Document da8OrNvGy0XDjMYmzbGn8VOnB

A CASE STUDY* POLY CHLORINATED BIPHENYLS by Edvard J. Burger, Jr. Office of Che President's Science Adviser Science and Technology Policy Office Washington, D.C. December 1974 `Written for the study on Decision Making for Regulating Chenicsls In the Environment, Environmental Studies Board, National Research Council, National Academy of Sclencea,undertaken at the request of the U.5. Environmental Protection Agency, Contract No. 68-01-2262. HONS 207339 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. Hence, the "decisions" leaned heavily upon persuasion and on para-regulatory moves. Nevertheless, the Government's decisions m this care 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 tne Government (and by parts of the private sector) were taken del j ucj-ntL 1 y and on the basis of unusually good analysis and mfonneti.cn. The PCH decisions, in brief, were unusually v;ell informed decisions when comjaicd to others of this type and the analyses used to arrive at the 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 P^-Ti question contributed to the deliberations and to the analyses. At the sate t: c, an outride group of scientific experts was engaged by tne Office of Science ar.c Technology to consider PG3's from a broad perspective ns a ease study of a hazardous substance existing in tne environment in trace quantities. The Government*s major deliberative body for its decisions was an interagency, PCB Task Force--run jointly by OST and the CF.Q. The case study of the outside advisers to OST was timely and useful to the Government's own analyses. MOBS 207340 z The term, polychlorinated biphenyls, rule.,: to a family of chlorinated oignnic compounds which were developed for commercial use in the* late 19?0's. Vhfli. uscmhies!! was attributed especially to their high decree of physical and chemical stabillfy--even at high temperatures--and because of sone unusual electrical properties (high degree of dielectric capacity), (interestingly, it was tnis high thermal stability which made PCB's so useful technologically which also presented an environmental nazard). Hence, PCI1's found particular utility as heat transfer fluids (because they did not break down or burn), hydraulic fluids, insulating materials ju t) am.101 tners and capacitors, and in a miscellaneous category of "plar.tici/,cr" uses (paints, plasticizers, carbon-less caabon paper). There was only one manufacturer in the United States, the Monsanto Company, viiich produced the basic material for all of the users. Produc tion roughly doubled between 19G0 and 1970 and the U.S. production was estimated to be roughly one-half the total world production. The demonstrated usefulness of PCB's, especially in its electucal 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 PCB's specifically. This was par ticularly true for certain heat exchangers arid for enclosed, power transformers. Beginn'nparticularly around 19GG, public and professional anxieties began to be raised over possible environmental and health hazards associ ated :th PCd's. These generally were of two sorts: 1 , 'Mr- (I i rove y of fat-r.olnbl e , organic compounds mrludinr chin t 1 nn 11 1 liydrofarhcins and bOT m trace quantities in a widely distributed natterr in HONS 2073*1 d llm cnv i i immriil -- oil,on distant from n mivnl com (,('. . PCIFs were among the materials found but were often run maud j it -in analytic sense With other substances, PCD" s were first distinguished from the "unknown interfering compounds" found in nature in 1966 by Jcnsciii/ ami the next year by Widmarki/. On the basis of this latter report, the lood and lirug Administration was moved to develop analytic methods to distinguish between PCD1a and chlorinated organic pesticides encountered in monitoring for regulation. In February I9u9, hr. Robert Hisebrougfu gathered attention by warning, m an articlr in the Han Francisco Chronicle ol dangers of PCU1 c m tire eco-cyptcin. Over the next 6-7 months, the KDA increased its surveillance of foodstuffs for" evidence of I'd' residues. Notable positive findings were m fish. Monitoring of foodstuffs, raw agricultural products, Ji'.h, and feeds for PCB'c was augmented throughout 1970. PCB` s kirr found in fish and marine animals in high concentrations close to plant s which manufactured tire chemical. 2. Accidental spills or leaknr.c.: of large Quantities ol` polyc-hlon nat.ed biphenyl', with consequent contamination of foodstntfs and animat feeds. In 19GB, PCIi's, used as a heat-cxchangc fluid m a pasteuriser, leaked into rice oil being manufactured for home coohiriG use m a plant m Japan. Moie than 1000 persons were affected by the contaminated iice oil, many of whom exhibited persistent skin lesions as well as systemic disease (Yusiro disease). In July 19/1, leakage of heat exchange fluid caused contamina tion of pdsk('uri..cd l j rJi meal which was used as a feed ration for chjriens and catfish. MOWS 20?42 4 In addition to these two major afeiis of consent, TCI)'s began to be reported with increasing frequency m poultry nd ^ggs, and in j,a aging material for food. PCB' o appeared with increasing frequency in 19/0 and 1971 in the professional scientific literature dealing with wildlife and the . y> i/ ,, environment. In September 1970, the National Swedish Environment Protection Board held a conference on PCB's."