no trend by these measures for liver.cancer deaths, and a slight increase by latency but* not by length of in m m a 10093;! II Ju d ith A. Zack/Page 5 e x p o s u r e f o r r e c t a l c a n c e r d e a t h s . A n o t h e r s t u d y olf 1 3 1 0 w o r k e r s f r o m a c a p a c - 1 itor-manufacturing plant with at least six months employment between 1946 and 1 9 7 0 f o u n d s t a t i s t i c a l l y s i g n i f i c a n t e x c e s s d e a t h s f' r o m a ;ll l c a n c e r s ( i n m a l e s ) and all causes (in fe males).2 Suggestive, but not statistically significant, excesses were noted for deaths due to digestive system cancers (in males) and malignancies of lymphatic and hematopoietic tissue in males and females). No deaths were attributed to liver cancer or malignant melanoma. Due to the rela:| tively young age of this worker cohort and the resul tant small number of deaths (n = 27), site-specific excesses were based on two or three deaths; therefore, ii further study of this cohort was proposed by the authors.! i At about the time of the initial report dealing with the mortality experi- ence of an occupationally-exposed worker cohort, a prelimi nary review of the mortality experience of Monsanto workers involved in1 the production of PCBs was carried out. The present study represents a completed: analysis of this w o r k e r c o h o r t ' s m o r t a l i t y , w i t h p a r t i c u l a r a t t e n t i o n i g i v e n! t o o v e r a l l c a n c e r , liver and pancreatic cancer, and malignant melanoma. Materials and Methods During the period from 1936 to 1977, PCBs were manufactured at Monsanto Company's Sauget, Illinois plant. Throughout this period,; the process of m a n u f a c t u r e r e g a i n e d r e l a t i v e l y u n c h a n g e d . T h i s p r o c e s s , jin b r i e f , i n v o l v e d \I the batch chlorination of biphenyls in the presence of iron and iron chloride catalysts. The crude mixture produced in the chlorinators' was then aerated, distilled, earth treated, filtered, and transferred to storage tanks before shipping. While no industrial hygiene monitoring data were available to quan- i II ti fy the PC B- exp os ur e levels during the stuay time, in te rvi ew s wi th plant i I 1 personnel established the fact that PCB exposure levels did not vary consider a b l y w i t h i n t h e P C B d e p a r t m e n t . T h e r e f o r e , a l l w o r k e r s i n !,t h i s d e p a r t m e n t W f 20 i 100931 Judi th. A. Zack/Page 6 -were c o n s i d e r e d to h a v e a c o m m o n e x p o s u r e t o P C B s , a s we.ll as o t h e r c h e m i c a l s used in the department, including hydrochloric acid, trl- and tetrachloroh^n- zene, biphenyl, and-chlorine- gas. i j All male employees from the hourly roll who worked in the PCB department for at least six months between January 1 , 1945 and December 31, 1955 were i selected for the study. By use of the plant's coiqputerized work history system, union records, and manual work history verification , 89 male, hourly employees m e t the criteria for inclusion in the study. The vjtal status of 98.9 (88) of t h e c o h o r t w a s d e t e r m i n e d a s o f D e c e m b e r 3 1 , 1 9 7 7 , u s i n g 's t a n d a r d f o l l o w - u p techniques. Table 1 summarizes the results of the vital 'status tracing. A death certificate was obtained for each person found to be deceased, and coding -- - I or the un d e r l y i n g cause of death wa s p e r f o r m e d by an . e x p e r i e n c e d nosologist, using the International Classification of Diseases, Adapted, Eighth Revisi on.21 Using a computer program developed for such an applicati on,22 the observed nu mb er cf deaths among PCB wo rk ers wa s co m p a r e d with* those expected based on age-, r a c e - , and c a u s e - s p e c i f i c m o r t a l i t y ra te s of Uj.S. m i l e s . T o c o m p u t e ex pected numbers, person-years of observation were allocated to five-year age and c a l e n d a r ti me c a t e g o r i e s an d r u l t i p l i e d by correspond'ng race- a n d cause- se ed fic death rates for U.S. males. The resulting quanti ties were summed cver all ages and ye ar s to obtain the total expected numo; rs. Ratios of ob- served to expected number of deaths were expressed as standardized mortality r a t i o s ( S'-'.Rs) - S i g n i f i c a n c e t e s t i n g o f t h e S M R s w a s jp e r f o r m e d a t t h e 5 % l e v e l , | . i( assuming that the observed number of deaths follow aPoisson distribution.23 Results Of the 83 PCB workers for whom vital status tracing was successful, 58 v;ere v e r i f i e d living and 30 w e r e v e r i f i e d deceased, p e a t h c e r t i ficates were Fhnifi2l 1 0093-> F 't j n J u d i t h A . la c k / P a g e 7 obtained for each of the decedents. The person-years of observation contri- buted by the entity worker cohort are shown in Table 2. : A total of 1800.1 person-years were Observed at all ages, with the majority observed in the mi dd le- ag e range (ages 35-60 yrs. contributed 74%, or 1333.1 person-years to the total). Cross-classification of PCB exposure duration with vital status 1 (Table 3) shows that the majority of both living and deceased workers were exposed less than three years. The average length of exposure to PCBs for living and deceased workers was similar, with deceased workers having slightly more exposure time (3.7 yrs. vs. 3.2 yrs., respectively). C a u s e - s p e c i f i c S M R s a r e l i s t e d i n T a b l e s 4 a n d 5 f o r t h e 6 0 w h i 't e a n d 2 9 n o n w h i t e m a l e m e m b e r s o f t h e P C B s t u d y c o h o r t . D e a :hs duje t o m a l i g n a n t n e o - p l a s m s , a s i n d i c a t e d i n T a b l e 4 , a c c o u n t e d f o r 1 1 % '(8) ofi t h e t o t a l n u m b e r o f deaths. No cancer deaths were attributed to malignant neoplasms of the liver or pancreas, or malignant melanoma. While many of the ca icer-specific SMRs exceed 100, none are statistically significant. In[white males, lung cancer accounted for 75% of the deaths due to malignant neoplasms, while no single cause predominates in nonwhite males. Table 5 presencs a brief summary of the eight cancer deaths in the PCB worker cohort. i' Among the non-rrialignant causes of death (Table 6), diseases of the cir- culatory system accounted for almost half of the deaths, For the category of circulatory sjlstem disease, exclusive of arteriosclerotic heart disease, the SMRs for white males and for the total cohort were significantly greater than 100. The excess in deaths due to this category is afccount-ed for solely by the l experience of the white males, since nonwhite males 'showed an SMR of 93. No other causes of death in Table 6 showed observed deaths wh ich were statistically !0093fi I I uUd' tn A. Zack/?age ; j i\ g r e a t e r t h a n e x p e c t e d . T h e . o v e r a l l S M R f o r m a l i g n a n t aria n o n - m a l i g n a n t causes was 131 (30 observed, 22.83 expected deaths). .b rittle difference was f o u n d i n this overall S M R b y r a c e ( f o r w h i t e s , 1 3 3 ; f o r n o n w h i t e s , 1 2 8 ) . ** * Di scussion This investigation dealt with the m ortality experience of a cohort of 89 male workers involved fo r a least six months in the p r o d u c t i o n o f P C B s b e t w e e n January 1, 1945 and December 31, 1955. The only cause of m o r t a l i t y w h i c h showed a s t a tis t ic a lly sig n ifican t excess in observed deat h s w a s c i r c u l a t o r y diseases exclusive of a rterio scle ro tic heart diseasL THi s e x c e s s w a s a p p a r e n t only for white males. Circulatory, diseases in this category included deaths i from rheumatic heart disease, cerebrovascular disease, and other forms of heart disease. If this excess cause of death is not an artifact, one would postulate that t h e r e r a y a l s o b e a r e l a t i o n b e t w e e n r i s k f a c t o r s o fI t h e s e! c i r c u l a t o r y d i s e a s e s a n d P C B e x p o s u r e . B l o o d p r e s s u r e , a r i s k f a c t o r ( w h1e n e li'e v a t e d ) o f c o r o n a r y' heart disease (CHD) and cerebrovascular disease, has been; related to blood PC3 |i l e v e l s in two studies, wi th c o nf lic ti ng results. One study24 found that serum PCS-levels made a statistically significant contribution to explaining the variability of diastolic (but not systolic) blood pressure measurements in multiple regression analyses of data from a community exposed to DDT and PCBs, while another study25 found no such association. Studies! of lipids, which i have been associated with CHD and (with less consistency)! with cerebrovascul ar disease, have considered total cholesterol, high density 1ipoprotein (KOL), and r t r i g l y c e r i d e l e v e l s i n r e l a t i o n t o b l o o d P C B l e v e l s , Whil e n o c o n s i s t e n t a s s o c i a t i o n h a s b e e n s h o w n b e t w e e n b l o o d P C B s a n d to :al c h o l e s t e r o l o r H D L le ve ls, most,13 16 b u t not all,24 studies have shewn in cr eas ed triglyceride UnMUOtl 100937 levels with association increased blood PCB levels. Given between PCBs exposure and non-ASHD Ju d ith A. Zack/Psgs 9 l I the l a ck of 'support f o r an I circulatory system deaths from previously reported mortality studies, and the inconclusive relation between cardiovascular risk factors and blood PCBs, this excess 'cause of death mist be I! viewed as a preliminary finding, in need of support from! other studies. i! While previous mortality studies as well as toxicological studies have implicated a variety of cancers - digestive system, livej, pancreas, malignant melanoma - as possible results of exposure to PCBs, the present study provides no support to such findings. In the Monsanto worker cohort, no deaths were i attributed to liver or pancreatic cancer, nor were any malignant melanomas found. The overall excess in cancer deaths, while not statistically s i g n i f y cant (8 observed, 4.46 expected, SMR - 179), is mainly a result of respiratory * 'i ( c a n c e r d e a t h s in w o r k e r s f o r w h o m s m o k i n g h a b i t s w e r e not'1 a s c e r t a i n e d . i Although the present study's results do not support a carcinogenic effect associated with PCB exposure, there are significant limitations to the results. A principal limitation is the size of the worker cohort, which prevents the iI detection of increases in risk to deaths from rare diseases. A much larger c o h o r t f o l l o w e d f o r a l o n g e r p e r i o d w o u l d be n e c e s s a r y toj d e t e c t a t w o - f o l d f increase, for example, in observed liver ca nc er deaths. In order to allow for a latency period, the study cohort was limited to those working at least six m o n t h s u n t i l December, 1 9 6 5 . S i n c e P C B p r o d u c t i o n c o n t i n u e d u n t i l 1 9 7 7 , f u r t h e r f o l l o w - u p o f the m o r t a l i t y o f M o n s a n t o ' s P C B - e x p o s e d j w o r k e r s w i l l h a v e l a r g e r i numbers, as well as longer follow-up time. j t Another limitation common to retrospective studies of occupational cohorts I is lack of knowledge of exposures from other work-related activities. While p e r s o n a l h a b i t s , s u c h a s s m o k i n g a n d d r i n k i n g , c a n s o m e t i m e s b e r o u g h l y ascer tained1 if co-workers or family members are aval 1able (for interview, previous Fnnif&4 100938 J u d i t h A . Z a ck / P a g e 10 exposures, or concurrent occupational exposures during follow-up, are often impossible to ass$$s. The connection of an effect to a previous PCB exposure must first consider other potential effect-related exposures. A useful comparison'group in occupational mortality! studies is an unxposed industrial cohort, from the same plant, if possible. Ascertainment of mortality of such a cohort allows for corrparison of SMRs between exposed and u n e x p o s e d c o h o r t s , w h i c h r e d u c e s the p o s s i b i l i t y t h a t an! e l e v a t e d c a u s e of death in the exposed cohort is a result of a generally greater than expected cause-specific mortality in that area or industry. Such! a comparison group would have been useful in evaluating the elevated mortality due to non-ASHp circulatory system diseases found in this study. Given the size of the study cohort and the other limitations described above, the results of this analysis of PC3-expcsed workers' mortality experience are not definitive, but rather contribute to the health-effects research o n P C B s . A f u t u r e s t u d y o f t h i s c o h o r t c o u l d e v a l J a t e tie m o r t a l i t y o f w o r k e r s 1 i| involved frcm the initial through the final year of PCB production, and thus h a v e m o r e p o w e r to d e t e c t any p o s s i b l e h a z a r d s 'of PCB e x p o s u r e . Fnmf 5 1 0 0 9 3 !) J u d i t h A . Z a c k / P a g e 11 References ^_j 1 . M e i g s , J . W . , A i f c b o m , J . J . , K a r t i n , B . L . C h l o r a c n e f r o m a n u n u s u a l e x p o - i1 s u r e t o A r o c h l d r . J . A . M . A . 1 5 4 : 1 4 1 7 - 1 4 1 8 , 1 9 5 4 1i 2. 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D . , Squire, R.A., Linder, R.E., Stijandberg, J.D., Montali;. R.J., Burse, V.W. Induction of liver tunors in Sherman strain female rats by polychlorinated biphenyl Arochlor 1260. 0. National Cancer Inst. 55:1453-1459, 1975. 11. Ouw, H.K., Simpson, G.R., Siyali, D.S. Use and healttj effects of Arochlor 1242, a polychlorinated biphenyl, in an electrical industry. Arch. Environ. Health 31:189-194, 1976. j r 1 2 . M a r o n i , M . , C o l o m b i , A . , C a n t o n i , S . , F e r i o l i , B . , F o a `, V . O c c u p a t i o n a l e x p o s u r e t o p o l y c h l o r i n a t e d b i p h e n y l s i n e l e c t r i c a l wq r k e r s . I. E n v i r o n - m e n t a l a n d b l o o d p o l y c h l o r i n a t e d b i p h e n y l s c o n c e n t r a t i op.s. B r i t . 0. Industr. Med. 38:49-54, 1931. 13. C h a s e , K . H . , Wong, 0., T h o m a s , D. , B e r n e y , B. W. , Simon,, R.K. C l i n i c a l and metabolic abnormalities associated with occupational exposure to polychlor inated biphenyls (PCBs). J. Occup. Med. 24:109-114, 1582. 1 4 . r i s c h b e i n , A . , V l o l f f , M . S . , L i l i s , R . , T h o r n t o n ,[ J . , S e l i k o f f , I . J . C T i n - lj ical findings among PCB-exposed capacitor manufacturing v/orkers. Ann. N.Y.. Acad. Sci. 320:703-715, 1979. 1 5 . M a r c n i , M * r C o l o m b i , A., A r b o s t i , G . , C a n t o n i , S , F o a ; , V . O c c u p a t i o n a l e x p o s u r e to p o ly chl or in ate d biphenyls in electrical workers. II. Health effects. Brit. 0. Industr. Med. 38:55-60, 1981. 16. Baker, E . L . , Jr., Landrigen, P.J., Glueck, C . L . , Zack, M . M . , Jr., Liddle, J.A., Burse, V.W., Houseworth, W.J. , Needham, L.U. Metabolic consequences of e x p o s u r e to p o l y c h l o r i n a t e d b i p h e n y l s (PCB) in s e w a g e sludge. Am. J. Epidemiol. 112:553-563, 1930. , 1 0 0 9 11 t Judith A. Zack/Page 13 L r> L; 17. Bahn, A.K., Rosenwaike, I., Herrmann, N., Grover, Pi , Stellman, J., O'Leary, K . M e l a n o m a a f t e r `e x p o s u r e t o P C B s . N . E n g l J . M e d . 2 9 5 : 4 5 0 , 1 9 7 5 . v- \ 18. L a w r e n c e , C. 'PCB? a n d m e l a n o m a . N. E n g l . J. led. 2 9 6 : 1 0 8 , 1 9 7 7 . 19. Brown, D.P., Jones, M. Mortality and industrial hyg iene study of workers 1i exposed to polychlorinated biphenyls. Arch. Environ. Health 36:120-129, 1981. 20. Bertazzi, P.A., Zocchetti, C-, Guercilena, S., Foglia, M.D., Pesatori, A . , Riboldi, L. Mortality study of male and female workers exposed to ( |] PCBs. Int. Symposium on Prev. of Occup. Cancer, Helsinki, Finland, April, 1981. 2 1 . E i g h t h R e v i s i o n , I n t e r n a t i o n a l C l a s s i f i c a t i o n o'f D i s e a s e s , A d a p t e d f o r U s e I 1 in the United States. U.S. Department of Health, Education, and Welfare, P u b l i c H e a l t h S e r v i c e , P H S P u b l i c a t i o n H o . 1 6 9 3 1i W a s1h i n g t o n : U . S . G o v e r n ment Printing Office, 1977. 22. Monson, R.R. Analysis of relative survival and proportional mortality. Comput. Biomed. Res. 7:325-332, 1974. 23. Bailar, J.C;, Cderer, F. Significance factors for the ratio of a Poisson I| v a r i a b l e t o i t s e x p e c t a t i o n . B i o m e t r i c s 2 0 : 6 3 9 | 6 4 3 , ,964. 2 4 . K r e i s s , K . , Z a c k , M . M . , K i m b r o u g h , R . D . , N e e d h a m , L . l |. , S m r e k , A . L . , J o n e s , !. i B. T. Association of blood pressure and polychlorinated biphen>l levels. J.A.M.A. *45:2505-2509, 1981. 2 5 . B u m g a r n e r , J . E . , H a m m e r , D . I . , C o l u c c i , A . V . , C r j e a s o n ;, J . P . , F i n k l e a , J . F . ( Polychlorinated biphenyl residues in refuse workers. Research Triangle Park, North Carolina, National Institute of Environmental Health and ! il S a f e t y , P u b l i c H e a l t h S e r v i c e , D e p a r t m e n t o f Heajlth, E d u c a t i o n , a n d We i- fare, 10 pp ., 1973. Knoifi?8 100912 f' O J u d i t h A . Z a ck /Pag a 14 I Table 1 Follow-up St at us of P o l y c h l orinatd Bip venyl Workers as of December 31, 977 Follow-up Status Number Status known Verified alive Verified deceased Death certificate found . Death certificate net found Status Unknown Total 89 Fnniv>9 1009)3 Judit h A. Zack/Page 15 o- Table 2 Person-years of Observation Contributed by Polychlorinated Biphenyl Workers by Age Age in Years Person-ye^ars of Observation 20-24 25-29 11.41 1 63.8! " ub CVJ >--1 '30-34 35-39 40-44 222.5:t 283.2j v 45-49 325.3;f 50-54 2 9 4 . 