Document VJBbemo18NN16r170XXdgg7Ko

A Case Study: Polychlorinated Biphenyls Edward J. Burger, Jr., M.D,, Sc.D. Office of the Freottvni I Science Adnscr, S: H'ncc and Tr h'C V Policy Office, Washingion. D C, ABSTRACT The Government "derisions" on polychlorinated biphenyls (I'CHsTcimstiiuicd an unusual regulatory exercise comonreJ In much ol the cxiicriencc o! me pan few years,1 PCJii had been develnjicd tn the late lV20t to serve in instances where high physical and chemical stability were advantageous. In part, precise ly because of these peculiar properties, they bet aine recognized as /hsrtiailar environmental hazards. The processes of analysis and study by the Government for decision acre fuller and more deliberate than is often the case. A number of scientific reviews were joined in the process. Benefits as well as hazards were explicitly considered. Regulatory type action uj not taken until suitable information was marshalled and recent scientific evidence was given the benefit of interpretation. Finally, the process of deliberation was an unusually open one with the results of analy sis fully displayed. WfiilMl f<y ttM lludy OH DCUiol Mlkin| fw R#|vUii*l CHrmitth |i iIm Khwoimmai, tnvironimnn) Studies ttord, NtiiMl Rtuird CooneM. NifionaJ Atidimv of SeimcH. ind un4fflt*n M Iht of tM U S Environ FrotMtiM Aifttcr, CtitiKut No. M-Ol-2101. ihu mgff 1 I* KfNvmf tfTt, (hi National Aetdtmy of Sritneii or* ganitrd a workin| conference to cvplor* ih or Uonranwai dtCiiion>Aikiit| lo rigyliu chemieib in tht an* vuunmtnt, To isiisl thii tMifiriNi, a sarsaa of can Dudin of pm rvfulalory deeifiom #u talrtiiid from penom who had rriionabry druiled kowlrd|* of thin. Wh follow* n (he cm* tibdy or pttiyrhlnttnitid biphenyl* at out of ihi writ* used in iht NAS *tudy. The maturity of the Govern ment pruiiuuiicementt and dnitions in ihu (nuance derived figoi a icnei of trudk* and analytic nneiiii convened by the Office of the Prcid*t' Science Adviirr. fThi* *t^dv ii ijin itr ari'f lf a* .1 pjrl if I Ivm|i by tllr >ttlhir on UtuJjuno end~lUliiian Itr illti. JU Sv- ntiltiivli. ii Kv Lak.nyla..i iese ) INTRODUCTION - NATURE OF THE DECISION The process of Federal Government deliberation .u,j decision on puIydUonniied biphenyls (PCIM u.i, relatively circumscribed and straightforward- I lie Governnienl actually possessed little in the way e.i legal, regulatory authority. Hence, the "decisions" leaned heavily on persuasion and on para-regular.>, moves. Nevertheless, the Government s Jetisnmv this cate did lead to the intended and recommend,-J actions (reduction and restriction in certain uses <n PC'Bs) and a tightening of the procedures gov cm mg the manufacture, importation and continued use of ilwte chemicals. Most important, perhaps, wss the fact that the de cisions and actions assumed by the Government (and by parts of lire private sector) were taken deliberately and on the basis of unusually good analysis and inhu mation. "pie PCI? decisions, in brief, were unusually well infornted decisions when compared tu others m this type, and the analyses used to arrive at the de cisions were probably fuller and of a higher 'iiiTm;, than is the case with most regulatory actions. The several agencies of the l edeiirGovernmini concerned with the PCB question contributed iu the deliberations and to tlie analyses. At the same nine an outside group of scientific experts was engaged bv the Office of Science and Tecluu'logy to umviJcr PCBs from a broad perspective as a case study of a hazardous substance existing in the environment m trace quantities. The Government's major deliberative body for its decisions was an interagency. I'Cll Task Force - run jointly by the OST and the Cl U l v case sludy of the outside advisers to the OST was lone ly and useful to the Government's own analyses Journal ofthe hilrrnauonal Sociro for Trrlinolosy A rrmirmu. S/nme 1916 VISTA - luli-tii,iiioiwl Sncieiv for Tnhuuiufy A MeMBtrnr, Iv'aillWKtOn. D. C. HONS 206769 Till; ENVIRONMENT - OFTEN DISTANT FROM APPARENT SOURCES PCFls were among (tie iiutcrtals found, but when am lysed i lie y were often con fused with oilier sub stances PC Us were firsi distinguished front the "unknown micifeting compounds" found in nature in 1966 by Jensen1 <mti ilie next year hy Widmark ' On the basis of tins Enter reporl. the Fond and Drug Administration was moved to develop analytic methods to distinguish between POBs and chhriiiiiiti-d organic pesticides encountered in monitoring for tcgulaticm. In February 1969, Dr. Robert Risclnouglt gath ered attention by warning, in an article in the San Francisco Chronictc, of the dangers of PLUS in the eco-system. Over tltc next 6-7 months, the FDA in creased its surveillance of foodstuffs for evidence of PCD residues. Notable positive findings were in fish. Monitoring of foodstuffs, raw agricultural products, fislt, and feeds for PC Us was augmented throughout 1970, PCBs were found ill fish and in marine animals in high concentrations close to plants which manufac tured the chemical. ACCIDENTAL