Document 8R8qnpJM41zR6YpnRk70JYZBa

A CASE STUDY* POLYCHLORINATED BIPHENYLS by Edward J. Burger, Jr. Office of che President'a Science Adviser Science and Technology Policy Office Washington, D.C. December 1974 Written for the study on Decision Making for Regulating Chemicals In the Environment, Environmental Studies Board, National Research Council, National Academy of Sciences,undertaken at the request of the U.S. Environmental Protection Agency, Contract No. 68-01-2262. HONS Qbm* Polychlorinated Hi phonyis Introduction - Nature of the Decision The process of Federal government deliberation and decision on polychlorinated biphenyls (PCB's) was relatively circumscribed and straightforward. The Government actually possessed little in the way of legal regulatory authority, llcnce, the "decisions'' leaned heavily upon persuasion and on para-regulatory moves. Nevertheless, the Government's decisions in this case did lead to the intended and recommended actions (reduction and restriction in certain uses of PCB's) and a tightening of the procedures governing the manufacture, importation and continued use of these chemicals. Most important, perhaps, was the fact that the decisions and actions assumed by the Government (and by parts of the private sector) were taken deliDerate!;/ and on the basis of unusually good analysis and information. The PCM decisions, in brief, were unusually well informed decisions when compared to others of this type and the analyses used to arrive at Die decisions were probably fuller and of a higher quality than is the case of most regulatory actions. The several agencies of the Federal government concerned with the ?Cji question contributed to the deliberations and to the analyses. At Die same tin., an outride group of scientific experts was engaged by the Office of Science ai:c Technology to consider PCB's from a broad perspective as a case study of a hazardous substance existing in the environment in trace quantities. The Government's major deliberative body for its decisions was an interagency, FcB Task Force--run jointly by C6T and the CEQ. The case study of the outside advisers to OST was timely arid useful to the Government's own analyses. HONS 069365 2 DacW'ronnd - Chroiiolo-y ' The term, polychlorinated biphenyls, refers to a family of chlorinated organic compounds which were developed for commercial use in the late 19?0`s. Their usefulness was attributed especially to their high decree of physical, and chemical ctabiJity--even at high tempcratures--and because of some unusual electrical properties (high degree of dielectric capacity), (interestingly, it was this high thermal stability which made PC13's so useful technologically which also presented an environmental hazard). Hence, PCH's found particular utility as heat transfer fluids (because they did not break down or burn), hydraulic fluids, insulating materials in transformers and capacitors, and in a miscellaneous category of "plasticizer" uses (paints, plasticizers, carbon-less carbon paper). There was only one manufacturer in the United States, the Monsanto Company, which produced the basic material for all of the users. Produc tion roughly doubled between 1960 and 1970 and the U.f. production was estimated to be roughly one-half the total world production. 'Die demonstrated usefulness of PCB`s, especially in its electrical applications and as heat transfer and hydraulic fluids, led parts of the industrial and commercial worlds to become dependent upon them and to design certain types of equipment to use PCD's specifically. This was par ticularly true for certain heat exchangers and for enclosed, power tram;former Beginning particularly around 19G6, public and professional anxieties begun to be raised over possible environmental and health hazards associ ated v.'ith rCii's . These generally were of two sorts: 1 . Tl.o dli-covcry of fat-soluble., organic compounds including ehlotinnft' I livdrocarhons and bDT in trace quantities in a widely distributed pattern in MOMS 069366 the unvironmr.nl -- often distant. from ai;i)rm:nt sources. PCD*s were amoral the materials found but were often confused in an analytic sense with other substances. PCD's were first distinguished from the "unknown interfering compounds" found in nature in 1966 by Jenscal/ and the next year by Widmnrb^/. On the basis of this latter report, the Food and Drug Administration was moved to develop analytic methods to distinguish between PCD*s and chlorinated organic pesticides encountered in monitoring for regulation. In February 1969, Dr. Robert Risebrouglx. gathered attention by warning, in an article in the Dan Francisco Chronicle of dangers of KJR's in the eco-cyr.tem. Over the next 6-7 months, the FDA increased its surveillance of foodstuffs for evidence of PCD residues. Notable positive findings were In fish. Monitoring of foodstuffs, raw agricultural products, fish, and feeds for PCD's was augmented throughout 1070. PCD*s were found in fish and marine animals in high concentrations close to plants which manufactured the chemical. 