5! J 55-59 207.6 60-54 134.0 65+ Total 115.2 1 1800.1 r> inni 830 100914 f il 16J u d i t h A . Z a c k / P a g s J T a b le 3 Duration of Exposure to Polychlorinated Biphenyls by Vital Status Years of Exposure* Living (n = 58) Vital Status Deceased (N = 30) Unknown (n 41 1 ) <1 20 5 1 - 3 20 12 3-5 6 4 > 5 12 9 Total (n = 89) 26 32 10. 21 'Average Length of Exposure 3.2 yrs. 3.7 yrs, 0.7 yrs. 3.3 yrs. Lifetime exposure prior to 1-1-65 Fnnifi31 : 1009^ /v i f} J u d i t h A . Z a c k / r S g e 17 Table 4 Observed and Expec ted Deaths Due to Malignant Neoplasms by Race, PCD Worker Cohort I.C.D. No. (Eighth Rev.) Cause of Death White Kales 0 E SMR* Nonwhite Males 0 E SMR* 140-209 All Malignant neoplasms 4 2.70 148 4 1.76 227 140-149 Buccal cavity & pharynx 0 0.09 - 0 0.07 - 150-159 Digestive organs & peritoneum 0 0.75 - 1 0.58 172 155, 156 Liver 0 0.05 - 0 0.05 - 150-154, 157-159 Other digestive organs 0 0.70 - 1 0.53 189 160-1G3 Respiratory system 3 0.94 319 1 0.59 169 1 6 2 , 1 6 3 _ _ _ _ _ _ -- L y . n g - - - - - - - - - - - - - - - - - - - - -- 3 - - 0 . 8 9 - 3 - 3 7 - -- -- - I - - 0 r 5 5 - " 1 8 2 - - - 160, 161 185-189 200-209 164-104, 190-199 Other respiratory organs Genitourinary organs Lymphatic & hematopoietic tissue All other sites 0 0.05 0 0.28 - 0 0.28 1 0.36 - 278 0 0.04 1 0.23 435 1 0.12 833 0 0.17 i total1 0 E SMR* 8 4.46 0 0.16' 179 r 1 1.33 75 0 0.10 1 1.23 81 4 1.53 261 -17471" - 278 ~ 0 .Q.09 _ 1 0.51 196 1 0.40 1 0.53 250 109 *No SHR was statistically significant (all p-values greater than 0.05) rGOOt \ j- - - r-- { . . . . .l u.d i t h A . . u j i 's. )aiie y il Race Nonwhite Nonwhite Nonwhite White Vih i t e White Nonwhite White ( Year of Birth 1909 1913 1909 1893 1912 1916 1907 1906 Tabic 5 Case Summaries of Cancer Deaths Among Polychlorinated Biphenyl Workers Year of First Exposure Year of Death PCB Exposure Duration (mo.) 1942 1959 13 1954 1965 85 1951 196R 1943 1963 1951 1960 1951 1977 1945 1964 1940 1957 28 34 28 33 8 79 Death Certificate Cause of Death(ICO#) Carcinoma of colon (153.8) CarcinomatosisPrimary site, kidney (189.0) Carcinoma of lung (162.1) Carcinoma of right lung (162.1) Carcinoma of lung (162.1) Carcinoma of lung _ _ _ _ (162.1) .. . . . . . . . . . . . . . . Multiple myeloma (203.0) Metastatic carcinomacarcinomatosi s (199.0) F0jMfi33 100917 Ju d ith A. Zack/Pagc 19 Table 6 I.C .D . No. (Eighth Rev.) 390-458 410-413 390-409, 414-450 460-519 520-577 800-998 O b s e r v e d and tixpected Deaths Due to Non-ma1 i gnant Causes by Race, PCB Worker Cohort Cause of Death White Males 0 F. SMR Nonwhite Males 0 E SMR Diseases of the c irc u la to ry system 11 6.02 161 5 4.35 115 A rteriosclerotic heart di sease 4 4.99 00 3 2.20 136 All other c irc u la to ry system 7 1.03 526* 2 2.15 93 Diseases of the re s p ira to ry system 0 0.73 - 1 0.54 185 Diseases of the d ig e s tiv e system 1 0.75 133 1 0.45 222 External causes of death A ll other non-ma1ignant causes 0 1.43 - 2 1.10 102 l 0.95 105 0 1.30 - ' r Total 0 E SMR 16 11.17, 143 ' 7 7.19 97 9 3.90 226* 1 1.27 79 2 1.20 1 2.30 167 42 2 2.40 03 W H U O J Total O O o *p < 0.05 A ll causes, malignant & non-ma1i gnant 18 13.53 133 12 9.35 120 30 22.00 131 i "[To Pau 1 Wright...whol z. ~- played a :prominent role in ,forestalling EPA \ a ,promiilgati'bn unrealistic regulations to limit dlschargesTof PCBs." [Exh. 9: 522] i Finally, we pause to note again that none of these facts I1 were ever before the Court in Electric Power or known to that Court before its decision was filed. IV. THE DEFENDANTS' CONDUCT IN FRAUDULENTLY CONCEALING CRUCIAL FACTS TOLLED THE STATUTE OF LIMITATIONS [ The defendants' conduct in intentionally land deliberately concealing crucial facts that they knew about t ie toxicity and dangerous nature of PCBs tolled the statute of limitations in this case. The plaintiff will draw on the elements of the concept iof fraudulent concealment as stated in Electric Power. Each element will be discussed below. A. WRONGFUL CONCEALMENT I The thrust of plaintiff's claims against defendants centers on defendants' failure to warn aboujt what they actually knew about the dangerous consequences of PCBs exppsure. In a products liability case, where as .here, the issue is the failure to warn, they key issue becomes the adequacy of the warning. Poet v. American Cleaning Equipment C o r p i, 437 SW2d 516, 520 (Ky 1969). That warning, to be adequate,; was fully discussed i, in Post, as follows: "A warning is, by its nature, a] means of 34 FomftfS / -M o n sa n to V . n t t r Z '!: Niff* ol Nomino 1i C o m im r Paul Uff a# SUM T,. W O*0t. r c h t _________________,______________ !_______ ; Civilian Sgtmii Group Mpd. & Env. Kith. Pauli* Till Slry Cm ' Annuli Siliry Toxicolocv Manager 1 9 Pvrforminca $31.800 Cre win k D*0fimvn( Lacjfion Creve Oit* of urt inauN - 2 / 1 / 7 6 ______________ 04(V l_Jll Em0107 U n ir. Typ 0 A > ir a . I5 irct in m i l l c ilif o r y Worn tn e p p o n t na pi m u o *n.<n nat ip p ro p # n t iy e iio n o n in wild no nt, in u ' fe d ftIw.f l I. a i ciu tary T e c h n ic a l ^ A ccom plisJunent o f s ig n if ic a n t r e s u l t ? - 0icriO tn icft<*ffint no Ut i i f A i d u n u to U o n u n to iw i C ilM o r -JLQS At a recent meeting in Creve Coeur, Glenn Schweitzer, head of the Off Toxic Substances of EPA, offered some intiere sting comments. He obser that Monsanto's toxicologists were held tfn high regard at EPA. Howev since it lacked an in-house toxicology facility, Monsanto as a compan; not as highly regarded overall as duPont, Carbide, or Dow. Dr. Wright's professional and personal characteristics have contributi nificantly to Monsanto's image at EPA. He hasij shown unusual perseveri and dedication, frequently involving his pwn time, to review and intei large volumes of data which he subsequently organized for presentatior EPA officials. Particularly noteworthy wers his efforts on polychlori biphenyls (Aroclors) and chlorinated isocyanurates (ACL products) Ir former instance, his excellent analysis and synthesis of widely scatte observations played a prominent.rol in forestalling EPA's promulgatic unrealistic regulations to limit discharges of;| polychlorinated biphen^ EPA's proposed regulations would have precluded th use of these matei -by Monsanto's customers-. With respect to[ chlorinated isocyanurates, Dr. Wright has had several contacts with individual scientists at EPA answer specific questions that they had raisedjor to inform them of tfc status of additional studies which, had been undertaken*. Overall, by "virtue of the qualities of leadership which Dr. Wright has played, he has made an important contribution to Monsanto's image at E That favorable image will become increasingly important to Monsanto as areas of interaction with EPA multiply. i i n i N i l , g , , * ' *........................... C - l i i ; j n , , 1 0/ 7 i Fnnifi3S A ir| A m ouM RC onw w na*di 4A o o i O f 4 01V I i ^-- J 1 0v Awn jO O ' II 7} k 1 ( j l 5 2 2 S C H 05 8 79 I LM_on\salnt_o ^SKAREL 'i !I I Inspection and Maintenknce Guide AOM 001382 TABLE OF CONTENTS SECTION A I TRANSFORMER ASKAREL I. Introduction............................. II. History of Trade Name Types Page III. Table II -- Official Transformer Askarel Shipping Sp<icificatic n s .................. A. General Electric Company's Transformer Pyranol A13B3B B, Westinghouse Transformer [nerteen PPO 17336" IV. Interchaneeabilitv and Stability................................... 1; . . . . . . ' V. Directions For Handling and Personal Precautions. . .......... VI Finected Service Life.. . . . . . . . . . . . . . . . . . . . . . . I. . . . . . . VIT D i e l e c t r i c Streneth -- Moisture Relationship.............1 ........... . . . . . . . . . . . A. Table III -- Dielectric Strength vs. Amount of Dissolv ed Water in Askarel and Mineral oil : 8 . Table IV -- Approximate Solubility of Water in Askareli and Mineral 2-3 4 4 5 5 VIII. Table V -- Typical Values Found in Askarel Fluid Under Various Con ditions of Use............................................................ IX. Check Points For Maintaining Askarel Insulation. A. General Considerations B. Modern Sealing Procedures C. The Older Sealing Arrangements X. Periodic Fluid Inspection........................................ A. Visual Inspection B. Dielectric Strength XI. Inspection Check List.......................... XII. Contamination in Transformers.......... A. Table VI -- Effect of Common Insulation Materials on Power Factor and Dielectric Strength [' B. Table VII -- Effect of Common Insulation Materials on Volume- Resistivity XIII. Refining Askarel For Re-Use................................ ( A. Filtering Through Dry Blotter Paper To Remove Moisture and Extraneous Particles. Table VIII -- Guide to Rate |of Dissolved Water Removal By Filtration. I, B. Earth Treatment for Maximum Improvement of Power Factor, and Volume-Resistivity 1. Procedure 2. Effect of Earth on Removal of Scavengers 3. Table IX -- Approximate Relationship Between Ppwer Factor. Volume*Resistivity and Dielectric Strength of Transformer Askarel XIV. Cleaning Arced Transformers............................... XV. Sampling ASKAREL............................................ 14 15 17 ACM i SECTION B ASKAREL FILLED SWITCHES AND TERN INAL CHAMBERS I. Introduction.............................................. II. Sources of Contamination....................... III. Sealing Switches and Terminal Chambers IV. Askarei-hlted Switches' Maintenance. . . . Page 13 3 19 19 SECTION C Monsanto Analvtica! Services on Transformer Askarel........ ............. 21 A ppendix A. Askarei Stability and Composition of Arc Formed G as. ........................ j. . . . . . . . . . . . .B. Solubility of Gas in Transformer Askarel................. j C Approximate Vapor Pressure vs. Temperature For Transformer Askarel.. . . D. Effect of Temperature on Dielectric Strength of Askarel .. J........................ E. Viscosit> of Askarel and Mineral O il.................................... .......................... F. Densitv of Transformer Askarels............................................. j....................... G. Thermal Conductivity............................................................. 1....................... H. Heat Capacity.............................................................. ; ........................ I. Coefficient of Expansion. .. . .................................................j......................... J. Fire-Resistance...........................................................................-...................... K. . Seals. Properties and Procurement..... ............... 23 23 24 24 24 25 25 25 26 AC CO 130, i * I [V. in t e r c h a n g e a b il it y a n d STABILITY A. Interchangeability: I 1 | T htyo general types of askarel insulation shown in Taile II can be either mixed`or interchanged and there will be no difference in the operation of the transformer. However, askarel insulation must never be mixed with mineral oil. O e r 2rT mineral oil in askarel begins to lower its fire resistance. Further. materials of construction in the transformer that are compatible with askarel may not be compatible with oil and vice-versa. |For example: a significant amount of askarel in a transformer built for mineral oil 'will attack aaskets. adhesives, core bindings, impregnating varnishes, eItc. ~ B. Stability: Askarel liquid insulation is highly pure, fire-proof liquid made under close chemical control. It does not vary in composition like the commercial range of mineral oils. ; Askarel does not deteriorate when exposed to air, heat, hot metal; it does not break down over long use to form conducting or corrosive chemicals: it does not oxidize or sludge. Askarel will remain perfectly stable year after year unless broken down by exposure to severe arcing. | The only real "enemy" of askarel is contamination by water. Keeping askarel water-free will insure lonz^ -time service. t1i f Askarel is heavier than water. If water gets into ^ Narelj insulation, only a tiny amount (125 ppm) dissolves -- the rest floats or ;op. !V. V. DIRECTIONS FOR HANDLING A. Keep Dry: In handling, storing, sampling, inspecting askarel -- and in operating askarel transformers -- take every precaution to guard the askarel insulation from exposure to high humidity and moisture contamination. Keep 5. 30. or 55 gallon drums of askarel dry; lay stored drums on their sides with the bung at the highest point from floor to keep water off the drum head (which can be sucked into the askarel by the drum "breathing"). This! precaution is not necessary when drums are stored indoors, which is the preferred way of storing. Use Ordinary Personal Precautions: Transformer askarel has been made, handled, and used! for over 30 years without causing toxic or other ill effects. It can be handled with only minor precautions. If accidentally spilled on hands, no serious iskin irritation will occur. However, liquid askarel has a solvent action (similar to paint thinner) on the fats and oils of the skin and prolonged contact may lead to drying and chapping of the skin. AOH 001368 In case of contact. wash off the skin with soap and water;' remove and dry clean saturated clothing. Clean up spills with rags, sawdust or,absorbent c!av \ Eye contact may result in painful irritation but no permanent damaee to tjjsups. If askarel gets in the eyes, flush with large amounts of water. AsViih all eye first-aid, refer to a physician. To relieve irritation, physicians have ju&d a \% Pontocaine as well as opthalmic cortisone^ acetate solution, or: castor oil. Infrequent exposure to askarel vapors will not cause!ill effects. However, prolonged exposure to high vapor concentrations should be avoided. If hot askarel must be handled in a closed or confined area, provide the area with ordinary' exhaust ventilation -- or -- wear an organic cartridge respirator approved by the U. S. Bureau of Mines. VI. EXPECTED SERVICE LIFE Properly designed and installed askarel transformers will give trouble-free service for a minimum of 30 years. Since their introduction in 1932 the manufacturers report finding the over-all failure rate to be less than 0 .5 ^ for]a|I units under test and service conditions. The Edison Electric Institute's report (1956-1958) on their member utilities publishes the failure rate for askarel transformers as 0.13 per hundred banks per year. Even the rare reports of failure are invariably found to be due to improper sealing that allows moisture to enter. VII. DIELECTRIC STRENGTH - MOISTURE RELATIONSHIP The dielectric strength of askarel is highly sensitive to excess moisture; not sensitive to ordinary dissolved contaminants. While the dielectric strengthen also be lowered by severe arcing, askarel turns noticeably black or has particles of sooty carbon floating in it if arcing has occurred. Then the transformer shout d be repaired and the askarel replaced. New askarel has a minimum dielectric strength of 35 KV at 25*; a maximum moisture content of 30 ppm. If the dielectric strength is checked periodically and decreases significantly -- this indicates moisture pick-up, arcing, or both. When the dielectric strength has dropped to 26 KV or less, an analysis for water is necessary. If water is found in excess of 100 ppm at 25 C , its source should be located and corrections W fttn the moisture content approaches 125 ppm (saturation level)* the dielectric strength o f askarel drops below the value required for efficient insulating. The moisture content should not be allowed to rise over 70 ppm; it||shoutd be held as j ^ jnear as possible to 30 ppm. Maintaining a low moisture level will assure high dielectric strength and top operating efficiency. Table III shows the relationship of dielectric strength vs. moisture and Table IV indicates the approximate water solubility limits in askarel and mineral oiK A 0 M 001389 STATEMI:" FRCM: MONSANTO COMPANY ST. LOUIS, MO. March 3, 159 On February 24, the San Francisco Chronicle carried i1 a major fea tu re about "a menacing new p ollu tan t" found in the San Francisco Bay area. The a r t ic le was based on marine l i f e research ca rried out by Dr. Robert Risebrough p f the U n iversity o i C alifornia. I t stated that residues of polychlorinated biphenyl (PC3) were k i l l i n g c e r ta in b ird s and im plied at long-term threat to humans. Monsanto manufactures p o ly ch lo r i nated biphenyl and markets i t under our Aroclor trade name. (There are other manufacturers in Europe and J a p a n .)` We, th erefo re, would lik e to present some a d d itio n a l f a c t s . The work done by Dr. Risebrough dates back to e a r lie r i I research by other s c i e n t i s t s to analyze the amount o f p e s tic id e s in w i l d l i f e , s o i l end w ater. The i n i t i a l p e s tic id e research was extrem ely d i f f i c u l t sin c e any search to d ete ct m aterials in the p arta*per-billion range a lso brings out other "interfering" substances. -more- () inniRA2 .1 0 0 ? 