Document pV9G43oqDzZ703r0gEMOxGYX

A Case Study: Polychlorinated Biphenyls Edward J. Burger, Jr., M.D., Sc.D. Office of the President's Science Adviser, 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 experience oj 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 processes 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 nor 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. Written for the study on Decision Making for Regulating Chemicals in the Environment, Environmental Studies Board, National Research Council, National Academy of Sciences, and undertaken at the request of the U.S. Environmental Protection Agency, Contract No. 68-01-2262, this_par>er was completed in December 1974.1 1 In February 1975, the National Academy of Sciences or ganized a working conference to explore the process of Government decision-making to regulate chemicals in the en vironment. To assist this conference, a series of case studies of past regulatory decisions was solicited from persons who had reasonably detailed knowledge of them. What follows is the case study o.- polychlorinated biphenyls as one of the series.used in the NAS study. The majority of the Govern ment pronouncements and decisions in this instance derived from a series of studies and analytic exercises convened by the Office of the President's Science Adviser. (This study is also to appear as a part of a book by the author on regulation and human hc.Tlili.Jo he published hv Lexington UQnkiLiuc.l INTRODUCTION - NATURE OF THE DECISION The process of Federal Government deliberation and decision on polychlorinated biphenyls (PCBs) 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 pamregulatory moves. Nevertheless, the Government's decisions in this case did lead to the intended and recommended actions (reduction and restriction in certain uses of PCBs) and a tightening of the procedures governing the manufacture, importation and continued use of these chemicals. Most important, perhaps, was the fact 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 infor mation. The PCB decisions, in brief, were unusually well informed decisions when compared to others of this type, and the analyses used to arrive at the de cisions were probably fuller and of a higher quality than is the case with most regulatory actions. The several agencies ot the federal (jovernment 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 Teciinology to consider PCBs 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, PCB Task Force -- run jointly by the OST and the CEQ. The case study of the outside advisers to the OST was time ly and useful to the Government's own analyses. PHARMACIES EXHIBIT 1201 Journal ofthe International Society for Technology Assessment, Spring 19 76 ISTA - international Society for Technology Assessment, Washington, D.C. DSW 184835 HARTOLDMON0030161 THE ENVIRONMENT - OFTEN DISTANT FROM APPARENT SOURCES PCBs were among the materials found, but when analysed they were often confused with other sub stances. PCBs were first distinguished from the "unknown interfering compounds" found in nature in 1966 by Jensen2 and the next year by Widmark.3 On the basis of tliis latter report, the Food and Drug Administration was moved to develop analytic methods to distinguish between PCBs and chlorinated organic pesticides encountered in monitoring for regulation. In February 1969, Dr. Robert Risebrough gath ered 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 PCB residues. Notable positive findings were in fish. Monitoring of foodstuffs, raw agricultural products, fish, and feeds for PCBs was augmented throughout 1970. PCBs were found in fish and in marine animals in high concentrations close to plants which manufac tured the chemical. ACCIDENTAL SPILLS 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 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 persistent skin 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 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 1971 in the professional scientific literature deal ing with wildlife and the environment.4'5 In Sep tember 1970, the National Swedish Environment Pro tection Board held a conference on PCBs.6 One of ' Jensen, S.: A new chemical hazard. New Scientist, 32: 612 (1966). * Widmark, G.: Possible interference by chlorinated biphenyls, J. Assoc. Offic. Anal. Chem., SO: 1069 (1967). 4 Pcakall, D.B., and J.C. Lincer: Polychlorinated biphenyls. Another long-life widespread chemical in the environment, Bioscience, 20: 958-964 (1970). ! Pichirallo, J.: PCBs: Leaks of toxic substance raises issues of effects, regulation. Science, 173: 899-902 (1971). * PCB Conference, National Swedish Environment Pro- the sessions of this conference higltlightcd the "en vironmental problem". This conference, perhaps for the first time, 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.6 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 accidental spills and by the widespread finding of trace quanti ties of PCBs in the environment, there emerged in the lay press a series of stories and articles dealing with PCB contamination. Most of them occurred in late 1971 and reflected especially the contamination of foodstuffs.8^4 The FDA, aware that PCBs were 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 1970, "Action Levels" for PCBs in milk, poultry and fish. Action levels are temporary ^thresholds for regulatory decision pending the establishment of a more per manent regulatory policy and procedure. In August 1970, the FDA 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 PCBs. 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 series of inquiries from Congressmen and other elected officials over PCB contamination of food and the environment. On lection Board, Research Secretariat, Wenner-Gren Center, Stockholm, Sweden, 29 September 1970. I Marine environmental quality, A special study held under the auspices of the National Scientific Committee on Oceano graphy of the National Academy of Sciences Ocean Affairs Board, Durham, New Hampshire, 9-13 August 1971. Monsanto limits food plants' use of chemical PCB, The Washington Post, 30 September 1971. * Some dried foods found tainted by perilous chemical. The Washington Post, 28 September 1971. Tainted turkeys. The Washington Post, 24 September 1971. II Turkeys, salmon tainted by PCBs, The Evening Star, 23 September 1971. 11 A contaminant is found in cardboard. The New York Times, 28 September 1971, 15 If you think DDT's a problem, meet PCB, The New York Times, 30 September 1971. 14 FDA studying chance of contamination in containers for food. The Wall Street Journal, 28 September 1971. 