Document 65YLmZBVrrXN4ma175nyV59Q4

A Case Study: Poly lorinated Bipheny)/ Edward J. Burger, Jr., M.D., Sc.D. Office of the President's Science A dvtser. Science and Technology Policy Office. Washington, D.C ABSTRACT The Government "decisions" on polychlorinated biphenyls (PCBs) constituted an unusual regulatory exercise compared to much of the ex/*cricncc of the past few years.1 PCBs had been developed in the late 1920s to serve in instances where high physical and chemical stability were advantageous. In part, precise ly because of these peculiar properties, they became recognized as particular environmental hazards. The pr/tcesses of analysis and study by the Government for decision were 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 was not taken until suitable information was marshalled and recent scientific evidence was given the benefit of intcrjtrctation. Finally, the process of deliberation was an unusually open one with (he results of analy sis fully displayed. 'Written for the study on Decision Making for Regulating Chemical* in the l.nviroiiinent, Environmental Studies Board, National Research Council, National Academy of Sciences, and undertaken at the request of the ll.S. Environmental Protection Agency, Contract No. 68-01 -2262, this paper wa completed in December 1974. ' In I'ehruary 197S, the National Academy of Sciences or ganised a working conference to explore the process of Uoveromenf decision-making to regulate chemicals in the en vironment. In assist this conference, a series of case studies of past regulatory decisions was solicited from person* who had reasonably detailed knowledge of them. Whst follows is lh case study of polychlorinated biphenyl* as one of the series used in the NAS study. The meiorily of the Govern ment pronouncements and decisions in this instance derived from series of studies end analytic exercises convened by the Office of the President'* Science Adviser. (This study is Inn to eppeur os pert of e hook by the author on regulation and human health, to he published by Lexington Books, Inc.) INTRODUCTION - NATURE OF THE DECISION Hie process of Federal Government deliberation and decision on polychlorinated biphenyls (l*CBs) was relatively circumscribed and straightforward. The Government actually possessed little in the way of legal, regulatory authority. Hence, the "decisions" leaned heavily on persuasion and on para-icgulutmy moves. Nevertheless, the Government's decisions in this case did lead to the intended and icuimmcndcd actions (reduction and restriction in certain uses of PCBs) and a tightening of the ptoccdures governing the manufacture, importation and continued use of these chemicals. Most important, perhaps, was the (act that the de cisions and actions assumed by the Government (and by parts of the private sector) were taken deliberately and on the basis of unusually good analysis and infotmalion The PCD decisions, in brief, were unusually well informed decisions when compared to others of this type, and the analyses used to airive at the de cisions were probably fuller and of a higher quality than is the case with most regulatory actions. The several agencies of the Federal Government concerned with the PCB question contributed to the deliberations and to the analyses. At the same time, an outside group of scientific experts was engaged by the Office of Science and Teclinology to consider PCBs from a broad perspective as a case sludy of a hazardous substance existing in the environment m trace quantities. The Government's major deliberative body for its decisions was an interagency. PCB t ask Force - run jointly by the OST and the CM) Hie case study of the outside advisers to the OST was lone ly and useful to the Government's own analyses. Journal of thr International Socirty for Technology Assessment, Spring IV 76 (0/57.-I for Technology Assessment, Washington. D ( International Snnetv 005377 mgns willingness to supply information of this sort to the Government, but with the understanding that the data would not be released publicly except in a full and detailed fashion. In addition, the Monsanto Com pany expressed some concern over the seemingly disconnected character of the Government's activities lip to that time and the difficulties involved in finding responsible spokesmen for each of the agencies in volved. Monsanto made a strung plea (in the form of a condition for their supplying information) (liat they be peitniltcd to deal with a single spokesman fui (he Government. The office of Science and Technology, on the advice of the Counsellor to the President, did reach agreement with Monsanto on the terms of receiving the information.17 These were shortly rendered moot by a request from the linvironmcnlal Defense Fund for the same information. This