2 -- 2 MONSANTO COMPANY I S everal years ago, two Swedish s c e in t i s t s at Stockholm U n iversity's In stitu tio n of A n alytical Chemistry, Professor Gunnar Wiamark and Soren Jensen, reported they had id e n tifie d the other substances which were appearing during an alysis of ch lo rin a ted p e s tic id e r e sid u e s. They sa id some o f the m aterials were p o ly ch lorin ated biphenyl or PCB. The amount reported was in the p a r ts -p a r -b illio n range, or l e s s . Since PCBs are not "broadcast" or spread around the land as are p e s tic id e s , t h e 's c ie n t is t s I; r \ .th eorized th a t the source must be the in d u s tr ia l w astes o f PCB users. Dr. Risebrough's more recen t work reports the I d e n tific a tio n o f PCB, along w ith DDT and DDE p e s tic id e s , in the tis s u e s o f b ird s and f is h on the West Coast. The con clu sion s o f th ese s c i e n t i s t s are puzzling from sev era l a sp ects. P olych lorinated biphenyls are' sta b le chemical compounds which are e s s e n t ia lly in so lu b le in. water. Their use t does n ot make them e a s ily relea sed in to the natural environment. i A p rin cip a l market for PCB i s in e l e c t r i c a l ap p lication s i where they are used as in su la tin g flu id s for transformers and }! cap acitors. In th is u se, the chemical is completely sealed in mI metal con tain ers. Another market is for h eat-tran sfer applications Ij where the PCB flu id functions in a closed system. 1 0 0 2 ;,3 -- 3 .MONSANTO C, ANY In the fu n ctio n a l flu id s market! ve have carried out I| a program fo r 's e v e r a l years for the reclam ation o f used PCBs to reuse thes valuable m aterials. i I PCBs are a lso u sed 'in sev e ra l " p la stic-ty p e " a p p lica tio n s Here the chem ical i s incorporated in to the polymer as an in te g r a l part o f the s o lid m aterial. This ap plies whether the polymer is used as an ad h esive, an elastom er or & surface co a tin g . I t has also been implied that polychlorinated biphenyls are "highly toxic" chem icals. This i s not tru e. The t o x ic it y it | o f any m a te ria l, whether i t be chem icals, drugs, natu ral p lan ts or even foods, is r e la t iv e . Just lik e otbler in d u str ia l chemicals |i and home products now in widespread .use, PCBs are not hazardous when properly handled and used. During more than 30 years o f 1I U.S. production and u se, cases o f any toxilc e f f e c t have been extrem ely rare - - and then only where the sim ple precautions recommended for use were not follow ed . To our tacw ledge, p olych lorin ated biphenyls are n ot sprayed or dusted on crops, woodlands or any other a r e a s, as are p eetlcid es. I t i s , therefore, not only puzzling, but extrem ely d i f f i c u l t to conceive how commercially produced FCB can show up in w i l d li f e in the q u a n titie s I'repor'I ted. This r a ises the question whether the substances id e n tifie d in the Swedish i work, and new in C a lifo rn ia , are a c tu a lly PCBs -- or whether they are compounds which, due to the metabolism o other the marine environment, appear to be PCBs. -core- 100?24 -- 4 MONSANTO COMPANY . U nfortunately, even though techniques for a n a ly zin g ' tis s u e samples have become q u ite p r e c is e , the a b i li t y to analyze the p o ssib le impact o f n a tu ra lly occurring subs tances in the food i c y c le o f liv in g organisms has not made comparab le advances. Monsanto has a research program to id e n tify the compounds reported to be PCB by the Swedis i and C a lifo rn ia s c i e n t i s t s . We have always cooperated, on a regular b a s is , w ith fe d e r a l, s t a t e and u n iv e r s ity la b o ra to ries in th e ir a n a ly sis o f ch lorin ated hydrocarbon r e sid u e s. We w i l l 'continue to do so. A d d itio n a lly , Monsanto w i l l continue to e x e r c ise the h ig h e st degree o f co n tro l in I t s manufacturing, shipping and sto r in g o f PCB -- as we do w ith a l l products. The source o f the marine l i f e residue id e n tifie d as PCB i s not y e t known. I t w i l l take ex ten siv e research , on a worldwide b a s is , to confirm or deny th ese i n i t i a l s c i e n t i f i c conclusions. - 0 O0 - lino- <^5 00?i5 ! '..x.-ra w R Richard - Re search Center r t . A p ril 14, 1969 r ** DISPOSAL AND INCINERATION . c n m c c L O R - - - - - - - ;- - - - - - - - - - - - - tuet CC* TO P. Benignus - PBENI . A. Olson B ry a n t. M. Kountz A. Kuhn T. Johnson DOLSO JBHXA rccouN VKUHN NJOHN To defend the Aroclo'r p o s it io n , i t seems th a t we should provide fo r d isp o sa l o f and in cirieration -ofL off-grad e f lu id and work w ith Westinghouse and J ______ on the disposal of the off-grade capacitors as w ell. I think v/e can fo r esee th a t con trol o f the t o t a l m aterial b a l ance fo r Aroclor w ill be important for] future operation. We should th erefo re help co n tro l the E ntire cycle o f a capacitor. j At p resen t we are p u ttin g reclaim A roclor in to new Pydraul hydraulic f l u i d . Vie ca n 't r e a lly s a t is f y p o llu tio n people with th is explanation! This w ill . Just bring the fo ca l point* to hydraulic flu id s that much so o n er. - )* % *[i \ W ill you p lease look over the figure for ca p a citors/ add any d isp o sa l A roclor from transform ers. Please convey our guesstim ate to Bob Kountz fo r prelim inary sizing of incinerator. Capacitor Industry V estin g house At Present For Hyd F lu id For D isposal l80,00C Ib s /y r A5 0 Brums 230,000 lb s l* fi P roduction .6% Prod 6,000 lb !8 6.0% Production* 200,000 lb s/y r 6 .0 2 Production Future For Disposal 2% Prod 200,000 : 2% Prod 80,000 : 2% Prod '6 0,000 i Say 22*500,000 Say li-2 5 0 ,0 0 0 Say 2% 500,000 1 (: lb s/y r F n m * 100234 R ecycle and D estru ction o f O ff-Crade Capacitors fo r hou I * . .... westinghpuse prefers hot to.bury capacitor - wa,,t , \: \V Jlroclor. salvage parts? destroy therest ---- -~Monsanto asked to.see ihat we caAdo. Transformer IndustryTransformer Rebuilders Transformers Scrapped - W. R. Richard ms o M i l l K .V 7 100235 2542 i P. 0 . Benisnua - S t. Louis G eneral O ffice December 5* 1959 H. S. Bergen - wage V. ]a . Euhn . UKU3K ( PCS TCflBCITT PROBLEM PROPER DISPOSAL 0? SCRAP ARCCLOR R. g. S - -- EyyrntaTTm ff Re Kuneh . - u f f t E h V. R. Richard - WRICK J Qe Bryant D. A. Olson Over 6 months age we p o in ted out Impending need fo r Konsanto to provide an Incinerator# e ith e r on Konsanto property cr elsewhere to effectiv e ly dispose o f scrap Aroclor. Ve were surprised to learn a t a meeting l a s t Wednesday th at th is request has not received support. i Ju ly 1 9 6 9 , Jim Bryant d istr ib u te d a report in d ica tin g th e anount o f scrap e l e c t r i c a l Aroclor fo r d isp o sa l; ' Today we estim ate need to dispose o f about l.o E -lb s. a year o f asfcarels. About 300,000 pounds need to be incinerated* Hopefully,, the remainder can be returned t c Kossantol's p lan ts and d is t ille d * Arrangements fo r d is t illa t io n # a ls o remain' unprovided* i f the m aterial cannot be d i s t i l l e d then much so re than 3 0 0 ,0 0 0 pounds needs to be in cin erated , jj At th e present time our only means fo r d isp o sa l i s to a land f i l l . We are warned th a t t h i s w i l l no longer be accep tab le. Accordingly# Kr. Kcuntz w i l l now exp lore In cin eration and Kr* Kuhn w i l l explore d i s t i l l a t i o n a t our p la n ts. /da > F, 0 Behlgnus ii r 100250 2570 Monsanto Montante Coffloany SOO N. Lnee#pgn Bouiavare St loun. Mittoun a31a p* c n r 3t4] 6 9 4 *1 0 0 0 February 9, 1970 O+3A/0IC # O M G * U 3 M Dear Sir: Recently several newspaper and magazine articles have bean pu b l i s h a d indicating that Polychlorinated Biphenyls (PCBs) have been discovered at some points i n [soma {marina, aquatic and vildlifa environments. The quantities detected are said to be in the parts per million and parts per billion categories. It is claimed that the PCBs found strongly zjesemble chlorinated biphenyls containing 54% and 60% chlorine by weight. Products which are.sold by Monsanto under the trade names of Aroclox* 1254 and 1260 do contain chlorinated biphenyls. In addition to Arocloz* 1254 and 1260* Monsanto sells certain functional fluids containing Aroclor* 1254. These include Pydraul* 625, Pydraul* AC, Pydraul* AC - Winter Grade, Fydraul* 540, Therminol* FR-3 and certain dielectric formulations. Several other companies around the world also produce1 products containing chlorinated biphenyls. |i As your supplier of Aroelos* 1254 and 1;260 and formulated products containing 1254, we wlah to alert you to the potential problem of environmental contamination as referred to in the newspaper and magazine articles. jj W e would like to point out the following additional facts. 1 Products such as Pydraul* 90, 135, 230, 312, A-200, F-9, ISO and 60, Turbinoli 153 and Therminol* F M and FA-2 are hot formulated with Arocloz* 1254 or 1260. 2. PCBs w i t h a chlorine content of less than 54% have not been found in the environment and appear to present no potential problem to the environment. | f\ V J I -2 t > W have developed, and are now tatting, 'new formulations' to replace tha A r o e l o r * 1254 and 1260 components in our Pydraul^ products* T h a new products appaar to bal equal in performance and to hav e similar physical p r o p a rf t its. We feel that all possible cara should be( taken in the applica tion, processing and effluent disposal of these products to prevent them becoming environmental! contauninants, of interest to you m a y be an article in Chemical W e a k , October 29, 1969 regarding water pollution standards^ set by each state in the Union. It is attached* This article reflects that good manu facturing practice in the future may require that no products used b y any company should find their wa>j into waterways* Sincerely yours, f L.1 Donald A* Olson Director of Sales Functional Fluids Group nlc Attachment \ Fnnm sn AD* Q C 'Z k S i Environnwnt bncniiuu. ntt*/niifMIAii m m ocToaam * technology data for sulfur oxides and particulate matter will follow with similar studies for other polluants The huge ttc r requirements of the chemical industry* now the ftiiio i'i thirdlargest user-m ake water quaiuy and availability increasingly important factor* for site selecton. Legislation enacted in roams years has forced planners to pay close attention to pollution control standards. All SO states have had their water quality standards ap proved entirely or in part by the Federal Water Pollution Control Administration (FWPCA). Recently a state*by-state summary of key standards was put together for the Arst time. Surprisingly, it was not the FWPCA that did the job. Instead it was handled by an American Public Health Assn. (APHA) subcommittee headed by TVA Health Director F. E. Gartrell, assisted by the APHA Engineering and Sanitation Section. A portion of the study, covering standards for surface industrial water, is summarized in the tables starting on p. 80. Contrary to widely held opinions, there is considerable variation m state standards. Take the dissolved oxygen (DO) O n enten* in d conirol d i u h w b n <i,ued for i oollu. u ni and control n o o n s Have bien designaied. a comol.7i.ed process involvmj nandards. heannts and .mplememauon and enforcement plans - ill be initialed that can lake over a year to produce standards. So far. nojfirm sulfur oxide or particulate standards have emerged. But Na PCa ]s criteria for team s the standards susgest they'll be tough. The oxide cniena report, for example emphasizes chat there'are deleterious effects to man at con centrations as low asO.IM ppm. NAPCA's control1diju reports present detailed apprauals of vinous methods and equipment, along with estimated costs. As in the case of water, the costs w,u be hah. ilihouzh some pollutinu-m ainly sulfur dioxide-wi|| have recovery values. NAPGA is sponsoring a number of research projects to improve tcchnology.ijpolluiion control is being spurred by financial assistance programs (mandated by state law> now operative in the following 28 stes: standard, for example. Minimum allowable DO (as milli grams per liter or percent saturation) is the single most impor tant standard to chemical site evaluators. As a rough rule of thumb, a 2-mg./l. standard is considered to be one industry can live with comfortably, while a 6.0 mg./l. value is pegged "extremely tough." Arizona, Arkansas. j California. Connecticut, Florida. Georgia. Idaho. Illinois. Indiana, Maine. Massachusetts. Michigan. Missouri. New Hampshire, New Icney. New York. North Carolina. Ohio. Oklahoma. Oregon. Rhode Island. South Carolina. Tennessee. Vermont Virginia. Washington. Wisconsin andfWest Virginia. : California. Wyoming and Washington have set the stan In addition.' Pennsylvania offer* financial aid sanctioned by dard at 6 mg./l. or higher. But a few states such as Con administrative ^regulation. Several states, including Utah and necticut. Maine. Illinois. Indiana. Massachusetts. Virginia and Wisconsin require 2 mg./l. or lower. Maryland haveRegulative studies under way. The incentives take t yanety of forms. Most common are Other standards--notably turbidity, taate. odor, color and exemption from personal property taxes (e g.. .Arkansas), fast solids-may also be important, depending upon the nature of deprenation (Arizona), exemption from ad valorem equip the chemical plant's waste effluents. These standards also ex ment and structures taxes (Connecticut), exemption from lo hibit siate-by-state differences. Moreover, they are generally cal uxes for |suted period of time (New Hampshire), less specific than the straight numerical DO standards. operating loss deductions (New York): credit against state in Although chemical plant site experts see little point in come taxi Oregon). "running from tough standards." the criteria do make a Quantity: Trie large chemical complexes now in vogue difference: Plans for two nonferrous meuis plants in Puerto make w ater-and lots of it--n major site erttenon. The cooler Rico are now on the shelf, because of standards that call for a the water is. the better, for it can reduce the investment in -*5 mg /1. DO. no wastes that interfere with the esthetia of the waten and other specifications. No compilation of ground water standards has yet been heat-exchange equipment. Occasionally, plants can manage on ground water, but usually surface water is required. That means location |on or near the big. drought-resistant nvers. published. Ground water standards may prove important in the future as companies arc forced to use costly deep-well dis posal for wastes. Availability o f ocean waste disposal services is also looming Wests Caagg important. psaeatag for pollution control is high. A recent FW the organic chemicals industry esti- mated that fadlities can increase in- stalled capital 40% or more. Between tflig-TJ, the organic indrnry would have to shell out S112.3 million to remove 10% o f its biological and chemical oxygen demand west* and 65% of its suspended solids. Removal lev els of 83%. 13% and 71%. respectively, for biologic oxygen de mand. chemical oxygen demand and suspended solids would require S242.6 million, while 91%. 30% and 89%. respectively, would up the ante to S60I million. Cleaner A ir Establishment of air quality standards is not nearty as far advanced as arc water standards. The National Air Pollution Control Administration (NAPCA) is still desig nating regional air control regions. At last count. 16 regions had been formally designated and another 41 had been pro posed. NAPCA has issued air quality cniena and control There art leu than 200 |nvers in the U. S. with minimum flows over 50 cu. ft. per second tC W Oct. 3. '68. pp. 94-93). For companies whose plant needs at least 100 cu. ft/second, the list numbers only 150 (excluding Alaska). Sea water is generally avoided because|of high equipment corrosion costs. Piping water in is expensive. Duval, now opening a 15 mil lion tons/ycar sulfur mint in the and Northwest area, was forced to install [a 36-in.. 38-mile-long water lint and a *0- million-gal. reservoir. Cost1of the water supply system hasn't been disclosed, but it is estimated that the tab was at least sev- ral million dollars. | The adequacy of domestic water resources in the year 2000 has recently been evaluated by the Geological Survey. Na tionally, projected demand will be 173% of potentially as sured supply. Only in three! regions. New England. Ohio, and the South Atlantic Easternj Gulf, will future water require ments be easily met. Economic growth may be handicapped m nine regions: Eastern Great Lakes. Lower Mississippi. Up per Missouri?Hudson Bay. Lower Missouri. Western G ulf- Rio Grande. Pecqa. Colorado. Great Basin, and Central and South Pacific. AOK 002V ,, For the first timo, a summaryof watar qualitystandards set byall 50 states. MisdnO yM AllewiWe TtwperstiifeCf)eUeweye oiyfM i b lm ni c ur vM ts M e t ( m l A i m* U f %) Ottitr s p . " - 1A ll 1 0 2.0 I t S Ft. Qt la dldKflvUy. i^-- * S5ter),,Hn* 10* sr im nr* dirsctip or indirectly itn mouctnn us*. Alaifca ?.o-i.o 70* Art** .3-l.t o.s t r A r k a n s a s i . O - S . O (n 2r 4v1).0 95' 3.0 - - t* escee* limits of p m o h :*.