30 Journal ofthe International Society for Technology Assessment, Spring 1976 .. ,tsi2S HARTOLDMON0030162 16 August 1971, Senator McGovern addressed a let ter to the Commissioner of the FDA, reflecting this 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 fishing 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 still not clear and there were glaring gaps in information. What really were the 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 for the meeting was the reported series of accidental spills and leakages.15 Shortly fol lowing that meeting, the 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: (1) the 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 polyclilorinated 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 11 Transcript of proceedings of the interagency meeting on polychlorinated biphenyls (PCBs), Food and Drug Adminis tration, Department of Health, Education, and Welfare, Washington, D.C., S August 1971. be able to provide the data on a confidential, non public, basis to the Government. In October 1970, a review was begun, in the 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 occupational medicine and geology. Three case studies were begun from which it was hoped to draw generalizable ex perience. The particular subjects for the case studies were chosen because they were thought to be of im portance, because regulatory or other governmental action had not yet been taken but could be expected at some time in the reasonably near future, and be cause it was thought that there existed sufficient information from which to draw conclusions. The choices were cadmium, arsenic and PCBs. Thus, as the Government began to develop its own position on PCBs in 1971, the OST-initiated study was already under way. What followed, in part, was for the Government to borrow the experience devel oped by the OST Panel and even for the two exercises to be joined to some extent. Notwithstanding, a separate and identifiable PCB report was published by the members of the Panel on Hazardous Trace Sub stances.16 On 1 September 1971, the FDA held a meeting with the USDA, the EPA, the Council on En vironmental Quality, and the Office of Science and Technology, to explore options for 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 acceeded to this req uest and agreed to collaborate with the CEQ 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.11 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 distribution and usage, and estimates of losses into the environ ment.18 Again, the manufacturers expressed their u Polychlorinated biphenyls -- environmental impact, A review by the panel on hazardous trace substances, March 1972. Environmental Research, S: 249--362 (1972). n Press release on interdepartmental PCB task force. Food and Drug Administration, Department of Health, Education, Sl Welfare, 5 September 1971. ** Letter from Edward J. Burger, Jr., M.D. of the OST to Mr. John Mason, The Monsanto Company, 15 October, 1971. Journal of the International Society for Technology Assessment, Spring 19 76 31 ncuu 4 aan-17 HARTOLDMON0030163 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 up to that time and the difficulties involved in finding responsible spokesmen for each of the agencies in volved. 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 the Counsellor to the President, did reach agreement with Monsanto on the terms of receiving the information.19 These were shortly rendered moot by a request from the Environmental 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 develop 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 PCBs. 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 totally 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. 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 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. Thus, as well as serving as a review of the scientific-aspects of PCBs, the Task Force explicitly reviewed a number 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 ** Memorandum from John Dean, Counsellor to the Presi dent, to Edward J. Burger, Office of Science and Technology, concerning the Freedom of Information Act, 4 October 1971. and commercial dependencies built up over the years. This explicit review of the benefits of PCBs, which is often not done for regulatory decisions, was of vital 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 "essentiality" 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 for 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 other uses.20 The Government Task Force report included a sys tematic summary of monitoring experience for PCBs in food. It had been this matter.of PCBs in food as much as any other which had brought PCBs to public notice. Hence, it was thought highly 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 laws for their appli cability to PCBs. Tills 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 regulatory 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".20 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 the 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 this reason, the Commissioner of the FDA felt compelled to held a press conference to "... try to help establish a perspective on PCBs .. roughly a month after the Task Force had begun its work.21 This was an appropriately reasoned state ment which attempted to allay fears and discourage demands for a sudden, outright ban on PCBs (even if 2 Polychlorinated biphenyls and the environment. Interde partmental task force on PCBs, Washington, D.C., May 1972. National Technical Information Service, U.S. Department of Commerce, Springfield, Virginia, No. COM-72-10419. si Statement by Charles C. Edwards, M.D., PCB press brief ing, Food and Drug Administration, 29 September 1971. 32 Journal ofthe International Society for Technology Assessment, Spring 1976 HARTOLDMON0030164 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 third 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 of "scientific" reviews of materials which were of impending regulatory concern and for which no systematic accounting of scientific informa tion had been done. The philosophy 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 of ihe available scien tific understanding. At the same time, members of the 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 PCBs.22(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 presentations 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 ex ercise 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. More important, relatively little more was reported on PCBs in any form in the lay 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 had 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.2J In addition, the Monsanto Company quietly assumed for itself the role of distributor as well as manufacturer in 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 of PCBs to installations in which 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 transformers. These latter were judged to be essential uses and represented "closed systems".24 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 report, 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 had 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 32 National Institute of Environmental Health Sciences meet ing on polychlorinated biphenyls (PCBs), Rougemount, North Carolina. 20-2 1 December 1971. Proceedings pub lished in Environmental Health Perspectives, Experimental Issue No. I, April 1972, National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina. is Monsanto Industrial Chemicals Company, press release: Monsanto releases PCB production figures to Department of Commerce. 30 November 197 1. m Press release accompanying the release of the PCB interde partmental task force report on PCBs, Washington, D.C., 12 May 1972. Journal ofthe International Society for Technology Assessment, Spring 1976 33 HARTOLDMON0030165 essentially ait other uses -- heat 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 Monsanto 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 plea for passage of a then-pending bill in Con gress to close this 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. 