SHILLS OR LLAKACF.S OF LARCH QUANTITIHS OF POLYCHLORINATED DIPHLNYI-S WITH CONSEQUENT CONTAMINA TION OF FOODSTUFFS AND ANIMAL FHEDS. In 1968, PCBs, used as a heat-exchange fluid in a pasteurizer, leaked into rice oil being manufactured for heme cooking use in a plant in Japan. More than 1,000 persons were affected by the contaminated rice oil, many of whom exhibited peisisieni sk nt lesions as well as systemic disease (Yusho disease), in July 1971, leakage of heat exchange fluid caused con tamination of pasteurized fish meal which was used as a feed ration for chickens and catfish. In addition to these two major areas nf concern, PCBs began to be reported with increasing frequency in poultry and in eggs, and in packaging material for food. PCBs appeared with increasing frequency in 1970 and 1971 in the professional scientific literature deal ing with wildlife and the euviionnient 4,1 In Sep tember 1970, the National Swedish Environment Pro tection Board held a conference on PCBs.* One of 1 Jtnwn, S. A nw ehtmicai hatarS, Niw Sciential, )1: *11 (I***). 1 Widmaik, G-: foitible Intfifrrtnct by c hlorm attd bu'lirnyls. J. Allot. Off*. Anal. < ti*ra.. JO to** (l**ry * IVikitl, and J.C. LMi<rr- Put ychtormated liiphirnylfc Aflolhfi imiflif* widespread chemical in jhe fnvironmeM, EJ.OAfiffKC :0 *5*-*A4 11**0). * ^NmiIIh. ). t'Cflb l.nki nf lotir fubiiincr nitnmun of effect*. ftful arkio. Science, i ?) I** - *01 < t **0- * fCU Conference, National Swedish Tuvirunmetit ft*. \\\t seisiuns of tlirs conference highlighted tfic ci:- vifiinnicnlal jm>hlrj|i" TTvjs cnnfcience. pertup* ior the first lime, brought together the extent of under standing on the manufacture. use. and bit'K-uicjt effects of, the extent of environmental com j mui j r t-.-n by. and the analytic uicihinlt for, PCBs * In August 1971, an Euviiunmeni.il Qualm- Work shop was convened an Durham, New Hampshire, by the National Academy of Sciences, to consider Marine Environmental Quality arid Ocean Polio tants.1 PCI) coin a mi nation was highlighted. In addition, provoked by built the accidental spills and by the widespread finding of trace quamittes of PCBs in the environment. Ihcic emerged m rhe jay press a series of stories and articles dealing with PCB contamination. Most of them occurred m Inc 1971 and reflected especially the contamination nf foodstuffs.*14 The FDA, aware that PCBs were to be found as a contaminant in the environment, and alcn to the occasionally teported cases of accidental sptil.iees. elected to engage hi watchful surveillance of food. It did this in pan in coo|teration with the Department of Agriculture. As a result of the findings of PCBs specifically in fish and milk, the FDA established, between December 1969 and Fcbiuary 1670. "Action Levels" for PCBs rn milk, poultry and tish. Action levels are temporary thresholds for regulatory decision pending tltc establishment of a more ;vi. manenl regulatory policy and procedure. In Augu>i 1970, live FDA established a similar action level tot eggs. During 1970 and 1971, the FDA used these guideline values in various seizures of foods found contaminated with PCBs. The number of reported contaminations of foods, recreational fish, packaging materials and animal feeds increased toward live latter half of 1971. Accompanying the announcements in the public press find, undoubtedly, reflective of them), there also occurred toward tltc end of 1971 a scries of inquiries from Congressmen and other elected officials over PCB contamination of food and the environment On ttclton Bord, Research S*crelarii, Wcnnft Cf<n Ohiit Stockholm. Sweden. 2* Krpiemb#* i*io ' Marine environmental quality. A ipcciat tudy held wiJr the luipicrt of the National Scientific Onmmiitvv on I'cYnruv ffaph)' of th* National Academy of Science* Ocean AfftKi Hoard Durham. New Hampshire. * - 11 August J ?tj * Monsanto Jimiti food pijtHi' u*r of chemical K'li, The Wighinpon Pml, 10 September 1 til. * Some dried fwdi found tainted by perilous cbemicU, inr Wsihlniion Putt, m September 1*11. '* Tainted fgrkeyi. The W*>hj|ion poi. 14 Stpiembei t*7t M Turkeys, salmon tainted by PCbs. The l venh| Star. M September |*1| * a contaminant a* found in cardlrwul. The New Y'.tV Timet. 4B September tail. r* jf you think !>!>!''* a problem, meet l`CH. Viir New Ytok Time' TO September t**M. VDA ttudynif fhiiKi of contamination ui crintjureiA tot foods The Wai| Street Journal. IS Sepu-mber i*?l 3U Journal oj the International Society Jar Technology Assessment. S/tring 19 7(> HONS 206790 16 Aligns) 197|, Senator McGovern addressed a let ter to Hie Commissioner of Hie FIJA. rc Heeling this concern. In September, Governor Miliken of Michigan sent a tclcgtam to Lliioii Richardson, Secietary of HCW, |n wltjeii lie announced a restriction of com mercial salmon fishing because of (lie finding of PCBs in fish By August 1971, the FDA (and io some extent, the L'SDAl found n.sclf rapidly propelled into a posi tion where it would be "required'' by public pressure and advocacy to take a stronger and more