information ultimate ly served as important background for the Govern ment'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 with knowledge of the physical properties of PCBs to dcvelup a com posite picture of the rates and routes of environ mental transport and disposition. The data were reflected in a series of coefficients for a model of transport of l*CBs. While this was necessarily a crude description, it served as a very useful instrument for placing PCBs in perspective. It replaced what other wise would have been a tot ally qualitative - even intuitive exercise. It pointed up important gaps in knowledge. Finally, some verification was afforded by the results of physical measurement and monitor ing. Tlris 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 review 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 compare the effects of controlled laboratory 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. Tims, as well as serving as a review of the scientific aspects of PCBs, the Task Force explicitly reviewed a numbci of broad aspects of the PCB ques tion. Most important, perhaps, was the exploration of the benefits or utility of PCBs and of the industrial Memorurtdum (mm John Dean, Counsellor to (he Presi dent, lo rdward J. burger, Office of Science and Technology, concerning ilte freedom of Information Acl, 4 October 1971 and commercial dependencies built up over the years This explicit review of the benefils of PCBs, which is often not done for regulatory decisions, was of viial importance for decision-making on PCBs. The Nation al Bureau of Standards engaged in a review and analy sis of the benefits and even the "essemiaUiy" of each of the several uses of PCBs. In this, the NBS received advice from the National Industrial Pollution Control Council, especially concerning the electrical uses of PCBs. In each of the cases examined, the question of a possible and satisfactory replacement lor PCBs was raised. This review became the basis for the ultimate decision to preserve electrical uses of PCBs (for which there were true dependencies and no satisfactory sub stitutes) and to restrict olltei uses.70 The Government Task Force report included a sys tematic summary of monitoring experience for PCBs in food. It had been tliis inattci of PCBs in food as much as any other which had brought PCBs to public notice. Hence, it was thought lughiy desirable to sys tematically lay out the apparent extent of food contamination and to consider what the patterns of contamination would suggest for public policy and Government action. The Task Force Report explicitly reviewed all of the pertinent Federal regulatory taws for their appli cability to PCBs. This was, therefore, an exploration of the power of the Government to control and limit the manufacture, distribution, use and disposal of PCBs. This review pointed out something that was already known -- that existing regulatoiy authorities were capable of responding to specific incidents of contamination of foodstuffs once they were rec ognized. However, it acknowledged that the Govern ment's legal armamentarium was generally ". . . inadequate to prevent more PCBs from entering the environment".70 In addition to the above, the Interdepartmental Task Force review considered the chemical and physi cal properties of PCBs, the occurrence, transfer and cycling of PCBs in the environment, and (he known biological effects - especially on man. During the time that the Government review of PCBs was being pursued, the level of public concern over these chemicals continued to rise con siderably. For litis reason, the Commissioner of tfie FDA felt compelled to hold a press conference to ,. try to help establish a perspective on PCBs . . roughly a month after the Task Force had begun its work.51 This was an appropriately reasoned state ment which attempted to allay fears and discourage demands for a sudden, outright ban on PCBs (even if it Polychlorinated biphenyl* and I ha environment Inivrtle part mental task force on PCHs, WashingTM, May 1972 National Technical Information Service, U.S. Department of Commerce, Springfield, Virginia, No. COM - 72 - 1041V. *i Statement by Charles C. Kdwards, M.D.. I'Cll press hrtef- inf. food and Drug Adminitiratinn, 29 September I '>7 i. 3?. Journal ojthe International Society for Technology Assessment, Spring 1970 MUNS 065878 the Government had been capable of invoking one). The statement deferred to the ongoing process of re view and deliberation as the basis for considered de cision and action. There was, finally, a tliird review of PCBs under taken within the Federal walls. One of the national institutes of health, the National Institute of Environ mental Health Sciences, had sometime before elected to conduct a series ol "scientific*' reviews