^ One of the sessions of tins conference highlighted the "environmental problem." This conference, perhaps lor the 1irat time, brought together the extent of understanding of the manufacture, use, extent of environmental contamination, analytic f,/ methods, and biological effects lor PcB' c In August 197.1, an Environmental Quality Workshop was convened in Durham, New Hampshire'* by the National Academy of Sciences to consider Marine Environmental Quality and Ocean Pollutants.^ PCB contamination was highlighted. In addition, provoked by both the accidental spills and by the widespread finding of trace quantities of PCB's in the environment, there emerged in the lay press a series of stones and articles dealing with PCB contamination. Most of them occurred in late 19/1 and reflected 7-] especially the contamination of foodstuffs. ------^ The FJW, aware that PCB*s were to be lound ns a contaminant :n 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 m cooperation with the Department of Agriculture. As a recult of the finding', of ]C'B's specifically in fish mui milk, the PiVt established, between December 19G9 and February 19/0, "Action Levels" for HONS 207343 PCB's jm milk, poultry and fish. Action levels are temporary trirenhulds for regulatory decision pending the establishment of a more permanent regulatory policy and procedure. In August 1970, the >'IV\ established a similar action level for eggs. During 1970 and 1971, the FDA used these guideline values m various seizures of foods found contaminated vutli PCB's . The number of reported contaminations of foods, recreational fish packaging materials and animal feeds increased toward the latter half of 19/1, Accompanying the announcements in the public press (unci, undoubtedly reflective of them), there also occurred toward the end of 19/1 a scries of inquiries from Congressmen and other elected officials over PCli cont.unmation of food and the environment. On August 16, 19/1, Senator McGovern addressed a fetter to the Commissioner of the PDA reflecting this concern. In .September, Governor Milikcn of Michigan sent a telegram to ElliutL Rienardson, Gcc-rctary of HEW, in which he announced a restriction of commercial salmon fishing because of the finding of KfB's in fish. By August 19/1, the FDA (and to some extent, USI1A) found itself rapidly propelled into a position where it would be "required" 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 gap:, m information. What really were the biological effects of the complex known as 1'Cll's? How did the various PCB's vary m 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 HONS 207344 6 their manufacture? lluw widespread was Hie 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 pCfi's and the selective, higher level contamina tion of foods and feed had to be joined at some point m 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 t)>e state of scientific understanding of Foil's. The text for the meeting was the reported scries of accidental spills and \/\f , leakages.-- Shortly following that meeting, the Department of Agricultuic and the Commissioner of the FDA asked the Office of the President's Science Adviser to pi ovule assistance and act as a focus for the Government's actions and decisions concerning PCH's, This request was inode because: (l) the issue cut acioss 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 1970, spokesmen for the Monsanto Company agreed to meet with the staff of the President's Science Adviser in OST to discuss a nmr.bci of issues concerning IL'D's including a series of animal toxicology studies which Monsanto had undertaken. During this meeting, Monsanto was asked for information concerning the amounts of PCD it manufactured and dis tributee. The company, being the sole producer m the U.Cwas 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 207345 7 In October l`J/0, a review was begun in the Office of Science 'd"n7T~TecTTnology of the general subject of hazardous substances existing in the en vironment, in trace quantities. This review, known ultimately as the Panel on Hazaidous Trace Substances, had as its major goal the identification of the needs for information by the Government m making judgments about trace ha^ardou., substances. The Panel was composed principally of non-GovcrnmcnL experts in the fields of ecology, chemistry, biology, environmental and occupuljanal medicine and geology. Three case studies were bct,un 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 IT'd's. Thus, as the Government began to develop its own position on PC1P s in 1911, the OGT-iniLiatcd study was already under way. What Jo]lowed, m 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 ha.