fori bright positron against l*CBi. The scientific issues were still not clear and there were glaiing gaps >n information. What really were the biological effects of tItc complex known as I'CBs? How did the various PCBs vary in human toxicity and which members of the 1*CB fami ly were found as contaminants? Was observed tox icity due to PCBs proper or to contaminants pro duced during their manufacture? How widespread was the contamination, and how good was the moni toring system in picking up accidental spills? Further more, it was dear that the twin issues of widespread environ mental amtanunaiion, by trace quantities of PCBs. and tlte selective, higlter level contamination of foods and feed, had to be joined at some point tn Government decision-making. On 5 August, 197), the FDA, on its own initiative, called a meeting of spokesmen from each of several Govern men( agencies and Federal research laboratortes to review the slate of scientific understanding of PCBs. The (ext for (he meeting was the reported senes of accident si spills and leakages.(> Shortly fol lowing that meeting, the Department of Agriculture and >he Commissioner of Ihe FDA asked tlte Office of the President's Science Adviser to provide assis tance and act as a focus for the Government's actions and decisions concerning PCBs. This request was made because: (l) the issue cut across several Federal agencies and also involved outside scientists. (2) the issue was rsptdly becoming uncomfortable for the FDA to handle alone, and (3) the Office of Science and Technology already had under way a scientific review of polychlorinated biphenyls and Itad quietly hipin to gather information several months back. -ha ApeB 19?( spokesmen for the Monsanto Comjfife tested to meet with (he staff of Hie President's Mwea-Advims- In the OST to discuss a number of iMVomceininf PCBl. including a series of snimal tmckokip studies which Monsanto had undertaken. During this meeting. Monsanto was asked for infor mation concerning Hie amounts of PCB it manu factured and distributed. The company, being the sole producer in (he U.S.. was reluctant to make pub lic tills information, although it repotted that it mighf " T'amcnpi or protr,-diets nt ihr initiate"** owttint on potycMtirinalft biphriiyl- CPCUxS, IihiI int llrvf A dmmiv tfdinn. Drpjruneni r Health, l.ducauun. ana Wrltart, IVC,, S Aufiui 1*71. be able to provide the data on a confidential, m-tipublic, basts to Hie Government In Ociober 1970, a review was begun, in tne Oi 'i.v of Science and Technology, of the general sulqcci m hazardous substances existing in Hie enviriuniieni ;r; trace quantities. This review, known ultimately ,n i,.._Panel on Hazardous Trace Substances, had as ik major goal ihe identification of llie needs for nm-i 'nation by tlte Government in making jmJi-uK-nu about trace hazardous substances Tlte Panel was composed principally of m-igovernment experts in the fields of ecology. L|,emi>try. biology, environmental and occupanun.il medicine and geology. Three ease studies were iioeun from which it was hoped lo draw genculi^bk e\perienet. The particular subjects for Hie case studies were chosen because they were thougJtt io be ni ,n,. portance, because regulatory or other govern menial action had not yet been taken but could be e\pccicd at some time in the reasonably near future, and '-tcause it was thought that there existed suiricic-nt information from which to draw conclusions. I liechoices were cadmium, arsenic and PCBs. ^ Thus, as ihe Government began to dovejgp its own position on PCBs in 1V71, the OVT-mmied study w*a alresdy under way. What followed, intpait, was for the Government to borrow tlw expertwee devel oped by the OST Panel and even for the two t\ei.-iws lo b joined to tome extent. Notwiihiiamiiui- separate and identifiable PCB report was puMi-ii. in (Itc memben of the Panel on Hazardous Trace Sub stances.'* On I September 1971. the FDA held a meeting with the USDA, the ETA. the Council on Luvirottmemal Quality, and the Office of Science and Technology, to explore options for further jcmm concerning PCBs. The FDA and the USDA requested that the OITioe of Science and Teclinolo^ take a lead roic in handling (hit matter OST accecdcd iu ilm req uest and agreed lo collaborate whit the CLQmrlie i.uk This became known at tlte liircrdcpjriiiierii.il i.isk Force on PCBs. The Task Force was announced nn > September in a joint FDA-USDA press conieirucc*1' On IS September 1971, the OST Panel un Haz ardous Trace Substances and Hid goverumcni.il l.i-.k Force met jointly with representatives of ihv Mon santo Cuinpeny. Tlie principal agenda item of tins, meeting was a request for information umceriuns the amounts of PCBs produced, patterns of distribution and usage, and estimates of losses into the environment.1* Again, the manufactured expressed Him '* Potr<fctaimi(H biphenyl* by lb* pentl on hiiirdrwi iice impa.i x .nn n, m uJi If 7J. KpwikH, J '* Fietx rrleegc wi rr>Jer4e I'CU iitk i irrx- i m-tl nd l)ru( AdmiBDiriiWfl, lle^gKAtenl of Hfalilt, Uiuvjt' -n 