2. 'Accidental spills or leakages of large Quantities of polychlori nated biphenyls with consequent contamination of foodstuffs and animal feeds. In 1906, PCIf s, used as a heat-exchange fluid in a pasteuriser, leaked into rice oil being manufactured for home cooking use in a plant in Japan. More than 1000 persons were affected by the contaminated rice oil, many of whom exhibited persistent skin lesions as well as systemic disease (Yusho disease). In July 1971, leakage of heat exchange fluid caused contamina tion of pasteurised fish meal which was used as a feed ration for chickens and catfish. MCKS 069361 4 In addition to these two major arena of concern, rCD's begun to be reported * with increasing frequency in poultry ui ,d ..ggs, and in pu. -. aging material for food. PCU's appeared with increasing frequency in 1970 and 1971 in the professional scientific literature dealing with wildlife and the V> V environment. In September 1970, the National Swedish Environment Protection hoard held a conference on PCB's.1^ One of the sessions of this conference highlighted the "environmental problem." This conference, perhaps for the first time, brought together the extent of understanding of the manufacture, use, extent of environmental contamination, analytic methods, and biological effects for PcB's.1^ In August 1971, an Environmental Quality Workshop was convened in Durham, New Hampshire*by the National Academy of Sciences to consider Marine Environmental Quality and Ocean Pollutants.^ PCD contamination was highlighted. In addition, provoked by both the accidental spills and by the widespread finding of trace quantities of PCD's in the environment, there emerged in the lay press a series of stories and articles dealing with PCD contamination. Most of them occurred in late 1971 and reflected especially the contamination of foodstuffs. 7-13/ The PM, aware that PCD's were to be found as a contaminant in the* environment, and alert to the occasionally reported eases 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 recult of the findings; of iCB's specifically in fish and mil];, the FLA established, between !>ecomber 1969 and February 1970, "Action Levels" for MOHS 069366 PCD's in milk, poultry and fish. Action levels are temporary CfirartTuldi. for regulatory decision pending the establishment of a more permanent regulatory policy and procedure. In August 1970, the FI A established a similar action level for eggs. During 1970 and 1971, the FDA used these guideline values in various seizures of foods found contaminated with PCD's. 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 (und, undoubtedly reflective of them), there also occurred toward the end of 1971 a scries of inquiries from Congressmen and other elected officiuls over PC13 contamina tion of food and the environment. On August 16, 1971, Senator McCovern addressed a letter to the Commissioner of the FDA reflecting this concern. In September, Governor Milikcn of Michigan sent a telegram to Elliott Richardson, Uocrctary of HEW, in which he announced a restriction of commercial salmon fishing because of the finding of PC IP s in fish. By August 1971, the FDA (and to some extent, USDA) found itself rapidly propelled into a position where it would be Mrequired" by public pressure and advocacy to take a stronger and more forthright position against PCB's. The scientific issues were still not clear and there were glaring gaps in information. What really were the biological effects of the complex known as T'ClPs? How did the various PCB's vary in human toxicity and which members of the PCB family were found as contaminants? Was observed toxicity due to PCB's proper or to contaminants produced during MOWS 069369 6 their manufacture? How widespread was the contamination and how good was the monitoring system in picking up accidental spills? Furthermore, it was clear that the twin issues of widespread environmental contamina tion by trace quantities of pCfl's and the selective, higher level contamina tion of foods and feed had to be joined at some point in Government decision-making. On August 5, 1971, the FDA, on its own initiative, called a meeting Of spokesmen from each of several Government agencies and Federal research laboratories to review tl*3 state of scientific understanding of PCB's. The text for the meeting was the reported scries of accidental spills and \aJ leakages.--' shortly following that meeting, the Department of Agriculture and the Commissioner of the FDA asked the Office of the President's Science Adviser to provide assistance and act as a focus for the Government's actions and decisions concerning PCB's. This request was made because: (l) the issue cut across several Federal agencies and also involved outside scientists, {?.) 