-.nrdous Trace Substances. 15/ On September 1, 19 Jl, the FM held a meeting with UGW\, MPA, the Council on Environnental Quality and the Office of Science and Technology to cxploie options for further action concerning PCfs's. The FDA and the U3DA requested that the Office of Science arid Technology take a lead role in handling this matter. OGT uceeucU'd to this i eqaest and agreed to collaboiate with the CL't;. in v! HOWS 207346 a task. This became known as the Interdepartmental Task Force w PCU'-a^ The Task Force was announced on September 5 in a joint FM-ll ;:i\ press conference .I--hJ On September 15, 19V1, the OST Panel on Hazardous Trace Substances and the Governmental Tank 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 HCB's produced, patterns of distribution and usage, and estimates of losses into the environment^ Again, the manuiactu)er 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 iuJ] and detailed fashion. In addition, the Monsanto Company expressed some concern over the seemingly disconnected character ol the Government's activities up to that time and the difficulties involved m finding responsible spokesmen for each of the agencies involved. Monsanto made a strong plea (in t.he 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 Counselloi to the President, did reach agreement with Monsanto on the terms of re- iu/ ceiving the information. These were shortly rendered moot by a request by the Environmental Defense Fund for the same information. This informa tion ultimately served as important background for the Government's decisions and wa:; leaned on heavily by both the OCT Panel and the Task Force. The 037 Panel combined the production figures and Dio data on distribu tion and use with knowledge of the physical properties of FCD's to develop a com]>osito picture of the rates and routes of environmental transport and dispur, itiosi. Tho clai a were reflected in a scries of coefficients foi a model MOMS 207347 9 of transport of PCB's. While this was necessarily s crude descrie^.ienlt served as a very useful instrument for placinc PCD's in perspective. It replaced what otherwise would have been a totally qualitative--eveu 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 jt 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 m its report. It explored additional territory as well--ieflective 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 PCB'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-mailing for PCB's. The National Bureau of Standards engaged in a icvicw and analysis of the beneiits and even the "essentiality" of each of the several HONS 2073*8 11' uses of PCB's. In this, the NBS received advice from Ithc tfatjorral Udiigtfhi Pollution Control'Counci 1 especially for electrical use; of rcB' o . jri e icu of the cases examined, the question of a possible and satisfactory 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 JiV 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 as much as any other which had raised PCB's to public notice. Hence, 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 PCB'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 cupublc 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." 12/ 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--especially on man, i MOWS 207349 11 During the time the Government rdview of rCB* s was being pursued" unj - height of public concern over these chemicals ''''nt-'r'ued 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.--1'0 / This was an appropriately reasoned statement which attempted to allay fears and dis courage demands for a sudden, outright ban on PCD'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 senes of "scientific" reviews of materials which were of impending regulatory concern and for which no systematic accounting of scientific information had been done. The philosophy in this case was to bring together in a conference spokesmen for the principal research projects--published 01 under way--in order to take the measure of the available scientific understanding. At the same time, members of the press--espccially scientific vritcrs--were invited to attend these sessions in order to enjoy the products of this review process. Thus, the aims were to educate both scientists and the public about the science and its interpretation. HONS 207350 12 In December 1971, the National Institute of EuvjJrdjMftMVtkJffra^l, Sciences held the fir-t of thii series of confuicncoc in i.c*itn Carolina-- ?aJ* tins one on PC'13'c. Many of the same spokesmen who were enlaced in the other reviews made presentations at the "open" conference. One of the