of materials which were of impending regulatory concern and for which no systematic accounting of scientific informa tion had been done. The pliilosophy in this case was to bring together, in a conference, spokesmen for the principal research projects - published or under way - in order to take the measure ofihe available scien tific understanding. At the same time, members of (he press - especially scientific writers - were invited to attend these sessions, in order to enjoy the pro ducts of this review process. The aim was to educate both the scientists and the public. In December 1971, the National Institute of En vironmental Health Sciences held the first of this series of conferences in North Carolina, and it was on l*CUs."(Since then, the NIH has held similar reviews on lead, automotive emissions, and other substances of current public and governmental concern.) Many of the same spokesmen who were engaged in the other reviews made piesentalions at the "open" conference. One of the major accomplishments of this meeting was to impart an understanding to the press and sci ence writers of the character of the scientific evidence and the scientists* own interpretation of experimental findings. The net (and immediate) effect of that excicisc was to take the newsworthiness out of the PCB issue and to remove it from the category of the sensa tional. Very little was actually reported in the press of that meeting. Moic important, relatively little more was reported on PCUs in any form in the by press. The principal "control" actions for PCBs were the result of persuasion by the Federal Government rather than by direct regulatory exercise. The Govern ment possessed no real regulatory authority to con trol the manufacture, distribution or use of PCBs. However, the persuasive influence of the several Government inquiries - especially the PCB Interde partmental Task Force - was not doubted. Thus, the major action was taken "voluntarily" by the Mon santo Company, the sole U.S. manufacturer. Beginning in 1970, the Monsanto Company had begun to reduce the sales of PCBs - especially for non*electrical uses. Domestic sales for PCBs for non- electrical uses liad risen from 12,000 tons in 1968 to 16,000 tons in 1970. By 1971, this figure was re duced to approximately 4,000 tons.1' In addition, the Monsanto Company quietly assumed lor itself the role of distributor as well as manufacturer m order to exercise some control over end-use of PCBs. In this way, the manufacturer was able to "discontinue sales of PCBs for use in paints, plasticizers, sealants, ad hesives and other `open-system* uses". Thus, during 1971 and 1972, the Monsanto Com pany also restricted (or attempted to restrict) sales ol PCBs to installations in wliich food or animal feed was processed. The principal recommendation of the PCB Task Force was the discontinuance of all uses of PCBs ex cept in electrical capacitors and transformer. These latter were judged to be essential uses and represented "closed systems'*.14 To the extent that it could exer cise this type of restriction on distribution, the Monsanto Company again undertook "voluntarily'' to control end-use through its control of the manu facture and sale of PCBs. OBJECTIVES The Interdepartmental Task Force report on PCBs was issued publicly in May 1972 and was accom panied by a statement of governmental "thinking" and governmental "action". Perhaps the major con clusion reached in the lepoit, which became an objec tive in Government decisions, was that of limited restriction on PCBs. PCBs were seen as having certain essential uses in electrical transformers and capacitors and it was judged in the country's best interest not to be totally denied the use of PCBs. This was a direct reflection of the analysis performed by the National Bureau of Standards of the utility and essentiality of PCBs, which pointed to the possibility of an increase in fires and explosions from encased or enclosed transformers if PCBs could no longer be used repre senting the possibility of trading one hazard for an other hazard. In addition, it derived from the attempts to map out the patterns of environmental dispersal of PCBs which liad been lost from human use. Electrical applications were seen as "closed** ap plications and were not thought to contribute to en vironmental distribution. Other uses of PCBs were reviewed as either not essential, potentially or actually contributory to the environmental "load", or were found to have suitable substitutes. This, then, pointed to an elimination of > National Institute of Environmental Health Sciences meetins m> polychlorinated biphenyl* (PCBs), Kougcmounl, North Carolina. 