4 WrllMi. i Iff1 i* LrtUrr Ircim I dwanl J, Huiipc, Jr.. %10 af m<- <r. t i-. Hr, Joftn Mans*. The Uon>6nio Cump.tisy. i j (muUi. r"' t Journal of the hitcnuHional Sot rc'/.i for Tcdmulugy Axsesxnwtu. Xl'ing I 'i 7(, J | HONS 206791 willingness (u supply information of iIns soil :n (lie Government, but with the understanding liui the d.ua would not be released publicly fs^epi ic a full and detailed fashion. In addition, the Mauveu> C ompjiiy expressed some concern ovei the seemingly disfoniieeicd chji.icicf oi (lie Coscinmem's .iciimios up In Ihal lime and lhe Jrllicullivs imolvcd in finding responsible spokesmen for cash of ilie .igcnucs in voiced, Monsanto made a strong plea (in ihe foim of a condition fnt lltcir supplying intontuiioii) that they be |vruutted to deal Willi a single spokesman for (tie Government. The office of Science and Technology, on the advice of (lie Counsellor to the President did reach agreement with Monsanto on the terms of receiving the in lot mat ion.1'* These were shortly rendered moot by a icqucst front the Tuvnonmemal Defense Fund for Ihc same information. This information ultimate ly served as important background for the Governmerit's decisions and was leaned on heavily by both the OST Panel and the Task Force. The OST Panel combined the production figures and the data on distribution and use wttlt knowledge of the physical properties of PCBs to develop a com posite picture of the rates and routes of environ mental ttansport and disposition. The data were reflected in a series of coefficients for a model of transport of I'CUs. While this was necessarily a crude description, it served as a very useful instrument for placing KBs tn perspective. It replaced what other wise would have been a totally qualitative - even intuitive - exercise. It pointed up important gaps in knowledge. Finally, some verification was afforded by tlte results of physical measurement and monitor ing. This attempt at environmental modelling was a major contribution by the Panel to decision-making. The OST Panel report was also appropriately criti cal in its renew of biological effects and analytic methods for PCBs. It considered what was known of the mechanisms of observed biological effects, and relationships between variations in chemical structure and biological activity, and it attempted to compete the effects of controlled laboratoty experiments with observations made on animal populations in nature. The Interdepartmental Task Force reflected much of this information In its report. It explored addi tional territory as well - reflective of the fact that it was a Government report which focused on a number of specific, pragmatic, governmental or - public problems. Thus, as well as serving at a review of llie scientific aspects of PCBs, the Task Force explicitly reviewed a number of broad aspects of tlie PCB ques tion Most important, perhaps, was tlie exploration of ihc benefits or utility of PCBs and of the industrialii ii MftMorindmir from John ttesu, Cuvnultor |o ihr fitiidt-nl. In I t|tvaif I liofprr. Dffifc of S.-t.-n<-f md Y*rUfto)ngy. trincvrnuia ihc Hecdmti of litfuirtotum Act. 4 Oclolxf Jfti. and commercial dependencies bun It up over the v-jrs Tins explicit .view of the bene (its of l`t Its wtmii :s nl'tcn not clone fur tcgulaiory dccr-ions, w.i; or uni importance for decision-making on KBs. Tin-- Viiion- al Bureau of Standards engaged in a ievicw and ainiy sis of the benefits and even tlie 'essentiality " of each or the several uses of KBs. In Hus. Hil MJS reuned advice horn the National Industrial Puliation ConlMl Council, especially concerning die elcclnc.il uses oT KBs. In each of the cases examined, die question of a possible and satisfactory rcplaccmcni for 1'CISs was raised. This review became the basts lor the nltmure decision io preserve electrical uses of PCBs (for which there were true dependencies and no satisfactory sub stitutes) and to restrict other uses.10 The Government Task Force report included a sys tematic summary of monitoring experience for PCBs in food- It had been this mailer of KBs m food as much as any other which had brought K Bs to public notice, lienee, it was thought lugiily desirable to sys tematically lay out the apparent event of food contamination and to considci what the patterns of contamination would suggcsl for public policy and Government action. The Task Force Report explicitly irview-cd all of the pertinent Federal regulatory laws fol then appli cability to PCBs. This svas, therefore, an cxplonnun of the power of the Government tocontiol ,md imut the manufacture, distribution, use and disposal of KBs. This review pointed out something lliai v. already known - that existing regulatory authorities were capable of responding to specific incidents of conramination of fuodstufls once they were tecognued. However, it acknowledged tha' the Govern ment's legal armamentarium was generally . . inadequate to prevent more KBs from entering tlie environment". In addition to the above, the Interdepiitmental Task