major accompl irdiments of this meetine was to impart an understand me to the press and science writers as to what the character of the scientific evidence vias and what was the scientists' own interpretation of experi mental findings . The net (and immediate) efiect of that exercise was to take the rewswortlupss out of the iCll issue and to remove it from the catc^oiy of the sensational. Very little was actualiy reported in the press of that meeting- More important,, relatively little more was reported on PC))'a in any form in the lay press. The principal "control" actions for PcB*s were the result of per suasion by the Federal r.ovcrnmcnt rather than by direct regulatory exercise. The C.ovciament possessed no real ret;ulutai y authority to control the munuiiictin c, distribution or use of PCU'g. however, the persuasive influence ol the several Government inquiries -- especially the 1-CD Interdepartmental Task Force--was undoubted. Thus, the major action was taken "voluntarily" by the Mansanto Company, the sole U.S. manufacturer. *5incc then, Nlll has held similar reviews on lead, automotive emissions, and other substances of current public and Governmental concern. HONS 207351 IS Beginning in 1970, the Monsanto Company had begun to reduce the sales of PCD's -- especially for non-electrical uses. Ponte otic salc3 for PCH's for non-electrical uses had risen from ]2 thousand tons in I960 to 16 thousand tons in 19/0. By 1971, this figure was reduced to approximately 1 thousand tonsIn addition, the Monsanto Company quietly assumed for itself the role of distributor as well as manufacturer in ordei to exercise some control over end-use of PCB' c. In this way, the manufacturer was able to "discontinue sales of PCD'0 for use in paints, plasticizers, sealants, adhesives and other `open-system* uses.1' Thus, during 19/1 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 Porce was the discontinu ance of all uses of ]'CD's except in electrical capacitors and transformers. These latter wore 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 cnd-usc through its control of manufacture and sale of FCB's. HONS 207352 Ob i c c1 ivr~ 14 The lntcrdepai tmental Tj-w. force report on Pt*13' s was inauni pub- lically in May 19Vf and was accompanied by a statement of Governmental "thinknif:" and Governmental "action," Perhaps the major conclusion reached in the report which became an objective in Government decisions was that of 1 urn ted restriction of PCD's. PcB's 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 of ICB's, This uas a direct reflection of the analysis performed by the National Bureau of Standards of the utility andi essentiality of PCB's which pointed to the possibility of an increase in fires and explosions from encased or enclosed transformers if ICB's could no longer be used--representinc 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 ICb1 s winch had been lost from human use. Electrical applica tions were seen as "closed" applications and were not thought to be contributory to environmental distribution. Other uses of pCjj1 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 oilier uscs--heat exchange fluids, hydraulic fluids, and the miscellnncou 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 ICB's--in fact, the principal Governmental action. MOMS 207353 15 Highlighting of the fact that true! regulatory control t>.y*"Vh'6 S6fr6fin.Wr was limited became 1 he l,e\L for a plea for pas*"'gc of o then-pending bill m Congiess to close this gap. A second objective, then, became the enact ment of the Toxic Substances Control Act which would permit the Government to cxcicise useful control of industrial chemicals at their source. The regulatory tools which the Government did possess in this case permitted enforcement action after l'CB*s were found in foods for human consumption and in animal feeds. Here, the FEA and the UGIA re-statcd their thresholds for action (which had been.evolving over the previous lour 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 watcis downstream from plants manufacturing PCB's and the Just.icc Department was close behind with enforcement teeth, Infornnt ion The PCD "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 documeniation of past experience. In addition, this information was better assembled and analysed than was usually the case, rerlnps Lime was . n impojtant 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 MQNS 207354 16 meeting on PCli's had been held in lgvo .i-/ The Office of Oci tree and Tech nology had begun its review and analysis of rCll's by December V.l/O ur.d the results of its analysis were made available as they emeirocl. The Government's oi n seT.cntir.Ls reviewed and interpreted the base of technic.il knowledge ovei lougbly six months beginning in September 10/1. In December 197], a third forum of scientists were brought together by NIil to levicw