10 II December 1971. Proceedings pub lished in I'.ovlionmental Health Perspectives, Experimental Issue No. I, April 1972, National Institute of Environmental Health Sricncus. Research Triangle Park. North Carolina. u Monsanto Industrial Chemicals Company, press iclease Monsanlo releases PC I) production figures to Dcpaiimeoi <( Commerce, 30 November 1971, Press release accompanying die relensc of the I'Cll lotoUv partmcntal (ask force report on I'Clls, Washington. DC, 12 May 1972. Journal of the International Society Jar Technology Assessment, Spring 10 7f> 33 HONS 085879 essentially all other uses - heal exchange fluids, hy draulic fluids, and the miscellaneous category of "plasticizer* uses. The objective of limited restriction became the basis for governmental persuasion of the Munsanlo Company to restrict its distribution and sales of PCBs in fact, the principal governmental action. Highlighting of the fact that true regulatory con trol by the Government was limited, became the text for a pica for passage of a then-pending bill in Con gress to close tills gap. A second objective, then, be came the enactment of the Toxic Substances Control Act which would permit the Government to exercise useful control of industrial chemicals at their source. Tire 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. Here, the FDA and the USDA re-stated their thresholds for action (wliich 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 that over industrial effluents and ambient water quality. Here, tltc Environmental Protection Agency stepped up its effort to assess the foreign clicmical content of waters downstream from plants manufacturing PCBs and the Justice Department was dose behind with enforcement teeth. The processes of review in tliis case explicitly sought information for a broadly-based decision Thus, there was a dedicated attempt, lot example, to determine the benefits or utility of PCBs and o( the costs that could be expected if their uses wore re stricted or denied. This information was later found to have been highly influential and important in formulating the Government's position. One other element of information winch piovcd to be important was the analysis of environmental distri bution and dispersal. The analysis itself was some thing of an experiment. It wus reasoned early on by the participants in tire OST review that it should be possible, starting with some elementary information on total amounts of PCBs produced, and patterns of distribution in commerce and disposal, and armed with a certain elementary understanding of physical and chemical properties, to build a model predicting PCB distribution in the environment Tlus. in fact, was done, and the coefficients used in the model were partially tested or "validated" against the physical measurements of PCBs in the environment winch hail been repoiicd in the literature. This exercise and the information from it became the basis, for example, of the judgment that PCBs used in electrical capacitors disposed of in the earth by burying in landfills would not be expected to migrate very far tluough the soil and would not represent a significant source of en vironmental pollution. INFORMATION The PCB "decisions" were perhaps among the best informed of governmental actions of this type in re cent years. There was, il turned out, a certain body of scientific and lecluiical knowledge about PCBs and a modest documentation of past experience. In addi tion, this information was better assembled and analyzed than was usually the case. Perhaps time was an important factor since time was permitted for deli berate and reasonably careful study and reflection before decisions were announced. Thirdly, there was more opportunity for public airing and scientific interpretation before decision-making than is usually the case. A Swedish scientific meeting on PCBs had been held in 1970.* The Office of Science and Tech nology had begun its review and analysis of PCBs by December 1970, and the results of its analysis were made available as they emerged. The Government's own scientists reviewed and interpreted the base of technical knowledge over roughly six months begin ning in Scptcmher 1971. In December 1971, a third forum of scientists was convened by the N1H to re view much of the same material. Thus, the process of interpretation and maturation of data by scientific pccis - while characteristic of the traditional scienti fic process but unusual in regulatory decision-making was played out in tliis case. IMPLEMENTATION The principal "decisions" deriving from tliis exercise were to restrict PCBs to "closed-system" clcctrir.il uses. Theie soon emerged a few additional issues which reflected cither loose ends or areas which do serve some additional study. The principal reason for denying the use of PCBs as heat-exchange fluids was to avoid accidental spills and leakages of PCBs into