Force review considered the chemical and physi cal properties of KBs, the occurrence, transfer and cycling of KBs in the environment, and the known biological effects - especially on man. During the time that the Government ievicw of KBs was being pursued, the level of public concern over these chemicals continued to nse con siderably. For this reason, the Commissioner of the FDA felt compelled tt> hold a press conference to *. . . try to help establish a perspective on KBs . . roughly a month after the Task Foie*. hud begun ns work.11 This was an appropriately reasoned state ment which attempted to allay fears and dtscouiage demands for a sudden, outright ban on I'CDsfevcn if ) PolyelilorUlJli-4 bipK-nyU and lh< ltli*rde pa'immUr N.iiion.ii liKct on rent. Wahn>i:Mn. D C., May cV2 1 iifvfln,ili*i Servin'* U S. tVi',.ili''> nf Commt'fCf. Virpinri, N. ? J - 104 14. g. Statfffl*i>l by ChtllrN !* i Jtvjrdv M.t) . I'Cll pryt bm'l lfi|. >v<d and f>U| 19 Svptv\\%b<t isOr .12 Journal o) the International Sneiely Jor Tvclmuloj'v Assessment. Stiriug I't7f> HONS 206792 the Government had been capable of invoking one). electrical uses lead risen from 12.000 tuns m I'H.k to The statement deferred lo the ongoing process of re 16.000 ions in 1970, By 1971, sins ft curt was i; view and deliberation as the basis for considered de d-.iccd io approximately 4,000 tons '1 In aJJiiion. cision and action. (iic MiviisanioCompany quietly assumed lor nsciiine There was, finally, a rlurd review of PCBs under role of distributor as well as manufacturer m order io taken within the Fedctal walls. One of ihe national ' crcisc some couiiol over end-use of PCDs In this institutes of health, the National Institute of Environ way. Hie manufacturer was able io "discontinue soies \ mental Health Sciences, had sometime before elected of PCBs for use in paints, plasticizers, sealants, ad to conduct series of "scientific" teviews nf materials hesives and other 'open-system' user" which weic of impending icgulninry concern and for Thus, during 1971 and J972, (lie Monsanto Com which no systematic accounting of scientific informa pany also restricted for attempted to test net < sab-s nf tion had been done. The plulosoplty m this case was PCBs to installations in winch food or animal feud lo bring together, in a conference, spokesmen for the was processed. principal research projects - published or under way Tile pnncipal recommendation of the PC I) Task - in order to lake the measure of she available scien Force was the discontinuance of ail uses f PCIh ex tific understanding. At the same time, members of cept in electrical capacitors and transformers These the press - especially scientific writers - were invited latter were judged to be essential uses and represented to attend these sessions, in order to enjoy the pro "closed systems".'4 To the extent that it could ever- ducts of this review process. Tlte aim was to educate cue this type of restriction on disinbuimn. ihe both the scientists and the public. Monsanto Company again undertook "voluntarily" io In December 1971. the National Institute of En control end-use through its cuntrol of ihe manu vironmental Health Sciences Isold the first of this facture and sale of PCBs. series of conferences in North Carolina, and tt wav on PCBs.,,(Since then, the N|H has held similar review son lead, automotive emissions, and other substances of OBJECTIVES current public and governmental concern.) Many of the same spokesmen who were engaged in the oilier The I nterde pari mental Task Force re pen on PCBs reviews made presentations at tlte "open" Conference. was issoed publicly In May 1977 and was accom One of the major accomplishments of this meeting panied by a statement of governmental "thmUny ' and was to imparl an understanding to the press and sci governmental "action" Perhaps the nmur con ence writers of live character of the scientific evidence clusion reached in the report, which became an objec and the scientists' own interpretation of experimental tive in Government decisions, was that of rimi/cd findings. The net (and immediaie) effect of that ex restriction on PCBs. PCBs were seen as having certain ercise was to take the newsworthiness out of the PCB essential uses in electrical transformers and capacitors issue and to remove it from (he category of the sensa and it was judged in tha country's best interest not to tional. Very little was actually reported in the press be totally dented the use of PCBs. This was a duces of rhat meeting. More important, relatively little reflection of tlse analysis jjeiformed by the National more was reported on PCOr in any form tit the lay Bureau of Standards of the utility and essentiality of press. PCBs, which pointed lo the possibility nl an increase Tlte principal "control" actions for PCBs were the in fires and explosions from encased or enclosed result of persuasion by the Federal Government transformers if PCBs could no longer be used - repre ratlier than by direct regulatory exercise. The Govern senting the