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 19 fO, spokesmen for the Monsanto Company agreed to meet with the staff of the President's Science Adviser in OCT to discuss a number of Issues concerning ICB's including a scries of animal toxicology studies which Monsanto had undertaken. During this meeting, Monsanto was asked for information concerning the amounts of ICD it manufactured and dis tributed. The company, being the sole producer in the U.O., was reluctant to make public this information although reported that it might be able to provide the data -on a confidential, non-public basis to the Government.. HONS 069370 7 In October 1970, a review was begun in the Office oT Gcielicc"druTTecIP nology of the general subject of hazardous substances existing in the en vironment in trace quantities. This review, known ultimately as the Tanel on Hazardous Trace Substances, had as its major goal the identification of the needs for information by the Government in making judgments about trace hazardous substances. The Panel was composed principally of non-Govcrnmonl experts in the fields of ecology, chemistry, biology, environmental and occupational medicine and geology. Three case studies were begun from which it was hoped to draw generalizable experience. The particular sub jects for the case studies were chosen because they were thought to be of importance, because regulatory or other governmental action had not yet been taken but could be expected at some time in the reasonably near future and because it was thought that there existed sufficient information from which to draw conclusions. The choices were cadmium, arsenic and PCb's. Thus, as the Government began to develop its own position on PCH's in 1971, the OGT-initiatcd study was already under way. What followed, in part, was for the Government to borrow the experience developed by the 03T Panel and even for the two exercises to be joined to some extent. Notwithstanding, a separate and identifiable PCD report was published by the members of the Panel on Hazardous Trace Substances.IS/ On September 1, 1971, the FDA held a meeting with US HA, EPA, the Council on Environmental Quality and the Office of Science and Technology to explore options for further action concerning PCB's. The FDA and the U3DA requested that the Office of Science and Technology take a lead role in handling this matter. OGT uccecdud to this request and agreed to collaborate v/ith the Ch'U in i\. HQhS 069371 0 tank. This became known us the Interdepartmental Task -Foret? e ECiP The Tusk Force was announced on September 5 in a joint FEW-l! MilA press 10/ conference.--' On September 15, 1971, the OST Panel on Hazardous Trace Substances and the Governmental Task Force met jointly with representative of the Monsanto Company. The principal agenda item of this meeting was a request for information concerning the amounts of PCB's produced, patterns of distribution and usage, and estimates of losses into the environment.--^ Again, the manufacturer expressed its willingness to supply information of this sort to the Government but with the understanding that these data would not be portrayed publically except in their full and detailed fashion. In addition, the Monsanto Company expressed some concern over the seemingly disconnected character of the Government's activities up to that time and the difficulties involved in finding responsible spokesmen for each of the agencies involved. Monsanto made a strong plea (in the form of a condition for their supplying information) that they be permitted to deal with a single spokesman for the Government. The Office of Science and Technology, on the advice of Die Counsellor to the President, did reach agreement with Monsanto on the terms of re ceiving the information. These were shortly rendered moot by a request by the Knvironmcntal Defense Fund for the same information. This informa tion ultimately served as important background for the Government's decicacns and was leaned on heavily by both the OST Panel and the Task Force. The 037 Panel combined the production figures and Die data on distribu tion and use with knowledge of the physical properties of FCB's to develop ii composite picture of the rates and routes of environmental transport and disposition. Tho data were reflected in a series of coefficients for a model HONS 0693 72 9. of transport- of PCB's. While this was necessarily a erructe description, it served as a very useful instrument for placing PCB's in perspective. It replaced what otherwise would have been a totally qualitative--even intuitive exercise. It pointed up important gaps in knowledge. Finally, some verification was afforded by the results of physical measurement and monitoring. This