foodstuffs (where heat was used to "pasteurize" the food material). However, there wete often PCB heat exchanger applications. One of these, for example, involved the use of heat on off-shore oil rigs to maintain low viscosity of the oil. PCBs had been chosen here because of the char.ic teristics of lugh thermal stability and low probability of fire and explosion, and many of the heal exchange devices had been designed specifically around Ihe use of PCBs. Denial of the use of PCBs in this case raised the spectre of an increase in the number of fires m off-shore oil rigs or the continued use of PC lb. from imported sources. This general question of worldwide (as opposed to U.S.) production and use of PCBs, became a mattei of immediate concern. Theie was an early visit of a spokesman from the Swedish Government to the Office of Science and Technology. The Tariff Corn- 34 Journal (>}'the International Society for Technology Assessment, Spring IV7h MUNS 005360 I mission and the Customs Bureau wen* pressed to search for signs of imported PCBs." Perhaps most useful was the fact that the OECD was persuaded to take up the question of the industrial production and comntcrcinl use of PCBs in tire industrialized parts of the world. PCBs, in fact, became the major example of intergovernmental `'consultation" in a mechanism which the OECD had established Tor this purpose. The U.S. position and the information behind it be came major elements in the OECD position paper*' and in (lie deliberations at the OECD in November 1972. Trace amounts of PCBs in packaging materials be came a mallei of particular concern. In part, this was due to uncertainty over their origin. There was some evidence Uuil trace quantities of PCBs were magnified in the process of recycling paper. To the extent that lids was true, the Government and national policies aimed at recycling were seen to be in possible jeopar dy. One of the principal motives for exploring this particular issue, apart from the economics of paper and cardboard production, was the contamination of food wrapped with PCB-containiog paper. There fol lowed, therefore, a series of investigations by the I'oml and Drug Administration into the process and rale of migration of PCBs from packaging materials into foodstuffs which the packages contained. In IVeember 1972, the FDA produced an Environ mental Import Statement (perhaps the only one of its kind from that agency) on its proposed rule-making for I'CBs.*7 Among other things, this document sum marized the FDA investigations and positions regard ing PCBs and packaging, CONCLUSIONS. OBSERVATIONS, AND RECOMMENDATIONS The 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 was (he fact that time was taken for deliberate study and deliberate action, even in the face of public outcries for immediate action. Thirdly, tire "decisions" were taken without much tangible legal authority for governmental control. >* Letter from Alvin Aim, Council on Knviron mental Quali ty. Ic* Mr. Vernon Acree. Commijvioner, Bureau of Qurturm, 23 June 1972. ** Organization tor t'-conomic Cooperation and Developmnt. environmental Directorate. Sector Group on lliilntrmlcd Occurrence of Chemicals in the tnviromnent. Polychlorinated biphenyls - proposals for concerted aettun, 13 October 1972. ** Food and Drug Administration, Final environmental iiopaci statement. Kule making on polychlorinated biphe nyls. Department of Health. Kducation, and Welfare. 18 December 1972. They represented, instead, persuasion and voluntary action. It is worthwhile, perhaps, to examine some of the factors which contributed to any successes that can be claimed. 1 The PCB decisions represented, pet haps, a some what more manageable challenge than many. Only a single U S. manufacture) was involved Fuither, the majority of commercial and indus trial uses and the majoi users were known 2 There was sunn* information which pioved useful in decision-making. Quautiiaiive figures showing production were provided albeit only after a delay - which woe essential in dctcimmmg the scale of the problem and its change with lime Similarly, the cuuospondmg Hguics fm com mercial distribution were essential in ascertaining the patterns of human use and dispersion. To complement these data, there were at least some results of physical measuiement and mumtoimg of PCBs in the environment oi indices of dis persal. In terms of hazards, there was a legacy oT at least some documentation of picvious human ex posure and some laboratory data. However, many questions remained. Perhaps, most impor tant, was the luxury of critical review (in fact, several critical reviews) of tins information I uiliter, these reviews engaged some very good scien tific talent - both inside and outside the Government and in a way winch permitted the decision-makers to be very well informed of then advice. In terms of benefits, a specific analysis was commissioned of tiic utility and essentiality of PCBs. (It is interesting to note that while this was done well, the National Bmean of Standards en tered into tills exercise very reluctantly, seeing in it the perils of the battery additive episode of some years before.) Finally, there was pcrfoimcd 1 lie unusual but highly useful attempt at modeling the pat terns of rates and unites of distribution of PCIJs in the environment. This was done for the most part as an experiment to determine whclhet such an exercise could be performed. It did. in lad, provide some useful and immediate insight. 