much of the same material. Thus, this process of interpretation and maturation of data by scientific peers--uhile character!stic of the tra ditional scientific process but unusual in regulatory dccibioii-making-- was played ovit m tins case, 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 PCD's and of the costs that could be expected if their uses were restricted or denied, 'ihis information was Inter found to have been highly influential and important in formulating the Government's position. One othci element of information which proved to be important was the analysis of environmental distribution and dispersal. This analysis, itself, was something of an experiment. It v;as reasoned early on by the participants in the (YT review that it should be possible, starting with some elementary information on total amounts of PCB's produced and patterns of distribution in commerce and disposal, and armed with certain elementaly understanding of physical and chemical properties, to build a model predictive of 1CIJ distribution in the environment. Thin, m fact, was done and the coefficients used in the model were partially tested oi "validated" against the physical measurements of PCB1s in the environment HONS 207355 17 which had been reported m the literatuie. This exercise and the infor mation from it became the basis, for example, cr the judgment tnat PCB's used in electrical capacitors disposed ol in tne earth by burying in landfills would not be expected to migrate very far thiough the soil and would not represent a significant source of environmental pollution. Imn]cim-nla l ion 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 mason for denying the use of PCB's as 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 PCR heat exchanger applications, One of these, for ex ample, involved the use ol' heat on off-shore oil rigs to maintain a low viscosity of the oil. PCB's had been chosen here because of tin* charactci istics of high thermal stability and low probability of fire and explosion and many of the hent exchange devices had been designed specifically around the use of ICU's. Penial of the use of PCB's in this case raised the spectre of an increase in the number of fires in off-shore oil ngc or the continued use of PCD's from imported source'-.. Tins general question of worldwide (as opposed to U.o.) pi eduction and use of FCB's became a matter of immediate concern, 'i'luue was an early visit of a spokesman from the Swedish Government to the Office ol1 Science and Technology The Tariff Commission and the Customs Bureau wiu MQNS 2G73S6 i 10 pressed to scare)) Ioj signs of imported 1/ Pci haps, mo it useful wa= the fact that the OECD was persuaded to take up the question of indus trial production am) commerclal use of PCB*s in the industrialized parts of the world. PCjrs, jn fact, became tlie major example for intergovern mental "consultation in a mechanism which the OECD had established for this purpose. The U 0. position and the information behind it became major elements in the OECD position paper^o and in the deliberations at the OECD in Novembci l'J/C, Trace amounts oj l'C'li'a in packaging materials became a mat Lei ol paiticular concern. Jn part, this was due to uncertainty over their origin. There was some evidence that trace quantities of POP 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 l'or exploring this par ticular issue, apart from the economics of paper and cardboard pieduction, was the contamination of food wrapped with PCB-containing paper. There lolfowcd, therefore, a scries of investigations by the Pood and Drug Administration into the process and rate of migration of PC131 s from pack aging materials into foodstuffs which the packages contained. In December Id/P, the F!lA provided in the form of an Environmental Import Statement (perhaps J. he only one of its kind from that agency) oil jtc bp/ proposed rule-making id PCD- s Among other things, this document summarized the FDA investigations and positions jegardmg PCB1 s and packaging, HONS 207357 19 Cone Ins iorir., Obscr/'i t.1 mi" t and IVcommcnd it unr The Govcj wnl. decisions" on TCD'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 was generally well prepared. Related to that was the fact that time was taken for deliberate study and deliberate action, even m the face of i-ublic outcries for immediate action Timely, the "dcci: ions' were taken without much tangible legal authority for Governmental control. They represented rather persuasion and voluntary action. It a .worthwhile, perhaps, to examine some ol the factors which contributed to any successes that can be claimed. 