* ...... Stanaarat. TurSidrty: No imposed values mat would .ntsrfsra with= 'stallion a*T i vi *iam sf troeautmr eInht.. uCeler: Trua eoior im i .nan sthatie considerations. falM st Ne dissoiv* soi.da soova na* turn conditions eauim corrosion or scaling problems. No *61 vidone* af other oat.no solids iIua * . N_ iw oosm sediment leads that woui interfere ,m estaonsnad trttmmi i** t*.* Tasia lufestanaaai Chtmicai conitituants mould EM b *fa * eancamratieno found to &a ot puai.c ttsanh fcgnincsnas.* I ^do adtsftp Nat td aacaad 1/30 of ih i KF^e valua given for continuous weupationai esoasura m h |3 HandtMak U . TurSIdlty SO JCU (strsarns): 23 JCU dak*). Caiart Fra, from wssta m atT n a i* m ameums sufficient ta chan* asisun* color enough to interfere with induatnal use or ta ereata nuisance. Testa and Oddn 7rd frain wastes in amaunts sufficient td produce enough W k dnljodar ta ersata a nuisance or interfere with induatnal usa. la tld ti Fraa fia m ja iik a that would 6a unsightly, p u tm c M o d a iM ar m amaunta mat wauid interfere with induatnal usa. '**a SwMdMam Fraa from astaa taxi* Id human, animal, plant ar aauatta Ufa ar in amounts that wauid Intarfara met induatnal usa. I * 0 {vara(a dadlaaadiNyi "Aula* and eguiatiena far th* Central af renfsJng fr an* crosa M e d ia tio n .ir tir u i dear* of Hearth. aaaiy. T U rld ltr Na dt saction) tmctiy viuaia mcraasad dua ta wastes. Cdtan Shall net 6a Im> craasad ta tna affiant mat it mtsrfara* with Industrial ua#. prasaift or, future. Taasa and Odan Must nat eaus# affanaim odors or otherwise interfere with industrial usd. SelldM N * dl*> tmetty vrsiata pdrsictanv solids. battam deposits ar sludge banks duafta w*sta*.'jT*ffia Subctsnant Must nat ba present In ameurrts iaa>c ta human, animal.' plant or aquatM Ufa. C illfd n rii t .s - l.i 7 .0 -1 . (Coastal watars) 7 1 .(T ra s h watar) Nona mat would causa aeotoiicai chsnf* or n*rm aQvatic life (eoasisi watars) 1.0 Coastal w atar 9.0 (unless naturally lOw*r) . adlaaathrttr snail not aacaad 1/10 of ma MFC values givan for continuous accue'attonal aacesura m N i l Hanoboca W. Tufktdttyi Fa 'rom 'wattes that eoufd altar star's sting turbidity. Caiar Fraojfrom aubatancas attriautabla to waatas that produce oatnmantsl caiar. Taata and Odart No suoatanen that impart fa*t.*n taata ar odor. Sends; 0 solved solids In fresh water m utt net| eaeeed 100 m g ./i. at any time: annual mean: 173 |m f.* L. Sattisabia solids mutt not be able to chant nature af stream bsttam ar rurm uatic amnrsnmant Taala Subatanaasi At alt times fras from coneantratiant harmful ta humane, aduant lift air mid or domestic animals. Colan dd 9 .0 - .0 - 9r 3.0 t !| tsdlM sdadyi Not t* aacaad 1/10 af the llW ir H k values m i l l Handled* I I . Tuididfiyi Must net mtarfara itn tub- lih*d t*vat* of traatmant. Caia r dfaaies prasant must not cause appreciable chan* in color or mtarfar* with industrial use. T a il* and Oder Fraa from w ait** mat causa odor or ap- or*ciaOi chanya -n taata. S*Udsi Fra# from aatat that are unsiffitty. dutratcant ar odaraws or waui* mtarfar* witn uia. Taala T uttta rt t it Fraa from waatas m cancsntrsnans or com* binations sufficient ta 'harm human ar ammsi lift. ' H artia i m i 1.0 Nan* uniaaa n cammandad umita far m* duitnai ua* 2.0 S O * ar 4.0 4.0 11m-- i i j i Limits !(ta ba aaamvad by aperosdat* stai* aganey. TurSW y, CaMr. Taata and Odan Non m such quanti ties that would imsairj industrial usa. Saildsi Umitad to smalt amounts mat may result frsm discnar* of appropriately treatad waatas. Tads Substanaaai Fm* from chemical constitu ents in eshcantrabond ar camknabans harmful ta human. ` `-----1Ilfs. ' ________ _ Alpha emitters limitad td 1 m/1-: bat* mittar*. is 1.000 p * /l. Calar, Tama shd Odan Nana m concentrations that causa amor, testa 'ar edar. Sands Fra* from unsightly tnd maiederius | nwisaneaa I due to ftaatinf solids ar aiudge d * pasts. Tims Su*etswssi Nana in esneantrabana narmful (synar* fiawaady or. atnarvi**)' ta humans, fish, shwiflsh, midiifa ar aquatM Ufd.{ ;| nadialam Ornas Oata-- LOOO es/1. (in absent* af Sr-90 and aipfia mineral. TurS dltyt K JCU. CaMn Must net rendar water unfit far industnai-caannf or proea*K *tar suapiy purpose*. Toabas Mum [nat mnaarl watar u nit far industrial usa; phenota 0,001 maajmurn. SaMdmlOitsaivad salida must nat asesad 1.000 m ./!.; monthly avers*: SOO m # ./l. Must ba free from floatm* wastaa that Jara unsipmiy ar da<atn*us or other wait* that saw* ta fon.t putrtscnt ar aaiacbanaai* aiuda oaoosits. Tads M a tM ts a Fraa from waatas Harmful ta human, animal ar aawab* lif. Cu. 0.1 m ./l.; Zn, 1.0; Cf. Q.H; F6. 0.09; Fa. 0.3: Aa. OJ* 9. 10. Cn. non* liin i A C M CCi<r53 i r pH AUw tW TM tysraturt (T i a ltm M t lm -- i i t i t i am DttartnH W* (*m. i/nLts aV i Othw Requlnments rm O M r f i a L 4 I - Hawaii MJP I1 n0ta* s(a)a b M 2.5 l o (asar ) 4.9 SadtaacWvrtyi M u * eanferm ta ttata ststutM. Taste an* M a n Fra from tn mat e m u ~ aitlona sr intartan arts industrial u m . SaMn Fra r?n * *? tnat at n s ,* * * , piutraaeani or a m S S j o?aiw " C T r ** Intarfan wfW inauatrtal u m . Ta S u 2 m ^ ? * in canearation* tnat uid p rw , * or im arfan r*i in*urt*f uaa. TM ,Wfv11' , or . I 'I' H .M b y m .MttoiMt iH Utitm1/i3n0mofutflt vftlUM rtM (w y ftf ebaa by land d--*tamni ar ncvtturai u m Taata an* fla ir W W a*. a ** r dUuttan V * miatun. must nat ntsrftn *,w lm usa, 7i S i t a t s s w * frm fmnt iu Entire as in eoa* cemnttcna Jharmfld M human. animal, M marina i.fi or tnat m*k * natan unsuitable (*r industrial m * Id a h * .s -9 .0 0.9 r Only atar U * or 7 9 (at sonai lev) " * Standards. ,T iu M |i * * w s Orifiliinf watar He obiactlonseit tumidity tnat ean oa tr*eaS ta a pami sure. la lM n Ma floatin* or w o m a n mat* * * -- * .* * I advanafy .ffact Industrial J1** - 9**9*tanaata| Ha astaa at othar man natural origin (n eoncantmlana at aubita haaitft tlgmfleanca or mat eouM advm afy affaai induadrtal uaa. llllM ta 9.0 -9 .0 -- 91* Indiana s.o-t.o -- 95* I'o / tm is lm. *. * * * ^*9* fron* *a *ta * mat product colar. em a rio! d ) 2 n T . F2 fl* Tr*m J l a Ethat a# * an far-m unsigrrtfym, dt4aiu tartan* ar mitraacsnt daaaerta. Tana Subataneata Fna tram wattaa ta c a n c a r*** ar eamMiiatlane harmful ts human, anim ai slant ar estiede iffa. 1.0 2.0 (dai* w in * } Citar.Tama]and Odan Fna tram attaa tftat snduea calar, .tasta or osar in sudi a asna a i la craam a ngiaanca. Saddta Oitaehnd aa(Ma muat nat icmd 1,000 m + /U morttniy avan * * 790 m f j/l. Must ba tra# fnm unanMtr. putraacant dal tartana ar otftawrtaa eSfactlenaaie attaa. Tada twalanaaM Fna from aataa in caneom rrtani #r eamWnatfana harm M human, anim ai s ia ac asuada tifa. Iowa -- Kansas .5-9.0 -- Caiar, Tarla land Odan | Fna from attaa that produsa aalar, taat# or odorila uch a dtna aa ta Sa dotrtmanta) ta Industrtal uaa. Saddm Fna from datm* a n ta in amaunta that aauld Sa uril*htty ar | dalitartaut' ar othar aat*a that atti* ta tana putnacant i r obncffena'Ma twdsa dn auta. Tana Sua m n a s i Na aataa m concantratlona ar camsinatiena ditr*m m tal ta human, animai or aauatiS Ufa ar ta industrtal usa. 4.0 IW W dRfi NaI[mcraaaa thI at cautas tuaatamtal ttiU c o n tri* uh naturai odranea \mr that if detriments* ts induatnaf uaa. Catari Oiachargas af cster-eroducm* tuiatancaa lim n * to cam camraoana nt ditrimsmat ta induttnal u m . Tasta and Odart Coneantratian i> m it* ta masa that auld n * rrtuit m nade Wa offensiva aaar* ar qtftanniM intarftn nh industrial uaa. M * Fna fram haatin* di ar i ar material in amounts that wauM ia um ifhtty or aatrmantai ta induttnal u m . Tasta l k amia nuiutiinat uHtancaa fmimt M maintain bale ear* centrada au n manta* fr indairtal um Ksntushp 5.0-9.0 -- 99* 7 1-(0 FaS.) 2Vhr 1 0 7 day Catar, T am and O danjw aatM m u * net cnata a nuiaanen l atida* Oiesehd Mita m u * n * i u h 1.000 m *./l.; monthly avarasac 750 'm *./I. N a|fleatinf itn in unupntty or dat lanaua smaunn; n ornar * it n m u tatua ta form putr* ar aeiaedanslita ludia*.] Tasta S ultana sat N# tin m com can trttiart ari camauiadar* harmful ta human, animal, plant LotiM i 5.4* 90 . . . . , , *^_irfla lim iti tt far all mdicactl* iiotooaa r laaaad a* a *& iailda Nona met aid pmduc hoatin mataata aJud* banaa ar|*aaa m bottam. uthar organia or in arcam i Tasta Sudatane Na asta concantrattana or. eanu hsrm1 fid ta am1 ai ar plaid tifa, 2.0 Hai ta taeaad 'U FHfl OrtMin* watar Standard, r, Taata and O dvt Fna fnm in n in * impart turtadltp. alar, tana ar ldr ar impair inauatrtti usa. Saiitaa Fna fnm c*uda daaaaita. saUd rafuM ana hoatm* aaiK*. Tana uSKtataasi Ha cfnmwal eansatuant* fnm sia M unta Maryfamd ro^p.o (tasa naturad 100* 0 (untai " itu n * y K7W1T) harmfu* ta human* ar mt evmafy a ffa * induttnal u t [ <1 Cam . Taata and Oda Fna fnm tata ruttanti m * ehane usan* eam ar induca tasta and dar ta auch * d a *r a ta cnata a nwsanaa ar mtarfan iW ihduatnai u m . Satid Fna im aaaaa tnat daai aaa ta tana danesi, cnata a nunanea muffare ufi mautanal] uaa and a n uns<*imy. putm eam or ita r m Tatae SuaatanM * Fna fnm m a aataa that mtartara arti indurtruf irte ar m * a n hamtfid human, m ani animai tSHCh .0 -9 .0 -- 2.0 SadtaaalMm Haru in cancantradana harmful ta human, animai ar aauatta irta.]TmtaWta. Calar. Tasta and Oda Nona in cam LantriP W mat uid impaw industrial ina. Safldii Nana a*, io i h M th * nid i may negli fnm tn* dncharpa fnm BStedmatimnt fatiim ta srwndln* apanartau tm tm am . Tata* ------- -- I ar camamatiani narmful A 0 002<|5< 11 Water quality standards H MkhifJa M J '-41 ._ D fu th r* M ifartbira 0*) tllm M a xrv t IMTHN (fatal M agiara i t m i w M w t m g ./L r t% ) OtttarRsqulremenei ! nouf) lA pro* *d*4edvfyi Stendertfa ts 0 eatablishad , n,_ . > ,n * '" * * " 'UBI* en daitarlyus aflicta. T u ra * * , calen Na 3o?. tionWa unnaturei turdlty 9r estar m o u 7 m i^ ^ u * 'ntTe marfora|w.'ii industrial usa. Tarta ana o aJT l.7aw .,V i. i may tMeama miunaua la industrial u m . latida: o iiu ivea salida nturt net exeoed 790 m ./I.; menthiy avenga*. 500 mg / I Na satn,| artlds .sr sdiact.on.Ma dago*tp , Ju.nTbra h.f u ld mtarftra w tft industrial usa. T ., * SwbbJra U niS d a escentraLona lase tnsn tnosa that a n or may bacante mjuriaualta tiis u a . * * sacama M i n n M d t a c.o-9.0 -- H* M ln J ttJ H d o - u lo *r i<r M I u m M t.3 -9 .0 - 90* f *Cavarais at crass section) Calar, Tetra and Odar. la id a Freo frani ansa tnst e_a_u_sa nuitanca [condition*.1 s u d i as m e le ra i diacsiantiV n.' onoaiowa oda^b a f iflc in t flu iJ A f solida, .scasate, suspanaad salida or ludga dapeaits. 3 . 0 Color, Tarts and Odsrt Fras from wastes that product color o r- odor m such degree] a t ta create a nuisance. Sailda: Onsatvad solids 'nun n rt nscaad 1.900 m g ./l,: monthly avarags 790 mi*7 L Must 9* Naa from floatind wastes that lertla to form unsightly,) drtetarfeus, objectionable er putrescent daeesits. Tasla SwMtanaati No seta, in eancantratiana sr combinations harmful ts human, amm il ar aquatic tits. d.O* I >i RartaacWdyi Orosa Bats: 1.000 dc/ 1. (In absence t f 9r-90 and alpha amittors). I 'M : 10 pc/1. Oiasalvad IU -2 2 i 1 pe/1. Cortn <"u oat esuaa auBatsntial vmbie contrast with natural appearance of s tra in ar intarfars with industrial uss. Tasts and Odan Limited ta cancantratisna that would not result m nattcra bio offensive odora |ar otherwise intarf ara with industrial use. M td n No natrcaaiio smania or merganrt dacweita or floating material in unaighBy or daiatarl.ua amounts. Tsais Coneantratians not datnmantsl ta industrial uaa humans, flail, wildtlfaC F:1J. Montana i^ d .s 0.9 No advarsa change N s b m f c a a , 9 - t . o 1.0 wr O C9L*J(May- 10* (Now.* Apr.) Asia: 27h r. -- Radiesertvltyi Nat to `asesad `92 PH I Orlnfcing Water Standards, TurMOrtyr [Must nat [interrar with artaSUshad lavala of tract, mam Cesar, Tasta and Odati Water shall ss maintained in cam dition not [offensive t i sanse at eight sr smell. SaUdst N . dash ing solids [and sludge] deposits in amaunta deleterious to Indus* tnal usai no isoim enu or tattiaasta aalidt that sheet treatment lavata. Tarta SuStrtnsaai Amaunta present must not adversary affaet industrial uaa.!| I !| j,0 RadloaedvWy; Mutt conform with Radiological Health Regula* tlona (ls t.[*d l. Stata [of Nafiresha. M . Turaally: Ns mera than 10% increase above normal lavai. Catar. No evidence of menar that creers nunsnc condirtene. Tasti and Oder; Lesa than amounts that would 'degrada water duality lor mduatnal uaa: p1 ,h3o0 n0 alm: 0g..07 01 1. m g ./l.|9o tld si Ne mora than O2 0ita% etvmederssaetnads(limm y it 1 0n0ot u m c g m ./U from any [ paint asures. Ns waste salida that permit dtpaef* Bon ar aro, deieteneu ta industrial usa. Tarts Surtetancaai Nana in coneantratians ar emOmetiens that would rondar water um suitable fair industriel usa. 1 CUCI Nevada i.s-9.9 Annua) m7.e4-diiaJn: NawHuNfM*^^ - NdwJgyggfqj >j -- t r (UhlSM nrrtSSb naom O 9.0 1.0 (avaraca. J u n -4 U Na fncreasb that would intarlar wirtt Otta usa" 9* (up 90 97*) 9 .0 4.0" Wailea i t Nyi Limitad ta 1/10 of the lithr.-w aeh valas m N IS HandBoaS} i f . TurhtdHy, Calar, Tasta and Oder Fraa from wastes m amounts sufficient ta change e n a tin g tu rp id ity or colar anawph ta creata a nuisance or interfere tin ndustnal usa. ar ta produca tasta er odor m the water. Senas: Free from floating orj other waataa that sania ta form tiudge sansa or dapositi in amounts | that would BS unsightly or odorous ar ntarfara with mduatnal uaa. Tarta Substancai: Fraa from waataa in concentrsuena ar cimbmatiana toxic ts numan. animal, plant or squarta Ilfs sr that intarfars with industrial use. Turbiilly . Casse, Tarte jand Odan Nans in abjactionabia amounts, SaUdai Hai floating solida or siudga depositi m :oi*ctionae casmm ah ui nn ita. Tarts m toxic cancantrxodna ar Naha noticeable in watar ar dapositad along nera Corta, Tasta and Odor. Nan. that ara offensive ta humane or detrimental W aguaba Mats. Tarts 9uestanca*: Nona that a sr os as in mental ta aquatic biota. Nbw IMMm .MS Must nat pollute or moho watar unlit for thrt usa Na oxygen demand OUI would causa padwtrtn Nat grastar than 1/10 ef tha 4b-hr. volua m N9S Manaiaaa 49. TuraiSH)ji hall nat cauta auastantial visibia con* tra wtth [naturai appeannee. Cartsi fhauia noi creata an esthabaaiiyl unaaairaaw cansitwn. Tassa and Osar: No odora othsr than sf naturai ngm. thrt ara astheticaiiy obioctionaaia ar obMxiaua. SaUdrt Ha ortoattanaMo Roabnq todos or oaona and adimant that usmfleantly aitar t n settica sf bonem. Tsart gubotasaort No amaunti tsart ta fiumana, punta, flsn. animala. Na T arli m j -- 4* 9* (avara Ratas V h r. *V 24h ra 3.0 Coirti Ne orterad w sairt that alena or in comemationa max* watar uftauiUMe far induatrial usai 9 o d *i Ha flaaung or icnim arte padda 'ar studia deposita that ara rsaany viuoia and a^ tneutaart u wastaa: Tala Subart nra Nana aione or m eem. btnabans that oavd tmaoir ir lam acm 002^55 I Water quality standards r " ~DftMtvi I pH AUtvaMo Tmpr*twCV) alternilo irrv M *I _____- Bwp_ t --tette MMail-- iWj k* * r i M w <N* I ( mb H u JVb Lh ai rw%I ) a.o s# . s w Ott\m /s s a y i S K s -- * " . s i ' 0;- s Ohi S.O-t.O -- OktehMU I .J 4 J -- Or*fM .9-9.0 -- PaimsyWunte .o-.o -- h*# (tim a co-H3 -- ,SMrtfiCarelfM9c.0o--ic.Js t (swamas) Starti DahH i M J i.o I- r 10* 39..00(for1 hr./day) daoartmarii.Cater.Tattiandd0Mtt Na*cca,tottaiB'thawtIctoaltairhaiaitui f u ^ r ^ m ' liysr S' 3* tr si.r* w2laa*tt(aao)rnly70if* 2*/Tir. ior* ir.at/ah:r. hwtww human, animal a21 v.. 00ar(adaIt)e 4.0 ^y* i0*?*1. i thatraduracalor ar * "p lan et. IUj Qitiolrad IVI. Mut M T If]! I?temL lbea?tfine*rothpmr*"twiti|tr t(thatriHgtetla79t0o yarr--1rr-rnT^T- ^*MT"nti*ei^f^uiy1tfttM hiCu^ifl,^i,idf^*f,0t0i*Vu'tn*>ui1* **ir*ln*Q<uc iotnteet*rlmirf*et>mQihmiy . Avaraea cancamrwm tt saints a contrallad teefl!#i| *elatianfc Turtetetyi Nana that causas vuibia centra * natural cand id*. Caten Nana that h raraiatrat" ram rateacentrattana detrimental ta Industrial im , arte O an Ha concantrsdana that m u m cauaa effenteva d i in vfcuute at water ar etharviaa Intarfara with Induatffte uml oMb Fraa tram atine atete, bettam <--aaiti ar ethar materials. Tatea Sanuibmsatla.1ntitaelnNt aanraaIngaetutaanUtfftata.a that maha n t v tana la human. 9.0 Radiada* funat aaaa atearnal haawc TurMteterSJCV ahava natura.1 Cater, Taste aite Odan fta aajaedonsbla diacatenea or conditions etthatically effanihm ta human anta* af tmoti. M it e Na fleatme elida. oreante ar inorgante injunaua ta industry. Taste Suhotenaaa Na aanditiana to euMte hoawu ;| Ca9.vO0arrWaaiet|e eater, Taate and Odan fta wtataa that aradura edera, or otate in mounts harmful ta industrial u i, Salida: Otuatvad Mlida m in i not astead 790 m f./!.; mantnry raga: 900 m ./l. Na flaatme - a *! ar tubaurtcra that saftta to form nudga in amounts h arm ful M intu ttnsi usa. Tatet Substances: Nona In amaunta harmful ta industrial an 3Sd.a.0oy**) (1 TetecSubetenaateNa eancantratlanaorcombina* hte./tienanairmfuiu human, animaiaraauatiila.Turtedlty,Taate and Odn Nona m'eoncatitratianathatautd imoair indurata! usa.Mte Na saltarafuaa.astines#J*aaraJudeadapastM Turbidfty.Caia,TastaandOdan Traetramwaataathatchine* i r . (awamaa) thaa>bnf turtedityareoiararthatproducalaataardarta atichadaeraatata'cautoanuiianeaormtarftfowithinduiMal uaa.faddte Nana tram atta laureaiamounts thataraun* ghtly.iMtraacanvodsteuaorthatcauseanuiaancaormtartera w.tnirteiistnaluaa-TtiMSwaaUnsaaairtofmm attahannfUi tahuman, animai, giant'araguabslitiarthatintarlatedlrarty armdlrwttymin mauftinaluste Rateaasdvten Nana aarmntad In star untata raadUy aaluWa ar isaatetaM andlm guantitias aitawad ty fadaral ar tuta ae*nsrateCalar*Tat and Odan Na waitaimtteraducamatte nal anularitian arundasirablaaiam. SaUdaiQaasivoduaa must nat mite 2.000 me/ 1-N* waataa araduona fteatind aalidte afwaea a#aau ar athar alfanaiva alfacts. Taate tute dama1Nana m ancantradana teste ta human, animai ar aauada ite Cnauh faara*Ri____ veoanndittioafnfadnsar#Turbtelte, Nana thatcaute advaraaly affateindustriai uaa. Nana inmouwtaoreaneantratlanathatcaute ta sactteiatetarate*y esnransanat traatmaite Tute and Odan Nana thatwaute raauftm Ulta aradarthat ^.