3 There was a single spokesman for the Govern ment. The agencies involved early determined that the PCB question cut across scvcul depart ments. This, by itself, was probably not per suasive and the joint request from the FDA and the USDA to the OST to "take on" the P('H question arose also from a desire on their part to push on to someone else a tough in "hot" de cision. It should be noted, also,that tin- OST hail already begun a review of PCBs The fact that there was a single spokesman Journal ofthe International Society Jbr I'ei luto/ngy /1,Y.vr.v.w//<'///, Spring I{) 7(\ 3 S MQNS 0d5aai piovcd important in arriving al an ordctly de cision. The Monsanto Company insisted on deal ing only with a single spokesman after months of unconnected and frustrating interchanges with a variety of Government agents. The fact that their was a single spokesman also undoubtedly made it easier to amass and analyze in an orderly fashion the variety of information from several sources. The fact that it was an Executive Office spokesman was probably important in soliciting certain other studies in parallel (such as the National Bureau of Standards* study of benefits) and the review of the Government-wide legal option for regulatory action. 4 Although already mentioned, the scientific infor mation (especially that related to biological ef fects) underwent the benefit of several reviews. Tins had two salutary effects. It assured scientific interpretation by peers and it developed a con stituency among scientists for the decisions ultimately taken. 5 The decisions were deliberately broadly-based. While this may appeal elementary, this facet is generally not characteristic 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 turn. Again, a single spokesman lot the Government and one placed above the operating agencies was probably a necessary feature in this broad examination. 6 The decision process was a relatively open one. The fact that there was an (nictdcpnii mental Task Force was public knowledge from the out set. The Task Force published its full icpoit. Similarly, the reports of the OST Panel on Haz ardous Trace Substances and the report of the NIH meeting on PCBs were published, Fuithei, science writers and other members of the puss were specifically invited to paiticipate in the NIH meeting. (Note that the question of fieudoin of information was a matter of some concern duimg the deliberations of the Interagency Task Fincc in the Office of Science and Technology.,ft) 7 Time was permitted for deliberate decision making. At one point, in fact, the Commiwonei of the Food and Dtug Administration held a press conference in which he specifically an nounced that he would not proceed with nn out right ban on PCBs and deferred to (lie study process that was then underway." This, of course, contradicts the classical argument which insists that Governments must make regulatory decisions immediately without the luxury of time for good decisions. Q8&a8* 3f> Journal of the International Society for Technology Assessment, Spring / V 76 TUB ENVIRONMENT - OFTEN DISTANT FROM APPARENT SOURCES PC'Bs were among the materials found, but when analysed they were often confused with other sub stances. PC'Bs were first distinguished trom the "unknown interfering compounds" found in nature in 1966 by Jensen2 and the next year by Widmark.3 On the basis of this latter report, the Food and Drug Administration was moved to develop analytic methods to distinguish between PCBs and clilorinatcd organic pesticides encountered in monitoring for regulation. In February 1969, Dr. Robert Risebrough gathctcd attention by warning, in an article in the San Francisco Chronicle, of the dangers of PCBs in the eco system. Over the next 6 -7 months, the FDA in creased its surveillance of foodstuffs for evidence of 1*01) residues. Notable positive findings were in fish. Monitoring of foodstuffs, raw agricultural products, fish, and feeds foi PCBs was augmented throughout 1970. PCBs were found in fish and in marine animals in high concentrations dose to plants witich manufactuicd the