attempt at environmental modelling was a major contribution by the Panel to decision-making. The OST Panel report was also appropriately critical in its review of biological effects and analytic methods for PCB's. It considered what was known of the mechanisms of observed biological effects, relation ships between variations in chemical structure and biological activity, and it attempted to compare the effects of controlled laboratory experi ments with observations made on animal populations in nature. The Interdepartmental Task Force reflected much of this information in its report. It explored additional territory as well--reflective of the fact that it was a Governmental report which focused on a number of specific, prugmatic, Government or public problems. Thus, as well as serving as a review of the scientific aspects of PCB's, the Task Force explicitly reviewed a number of broad aspects of the PCB question. Most important, perhaps, was the exploration of the benefits or utility of PCD's and of the industrial and commercial dependencies built up over the years. This explicit review of benefits of PCB's, which is often not done for regulatory decisions, was of vital importance for decision-making for PCB's. The National bureau of Standards engaged in a review and analysis of the benefits and even the "essentiality" of each of the several 0693?3 HONS 11' uses of PCB's. In this, the NBS received advice from (the ffaCjpTTai Pollution Control'Council especially for electrical ucc:; of rCB' c. jri e;icu Of the cases examined, the question of a possible and satisi'actory replace ment for PCB's was raised. This review became the basis for the ultimate decision to preserve electrical uses of PCB's (for which there were true dependencies and no satisfactory substitutes) and to restrict other uses,!!!/ The Government TasK Force report included a systematic summary of monitoring experience for PCB's in food. It had been this matter of PCB's in food us much as any other which had raised PCB's to public notice. Bence, it was thought highly desirable to lay out systematically the appar ent 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 laws for their applicability to FCB's. This was, therefore, an exploration of the power of the Government to control and limit the manufacture, distribution, use and disposal of PCB's, This review pointed out (which was already known) that existing regulatory authorities were capable of responding to specific incidents of contamination of foodstuffs once they were recognized. However, it acknowledged that the Government's legal armamentarium was generally "... inadequate to prevent more PCB's from entering the environment." in/ In addition to the above, the Interdepartmental Task Force review considered the chemical and physical properties of PCB's, the occurrence, transfer and cycling of PCB's in the environment and the known biological effects--ecpccially on man. MOMS 069374 11 During the time the Government review of FCB's was being p'urHuoifT'TlTG-^ height of public concern over these chemicals ~r>nfinued to rise somewhat. For this reason, the Commissioner of the FDA felt compelled to hold a press conference to "...try to help establish a perspective on FCB's..." roughly a month after the Task Force began its work.^^ This was an appropriately reasoned statement which attempted to alluy fears and dis courage demands for a sudden, outright ban on FCB's (even if the Govern ment had been capable of invoking one). The statement deferred to the ongoing process of review and deliberation as the basis for considered decision and action. There was, finally, a third review of FCB's undertaken within the Federal walls. One of the National Institutes of Health, the National Institute of Environmental Health Sciences, had sometime before, elected to engage a series of "scientific" reviews of materials which were of impending regulatory concern and for which no systematic accounting of scientific information bad been done. The philosophy in this cane was to bring together in a conference spokesmen for the principal research projects--published or under way--in order to take the measure of the available scientific understanding. At the same time, members of the presG.