^jteteum farmdwatrtel racasaine SaMai Ouurvad mustnataicaad900 mf./t-Nadladnstfyviublaalida, tethideafeanasthatcauteao atrimenttete Ttte SuisteMMi Nana that te*aucas aste uldadraraalyaffatewatarfarindustriaiu m 40 flitTinrm Raeutetsd terTana Radlatian Cantral Ate arte Tasaa Raeufttiana terCantra!teRadiatfan.TurbtertytNa tute tarmai inaraasa dua tewaatM Colan Na Buaaurtbai viaitea cantra [radi naturai appcararai te ftearrme .stara alter TZtrTrk** ateitetetiaalyaatmtnt Tactaand Ofanfte cansantradonc that radura affanahraadtei. SteMn OUaterad alteamute natmte 1.00 mvu uniraawatar vara anly terrrafl~i teuatSalmaantiilyInafram tifinearnoabla iimrt T rari dite waute adraratey affate nduatnal m Tatealadatenaate SfiaUnat acute archratea tsi*ny humana ammala artuada iteM l P O M 55 AOM 0 0 1 4 5 6 I Water quality etandard * * t, (f)Jlewe6*e U ta* ,0 -- ia ti raw aPdvaamPtadt DfeSdtvwl ctm (mlalaraw wf./l.at%) Wwr Requlnmtnti RadNactu wyi Shall irai aacaaa l/lo Varm ent .0 4 .9 -- V iratala (9l.0a -a9m.0s a -- 99** (uni** N ciuddan naturally cfta*f*e w at aO aVle v a * higher) couid **rm aduatw irta W tlh lltftM .9-9.9 0.9 7 0 f Ct M- 9 n) ot / Wal Viratala ^ x e u a ta r 9 .9 -9 .0 Caoln a tar 9 .0 -9 .0 WIk o m Jh .0-9.0 Toolin a 9 * (M ay 3' A7p3r '. )(Dae.- 2Vahtar :. (Oae.-Apr.) mburat ct ata ar tmanr tian paaaa# 0.9 r < .n *jn u , or oOorooi olooto or bollo- CoT" Taaia k M im m Na aera* in eancantratlo or comp!nation I0 M ta human. animal, plant ar auatia lilt or War *ouid infartara i * mdwatnai uaa. 3.0" 9 .0* (1 day) h r ./ adlaaaBvWyt TgraUdy, Te e apanavtdtiy aeeroonata nata g*ney. Tea; ena oaan Nana in caneintra liana ma auld imamr industriai uaa. Satldn No Reatina aoiiia. eluda dapaaita *r tana raiu. Tana lu H tin c a Ho enmieai :on- tituanta caraan n u i** r tam pinate** harmtgi ta human, animai ar auaM NI.ri 1.0* f ,1 Odfpt ^atai an Odati Ma aataa that ehin* aaiatin colar 2 .0 " (dady a*araat ar prtMuea ;oar ta auefi a m 'n a ta eraata a nu.aca or intarlata idi mduttrial uaa. S*flai Na ltaatin-waataa that ara uneifJttfy ar eraata a nuiuraa ar afflar anta that ta n a m form uAtJfhtfy. putraveant ar enut tiaaaaa Tana S* tanaaai Na aataa ut esneantratwta v amainaeam that oui intarlar iraatfy|r indlraetfy tth Indiiedi! uaa. C.9 or 70% RadteacdvNy, Tana 1Piu m ati tal eancartiaO ana that Quid advaraaty affact .nduatftal uaa. Turttawyr Lata man 10 JCU arar naturai aanttina.ieatar. Taata and Odar, addai Oiatahad. euapanaad. |R **ti t ar, wmarad mattar had naa radaaa tathatw vafwaa aa aa ta affa induatrtal wa 1.0 2.0 (daay avara) Calar Nana .that aPidctranaPI*. Taata aad Odan Na iK a r ta i* awa odar m vwmity ai tha vaiar, addai Na iiunctty vftiPU Roatm, aattlaapta ar tuaaandod ali tH unraaaanaai tund or dwantity. [Na oPtaettnaPl* P*ttam datatila ar eiudfa kana. Tana Sudata*aa* Na jeancantraMna al matanaia pati to human, animai ar R*h Ufa, 1.0 2.0 (daay avara) Calar, T*w' and Odati Na m aialala imauein* eolor. taata or odar m amounta mat auld eraata a mutane. Satldsi Ola* aaivad aafad m *it ai vieta 1.000 m ./l.. dauy (riga: 790 m f ./l. Na floating ar twpm*rfad daPrta ar atta tuonane** that auid cauta oaiaetionaaia dapatiti >n maunta ta craau a nuieanaa. jTaaw SuPauraaai Nana m eancantratian* ar cari** Pinatiana to u ta human* ar a l putii haaith ugmAcanca. Wywninf P .l-9 .5 -- r (far atraam * 77fttiara nat .0 diaaaPvNyi Nat t* a in a d 1/30 ai N f Han*aa* vatua*. TurPMdy: N m ar* mah i l iCU dava naturai (nn tur*iity 't ISO JCU ar amarvi. na mar* man 10% aaava naturai. Calan Cuantan? fra al aataa that aititi? attar naturai eaiar f atar ar imaan eaiar ,ta vaiaci* ar ttmeturaa. Taata and Odan Caaanttaity fra from in H tm ta that avtd oraduca oatactatia dar at em I uaa. Sanati Cuantan? ir* from floating ar earttaaBia aaiiaa mat ara unaihtiy r lama la farm eiuaga. tana or tattam daaaarta. Tana SuPauraa fra from tu ia lutatane eancantrnan* ar eamamatian* tu ia ta human, animai r guati ufa. Il lUdHi Cantrai M m iNtratian aeprwrai. I __ ____ ___ . frani unnaturai n atta aurata, at any pawt mrauchout tha t*ran atraam raach. T > hi<nat ,, c k iy ^ a tra rja T Iw S u et Oiandardt: JCU--J*eluen Canjgia U niti: pe/l.-aw oeun fa r iim . t di Unita Stata. TarntanatL na ma Odinet pf Columpia. Amanean Puara Haaiw A ia*., luteom - S E a T o m fl^ lim e ra , piara nutrrano. ad. ira a a *. eeum. Patiam daaaana. aaadcida*, tra a t a r ^ M c aaurtpnta nat meniad. Tema autaa ta f aunaarta far aaen atraam racen ar rwar oatm, m emneena raauaamanL 1 This rtpnirt is an n carp t from th t "Plan t Silas, f6 9 " report that appoarod in tha October 29.1969 iasuo of CHEMICAL W EEK N ) Copyright 969 McGra+-Hilt. tne.. \#u York. S.Y. This urtidt may not bt reproduet h diaut permistin. I7U1 ACH CC457 ! Monsanto MONSANTO INDUSTRIAL C H fM tC A LS c a 8 0 0 N. Lmdfttrgh 9oulvar0 St LJjii, Muiouri 83109 I Phon*: (314) 834-1000 SPECIAL UNDERTAKING BY PURCHASERS OF POLYCHLORINATED BIPHENYLS Monsanto Company ("Monsanto") manufacturer certain poly c h l o r i n a t e d b i p h e n y l produ c t s ("PCB'Is") w h i c h ("Buyer") desires to purchase. While Buyer desires to purchase PCB's because of certain desirable flame resistant and insulajtor properties, B u y e r ackno w l e d g e s that it is a w are and has b e e n a d v i s e d b y Monsanto that PCB's tend to persist in the environment; that care is required in their handling, possession, u s e and disposition; that tolerance limits have been or are * b e i n g established for PCB's in various, food products. Monsanto has therefore adopted certain restrictive policies with respect to its further production, sale and delivery of PCB's, including the receipt of undertakings from its customers as set forth below, and Buyer is willing Co agree to such undertakings with respect to sales and/or deliveries of PCB's by Monsanto to Buyer. Accordingly, Buyer hereby covenants and agrees that, with respect to any and all PCB's sold or delivered by or on behalf of Monsanto to Buyer on or after the date hereof and in consideration of any such sale dr delivery. Buyer shall 'defend, indemnify and hold harmless Monsanto, its prtaanit past and future directors, officers, employes and agaatS? from and against any and all liabilities, claims, damages, penalties, actions, suits, losses! costs and expenses arising out of or in connection with the receipt, purchase, possession, handling, use, sale or disposition of such PCB's by, through or u n der Buyer, w h e t h e r alone o r in combination with other substances, including, without implied limitation, any contamination of or adverse effect on humans, marine and wildlife, food, animal feed or the environment b y reason of such PCB's. unii of Monsa n t o C o m p a n y AC* C02<t6C I / -2 All existing contracts for the saleof PCB's by Monsanto to B u y e r ar e h e r e b y a m e n d e d to c o n t a i n trie p r o v isions set forth above. | Nothing herein shall create or impl^ any duty or obligation of Monsanto to sell or deliver any PCB's to Buyer. No condi' tions, understandings or agreements purporting to modify or vary the terms hereof shall be binding unless hereafter made in w r i t i n g s p e c i f i c a l l y r e f e r r i n g to this] ag r eement and signed by the party to be bound and no modification or v a r i a n c e of the a b ove u n d e r t a k i n g s h all bis effected b y the acknowledgment or acceptance of any sale document, purchase order, shipping instruction or other! forms containing terms or conditions at variance herewith. ____________________________________ (Buyer) BYt______________________________ TITLE: DATE: MONSANTO COMPANY I ! BY: ! ________ I I WO K .n m R R 8 ADM CC*<t61 C IV IL A C TIO N NO. 6 5 - C I - 1 7 2 4 D A V ID ADAMS, e t . a l . P IK E C IR C U IT COURT D I V I S I O\ N N OH . 1 P L A IN T IF F S vs. KENTUCKY POWER, a s u b s i d i a r y o f A m e rica n E l e c t r ic P o w er; W ESTINGHOUSE E L E C T R IC CO RPO RA TIO N ; A L L IS -C H A L M E R S CO RPO RATIO N ; M cGRAW -EDISO N COMPANY; SANGAM O -W ESTIN COMPANY, I N C . ; GENERAL E L E C T R IC CO RPO RATIO N : a n d MONSANTO COMPANY .1 DEFENDANTS DOCUMENTS R E F A IL U R E TO WARN OF A D V E R S E HEALTH E F F E C T S ATTENDANT TO EXPOSURE TOl PCBS ii ii ii i Wim?* t " YEAR PRODUCTION AND SALES ' POLYCHLORINATED BIPHENYLS (iPCB) ! MONSANTO INDUSTRIAL-CHEMICALS [COMPANY (SHORT TONS) U.S. PRODUCTION I i DOMESTIC SALES E lectrical* All** In su la tin g * ojther \ Liquids Uses Uses i U.S. EXPORT SALES A ll Uses 1971 (Est) 1970 1969 1968 1967 1966 1965 1964 1963 1962 1961 f 1960 20236 42527 38194 41427 37655 32925 30240 25417 22367 20986 20333 20786 14417 20268 18564. 20568 20387 18897 16203 13769 11448 11683 11108 12444 4401 : i 1 5263 !i 1 5034 : * 11990 > I l j j; 10642 j 9695 j 8666 j j. ! 7618 j 7339 ' j 7661 5163 4938 6826 5312 5616 4062 3426 2117 2048 1824 1809 2076 1827 * Closed Systems - Transformers and Cspacitors ** Including Heat-transfer Systems, Hydraulics/Lubricants, Plasticizers 100 Foni2 FCB MANUFACTURE AND SALES MONSANTO INDUSTRIAL CHEMICALS COMPANY 1957 thru 1964 (thousands of Pounds) a * S' o o <1 U.S. PRODUCTION DOMESTIC SALES (LBS.) U.S. EXPORT SALES DOMESTIC SALES BY CATEGORY 251 (1 ) 32299 (2 ) Heat Transfer.. -- -- ------ - Hydraullcs/Lubrlcants I612 Mine. Industrial 704 Transformer Capacitor 12955 17028 Plasticizer Applications Petroleum Additives (1) D O M E S T I C S A L E S BY P C B G R A D E Aroclor 1221 Aroclor 1232 Aroclor 1242 Aroclor 1248 A r o c l o r 125** Aroclor 1260 Aroclor 1262 Aroclor 1260 A r o c l o r tlCJl6 23 196 18222 1779 7587 31 -- 2558 252 (a . 15*19 755 5719 14099 3939 - 2685 1569 5984 16499 4573 - 16 113 10441 2559 6691 5982 184 72 - 254 240 13598 3304 6754 6619 359 102 1 O' wrtfntoncyvJ1 2260 37919 35214 (2 ) _ 2261 1962 36515 38353 38043 W - (2 ) 2523 1559 7921 16967 6244 - 4110 2114 6281 15935 9098 - 157 . 39I5 1 1601 7984 15382 8924 - IO3 155 18196 2827 6088 7330 326 189 94 241 19827 4023 6294 6540 361 158 l4o 224 20654 3463 6325 6595 432 210 2265 2264 44734 50033 38132 44869 3 6 4 7 ^ 4096 582 3945 1528 729O I 56O 6 9181 - 929 4374 1892 7997 19540 10337 - 361 13 18510 5O I 3 5911 7626 414 284 596 13 23571 5238 6e2S8l0l ISO * (1) Produc t i o n figures and Plasticizer Applications figures unavailable duFiM year indicated. (2 ) U.S. E x p o r t S a l e s figures unavailable during y ear indicated. ?( i U.S. PRODUCTION 60400 DOMESTIC SALES 51796 U.S. E X PORT SALES 4234 DOMESTIC SALES BY CATEGORY Rest Transfer 1237 Hydr.aul.l.cs/ ... . ----- - Lubricants 46l6 Mine. Indust r i a l 1841 T r a n s f o r m e r __________ 8657. Cops cl tor 23749 Plasticiser Applications H 696 petroleum Additives DOMESTIC SALES BY PCD GRADE ir^clor 1 2 2 1 irjolor 1 2 3 2 irsclor 1242 r dclor 1248 irDclor 1254 r>clor 1 2 6 0 rjelor 12 6 2 r)clor 1268 roclor 1 0 l 6 %1* * V 369 7 31533 5565 7737 5831 558 196 0 FCB MANUFACTURE AND SA LES MONSANTO IN D U ST R IA L CHEMICALS COMPANY X965 thru 197^ (Thousands of Pounds) 1366 65849 59078 6852 1261 8124 1968 82654 65116 11231 1262 76389 67194 10624 1212 85054 73061 13651 1971 34994 34301 1972 38600 26408 6388 1212 42178 37742 8346 1274 40466 34406 5395 1 7 6 6 2262 2529 3050 44238 4643 5765 8039 1779 - 891020684 1426 --I-IO7 1 - 29703 1283 --11585""" 29550 1079 12105 25022 13481 13361 14404 16460 - - 1439 3958 7403 1627 13828 26708 19537 -3060-- 752 1552 O _1155~-------- 0 as? i 3259 0 0 37742 34406 528 16 39557 5015 7035 5875 768 284 0 442 *. 302555 4704 6696 6417 840 287 0 136 90 44053 4894 8091 5252 720 286 0 507 273 45491 5650 Q822 4439 712 300 0 1476 260 48588 4073 12421 4890 1023 330 0 2215 171 21981 213 4661 1725 1 0 333* 171 0 728 807 3*95 305 0 0 20902 35 0 6200 0 7976 0 0 0 23531 57 0 6207 0 6185 0 0 0 21955 AUM 0 0 5 9 7 2 C C MONSANTO 'j& h i k> F n iv i 4 ,, PRODUCTION AND SALES , POLYCHLORINATED BIPHENYLS (iPCB) MONSANTO INDUSTRIAL CHEMICALS (COMPANY (SHORT TONS) -* YEAR U ,S. PRODUCTION 1971 (Est) 20236 t DOMESTIC SALES E lectrical* All** I n s u la tin g ' Other ' Liquids Uses Uses 1 14417 4401 i u .s . EXPORT SALES A ll Uses 4938 1970 42527 20268 1 5263 j 6826 1969 1968 1967 1966 1965 1964 1963 1962 1961 38194 41427 37655 32925 30240 25417 22367 20986 20333 18564. 20568 20387 18897 16203 13769 11448 11683 11108 * 15034 ! ! 11990 : [ 10846 ; [ 10642 I !; 9695 : 8fl 666 i 1` 7618 ! I 7339 1 ! 7661 . 5312 5616 4062 3426 2117 2048 1824 1809 2076 1960 20786 12444 5163 1 1827 I * Closed Systems - Transformers and Capacitors ** Including H eat-transfer Systems, Hydraulics/Lubricants, P la sticizers F n n i 5 1 0 0 J91 FniYif&R PCB MANUFACTURE AND SALES MONSANTO INDUSTRIAL CHEMICALS COMPANY 1957 thru 1964 (Thousands of Pounds) Xr % U .S . PRODUCTION DOMESTIC SALES (L B S.) U .S . EXPORT SALES DOMESTIC SALES BY CATEGORY 1251 (1) 3?2?9 (2) (2) Heat T ransfer "H ydraullcs/L ubrlcants M ise. In d u stria l T ransform er C apacitor P la s tic iz e r A pplications Petroleum A d d itives --- - -- -- 1612 1549 704 755 I2955 5719 17028 1099 (1) 3939 - DOMESTIC SALES BY PCB GRADE A roclor 1221 A roclor 1232 A roclor 1242 A roclor 1248 A roclor 1254 A roclor 1260 A roclor 1262 A roclor 1268 A r o c lo r 1 , 0 *l 61. 23 196 18222 1779 4461 7587 31 - *" 16 113 10444 2559 6691 5982 184 72 1252 i 960 1261 I 962 (1 ) 37919 36515 38353 31310 (2 ) , 35(221)*-- 37538 -- (2) 38043 -- (2)-- 123 44734 38132 36A7 1264 50833 44869 4096 2685 1569 5984 16499 4573 - 2523 1559 7921 16967 6244 - 4110 2114 6281 15935 9098 - 157 . 3915 * 1681 7984 15382 8924 - 582 3945 1528 729O 15606 9181 - 929 4374 I 692 7997 19540 10337 254 240 I 3598 3384 6754 6619 130529 -- IO3 18119565 2827 6O88 7330 326 189 94 241 19827 4023 6294 654O 361 158 -- 140 224 2O654 3463 6325 6595 432 210 * 361 I 851IO3 5013 75692161 4 l4 " 284 - 596 13 23571 5238 6280 Blll I 9O - ] ) Produc t i o n figures and Plasticizer Applications figures unavailable during year Indicated. 2 ) U.S. Export Sales figures unavailable during year Indicated. c AOM 0 0 5 9 7 2 PCB MANUFACTURE AND SALES MONSANTO INDUSTRIAL CHEMICALS COMPANY 1965 thru 1974 (Thousands o f Pounds) 2 s .S . PRODUCTION 60480 DOMESTIC SALES 51796 U .S . EXPORT SALES 4234 DOMESTIC SALES BY CATEQORY 1966 65849 59078 6852 ML 62466 8124 1968 82854 65116 I I 23I 1969 76389 67194 10624 12Z2 85054 73061 13651 1971 34994 34301 1973 38600 26408 6388 1973 42178 37742 8346 1974 40466 34406 5395 Heat T ransfer Hydraul l c a / t ---- L u b r ic a n ts M lsc. In d u str ia l Tran s f o r mer______ C ap acitor P lasticizer A pplications Petroleum A dditives 1237 1766 2262 4616 44258 4643 1841 1779 1426 - . f l e w -- - - 8910-- I-107-I- 23749 28884 . 29703 H 696 13481 13361 DOMESTIC SALES BY FOB GRADE 2529 5765 1283 - I I 585- 29550 14404 3050___ 3P?8 3fo -752 8039 1079 2152012025 7403 1552 1627____ 1155 000 13828 11134 ( ,, , 26708 1411 I2 5656 16460 1439 19537 3259 O 0 37742 34406 , Aroclor 1221 Aroolor 1232 Ar>clor 1242 A rcelor 1248 A r ce lo r 1254 A rjclor 1260 A rjclor 1262 A rjclor 1266 Aroclor 1016 369 7 31533 5565 7737 5831 558 196 0 528 16 39557 5015 7035 5875 768 284 0 442 . 25 43055 4 70 4 6696 6417 84o 287 O 1476 260 48588 4073 12421 4890 1023 330 0 2215 171 21981 213 4661 1725 1 0 3334 171 0 728 807 3495 305 0 0 20902 35 0 6200 0 7976 0 0 0 23531 507 6207 0 6185 0 0 0 21955 f t \: - I 'V THE PROPER HANDLING OF AROCLORS AND THEIR MIXTURES IN THE 1 , ELECTRICAL INDUSTRY j? . L! vf * *->i Monsanto Chemical Co. Organic Div. Sales' Dept. 800 N. Lindbergh Bly d.I St. Louis 66, Mo'. I -I . P . G . B E N IG N US J * n .r y IffiO M & 0 0 0 0 % `i 1 INDEX i Introduction - Page 1-2 Chapter 1 - Page 3-12 Page 3 Page 4 Page 12 Chapter 2 - Page 13-19 Page 13 Page 17 Chapter 3 - Page 20-21A Page 20 Page 21 Chapter 4 - Page 22-23 Page 22 Page 23 Page 23 Chapter 5 - Page 26-28 Page 26 Chapter 6 - Page 29-61 Page 29 Page 31 Page 31 Page 32 Page 33 The Proper Handling Of Aroclors And Their Mixtures In The Electrical Industry Procedure For Unloading Tankcars Of Aroclors* And Aroclor Mixtures Description of the Cars Procedure for Unloading the Car Drum Packaging Storage Tanks A) General Description (B) Detailed Description Gasketing and Pump Packing (A) Suggested1 Types Of Packing and |Gaske!tlng Materials 1 (B) Ga sleets For Askar el Capacitors and [Transformers Sampling Methods (A) The L s t m Standard Method (B) Monsanto Methods (C) Drum Sampling Laboratory Analysis and Procedure (A) For [Treating Aroclors and Their Mixtures with Earth T*est Proscedure] s (A) General Information (B) Detailed Instruction and Testing Methods 1. Procedure for Cleaning Electrodes 2. Dielectric Constant and Power Factor I 3. Dielectric Strength Frjniwa me oooo9i Page 44 Page 47 - Page 49 - Page 51 Page 52 Page 55 Page 59 Chapter .7 - Page 62-73 Page 64 Page 65 Page 66 Page 67 Page 68 Page 69 Page 70 Page 71 Page 72 Page 73 Chapter 8 - Page 74-76 Page 74 Page 74 Page 75 Chapter 9 - Page 77-79 Page 77 Page 77 Page 78 Page 79 I 4. Resistivity 5. Corrosion and Chemical Stability! 