possibility of trading one hazard for an 4 ment possessed no real regulatory authority to con other hazard. In addition, it derived from the trol the manufacture, distribution or use of PCRs. attempts to map out the patterns of environmental However, the persuasive influence of the several dispersal of PCBs winch had been lost fiom human Covemment inquiries - especially the PCB Interde use. Electrical applications were seen as "closed" ap partmental Task Force - was not doubted. Thus, the major action was taken "voluntarily" by the Mon santo Company, the sote U.S. manufacturer. Beginning in 1970. the Monsanto Company liad plications and were not thought tn contribute to en vironmental distribution. . Otlvet uses of PCDs were reviewed as either not essential, potentially or actually contributory to the begun to reduce live tales of PCBs - especially for environmental "load", or were found to have suitable noft-electncal uses. Domestic sales for PCBs for non- substitutes. This, then, pointed to an elimination of fi Nlionl tutii(u(r of t imfonmi-nial Health Science rnt- in| on pstjyI'lilufmated b*pl>ryh (PCUv). Ronfcmnurti, Ninth t'jridiiia. 20-21 1*11. J*nc> pub likhcd in I iiunmmhiiji llt-tilih IVfsiKcnvts, I iiH'rimrniil lu< Nf* I. Apitl 1*12. Ngi|>iijt Imuiuif- ti| | iitirtmmgiiui Jkifntsv Krwarch TiuJiffe P*rb. Nvii<h Cirnlina. ii Mnnianlo Indiltlrijl Clirmictlt Compaq, rrkm MnnAjfiln rfica'Ct pr4*dv*ci'rm figuri*' io n< figii mriri oT Cummfrcc. JO November i<*7|. JV<m ri`lr%e rctj wpanyntf (hr rvK'j'i' nl ilu- I'CH nuifd* parniKnui i*b ft(f irporl i*a KC'Ui. w^fimfiitu DC. i: M*y 191). Journal of the Itirrninhoiii/I Snarly for Technology Assessment, Spring IV /* .D HONS 206793 essentially a]] otltej uses - heat exchange fluids, hy draulic fluids, and itw miscellaneous category of "plasticizes" use*. The objective nf Imntcd restriction became llte basis for gove id menial persuasion of the Monsanto Company io restrict its distribution and sales of l*CBs -- in fact, ilie principal governmental action. 1 It glil i eh ting of the fact that true regulatory con trol by ihe Government was limited, became the text for a plea for passage of a ihen-pcnding bill in Con gress to close this gap. A second objective, then, be came the enactment of (lie Toxic Substances Control Act which would permit the Government to exercise useful control of industrial chemicals at their source. The regulatory tools which the Government did possess in this case permitted enforcement action after PCBs were found in foods for human consump tion and in animal feeds, flere, the FDA and the USDA re stated tlieir thresholds for action (which had been evolving over the previous four years), and announced the strengthening of their monitoring and analytic efforts. The other avenue of governmental control was tliat over industrial effluents and ambient watei quality, Here, Use Environmental Protection Agency siepped up its effort to assess the foreign cltetmcal content of waters downstream from plants ntatiufaciurtng PCBs and the Justice Department was close behind with enforcement teeth. The processes of review in (his case c\ph,r.l> sought info'Illation for a broadly bused Jt,:vun Thus, there was a dedicated attempt, lor example. i,< determine flic benefits or nnhiy of I'CUs and nj ihe costs that could be expected if (heir uses cte re stricted or denied. Tins information was later u-innl lo have been highly influential and nnpoil.irn in formulating the Govern men |'s position. One other element of information which proved io be important was lire analysis of environ menu! distubuiion and dispersal. The analysts iisrlf was some thing of an experiment. Is was reasoned cafly on t>y tlie participants in lire OST review that it should be possible, starling with some elementary information on tola) amounts of I'CBs produced, arid patiems ui distribution in commerce and disjHtsal. and armed wnh a certain elementary understanding of physical and chemical properties, to build a model predicting PCB distribution hi tlie environment. Tliis, m fact, was done, and the coefficients used in the model were partially tested or "validated" against ihe physical measurements of PCBs in the environ men i which had been reported In the literature. This exercise and the information from it became the basis, tor example, of the judgment that PCBs used in elect deal capacitors disposed of in the earth by burying in landliUs would not be expected to migrate very far through the vut and would not represent a significant source nt en vironmental pollution. INFORMATION The PCB ''decisions" were perhaps among the best informed of governmental actions of (hit type in re cent years. Tliere was. it turned out, a certain body of scientific and technical knowledge about PCBs and a modest documentation of past experience. In addi tion, this information was belter assembled and analyzed than was usually Ihe cate. Perhaps time was an important factor since lime was permitted for deli berate and reasonably careful study and reflection before decisions were announced. Thirdly, there was more opportunity for public airing end scientific interpretation before dediion-makutg than is usually the case. A Swedish scientific meeting on PCBs lud been held In 1970.