-especially scientific writers--were invited to attend these sessions in order to enjoy the products of this reviev; process. Thus, the aims were to educate both scientists and the public obout the science and its interpretation. HONS 06937S 12 In December 1971, the National Institute of KuvjjrddHWiti'tflLjTfcat^ Sciences held the first of this series of conferences in ilortn Carolina-- ZlJ* this one on PC13'c. Many of the same spokesmen who were engaged in the other reviews made presentations at the "open" conference. One of the major accomplishments of this meeting was to impart an understanding to the press and science writers as to what the character of the scientific evidence was and what was the scientists' own interpretation of experi mental findings. The net (and immediate) effect of that exercise was to take the r.ewsvorthiness out of the K13 issne and to remove it from the category of the sensational. Very little was actually reported in the press of that meeting. More important, relatively little more was reported on PCD'r. in any form in the lay press. The principal "control" actions for PcB's were the result of per suasion by the federal government rather than by direct regulatory exercise. The government possessed no real regulatory authority to control Die manufacture, distribution or use of PCIVg. however, the persuasive influence of the several Government inquiries--espccially the PCD Interdepartmental Task Force--was undoubted. Thus, the major action was taken "voluntarily" by the Mansanto Company, the sole U.S, manufacturer. Since, then, NUI bars held similar reviews on lead, automotive emissions, and other substances of current public and Governmental concern. 0693?6 13 Beginning in 1070, the Monsanto Company had begun to reduce the sales of PCD'c--onpeciftlly for non-electrical uses. Domestic sales for PC1V s for non-electrical uses had risen from 12 thousand tons in I960 to 16 thousand tons in 19/0. By 1971, this figure was reduced to approximately -1 thousand tons In addition, the Monsanto Company quietly assumed for itself the role of distributor ns well as manufacturer in order to exercise some control over end-use of PCB's. In this way, the manufacturer was able to "discontinue sales of PClf s for use in paints, plasticisers, sealants, adhesives and other 'open-system' uses." Thus, during 1971 and 1972, the Monsanto Company also restricted (or attempted to restrict) sales of PCB's to installations in which food or animal feed was processed. The principal recommendation of the PCB Task Force was the discontinu ance of al] uses of TOD's except in electrical capacitors and transformers. These latter were judged to be both essential uses and represented "closed systems."^/ To the extent that it could exercise this type of restriction of distribution, the Monsanto Company again undertook "voluntarily" to control end-use through its control of manufacture and sale of rCB's. HONS 069377 Objectivon 14 The l'ntcrdepai Uter.tal Tank Force report on PC]p j waz ?s;:uuu pub- lically in May 197 E and was accompanied by a statement of Governmental "thinking" and Governmental "action." Perhaps the major conclusion reached in the report which became an objective in Government decisions was that of 1imited restriction of PCD's. PcB's were seen ns having certain essential, uses in electrical transformers and capacitors and it was judged in the country's best interest not to be totally denied of JFC3's. This was a direct reflection of the analysis performed by the National Bureau of Standards of the utility andi essentiality of FCB's which pointed to the possibility of an increase in fires and explosions from encased or enclosed transformers if I^B's could no longer be used--reprcsenting the possibility of trading a hazard for another hazard. In addition, it derived from the attempts to map out the patterns of environmental dis persal of lCB's which had been lost from human use. Klectrical applica tions were seen as closed" applications and were not thought to be contributory to environmental distribution. Other uses of Poll's 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 essentially all other uscs--heat exchange fluids, hydraulic fluids, and the miscellancau category of "plasticizer' uses. This objective of limited restriction became the basis for Governmental persuasion of the Monsanto Company to restrict its distribution and sales of 1CB's--in fact, the principal Governmental action. HONS 069378 15 Highlighting of the fact that trutf regulatory control GttfrgftiiihfcnT was limited became the text for a pica for pas^-ige of a then-pending bill in Congress to close this cap. A second objective, then, became the enact ment of the 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 PCIV s were found in foods for human consumption and in animal feeds. Here, the FDA arid the UGJYV re-stated their 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 that over industrial effluents and ambient water quality, here, the Environmental Protection Agency stepped up its effort to assess the foreign chemical content of waters downstream from plants manufacturing PCB1s and the Justice Department was close behind with enforcement teeth. Informat.ion The ICB "decisions'* were perhaps among the best informed of Governmental actions of this type in recent years. There was, it turned out, a certain body of scientific and technical knowledge about FCB's arid a modest docu mentation of past experience. In addition, this information was better assembled and analysed than was usually the case. Perhaps time was e.n important factor since time was permitted for deliberate 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 HCHS 0693'9 meeting on 16 s had been held in 1970.