6. Inorganic Chlorides 7. Acid Number 8. Mois'ture :| 9. Hydrolysis Stability Test for Aroclor 10. Thermal Stability Method for Aroclors Typical Properties Aroclor 1232 Aroclor 242 Aroclor 248 Aroclor 254 Aroclor 260 Pyranol 481 Pyranol 488 Pyranol 1467 Pyranol 1470 Inerteen PPO 1 Quality Requirements of Aroclors Prior to *Use i!n the Electrical Industry Quality as Supplied to the Electricall Industry Typical Electrjical Quality of Aroclors [Used in the Industry Capacltor< Impregnation transformer Filling i \ Earth Refinement of Aroclors to Arrive! at the Desired Elec trical Qualities iI Earth Treatment in the Laboratory Preparatory toll Analysis Earth treatment by the Plant Manufacturing the Askarel Earth Refinement by the User Capacitor Manufacturers Transformer Manufacturers The Effect of Earth Refinement on Removal of Tin Tetraphenyl Scavengers from Transformer Aslcarel I m m cto ME 000092 r > r- Chapter 10 - Page 80-93 1 ^ .Page 80 : Page 83 Contamination |5 Avoidance of' Contaminating Askarelj Capacitors Avoidance of] Contaminating Askarell Transformers Chapter 11. - Page 9^-97 Page 9^ Page 95 Chapter 12 - Page 98-IOO Page 98 Page 99 Page 100 Reworking Contaminated Transformer Askarel| -1 Normal Conditions Arced Conditions Dermatology and Toxicology Skin Exposure Exposure to Vapors Vapors from i Severely Arced Askarel Transformer Attachments: Drawing No, 31-20847, The TankCar Drawing No. 31-20848, Dome Detail Drawing No. 9C-8170-5, The Horizontal Storage Tank Drawing No. D-13362, The Vertical Storage Tank Drawing No. 9C-8248, The Breathjer Drawing No. 9C-8278, The yarec "Gauge Drawing No. 9C-8178, The Unloading Platform V001K71 r.:.' 0 0 0 0 9 3 i I CHAPTER 12 j i DERMATOLOGY AND TOXICOLOGY * Skin Exposure Aroclors, or askarels, accidentally spililed on the skin do not cause an acute toxicity hazard, nor will they cause serious Irritation. The materials should be washed from the skin with soap and water. Prolonged skin contact Bhould be avoided. If work clothes becomL impregnated with I '1 these fluids, they should be removed and washed. I 'I When sampling tank cars, canvas globes and safety glasses, or goggles,- should be worn. No special clothing is required, but the w o rkers1 garments should be laundered at least weekly and changed, If Aroclors or askarels are spilled on the clothes. If accidental burns occur from contaIctwit1h hot askarels, * i the burn should be treated the same as any ordinary burn. Aroclor, or askarel, adhering to the burned arJa need not be removed immediately unless treatment of trie burn demands it I ] in which case, soap and water, or repeated washings with a vegetable oil should be used. Accidental' contJct with the eyes results in painful irritation, but not permanent damage | il to the tissues or the sight. In event of such contact, the eyes.should be flushed with a large amount of water for at least 15 minutes. The patient should then be referred to a physician who will treat with an ointment to soothe the eye. - 98- ME 00009 t Exposure to Vapors ' i Vapors from hot Aroclor, or askarel, have a degree of ii toxicity and should not be inhaled over a prolonged period of time. Experimental work on animals indicat1es that the maximum safe concentrations of vapors in work' rooms is in the range of 0.5 to 1.0 mg. per cubic meter of air. Harmful amounts of the materials are readily detectable by odor and irritation to the eyes. Usually, people can detect concen- trations of askarels in the amount of 1.0 mg, per cubic meter [ of air, which is the level regarded as the safe work room limit for an 8 hour day exposure. Capacitor impregnations may be done' at temperatures as I1 high as 266F. (130C.)* Following impregnation and draining ! 'I thechamber, exhaust ventilation should be applied to the chamber to prevent askarel vapors entering the! work room. ii Also, when opening a heated capacitor impregnating chamber, the workmen should wear a respirator during th:.s short interval of exposure. \ If transformer askarels are used at temperatures above 125 to 150F. to fill an open transformer, exhaust ventilation should be provided In the immediate area. The many years of satisfactory and safe use of Aroclors, or askarels, by the electrical Industry for impregnating capacitors and filling transformers has demonstrated the industry's ability to handle these fluids without hazard to the workmen. It is both simple and in line with "good lousekeeping " and personal cleanliness to exercise the sugges ;ed precautions in all cases. - 99- Fornai ME 00009 t Vapors from a Severely Arced Askarel Transformer Experimental data indicate that when askarel is decomposed jDy an electric arc, insignificant amounts of chlorine and phosgene gas are liberated. The gas is almost entirely hydrogen chloride, which is readily detectable by its odor and its irritating characteristics in even small amounts. Thereby, adequate warning of its presence is provided and significant amounts of fumes would be likely to cause a hazard only in a closed area. Individuals would not voluntarily expose themselves to serious toxic levels of the hydrogen chloride gas fumes. -100- 000090 FOREWORD The Aroclors*, chlorinated biphenyl and chlorinated poly-phenyls, possess unique properties which enable the fulfillment of requirements not met by other materials. This has won a prominent place for Aroclors. particularly, in the electrical insulatinge field and in such wid|ely' diffe-Iringe applications as nonflammable hydraulic media, hightemperature and high-pressure lubricants, neat-transfer and expansion media, sealing compounds, adhesivesj and protective coatings, including plastics, pigments, lacquers, paints and varnishes. This booklet describes the properties of thirteen Aroclors, each of which is representative of a series. For almost ejrery Aroclor described there is a dark-colored grade of other wise approximately the same physical and chemical char acteristics. These darker products are less pure but lower in price. j The Aroclors are efficient and very economical, both when used alone to accomplish results not attainable by other materials and when used as extenders to enhance the properties of other products. They are produced exclusively by Monsanto Chemical Company. *Jte|iil(r(J in L*. S. Pment Office. 1? . IIC f-1^ ^ 7M r i o t t o 19 i r F n m 1775 ME 00009 INDEX Page No. G EN EK A L P R O P E R T IE S ................................. 3 General Physical Properties of Some of the A roclors............................................. 4-5 Resistance of Structural Materials to Aroclors .....................................................6 A d h e siv e n e ss..................................................... 7 Specific V o lu m e ................................................. 7 Average Coefficients of Expansion, Aroclor 1248 ................................................. 7 C orrosion............................................................. 7 D en sity .................................................................9 Electrical P ro p e rtie s.........................................9 Non-drying P r o p e r tie s..................................... 9 Nonflammability ................................................. 9 So lu b ility .............................................................9 Specific Heat and Thermal Conductivity 9 Electrical P ro p e rtie s.........................................9 Thermal Conductivity of Aroclor 1248 . . 10 S t a b i l i t y ........................................................... 10 Toward A lk a lie s........................................... 10 Toward Acids .................................... 10 Toward H e a t ............................................... 10 Toward O x id a tio n ...................................... *10 Surface T e n s io n ............................................... 10 Thermoplasticity............................................... 10 Vaporization L o u ........................................... 13 Vapor P re ssu re s...............................................13 APPLICATION OF A R O C LO R S................... 15 A dhesives...........................................................15 Electrical Equipm ent....................................... 15 Expansion Medium ........................................... 15 Page No. Hydraulic Medium Power Tranismission Hydraulic Pressure Liquid Heating Medium Lubrication I. . . Air Compressors Cutting Oils . High Temperature Extreme Pressure Submergedj Lubrication Gaskets and Packing Materials DermatologyiIand Tox'Ii.cology. Suggested Uses for Aroclors in Plastics, Pig ments, Lacquers, Paints, Varnishes and Waxes 20 Compatibility with Various Materials . Ethvl Cellu|lose . Graphic Arts . . Impregnation . . 20 20 20 21 Moisture Proofing 21 Pigment J . . . 21 Paints and |Varnjshes...................................21 Rubber and Rubber Substitutes . . . . 22 Modified R*ubber Finish es.......................... 22 Vinyl Resins. . . ;|.......................................22 Nitrocellulose C o a tin g s.............................. 23 Waxes. 23 Diagrams Showing Practical Composi tion of Lacquers Using Aroclors 1254 and 1262 . . . .24-25-26 Other Literature on Aroclor Applications 27 ) 2 ForviG7fi tv F 0 0 O O F S I I packing. Likewise Duraroetallic's Spiral Asbestos Fiber may be uaed.^Doubtless. Johns-Manville and others have comparable packing materials which would be suitable- The following materials are being used satisfactorily as pipe thread compounds in Aroclor units: 1. Plastic Lead Seal. Durametallic Corporation. 2. Ordinary white lead. 3. Glyptal No. 2, General Electric Company. DERMATOLOGY AND TOXICOLOGY Skin patch test6 with a polyvinylchloride free film plasticized with 11.5 percent by weight of Aroclor 1254 (about 25 per cent based on the weight of the vinyl resin) and a similar amount of dioctyl phthalale showed that this film was not a pri mary irritant or a sensitizer. Also, skin patch tests on Aroclor 1254 alone applied to gauze and placed in contact with the skin showed no primary irritancy or sensitization. Other skin patch tests using canvas coated with Aroclor 5460 and an oil modified alkyd resin, in such a manner that the Aroclor concentration in the paint film on the fabric was about 17 percent by weight of paint solids and the finished coated fabric contained approximately seven percent by weight of Aroclor 5460 showed that this painted fabric did not produce primary irritancy or sen sitization of the skin. If Aroclors are skilled on jthe skin, the skin should be washed in the usual manner with soap solu tions. If accidental burns^ occur from contact with hot Aroclors, the^bum should be treated the same as any ordinary) burn. Aroclor adhering to the burned area need not be removed immediately unless treatment of the bum demands it, in which case use soap and water oir repeated washings with a vegetable oil. I At ordinary temperatures Aroclors have not presented industrial toxicological problems. If Aroclors are used at elevated temperatures such as 200or 300 C.j in open systems, methods must be designed to exhaust any vapors arising from these open systems. This applies especially to lower chlorinated Aroclors where experimental work on animals indicates] that the maximum safe concentration of vapors in workrooms is in the range of 0.5 to 1.0 milligrams per cubic meter of air. In the case of more highly chlorinated Aroclors such as Aroclor 1268, the allowable limit is about 10 milligrams per cubic meter of air and accord ingly, Aroclors of this type are believed to be of a much lower order of toxicitv. Where Aroclor v1apors m,1ay 'be encountered in workrooms, local exhaust ventilation together with general workroom exhaust is recommended. 19 i n n i f m ME 000115 I I ' (J ( i I iI " I I f I ! ! / A SK A R EL F/W 1R7R 400021 *I TABLE OF CONTENTS SECTION A 7 TRANSFORMER ASKAREL Page I. Introduction............ ........................................................... 1 II. History of Trade Name Types. . 1.......................................! -- .. .1 Table I -- The Composition of Transformer. Askarels ' ( III. Table II -- Official Transformer Askarel Shipping Specifications: A. General Electric Company's Transformer Pyranol A13B3Bs B. Westinghouse Transformer Inerteen PPO (7336-9) ! IV. Interchangeability and Stability......................................................... V. Directions For Handling and Personal Precautions......... ! -- . . 1 2-3 4 4 VI. Expected Service Life VII. Dielectric Strength -- Moisture Relationship--- . . . . A. Table III -- Dielectric Strength vs. Amount of Dissolved: Water in Askarel and Mineral oil B. Table IV -- Approximate Solubility of Water in As :arel and Mineral Oil. VIII. Table V --: Typical Values Found in Askarel Fluid Under Various Con ditions of U se....................... .............................................. IX. Check Points For Maintaining Askarel Insulation A. General Considerations B. Modern Sealing Procedures C. The Older Sealing Arrangements X. Periodic Fluid Inspection.....................................-- A. Visual Inspection B. Dielectric Strength XI. Inspection Check L ist...................................................... XII. Contamination in Transformers..................................... v A. Table VI -- Effect o f Common Insulation Materials bn Power Factor and Dielectric Strength & yj& bie VII -- Effect o f Common Insulation Materials on Volume* ^P*mivity XIII. Refining Askarel For Re-U se............. ........................ A. Filtering Through Dry Blotter Paper To Remove Moisture and Extraneous Particles. Table VIII -- Guide to "Rate of Dissolved Water Removal By Filtration. B. Earth Treatment for Maximum Improvement o f Power Factor and Volume-Resistivity 1. Procedure 2. Effect o f Earth on Removal o f Scavengers j I 3. Table IX -- Approximate Relationship Between Power Factor, Volume-Resistivity and Dielectric Strength of Transformer Askarel XIV. Cleaning Arced T ransform e............................................ ........... J ................... J. . . . . . . .XV. Sampling A S K A R E L ................... .............................. !...... 11 12 12 14 IS 7. !! 