chemical. accidental spius or LEAKAGES OF LARGE QUANTITIES OF POLYCHLORINATED BIPHENYLS WITH CONSEQUENT CONTAMINA TION OF FOODSTUFFS AND ANIMAL FEEDS In 1968, PCBs, used as a heat-exchange fluid in a pasteurizes, leaked into rice oil being manufactured for home cooking use in a plant in Japan. More than 1,000 persons were affected by the contaminated rice oil, many of whom exhibited persistent skin lesions as welt 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 of 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 197) in the professional scientific literature deal ing with wildlife and the environment.4'* In Sep tember 1970, the National Swedish Environment Pro tection Board held a conference on PCBs* One of * Jertiert, S.: A nfw chemical hazard, New Scientist, 32 612 (1966). * Widmark, C Possible interference by chlorinated biphenyls, J. Assoc. Offic. Anal. Chetn., SO: 1069 (1967). 4 Peak*)), 1>.B., and ).C. Linear: Polychlorinated biphenyls. Another long life widespread chemical In the environment. IlioxCiCliCC, 20 958--964 (1970). * Plrhiiollo, J.: I'CHs: Leaks of (oxic substance raises issues of effects, regulation. Science, / 73 . 699 - 9 02 (1971). * PC'll Conference, National Swedish Environment Pro- the sessions of this conference highlighted the "cn vironmental pioblem". This conference, perhaps foi the first lime, brought together the extent of under standing on the manufacture, use, and biological effects of, the extent of environmental contamination by, and the analytic methods for, PCBs." In August 1971, an Environmental Quality Work shop was convened in Durham, New Hampshire, by the National Academy of Sciences, to consider Marine Environmental Quality and Ocean Pollu tants.7 PCB contamination was highlighted. In addition, provoked by both the accidcniat spills and by the widespread finding of trace (pianii ties of PCBs in the environment, there cmcigcd in the lay press a series of stones and articles dealing with PCD contamination. Most of them occurred m laic 1971 and reflected especially the contamination of foodstuffs.**4 The FDA, aware that PCBs wcic to be found as a contaminant in the environment, and alert to the occasionally reported cases of accidental spillages, elected to engage in watchful surveillance of food. It did this in part in cooperation 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 February 1971), "Action levels" for PCHs in milk, poultry and fish. Action levels arc temporary thresholds for regulator decision pending the establishment of a moie per manent regulatory policy and procedure. In August 1970, the FDA established a similar action level loi eggs. During 1970 and 1971, the FDA used these guideline values in various seizures of foods found contaminated with PCHs. The number of reported contaminations of foods, recreational fish, packaging materials and animal feeds increased toward the latter half of 1971. Accompanying the announcements in the public press (and, undoubtedly, reflective of them), there also occurred toward the end of 1971 a scries of inquiries from Congressmen and other elected officials over PCB contamination of food and tire environment On lection bond, Kocaicli SccteUiiar, WennerCitu (enter, Stockholm. Sweden, 29 September 1970. 1 Marine environmental quality, A special study held under the auspices of the National Scientific Committee on Occam* graphy of the National Academy of Sciences Ocean AOjun Board. IHrrham, New Hampshire, 9- I 3 August I 97 I Monsanto limit* fond plants' use nf chemical PC It, The Washington Host, 30 September 1971. * Some dried loods found tainted by perilous chemical, The Washington Host, 28 September 1971. '* Tainted turkeys, The Washington Host, 24 September 1971. *' Turkeys, salmon tainted by HCBs, The I vi-nmg Star. 2 1 September 1971. " A contaminant is found in cardboard, the New York Time*, 28 September 1971. '* If you think DDT's a pioblem, meet HCH, The New York Times, 30 September 1971. 14 IDA studying chance of contamination in cnnt.iiner\ feu food, The Wall Street Journal. 2 6 September 197 1 ,U) Journal of the International Society for Technology Assessment, Sprint: / 9 7r> MQNS 035883 16 August 1971, Scuatoi McGovern addressed a tel ler to (he Commissioner of the FDA, reflecting (his concern. In September, Governor Miliken of Michigan sent a telegram to Elliott Richardson. Secretary of HEW, in which he announced a restriction of com mercial salmon Ashing because of the finding of PCBs in fish. By August 1971, the FDA (and to some extent, the USDA) found itself rapidly propelled into a posi tion where it would be "required" by public pressure and advocacy to take a stronger and more forthright position against PCBs. The scientific issues were stilt not clear and there were glaring gaps in information. What really