^ The Office of Science and Tech nology had begun its review and analysis of rCU- s by December '.'.I/O and the results of its analysis were made available as they emerged. Vlie Government's own scientists reviewed and interpreted the base of technical, knowlcdce over roughly six months beginning in September 1971. In December 1971, a third forum of scientists were brought together by Nil! to review much of the same material. Thus, this process of interpretation and maturation of data by scientific peers--while characteristic of the tra ditional scientific process but unusual in regulatory decision-making-was played out in this case. The processes of review j.n this case explicitly sought information for a broadly-based decision. Thus, there was a dedicated attempt, for example, to determine the benefits or utility of PCJV s and of the costs that could be expected if their uses were restricted or denied. This information wns later found to have been highly influential and important in formulating the Government's position. One other element of information which proved to be important was the analysis of environmental distribution and dispersal. This analysis, itself, was something ol' an experiment. It was reasoned early on by the participants in the OmT review that it should be possible, starting with some elementary information on total amounts of PC 13's produced and patterns of distribution in commerce and disposal, and armed with certain elementary understanding of physical and chemical properties, to build a model predictive of 1C 13 distribution in the environment. This, in fact, was done and the coefficients used in the model were partially tested or "validated" against the physical measurements of fCB's in the environment HONS 069380 17 which had been reported in the literature. This exercise ancJ the infor mation from it became the basis, for example, cr the judgment that PCB's used in electrical capacitors disposed of in tne earth by burying in landfills would not be expected to migrate very far through the soil and would not represent a significant source of environmental pollution. Imnlcmentntion The principal "decisions" deriving from this exercise were to restrict PCB's to "closed-system" electrical uses. There soon emerged a few addi tional issues which reflected either loose .ends or areas which deserve some additional study. The principal reason for denying the use of PCB's tvs heat-exchange fluids was to avoid accidental spills and leakages of PCD's into food stuffs (where heat was used to "pasteurize" the food material). However, there were often PCB heat exchanger applications. One of these, for ex ample, involved the use of heat on off-shore oil rigs to maintain a low viscosity of the oil. PCB's had been chosen here because of the character istics of high thermal stability and low probability of fire and explosion and many of the heat exchange devices had been designed specifically around the use of PCD's. Denial of the use of PCB's in this case raised the spectre of an increase in the number of fires in off-shore oil rigs or the continued use of PCB' c from imported sources. This general question of worldwide (as opposed to U.o.) production and use of PCB's became a matter of immediate concern. There was an early visit of a spokesman from the Swedish Government to the Office ol` Science and Techno Io/*y The Tariff Commission and the Customs Bureau woiu HONS 069301 10 pressed to search for signs of imported PUB's.i-i/ Perhaps, most useful wac the fact that the OECD was persuaded to take up the question of indus trial production and commercial use of PCB* s in the industrialized parts of the world. Kill's, in fact, became the major example for intergovern mental "consultation'- in a mechanism which the OECD had established for this purpose. The U.O. position and the information behind it became os / major elements in the OECD position paper-^ and in the deliberations at the OECD in November 1972. Trace amounts of ECU's in packaging materials became a matter of particular concern. In part, this was due to uncertainty over their origin. There was come evidence that trace quantities of PCD's were magnified in the process of recycling of paper. To the extent Unit this war. true, the Government and national policies aimed at recycling were seen to be in possible jeopardy. One of the principal motives for exploring this par ticular issue, apart from the economics of paper and cardboard production, was the contamination of food wrapped with PCB-containing paper. There followed, therefore, a scries of investigations by the food and Drug Administration into the process and rate of migration of ECU's from pack aging materials into foodstuffs which the packages contained. In December 1972, the EDA provided in the form of an Environmental import Statement (porhnpr 1 he only one of its kind from that rigcney) on jt.s proposed rule-making for ECU' s.