400022 I rv. INTERCHANGEABILITY AND STABILITY A. Interchingeability: The two general types of askarel insulation shown in Table II can be either mixed otinterchangcd and there will be no difference in the operation o f the transfonoer. However, askarel insulation must never be mixed with mineral oil. Over 2% mineral oil in askarel begins to lower its fire resistance. Further, materials o f construction in the transformer that are compatible with askarel may not be compatible with oil and vice-versa. For example: a significant amount o f askarel in a transformer built for minera oil will attack gaskets, adhesives, core bindings, impregnating varnishes* etc. B. Stability: Askarel liquid insulation is highly pure, fire-proof liquid made under close chemical control. It does not vary in. composition like the commercial range o f mineral oils. Askarel does not deteriorate when exposed to air, heat, hot metal; it does not break down over long use to form conducting or corrosive chemicals; it does not oxidize or sludge. Askarel will remain perfectly stable year 'after year unless broken down by exposure to severe arcing. The only real " enemy*' o f askarel is contamination byf water. Keeping askarel water-free will insure long-time service. Askarel is heavier than water. If water gets into askarel insulation, only a tiny amount (125 ppm) dissolves -- the rest floats on top. V. DIRECTIONS FOR HANDLING A. Keep Dry: In handling, storing, sampling, inspecting askarel -- and in o perating askarel transformers -- take every precaution to guard the askarel insulation from exposure to high humidity and moisture contamination. Keep 5, 30, or 55 gallon drums o f askarel dry; lay stored drums on their sides with the bung at the highest point from floor to keep water off the drum head (which can be into the askarel by the drum " breathing"). jThis precaution is not when drums are stored indoors, which is the preferred way of * B. Use Ordinary Personal Precautions: Transformer askarel has been made, handled, and used for over 30 yean without causing toxic or other ill effects. It can be handled with only minor precautions. If accidentally spilled on hands, no serious skin irritation will occur. However, liquid askarel has a solvent action (similar to paint thinner) on the fats and oils of the skin and prolonged contact may lead to drying and chapping of the skin. 400027 4 t ) I In case of contact, wash off the skin with soap and water; remove and dry dean saturated clothing. Clean up spills with rags, sawdust or absorbent clay. Eye ^contact may result in painful irritation but no permanent damage to tissues. If askarel gets in the eyes, flush with largIe amou|lnts of water. As with all eye first-aid, refer to a physician. To relieve irritation, physicians have used a 1% Pontocaine as well as opthalmic cortisone acetate solution, or castor oil. I1 Infrequent exposure to askarel vapors will not cause ill effects. However, prolonged exposure to high vapor concentrations should be avoided. If hot askarel must be handled in a closed or confined area, provide the area with ordinary exhaust ventilation -- or -- wear an organic cartridge respirator approved by the U. S. Bureau o f Mines. VL EXPECTED SERVICE LIFE Properly designed and installed askarel transformers will giyje trouble-free service for a minimum o f 30 years. Since their introduction in 1932, the manufacturers report finding the over-all failure rate to be less than 0.5% for all units under test and service conditions. The Edison Electric Institute's report (1956-1958) on their member utilities publishes the failure rate for askarel transformers as 0.13 per hundred banks per year. Even the rare reports of failure are invariably found to be due to improper sealing that allows moisture to enter. VU DIELECTRIC STRENGTH -- MOISTURE RELATIONSHIP The dielectric strength of askarel is highly sensitive to excess moisture; not sensitive to ordinary dissolved contaminants. While the dielectric strength can also be lowered by severe arcing, askarel turns noticeably black or has particles o f sooty carbon floating in it if arcing has occurred. Then the transformer should be repaired and the askarel replaced. I New askarel has a minimum dielectric strength of 35 KV at 25; a maximum mois ture content of 30 ppm. If the dielectric strength is checked periodically and decreases significantly -- this indicates moisture pick-up, arcing, or both. When the dielectric iCttith has dropped to 26 KV or less, an analysis for water is necessary. If water is found in excess of 100 ppm at 25 C., its source should be located and corrections made. When the moisture content approaches 125 ppm (saturation level), the dielectric strength of askarel drops below the value required for efficient insulating. The moisture content should not be allowed to rise over 70 ppm; it should be held as near as possible to 30 ppm. Maintaining a low moisture level will assure high dielectric strength and top operating efficiency. I i Table III shows the relationship of dielectric strength vs. moisture and^ Table IV indicates the approximate water solubility limits in askarel and mineral c f c n n i k r i I 5 400028 \ J ;) : i ( i i i i MONSANTO FUNCTIO NAL FLUIDS DEPT. 800 N. L IN D B ER G H B L V O . S T . L O U IS , M IS S O U R I 831M The infocaptfon herein regarding obtaining optimum results from askarel fluids is ygfar m sfo n n e r has been accumulated by Monsanto for over 30 yean from the eapciencs of oaken and usen of askard transfonsen and it is believed wfll bo balpftiL I Nothing herein shall be construed as applying to other than askarel insulation. D ata and maintenance suggestions herein do not apply to the other components of the transformer. All operating and maintenance suggestions recommended by the manufacturer of the transformer should also be carefully followed. ; Because these maintenance directions apply only to the askarel insulation, Monsanto disclaims any liability for damage to property or injury to persons arising from transformer operation. j Fnni82 400000 II I1 Monsanto i ii '! m o k i m t o in o u it r u l CHKUlCALS CO. SOO H. LintfBtrgM loultvtrd' S ) Louif. M tasoyrt' S31( q PKena: OU) 894-1000 Dear Sir: We are writing to advise you that Monsanto has adopted c e r t a i n r e s t r i c t i v e policies w i t h r e s p e c t to its further sale and delivery of all polychliorinated biphenyl (PCB's) p r o d u c t s u s e d as d i e l e c t r i c fluids i n .[transformers and capacitors including but not limited to^those sold under tradenames such as A r o c l o r InerteeriQt and P y r a n o l and under-the generic term askarel. : Effective 15 January 1972 Monsanto will sell and deliver these products only to manufacturers of transformers or capacitors who have entered into agreement to indemnify a nd ,hold h a r m l e s s M o n s a n t o in the u s e jof th e s e products. .The^.two co p i e s of such an a g r e e m e n t are attached. The a c c e p t a n c e b y M o n s a n t o of such an a g r e e m e n t is subject to receipt of financial and other information from you which, in Monsanto s opinion, makes the agreement meaningful. As we have previously advised you, studies indicate PCB's may be accumulating in the environment'! In some instances, P C B ' s h a v e b e e n found in food or 'iin thei food chain. For y o u r info r m a t i o n , a t t a c h e d is an a r t i c l e b y Carl G. Gustafson of the Federal Water Quality(Administration a p p e a r i n g in " E n v i r o n m e n t a l S c i e n c e & T e c h n o l o g y " which deals with this subject. Because)of Monsanto's concern over this problem, we are discontinuing sales of PCB's in any applications except as dielectric fluids for use in transformers and capacitors. unit of Wo a i i a i o Comoa nv i i Fomiti > 133 A O CG2W2 c Pag* 2 If you desire to continue purchase of these products from Monsanto afttr 15 January, pleajse have the attached copies of agreement signed by an authorized! officer on behalf of your company and forward a fully sighed copy, together with your most recent audited financial statement and any other information which you feel will assist Monsanto in its evaluation. If you have any questions please telephone (314) 694-2455 or write directly to Mr. H. S. Bergen! Monsanto Company, P. 0. Box 14617, St. Louis, Missouri |6317S. We sincerely regret any hardships thajt this decision may cause you but it is taken in an effort to continue to make available these products for critical electrical applications. iill Very truly yours, c Howard Bergen, Director Specialty Products Group Monsanto Industrial Chemicals Co /jf Enclosures Farn KR4 134 ACM MONSAKTQ INQUrmiAL c h i m k u u CO. 600 N.LinoKrgft Isuitvard S t. Ionia. M m o y ri 93188 PNOAa: OU) 981-1000 SP E C IA L UNDERTAKING BY PURCHASERS OF POLYCHLORINATED BIPHENYLS Monsanto Company ("Monsanto") manufacturas certain poly c h l o r i n a t e d b i p h e n y l p r o d u c t s ("jPCB's') w h i c h _________ ________________ ("Buyer") desir'es to| purchase. W h i l e Buyer desires to purchase PCB's because of certain desirable flame resistant and insulator properties. Buyer a c k n o w l e d g e s that it Is a ware anld h a s |b e e n a d vise d b y M o n s a n t o that PCB's tend to persjist in the environment: that care is required in their handling, possession, u s e and disposition; that tolerance limits have been or are b e i n g established for PCB's in various food products. Monsanto has therefore adopted certain restrictive policies with respect to its further production, sale and delivery of P Q ' s , including the receipt of undertakings from its cust o m e r s as set forth below, and B u y e r is willing to ag r e e to such undertakings with respect to sales and/or deliveries of PCB's by Monsanto to Buyer. 1 A c c o r d i n g l y , B u y e r h e r e b y c o v e n a n t s arid ag r e e s that, w i t h respect to any and all PCB's sold or delivered by Or on b e h a l f o f M o n s a n t o to B u y e r on of a f t e r the date h'ereof and in consideration of any such sale or delivery, Buyer s h a l l defend, indemnify and h o l d h a r m l e s s Monsanto', its present, past and future directors, officers, employes and agents, from and against any andall liabilities, claims. dama g e s , penalties, actions, suits', losses, costs and e x p e n s e s a r ising out of or in c o n n e c t i o n with the receipt,, purchase, possession, handling, use, ale or disposition of such PCB's by, through or under Buyer; whether alone or in combination with other substances, including, without implied limitation, any contamination of|or adverse effectjon humans. marine and wildlife, food, animal feed or the environment b y reason of such PCB's. ,.nil alMl ns C anaan, FnmfcRS 135 i AC ^ 002 - 2- A l l e l a t i n g contract for the sal* d f PCB's b y Monsanto to B u y e r are h a r a b y amended to contai'n tha proviaiona sat forth abova. j i N o t h i n g h a r a i n s hall c r a a t a or I mply !a n y d u t y or o b l i g a t i o n of Monsanto to sell or dalivar any PCB'a to Buyer. No condi tions, understandings or .agreements purporting to modify or vary tha terms hereof shall be indinjg unless hereafter made in w r i t i n g s p e c i f i c a l l y r e f e r r i n g to jthis a g reeme n t and s i g n e d b y t h a p a r t y to b e b o u n d [and n o m o d i f i c a t i o n o r variance of tha abova undertaking shall be affected b y the a c k n o w l e d g m e n t o r a c c e p t a n c e of jany s a l e document, p u r c h a s e order, shipping instruction or other forms containing terms or conditions at variance herewith. BY: TITLE: DATE: (Buyer) MONSANTO COMPANY CC2<i 136 ^a o O. n ^-- j ASICAIIEIB - Environmental Pollution kBy:|R.A. Lidgett II.A. Vodden 'In tro d u c tio n The presence of polychlorinatecd biphenyls* (VCBs) in wild-life specimens vas first demonstrated In 19G6 by JensenvlJ, who identified the unknown peaks, interfering with GLC chromatograms in the analysis for organo-chlorine insect icides in bird-tissues, as chlorinated biphenyls. Since then a considerable amount of analytical evidence has been accumulated to support the view that existPCB's in the environment over extensive regions1 of the earth in amounts which arc comparable in magnitude with those of insecticides Two features common to both organo-chlorine inse cticides and the PCBs being found in nature are that they arc persistent and accumulate in oil and fat 60 that the highest levels are found in fatty tissues ofi birds and in the blubber of certain marine animals. One noticeable difference is that, whereas insect- icides are found in significant quantities in nearly all species of animal and plant life, significant amounts of PCBs arc usually associated with the marine or aquatic cnvironsicnts. Thus the highest levels of PCBs have been found in fish-eating birds and in marine mamals. W W Not all PCBs arc found in wild-life; the jcliromatograms usually reported suggest that hoojologucs containing ^ or 6 chlorine atoms are the most common. It is often claimed that the closest match for jtlie chromatograms of wild-life extracts is that obtained from commercial products corresponding to 50-54/0 chlorine. Biphenyl is synonymous with diphenyl F n m 7 1 C 125 * 2- J V rs i s lr n r c rtml T o x ir it v T!c p r in c ip a l cause of con cern , amongst c o n s e r v a t io n is t s and e c o lo g is t s , about p o ly c h lo r in a te d b ip h e n y ls and o rg a n o -c lilo rin c in s e c t ic id e s is th at they a rc v e ry it a b lc chem ical compounds. They are r e s is t a n t 1o degradation bv o x id a tio n both ch e m ica lly and b io lo g ic a lly . C le a rly , i f the rate of d isp e rsa l of these m a te ria ls in to the environment is g reater than the rate of degradation, th e re w i l l be a ccu m u la tio n . The combination of p e rs is te n c e and accum ulation in fat d urin g t r a n s it io n through a food chain can r e s u lt in co n sid erab le in creases in c o n c e n tra tio n of these compounds; i t is q u ite p o s s ib le th a t a very low le v e l o f perhaps 1 p a rt in 10** in water can be concentrated through a food-chain of m arine or a q u a tic s p e c ie s , to le v e ls of about 1 p a rt in 10^, which are sometimes observed in the organs of- f is h - e a t in g b ir d s . The t o x ic it y of these compounds is re le v a n t s in c e the le v e l which can be accepted w i l l o b v io u s ly depend upon t h i s . I t is perhaps worth making the p o in t here th a t p r a c t i c a l l y a l l chem ical compounds a rc "to x ic to some exten t so th at any p e r s is t e n t compound would e v e n tu a lly become a t o x ic h a z a rd . Compounds of r c l a t i ' hig h t o x i c i t y , which are degraded in the environm ent, do not n e c e s s a r ily pose e c o lo g ic a l h a z a rd s. The acute t o x ic it y of p o ly c h lo rin a te d biphenyl* to ra ts lias been determ ined and, fo r example, the acute ID 50 v a lu e fo r A ro c lo r 12^2 is about, k m l./k g . In the present co ntext, however, the ch ro n ic e ffe c t of continued a s s im ila t io n i s p ro b ab ly more p e r tin e n t. The d iffe r e n c e in s e n s it iv it y of d i f f c s p e c ie s makes g e n e r a lis a t io n im p o ssib le , but p u b lish e d in fo rm a tio n suggests th a t c h ro n ic t o x ic it y of PC3s i s one or two orders of magnitude le s s than th a t of DDT. F o r sm a ll mammals, fe e d in g t r i a l s in d ic a te th a t a t le v e ls of 1 - 1 0 ppm in fo e d st no s ig n if ic a n t t o x ic e f f e c t is observed, but a t 100 ppm th ere are in d ic a tio n s of some long term e f f e c t s . P u b lish e d work a ls o suggests t h a t , as w ith o rg a n o -ch lo r in s e c t ic id e s , PCBs a f f e c t the breeding success of b ir d s . W Some marine anim al such as shrim p, are s e n s itiv e to PC3s, but again, the t o x ic it y of in se c tic id e s is known to be much h ig h e r. Thus, altho ug h i t may be argued th at there ia no immediate cause fo r alarm , s u f f i c i e n t evidence e x is t s to cause d is q u ie t amongst c o lo g is t s and c o n s e rv a tio n i I t is c le a r th a t continued accum ulation of p e r s is t e n t compounds lik e PC3s and org c h lo r in e in s e c t ic id e s cannot be a llo w ed , and means must be found to check the in c re a sin g p o llu tio n of the environment. __ #f the problems a r is in g in any d is c u s s io n of PCJ3s in the environment stc X ro s tile la rg e number of homologues and isom ers which a rc p o s s ib le . The commcrc p ro d u c t , in f a c t , co n ta in la rg e numbers of these in v a ry in g p ro p o rtio n s. These d if f e r e n t homologues and isom ers may have d if f e r e n t p r o p e r t ie s . For example, s in c e the low er c h lo rin a t e d compounds are r a r e ly found in w i l d - l i f e specim ens, i t suggested th a t these are degraded more r a p id ly than the more h ig h ly c h lo rin a te d s p e c ie s such as the p e n ta- and h e x a -c h lo rin a tc d b ip h e n y ls . The m ixture of PCBs e v e n t u a lly found in a w i l d - l i f e specimen may th e re fo re be v e ry d if f e r e n t from th.. i n i t i a l l y fed in to the ecosystem . Thus, although claim s to have detected s ig m f q u a n t it ie s of A ro c lo r 12k2, or i t s e q u iv a le n ts , in w i l d l i f e are ra re , i t is net p rudent to assume th a t these products arc com pletely a c c e p ta b le . On the other h p o ly c h lo rin a te d b ip h e n y ls co n ta in in g fiv e and s ix c h lo r in e atoms, such as are pre in tra n sfo rm e r a s k a r c ls , have d e f in it e ly been in d ic te d as environm ental p o llu ta n t l noifcfck I f 1 26 Analysis , ( 'Because of the need to measure P.C.B,!s at extremely low levels (often 1 port in 167 or less) the analytical method mustjbe bo Ji specific and highly ensitive. For this reason gas chromatography using electron capture detection & [ has been universally chosen with occasional identification and structure *I confirmation by gas chromatograph mass spectrometry. " i . r Analytical methods vary in detail between laboratories depending upon specific requirements, e.g. plant pollution control, analysis ofjwildlife samples etc. but essentially the method consists of the following steps:- 1.. Sample Preparation 2. Extraction of P.C.B.'s 3. Removal of interferences 4. Concentration 3* Gas Chromatography & Measurement. In general, it is found that wildlife samples being more complex require more * [l extensive pretreatment than, for example, plant effluent and for this reason analys of the latter will be described to illustrate*the basicj analytical method. The P.C.B.'s arc extracted from the aqueous sample, by shaking with hexane and it is possible at this stage to introduce a concentration step by using a high rati of sample to solvent, e.g. 300 ml, water to 100 ml. solvent. After two extractior II the solvent is reduced to 2-3 1. by evaporation on a steam bath and it is then passed through an alumina column with hexane as solvent' to remove interfering non-. P.C.B. ( H t r i a l s . The first 130 ml. of the hexane which elutes collected fro: the e o ljfe a a n d this is evaporated to a small known volume. This solution is used for gas chromatography. | ii ^j !