* The Office of Science and Tech nology had begun iu review and analysis of PCBs by December 1970, and the results of in analyst! were made available as they emerged. The Government's own tcieiiiitis reviewed and interpreted the bate of technical knowledge over roughly six month! begin ning in September I97J, In December 1971. a fluid forum of scientists was convened by Ihe N1H to re view much of tlie same material. Thus, ihe process of utterprct.'iiion and maturation of data by scientific peers - while chamcichttic of the traditional scienti fic process hut unusual in regulatory decision-making - was played out in this ease. IMPLEMENTATION The principal "decisions" deriving from this exercise were to restrict PCBs to "closed-system" electrical uses. There soon enterged a few additional issues which reflected either loose ends or areas which de serve some additional study. Tha principal teason for denying the use of lOs as heal-exchange fluids was to avoid accidental spills and leakages of PCBs into foodstuffs fwhere heat was used to "pasteurize" the food material). However, tliere were often PCD heat exchanger applications One of these, for example, involved the use of hear on off-shore oil rigs to maintain low viscosity of (he oil. PCBs had been chosen here because of the characIcristics of Itiglt thermal stability and low probability of fire and explosion, and many of flic heat exchange devices had been designed specifically around the use of PCBs. Denial of ihe use of PCBs in this case raised the speetre of an increase in ihe number of fires m off-shore oil rigs or the continued use of PCBs from imported sources. This general question of worldwide (as opposed to U.S.) production and use of PCBs. became a mailer of immediate concern. There was an early vis.i of a spokesman from the Swedish Covernmcni to ihe Office of Science and Technology. The Tanff Com 34 Journal of the International Society for Technology Assessment. Spring IV?6 HONS 206794 mission and (lie Customs Bureau were pressed 10 search for signs of imported 1'CUs "5 Perhaps most useful was the fact that the OHCD was persuaded to inkc up rile question of the industrial production and commercial use of PCBs In the industrialized pans of tire world. PCISs, in fact, became the major example of mici govern menial "consultation" m a mechanism which the OHCD had established for this purpose, .he U.S. position and ilie informanon behind n be came major efemems in the OHCD posilion paper16 and in the dchberalions at ilw OHCD in November 1972. Trace amounts of PCBs in packaging materials be came a matter of particular concern. In part, this was due to uncertainly ovet their origin. There was some evidence that trace quantities of PCBs were magnified in the process of recycling paper. To the extent that this was true, the Government and national policies tinted at recycling were seen to be in possible jeopar dy. One of tlie principal motives for exploring this particular issue, apart from the economics of paper and cardboard production, was tlie contamination of food wrapped with PCB-contiimng piper. There fol lowed. therefore, a series of investigations by the Food and Drug Administration into the process and rate of migration of PCBs from packaging materials into foodstuffs which the packages contained. In December 1972, the FDA produced an Environ mental Import Statement (perhaps tlie only one of Us kind ft our that agency) on its proposed rule-making for PCBs,11 Among oilier things, this document sum marized the FDA investigations and positions regard ing PCL's and packaging. CONCLUSIONS, OBSERVATIONS, AND RI-COMMENDATIONS Tlie Government `'decisions" on PCBs constituted an unusual regulatory exercise compared to much of the experience of the past few years. In the first place, the Government's position was generally well pre pared. Related to that wat the fact that time taken for deliberate study and deliberate action, even in the face of public ootcries for immediate action. Thirdly. Ihe "decisions'' were taken without much tangible legal authority for governmental control. i* from AM Alt*, CowncU m Fitif0nmniii Qvali- ly, 1o Hi, Vrtfion Acrvf, Con>muiioflr, ItKU# of Custom, 31 Jut* 1973. " OipniiBiiOA for Economic Coopcrftttoo and Dewlap, meni, Environmental DuretufaU, Sector Croup on Unintended Occurrence at Oemicelt in the Environment, Piklyehtorinsled taphenyte - proposals for eorvcericd action, t J October ]973> r Food end t>rv( Admlniilraiion, Final rnviionmental impact iWlvincMt. Rule mihinp on put yc hint mated hip he* nyt*. Dvpaftfnent Health, Iducatson. and tl December 1973. They represented, instead, persuasion md \ -l;iin,r\ action. Jt is worthwhile, pcrtiaps, u> examine smiv m tlie factors winch contributed to any successes i:,ji can be claimed. I The PCU decisions