-^ Among other things, this document summarized the EDA investigations and positions regarding PCD's and packaging. 06^8i *0s 19 Conclusions,, Obscrvnt i one > and Pocominond'if i ^ns The Government ' decisions" on PCB's constituted an unusual regulatory exercise compared to much of the experience of the past few years. In the first place, the Government's position \;as generally well prepared. Related to that was the fact that time was taken for deliberate study and deliberate action, oven in the face of public outcries for imincJiatc action. Thirdly, the "decisions'1 were taken without much tangible legal authority for Governmental control. They represented rather persuasion and voluntary action. Jt is worthwhile, perhaps, to examine some of the factors which contributed tonny successes that can be claimed. 1. The PCB decisions represented, perhaps, a somewhat more manageable challenge than many. Only a single U.S. manufacturer was involved. Further, the majority of commercial and industrial uses and the major users were known. ?.. There was some information which proved useful in decision-making. Quantitative figures showing production were provided--albcit only after a dclny--which were essential in determining the scale of the problem and its change with time. Similarly, the corresponding figures for commercial distribution were essential in ascertaining the patterns of human use and dispersion. `Jo complement these data, there were at least some results of physical measurement and monitoring of PCD's in the environment or indices of dispersal. In terms of hnxarus, there was a legacy of at least s^ne documentation of previous human exposure and some laboratory data. However, many qucvAjons remained. Perhaps, most important, was the luxury of critical review (in MGNS 069383 fact, several critical reviews) of this information. Further, these reviews engaged some very good scientific tilent--both inside and out side the Government nml in a way which permitted the decision-makers to be very well informed of their advice. In terms of benefits, a specific analysis was commissioned of the utility and essentiality of PCD's. (it is interesting to note that while this was done well, the National Bureau of Standards entered into this exercise very reluctantly-seeing in it the perils of the battery additive episode of some years before) . Finally, there was performed the unusual but highly useful attempt at modeling the patterns of rates and routes of distribution of PCB*s in the environment. This was done for the most part an an experiment--to determine whether such an exercise could be performed. It did, in fact, provide some useful and immediate insight. 3. There war. a single spokesman for the Government. The agencies in volved early determined that the PCB question cut across several depart ments. This, by itself, was probably not persuasive and the joint request from FDft and thc'UGDA to 03T to **take on" the PCB question arose also from a desire on their part to push on to someone else a tough or "hot" decision. It should be noted, too, the OCT had already begun a review of PCli's. The fact that there was a single spokesman proved important in arriving at an orderly decision. The Monsanto Company insisted on dealing, only with a single spokesman after months of unconnected and frustrating interchanges with a variety of Government agents. The fact that there wus a single spokesman also undoubtedly made it easier to amass and analyze in an orderly fashion the variety of information from several sources. The HONS 069384 21 fact that it was un 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 (jovcrument-widc leg'll option for regulatory action. 4. Although already mentioned, the scientific information (especially that related to biological effects) underwent the benefit of several reviews. This had two salutary effects. It did assure scientific inter pretation by peers and it developed a constituency among scientists for the decisions ultimately taken. . 5. The decisions were deliberately broadly-based. While this may appear elementary, this facet is generally not characteristic of regu latory decisions concerned with human health. Both benefits and hazards were explicitly explored. Economic consequences were considered. Each of several avenues of possible action was examined in turn. Again, a single spokesman for the government and one placed above Die operating agencies was probably a necessary feature in this broad examination. G, The decision process was a relatively open one. The fact that there was an interdepartmental Task Force was public knowledge from the outset. The Task Force published its full report. Similarly, the reports of the OoT Panel on Hazardous Trace Substances and the report of the NIH meeting on FCb's wore published. Further, science writers and other members of the press were specifically invited to participate in the NIK meet in/;.