**" Separation by gas chroma togr^hy involves passing tie sample in an p i* * " carri< gas through a column packed with a material which will selectively retain composer/ of the sample for limited periods. Components elute, from the column at periodic intervals and are detected using properties wbictJ differentiate Athejf components j from the carrier gas. | FnMRR9 10 127 t ' 2- - t -A There are many d e te c to rs in use in gas chromatography but fo r P .C .B . a n a ly s is i t is only p o ssib le to use the electron capture detector. This is based upon the f a c t th a t c e r t a in compounds w i l l a b s tra c t e le c tro n s iro n an a r t i f i c i a l l y produced plasma (ra d io a ctiv e so u rce ). Reduction in e le ctro n c o n c e n tra tio n ( i n base c u r r e n t ) i s a fu n c tio n of component co n ce n tra tio n and ca be measured w ith a s u it a b le a m p lif ie r . D e ta ils of the gas chromatographic system used by Monsanto are a v a ila b le as an appendix to the paper p lu s i l l u s t r a t i v e chromatograms. Measurement of the P .C .B , content from the gas chromatogram fo r p la n t f f f lu e n t i s g e n e ra lly a sim ple procedure - the chromatogram of the sample i s compared w ith chromatograms o f standard samples made up from known P . C . B . 's and, f o r a ccu ra te a n a ly s is , c a lib r a t io n graphs can be prepared from s p e c if ic peaks in the standard samples. In the case of environm ental samples however, i t i s more d i f f i c u l t to o b ta in a cc u ra te measurement of P .C .B , content because in many of these samples d e g ra d a tio n has o ccu rre d changing the chromatogram so th a t measurement by peak is le s s r e lia b le . Uowever, the experim ental e rro r although greater than that in the a n a ly s is of p la n t samples is s t i l l acceptable fo r the study of P .C .B . le v e ls in the environm ent. I 2 % m Fnni s o n 10 128 - 3- . Pollution Control It is clear that, if transfonscr and capacitor askarcls are to continue to be used in the electrical industry, positive effort must be made to control and prevent pollution by these products. Since the most significant levels of polychlorinated biphenyls arc found in species associated with the marine or aquatic environment, the highest priority should be given to preventing pollution of sewersJand waterways. Atmospheric pollution must also be avoided because PCUs, washed out by rainwater, may again end up in rivers and sea. I The manufacturers of askarcls have a clear responsibility to prevent pollution at the manufacturing sitcC' Fortunately the process itself is "dry", so that r aqueous effluent is not a by-product. Provided that sufficient care is taken to contain spillages and leakages during manufacturing andjhandling, pollution of drains and waterways can be avoided. Experience|has shown, however, that it is necessary to study all aspeets of the process, including drumming and tankor-loadin; facilities, with particular emphasis on the possibilities of leakages and spillages reading surface-water drains. Where any chance exists|of this happening, sumps or ( interceptor pits must be installed in the drainage system. It has also been found helpful to institute regular monitoring of plant effluent, using analytical teclwiq' similar to those described previously, to ensure that the instructions relating to the control of pollution are being observed. Atmospheric pollution at the manu facturing site is not a serious problea,since thejprocess is designed to avoid loss, but, again, good plant-keeping is essential to prevent accidental loss.j Close attention to detail and good plant-keeping or house-keeping practices are the main keys to pollution control and prevention at capacitor and transformer manufacturing plants. Facilities should be provided so that spills and leakages cannot run or be washed away to surface or effluent drains. Sumps or interceptor pits should be incorporated in any areas where askarclsj can spill or leak. In capacitor plants, vapour traps should be included) at venting points to [prevent atmospheric pollution. Care should be cxcerciscjd to ensure that all test-samples and waste askarcls are collected for disposal in an acceptable way. In the event of accidental spillage or leakJge this should be contained and absorbed on dry sand, ash or sawdust ready for disposal by one of the methods described in the next section. j i i Fnni k q i i 129 -.4 - I fr Waste Disposal . It is clear that askarel wastes should never be disposed of deliberately down effluent drains or sewers and that the utmost care should be exercised to prevent this happening accidentally* ' In the capacitor industry, waste askarels may arise in sevo.,.l ways. Liquid askarel from the impregnation' cycle may be too badly contaminated for further recycling; spent filter cake from-the treatment)plant|will contain roughly its ow. weight of askarel; .finished capacitors or capacitor elements which have been impregnated, but have failed electrically, test samples and cleaning solvents containing proportions of askarel are all waste products.which will require dispos In the case of liquid askarels, consideration should first be given to reclaiming. Some askarel manufacturers offer a reclaim service whilst others can refer users t specialist organisations who will do this. . Two basic methods of disposal of waste products exist. These arc dry tipping and incineration. In the case of askarelsi incineration should only be carried out under the correct conditions. In order to break down the PCD molecules thormaljly a minimum temperature of 800C L is necessary. At this temperature a residence jtiae o'f not less than 10 seconds will be required. At higher temperatures, shorter residence times may be acccpta 'Open-hearth incinerators are not suitable for this operation and their use would serve only to volatilise the askarel and pollute the atmosphere. With suitably designed closed tube incinerators, however, incineration provides a good method for the destruction and disposal of askarels. Since hydrogen chloride is one of the breakdown products, the effluent gases should be scrubbed with water which can then be discharged to a lime tank. Liquid askarel wastes can readily be handled by incineration, provided that beating is available on the feed^svstem to achieve pumping consistency. The major problem associated with such weier probably concc storage, collection and transport to the incinerator site. For solid wastes the problem is rather more complex, and, at present, it is thought that a two-stage process offers the mosjt hopeful solution. The first stage would consist of a rotary kiln furnace, operating st below 800C, to volati] the askarel. This would then ptss to the second stage for combustion at 1200C. Such a system would be capable of dealing with 'capacitor elements, and even compl< capacitors if these were first broken open by aj suitable crushing machine, in addition to spent filter-cake and other solids.) hv the Accidental leakageSor spillagc^of liquid should be absorbed on dry sand, ash or sawdust and treated as solid waste. Dry tipping, and subsequent covering'with earth at an approved site, offers a temporary expedient for dealing with askarel wastes. Although probably not acceptable as a permanent solution it is certainly better than indiscriminate dispersal of such produets into drains, waterways .and the atmosphere. Owing to its low solubility in water, askarels will be leaded out only very s l o w l y from a dry site, by rainwater, so contamination of streams and rivers from such sources will be slight. Tests carried out on stagnant water in close proximity to such a site indicated very low ( < 4 parts in 10^)jlevels of PCB. It is also known that soil normally contains multitudes of bacteria, some of which may be active against the lower hoaologucs of PCBs, so that over very long periods of time significant degradation may occur. In.these circumstances the delay imposed on the passage of the askarel materials into the aquatic environment may in fact pro a more permanent solution to the problem than might be expected. Nevertheless, Fnn*KQ2 10 . -5 dry tipping should be regarded an a temporary measure which should be abandoned when facilities lor proper incinerati on have been organised. Remarks made about the capacitor industry also apply to transformer applicatiu In the ease of transformers, a much bigger proportion of waste askarel could pcrluip ,Jbo reclaimed and efficient use of reclaiming organisations should be the first line '.of defence against pollution. The establishment[of acceptable specifications for reclaimed askarel could provide more incentive for reclaiming if, for example, 'these can be relaxed in any way. Certainly more [efficient usage of reclaimed aslcarcls should fora part of the strategy for the [continuing use of askarols in transformers. As with the capacitor industry, great care should be exercised to avoid spillages and leakages and where these occur they should be contained and absorbed on sand, ash or sawdust ready for subsequent disposal JlAV/mch 27/7/70 . i It I I F n m ftQft I I 1 0 131 l; i lVIFKIUNOfi ( } ) Jensen, S , Now Sc i r l i s t , 32, 612, (1966). ! ' 1 ,(2) P r o s it , I . , 'Je f f r ie s , D.J., & Uoorc, N.W*, Environmental Pollution 1.1 (1971 I (3 ) Holden, A.V, & liarsden, K ., Mature. 216, 1274 (1 9 6 ?). (4) Risebrough, R.W., Rieche, F, Peakall, D.B Hcrain, S.G. & Kirvcn, 1.X Rature, 220. 109S, (19 6 8 ). Honsanto Chemicals Ltd., Ruabon, Wrexham, Denbighshire, U.K. r u F n m KQ4 10 132 '7 ' // REPORT TO THE JANUARY MEETING OF THE BOARD OP DIRECTORS OH THE STATUS C? -O' PCB IMPLEMENTATION PROGRAM The worldwide PCB action plan reviewed with the Board In December / Is being fully implemented. Although customer acceptance h a s '* <n general, been positive, some are raising!questions which may c-ea problems. We remain hopeful we can| resolve these problems on 1 case by case basis. We are on our established time schedule, Th status report on the domestic program is,as follows: 1) Formal letter of notification to heat transfer customers was sent by registered mail on December 15, 1971, to all known users. All sales have been discontinued. Some customer conversions to other fluids have been made, and oiir engineer team is available to hel p others convert on request. I 2) All original equipment capacitor* and transformer customers for our PCB dielectric fluids were notified on December 21, 1971, that further sales after January 15, 1972, would be dependent on receipt of financially meaningful and acceptable hold harmless agreements. To daite six companies have com- . plied, which represent 63% of domestic dielectric sales: General Electric, Westinghouse, McGra^-Edison, ITS Imperial, Sprague Electric and Federal Pacific.| Additional customers .indicate they will comply and wej expect the majority to do \ so. Progress on this part of the program now permits us to v notify miscellaneous "top-up" customers and repair shops of our plan and will permit referral to original equipment manufacturers for fluids. The dielectric program is also being extended to a small group of miscellaneous dielectric customers using our fluid in themanufacture of closed.switch gears, electric magnets and hermetically sealed electric motors. iv i, ' 3) All plasticiser customers were notified on December '31* 1971, of our intention to discontinue PCT sales for this use effec tive March 31, 1972. In a limited number of hardship cases where the customer requires lead|time to develop alternate formulations, such as certain Investment casting customers, a program consistent with our overall program has been developed, including hold harmless agreements, to allow sufficient purchases before our cutoff date to permit the customer's required reformulations. . cc I AM i n m fiflR 130 OOtj -2- will eliminate sales of PCT' June 30, 1972. The status report on our EX-U.S.A. program is as follows: 1) All sales of PCB's for all uses other than as dielectric fluids will be terminated January 31, 1972. 2) Continued sales of PC3' s for use as dielectric fluids after March 31, 1972, will be dependent upon receipt of hold harm less agreements acceptable to Monsanto from customers whose financial responsibility makes such agreements meaningful in Monsanto's opinion. 3) Sales of PCT's Ex-U.S.A. will be discontinued on the same $ime schedule as used on domestic sales. The President has authorized MICC's Managing Director to make exceptions on a case by case basis. Two have been made in our Ex-U.S.A. program: 1) Because of the safety needs of the German coal mining industr; for our PC3-containing hydraulic fluids, sales will continue for this use for the shortest possible time beyond January 31# 1972, to permit clearance of substitute materials. Indemnity agreements are not possible, but techniques of sale reviewed with German counsel are being utilized to minimize our exposur 2) A commitment to sell 600 tons of our PC3 dielectric fluids was made to the Russian state purchasing authorities in December, 1971, prior to formulation of our Ex-U.S.A. program. Completion of deliveries before our March 31, 1972, cutoff date is not possible nor is an indemnity ,f$aslbl._..vFull^ .^ ,diac-loaure of-^problew Ti-being"rfiade*, fcut some deliveries will occur into July, 1972. We have been in close touch with the Federal Interagency Task Force under Dr. Edward J. Burger, Jr.'s direction. This task force is preparing to issue a report on PCB's about mid-February. We will be allowed to work with them in its preparation. On January 21 and 22, Monsanto representatives met with a group of scientists to discuss the general PCB situation. Present we*to Dr. Warren Muir, Council of Environmental Quality, Dr. Edward Goldberg, Scripps Institute of Oceanography, Dr. Robert Riseborougn University of California, and George Harvey, Woods Hole Oceano graphic Institution. The meeting went well and we feel the scientists left with a much fuller understanding of the overall PCB issue than they had previously. vom kok 131 AO* 006 0 2 i -3- ! we have d iscu ssed th e e s s e n t i a l i t y |o f the u s e .o f PCB's fo r d ie le c tr ic f lu id s w ith key companies I n `the e le c tr ic a l Industry C ? end General E le c tric and Westinghouse E le c tric have submitted . re o o rts to the N ational In d u s tria l P o llu tio n Council and the | O ffice o f Science k Technology In which ,jthey t e s t i f i e d as to the n ec essity fo r continued use In these a p p licatio n s and the steps) b e i n g t S e n to co n tain the PCB's in thesje e l e c tr ic a l d o s e d s y s t We expect to complete our e n tir e Implementation program on sched Ij I \ i i i- VJ i .i J i ADM 0 0 6 0 2 I U I l'VJ.:wt?T lu & lo -t f .Tr After leaving Bio-Test, Mr. Wrigh|t was, hired by Monsanto to be its manager of Toxicology. When Mr. Wright was indicted for his criminal, conduct, Monsanto spent hundreds of thousands of dollars in the defense of Mr. Wright. Yet,|today, Monsanto claims Ii it was an unknowing Mvictim" in the whole episode. Not an unpredictable position (although unquestionably strange) for this company to take. But, while Mr. Wright was still at Bid-Test in 1971, he participated in wholesale fraud in connection with Monsanto's PCB toxicological studies. Studies that Monsanto used to convince l federal regulatory agencies, and others, that PC3s were not toxic chemicals; indeed, studies that Monsanto used to convince those ii I| same regulatory bodies, and others, that PCBs "posed no threat to humans." These fraudulent PCB studies are before the Court. [Exh. 9: 262-521] The "testimony ~d^*Mr.~Phi 11ip Smith is^also before the | I- Court. [Exh*,>13] Mr. Smith details the wholesale fraud that Mr. Wright participated in on behalf of Monsanto in carrying out Monsanto's PCB toxicological? studies His testimony lays bare the sordid details of how Monsanto executives were completely aware of the massive fraud being authorized and paid for concerning these PCB studies. ^ tL c. ' i d Mr. Wright was not .convicted of his fraudulent PCB I] conduct - neither were the Monsanto executives that were involved. ^j j Instead, in July 1976, Monsanto presented Mr. Wright with a cash reward along with these congratulatory remarks: Fort1 K 9 R 33 After leaving Bio-Test, Mr. Wright was hired by Monsanto to be its manager of Toxicology. When Mr. Wright was indicted for his criminal conduct, Monsanto spent hundreds of thousands of dollars in the defense of Mr. Wright. Yet, today, Monsanto claims it was an unknowing "victim" in the whole episode. Not an unpredictable position (although unquestionably strange) for this company to take. But, while Mr. Wright was still at Bio-Test in 1971, he participated in wholesale fraud in connection with Monsanto's PCB toxicological studies. Studies that Monsanto used to convince federal regulatory agencies, and others, that PCBs were not toxic chemicals; indeed, studies that Monsanto used to convince those same regulatory bodies, and others, that PCBs "posed no threat to h u m a n s ." These fraudulent PCB studies are before the Court. [Exh. 9: 262-521] The testimony of Mr. Phillip Smith is also before the Court. [Exh. 13] Mr. Smith details the wholesale fraud that Mr. Wright participated in on behalf of Monsanto in carrying out Monsanto's PCB toxicological studies. His testimony lays bare the sordid details of how Monsanto executives were completely aware of the massive fraud being authorized and paid for concerning these PCB studies. Mr. Wright was not convicted of his fraudulent PCB conduct - neither were the Monsanto executives that were involved. Instead, in July 1976, Monsanto presented Mr. Wright with a cash reward along with these congratulatory remarks: 33