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. Here, the FDA and the USDA 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 PCBs and the Justice Department was close behind with enforcement teeth. The processes of review in 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 PCBs and of the costs that could be expected if their uses were 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 which proved to be important was the analysis of environmental distri bution and dispersal. The analysis itself was some thing of an experiment. It was reasoned early on by the participants in the 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. This, 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 which had been reported in the literature. This exercise and the information from it became the basis, for example, of the judgment that PCBs used in electrical capaciiors disposed of in the earth by burying in landfills would not be expected to migrate very far through 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, 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 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 1970.4 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 September 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 peers - while characteristic of the traditional scienti fic process but unusual in regulatory decision-making -- was played out in this case. IMPLEMENTATION The principal "decisions" deriving from this exercise were to restrict PCBs to "closed-system" electrical uses. There soon emerged a few additional issues which reflected either loose ends or areas which de 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 were 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 charac teristics 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 PCBs. Denial of the use of PCBs in this case raised the spectre of an increase in the number of fires in 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 matter of immediate concern. There was an early visit of a spokesman from the Swedish Government to the Office of Science and Tecluiology. The Tariff Com 34 Journal ofthe International Society for Technology Assessment, Spring 1976 HARTOLDMON0030166 mission and the Customs Bureau were pressed to search for signs of imported PCBs.25 Perhaps most useful was the fact that the OECD was persuaded to take up the question of the industrial production and commercial use of PCBs in the industrialized parts of the world. PCBs, in fact, became the major example of intergovernmental "consultation" in a mechanism which the OECD had established for this purpose. The U.S. position and the information behind it be came major elements in the OECD position paper26 and in the deliberations at the OECD in November 1972. Trace amounts of PCBs in packaging materials be came a matter of particular concern, fn part, this was due to uncertainty over 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 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-containing paper. 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 the only one of its kind from that agency) on its proposed rule-making for PCBs.27 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 the fact that time was taken for deliberate study and deliberate action, even in the face of public outcries for immediate action. Thirdly, the "decisions" were taken without much tangible legal authority for governmental control. * Letter from Alvin Aim. Council on Environmental Quali ty, to Mr. Vernon Acree, Commissioner, Bureau of Customs, 22 June 1972, u Organization for Economic Cooperation and Develop ment, Environmental Directorate, Sector Group on Unintended Occurrence of Chemicals in the Environment, Polychlorinated biphenyls - proposals for concerted action, 13 October 1972. 11 Food and Drug Administration. Final environmental impact statement. Rule making on polychlorinated biphe nyls, Department of Health, Education, and Welfare, IB 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, perhaps, a some what more manageable challenge than many. Only a single U.S. manufacturer was involved. Further, the majority of commercial and indus trial uses and the major users were known. 2 There was some information which proved useful in decision-making. Quantitative figures showing production were provided - albeit only after a delay - which were essential in determining the scale of the problem and its change with time. Similarly, the corresponding figures for 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 measurement and monitoring of PCBs in the environment or indices of dis persal. In terms of hazards, there was a legacy of at least some documentation of previous 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 this information. Fur ther, these reviews engaged some very good scien tific talent -- both inside and outside the Government and 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 PCBs. (It is interesting to note that while this was done well, the National Bureau of Standards en tered 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 pat terns of rates and routes of distribution of PCBs in the environment. This was done for the most part as an experiment to determine whether such an exercise could be performed. It did, in fact, 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 several 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 PCB question arose also from a desire on their part to push on to someone else a tough or "hot" de cision. It should be noted, also.that the OST had already begun a review of PCBs. The fact that there was a single spokesman Journal ofthe International Society for Technology Assessment. Spring 19 76 3 5 HARTOLDMON0030167 proved important in arriving at an orderly 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 there was a single spokesman also undoubtedly made it easier to amass and analyze in an orderly fasltion 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 legai 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. This 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 appear 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 for 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 Interdepartmental Task Force was public knowledge from the out set. The Task Force published its full report. Similarly, the reports of the OST Panel on Haz ardous Trace Substances and the report of the NIH meeting on PCBs were published. Further, science writers and other members of the press were specifically invited to participate in the NIH meeting. (Note that the question of freedom of information was a matter of some concern during the deliberations of the Interagency Task Force in the 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 he specifically an nounced that he would not proceed with an out right ban on PCBs and deferred to the study process that was then underway.34 This, of course, contradicts the classical argument which insists that Governments must make regulatory decisions immediately without the luxury of time for good decisions. DSW 184842 36 Journal ofthe International Society for Technology Assessment, Spring 1976 HARTOLDMON0030168