were (he biological effects of the complex known as PCBs? How did the various PCBs vary in human toxicity and which members of the PCB 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 clear that the twin issues of widespread environmental contamination, by trace quantities of PCBs, and the selective, higher level contamination of foods and feed, had to be joined at some point in Government decision-making. On 5 August, 1971, the FDA, on its own initiative, called a meeting of spokesmen from each of several Government agencies and Federal research labora tories to review the state of scientific understanding of PCBs. The text lot the meeting was the reported series of accidental spills and leakages.,s Shortly fol lowing that meeting, (he Department of Agriculture and the Commissioner of the FDA asked the 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)thc issue cut across several Federal agencies and also involved outside scientists, (2) the issue was rapidly 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 had quietly begun to gather information several months back. In April 1970, spokesmen for the Monsanto Com pany agreed to meet with the staff of the President's Science Adviser in the OST to discuss a number of issues concerning PCBs, including a series of animal toxicology studies which Monsanto had undertaken. During this meeting. Monsanto was asked for infor mation concerning the amounts of PCB it manu factured and distributed. The company, being the sole producer in the U.S., was reluctant to make pub lic this information, although it reported that it might * TtaMieripl of proceedings of the interagency meeting on polychlorinated biphenyls (l*CHs), l oad nnd Drug Adminis tration, Department of Health, Education, and Welfare, Washington, D.C., 5 August 1*71. be able to provide the data on a confidential, non public, basis to the Government. In October 1970, a review was begun, in (he Office of Science and Technology, of the general subject of hazardous substances existing in the environment in trace quantities. This review, known ultimately as the Panel on Hazardous Trace Substances, had as its major goal the identification of the needs for infor mation by the Government in making judgments about trace hazardous substances. The Panel was composed principally of non government experts in the fields of ecology, chemis try, biology, environmental and occupnti.iuul medicine and geology. Thice case studies were begun from wliich it was hoped to draw gcnerulUublc ex perience. The particular subjects for the case studies were chosen because they were thought to be of im portance, because regulatory or otlici governmental action had not yet been taken but could be expected at some time in the teasonably near future, and be cause it was thought that there existed sufficient information from which to draw conclusions. Pic choices were cadmium, arsenic and PCBs. Thus, as the Government began to develop its own position on PCBs in 1971, the OSTinitiated study was already under way. What followed, in pari, was for the Government to borrow the experience devel oped by the OST Panel and even for the two cxeiciscs to be joined to some extent. Notwithstanding, a separate and identifiable PC B report was published by the members of the Panel on Hazardous Trace Sub stances. u On I September 1971, the FDA held a meeting with the USDA, the FPA, the Council on Fnvironmental Quality, and the Office of Science and Technology, to explotc options fox further action concerning PCBs. The FDA and the USDA requested that the Office of Science and Technology take a lead role in handling this matter. OST accecded lo tins req uest and agreed to collaborate with the OFQ in the task This became known as the Interdepartmental Task Force on PCBs. The Task Force was announced on 5 September in a joint FDA-USDA press conference '' On 15 September 1971, the OST Panel on Haz ardous Trace Substances and the governmental Task Force met jointly with representatives of the Mon santo Company. The principal agenda item of this meeting was a request for information concerning the amounts of PCBs produced, patterns of distiibution and usage, and estimates of losses into the environ ment.18 Again, the manufacturers expressed their '* Polychlorinated biphenyl* - environment*! impact. A review by the panel on he/erdou trace stimuiinrs. March 1972. environmental Keaearch, 5: 249-362 (1972) 11 Press release on interdepartmental HOI talk force. I nml end Drug Administration. Department of IlcaUli. i diK.mon. fc Welfare, S September 197 l. '* l.eiier from l.dw;irrt J. Hurper, Jr . M.l>. t*l the OS I l<i Mr. John Mason, The MoinaiHo Company . | S October. 1 I Journal of the Internalional Society for Technology Assessment.'Spring l<J7(> } 1 HONS 085884