icpicsenied, perhaps. .1 Some what more manageable challenge than main Only a jingle U.S. manufactuicr was involved. Further, the majority of commercial .md mdus rial uses and tlie major useis were known 7 There was some information which proved useful In decision-making. Quaninanvc figures showing production were provided - albcn only alter a delay - which were e*icmtjl in dcicnmning the scale of tlie problem and in change with nmc Similarly, (he Corresponding figures lor com mercial distribolion were essential tn jscci taming the patterns of human use and dispersion To complement these daia. there were at least some reslihs of physical measurement and monitoring of l^Bs in the environtneni or indices of dis persal. In terms of hazards, there was a legacy of ji least some documentation of previous human e\ posure and some laboratoiv data. However, many questions remained. I'rrhaps, mi'-i imporiant, was the luxury of critical review tm fa,t. several Critical reviews) of tins informanon. fur ther, these reviews engaged some veiy good v.ien lific talent - both inside and oumde the Goventmeut and in a way which permuted the decision-makers to be very well informed of their advice, In terms of benefits, a specific analysis was commissioned of tlie utility and essentiality of PCBs. (It is interesting to note lhai wlulc tins was done well, the National Bureau of Standards en tered into this exercise very reluctantly, seeing in it tlie perils of iIk battery additive episude uf some years before,) Finally, there was performed the unusual bot highly useful attempt at modeling the pat terns of rales and routes uf distribution of I'CDi in the environment. This was done lor the most part as an experiment to determine whether such an exercise could be performed. It did. in laci. provide some useful ami immediate insight 3 There was a snip)* spokesman for the Govern, ment. The agencies involved eaily determined that the PCB question cut across social depart ments, Tilts, by itself. was probably not petsuastvc and (lie joint request from the I DA and tlie USDA to tlie OST to "take on" ihc PCB question arose also from a desire on their pari to push on to someone else a touch or ''Inn" de cision. It should be tinted, abo.th.it ihe OSf had already begun a review in If lb Tlie fact tlul !Iwre was a single spokesman Journal nj the International Sat iety for Terhnology Assessment. S/'miK 19 .'5 HONS 20*795 proved important in aiming at an orderly de cision. The Monsanto Company insisted on deal ing only wiih a single spokesman aiier months or unconnected and frustrating interchanges wiili a variety of Government agents. The fael I hot there was a single spokesman also undoubtedly made n easier to amass and analyze in an orderly fashion the variety of information front several sources The far, that it was an Executive Office spokesman wj probably important in soliciting certain other studies iri parallel (such as the National tJuteao of Standards' study of benefits) and the review of the Government-wide legal option foi regulatory action. 4 Although already mentioned, the scientific infor mation (especially that related to biological ef fects) underwent the benefit of several reviews, Tills had two salutary effects, ft assured scientific interpretation by peers and it developed a con stituency among scientists for the decisions ultimately taken. 5 Tire decisions were deliberately broadly-based. \Vlnle this may appear elementary, this facet is generally not characiemtic of regulatory de cisions concerned with human health. Both bene fits and hazards were explicitly explored. Economic consequences were considered. Each of several avenues of possible action was ex amined in lorn. Again, a single spokesman for the Gove rumen I and one placed above the opetamic agencies was probably a necessary feature hi tins broad examination. 6 The decision process was a relatively open one. The fact that there was an Interdepartmental Task Force was public knowledge from the out set. The Task Force published its full report. Similarly. Ihe reports of the OST Panel on Haz ardous Trace Substances and the report of th? N1H meeting on PCHs were published Further, science writers and oilier members of the press were specifically invited to participate in the Nil I meeting. (Note that tfic question of ficcdom of information was a matter of some concern during the delibciaitons of Ihe Interagency Task Force in tire Office of Science and Technology .19) 7 Time was permitted for deliberate decision making. At one point, in fact, the Commissioner of the Food and Drug Administration held a press conference in which lie specifically an nounced that he would not proceed with an out right ban on PCBs and deterred to the study process that was then underway This, of course, contiadicts the classical argument which insists that Governments must make regulatory decisions immediately without the luxury of tune for good decisions. .T(i Journal of the International Society tor Technology Assessment, Spring 1V70 MOMS 20*796