* "Mote that the question of freedom of information was a matter of come concern during Die deliberations of the Interagency Task Force in the Office of Science and Technology.Hi/ . HONS 069385 22 7. Time was permittee] for deliberate decision-making. At one point, in fact, the Commissioner of the Food and Drug Administration held a press conference in which he specifically announced that he would not proceed with an outright ban on PCD's and deferred to the study process that v:as then underway. S/ Til is, of course, contradicts the ciassical argument which insists that Governments must make regulatory decisions immediately without the luxury of time for good decisions. HONS 069386 Reference:; 1. Jensen, S., A now chemical hazard, Now Scientist, 52: G12, 19GG. 2. Widmark, G., Possible interference by chlorinated biphenyls, J. Assoc. Offie. Anal. Chem., 50: 1069, 196'/. 3. Peakall, D.B., ami Lincer, J.C., Polychlorinated biphenyls. Another long-life widespread chemical in the environment, Bioscicncc, 20: 950-964, 19/0. 4. Pichirallo, J., PCD* s: Leaks of toxic substance raises issuer, of effects, regulation. Science, 173: 099-902, 1971. 5. PCB Conference, National Swedish Environment Protection Board, Research Sormtnri nf.. Wennr-nrn Stockholm, Sweden, September 29, 1970. 6. Marine Environmental Quality, A Special.^Study held under the auspices of the National Scientific Committee on Oceanography of the National Academy of Sciences Ocean Affairs Board, Durham, Mew Hampshire, August 9-lb, 19/1. 7. "Monsanto limits food plants' use of chemical PCB," The Washington Post, September 30, 1971. B. "Gome dried foods found tainted by perilous chemical," The Washington Post, September 28, 1971. 9. "Tuinted Turkeys," The Washington Poet, September 24, 1971. 10. "Turkeys, salmon tainted by PCB's," The Evening Star, September 25, 1971. 11. "A contaminant is found in cardboard," The Mew York Times, September 28, 1971. 12. "If you think PUT' r, a problem, meet PCB," The New York Times, September 30, 1971. 13. "FDft studying chance of contamination in containers for food," The * Wall Street Journal, September 28, 1971. 14. Transcript of Proceedings of the Interagency Meeting on Polychlorinated Biphenyls (PCP1 s), Food and Drug Administration, Department of Health, Education, and Welfare, Washington, D.C., August 5, 1971. 15. polychlorinated Biphenyls--Environmental Impact, A Review by the Panel on Hazardous Trace Substances, March 1972. Environmental Research, 5: 249-502, 1972. M6NS 069387 2 16. Press release on Interdepartmental PCB Tank Force, Food and Drug Administration. Department of Health, Ech-rat* on, h Welfare, September 6, 19/1. 17. Letter from Edv.nrd J. Burner, Jr., M.D, cf OST to Nr. John Mason, The Monsanto Company, October 15, 1971. 10. Memorandum from John Dean, Counsellor to the President, to Edward J. Hunger, Office of Science and Technology, concerning the Freedom of Information Act, October 4, 1971. 19. Polychlorinated biphenyls and the Environment. Interdepartmental Task Force on INCH'S, Washington, D.C., May 1972. National Technical Information Service, U.S. Department of Commerce, Springfield, Virginia, No. COM-72-10419. 20. Statement, by Charles C. Edwards, M.D.^PCB Press Briefing, Food and Drug Administration, September 29, 1971. 21. National Institute of Environmental Health Sciences Meeting on Polychlorinated Diphenyls (PCD's), Rougcmount, North Carolina, December 20-21, 19/1. Proceedings published in Environmental Health Perspective:;, Experimental Issue No. 1, April 1972, National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina. 22. Monsunto Industrial Chemicals Company, Press Release. "Monsanto Releases TCD Production Figures to Department of Commerce ", November 50, 1971. 23. Press Release accompanying the release of the PCD Interdepartmental Task Force Report on PCB's, Washington, D.C., May 12, 1972. 24. Letter from Alvin Aim, Council on Environmental Quality, to Mr. Vernon Acrce, Commissioner, Bureau of Customs, June 22, 1972, 25. Organisation for Economic Cooperation and Development, Environmental Directorate, Hector group on Unintended Occurrence of Chemicals in the Environment, Polychlorinated Biphenyls--Proposals for Concerted Action, October 13, 1972. 26. Food and Drug Administration, Final Environmental Impact Statement. Rule Making on Polychlorinated Biphenyls, Department of Health, Education, and Welfare, December lti, 1D72. 0*IS 0693aa