1. The PCfi 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 ma.ior users weic known. ?. There was some, information which proved useful in decision-making. Quantitative figures allowing production were provided--albcit only aftei a delny--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 Jesuits of physical measurement ami monitoring of PCD* 3 in the cnvii oilmenl oi indices of dispersal. In terms of hn/.arus, there was a legacy of at least Swne documentation of previous human exposure and some laboratory data. However, many ifae.ition icmainccl. Perhaps, most important, was the luxuiy of critical review (m MOMS 207356 ;:o fact, several critical reviews) or tins jiifuniiatioii, Further, these reviews engaged some very good scientific talent--both inside and out side the Government nm! in a way which pcrmitt'''* the decision-makers to be very well infoimcd of tlieir advice. In terms of benefits, a specific analysis wan commissioned of tlic utility and essentiality of PCD1s. (it is interesting to note that while tins was done well, the National Bureau of Standards entered into tins exercise very rcluctanLly--seeing in it the perils of the battery additive episode of some ycais before), * Finally, there was performed the unusual but highly useful attcn.pt at modeling the patterns of rates and routes of distribution of PCD's m the environment. This won done for the most part ar> an experiment--to determine' whether such ari exercise could be performed. It did, in fnct, provide some useful and immediate1 insight. . There was a single spokesman for the Government. 'J'lie* agencies in volved curly determined that the PCD question cut ucross several depart ments. This, by itself, was probably not persuasive and the joint request from FM and the UGDA to 03T to "take on" the PCJ3 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 PCB`s, The fact that lhere was a single spokesman proved important id arriving at an orderly decision. The Monsanto Company insisted on dealing only with a single s]'OhoM.ian after months of unconnected and frustrating interchange s wj.th a vaiiety of Government agents, The fa<_t that there was a single spokesman also undoubtedly made it easier to amass anJ anal} in an order! v fashion the variety of information from several sources , `I be HONS 207359 fact, that it was un Executive Office spokesman was probably important in soliciting cci'taj.ii otnci studies in parallel (such ns the fhiLional bureau of Standards' study of benefits) and the review of the govcinment-widc legal 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 mtcr- pictation by peers and it developed a constituency among scienLists for the decisions ultimately tahen. . b. The decisions were deliberately broadly-based. While this may appear elementaly, this facet is generally not characteristic of regu latory decisions concerned with human health. Doth benefits and hazards were explicitly explored. Economic consequences were considered. Each of several avenues ol possible action was examined in turn. Again, a f.iugje spokesman foi the Government and one placed above Die operating agencies was probably a necessary feature in this broad examination. Cl. 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 OST panel on ilnrardous Trace Substances and the report of the Nil! meeting on Inch's weie publisned. Further, science writers and other members of the press were specifically invited to participate in the NIK meeting.* *Mote that the question of freedom of information was n matter of some concern during the deliberot ions of the Interagency Task Force in the Office of Science and Technology.Hi/ HONS 207360 22 7. Time was pcimittcd for deliberate decision-making. At one point, in fact, the Commissioner of the Food and Drug Administration held a press conference m which lie specifically announced that he would not pioceed with an outright ban on FCB's and deferred to the study process that was then underway. ZJ This, of course, contradicts the classical argument which insists that Governments must make retaliatory decisions immediately without the lu/iury of time for good decisions. HOMS 207361 Reference 1. Jensen, S., A rr-w chemical hazard, New Scientist, 32: G12, 19GG. 2. Widtnnrk, G., Possible interference by chlorinated biphenyls, J. Assoc. Offic. Anal. Chem., 50: 1060, 1967. 3. Peakall, D,B., and Lincer, J.C,, Polychlorinated biphenyls. Another long-l-il'e widespread chemical in the environment, Uioccicncc, !'0: 950-964, 10/0. 4. Pichiratio, J., PCB's: Leaks of toxic substance raiscc issuer, of effects, regulation. Science, 175: 099-902, 1971. 5. PCB Conference, National Swedish Environment Protection board, Research Secret nr Wpmor-flron rvnt<r^ Stockholm, Sweden, September 29, 19/0. 6. Marine Lnv ivonn cntal Ouality, A Special^Study held under the aurpiccr of the National Scientific Committee on Oceanographv of the Motional Academy of Sciences Ocean Affairs Board, Durham, New Hampshire, August 9-11, 19/1. 7. "Monsanto ]imits lood plants' use of chemical PCB," The Washington Post, September 50, 1971. B. "Come dried foods found tainted by perilous chemical," The Washington Post, September 26, 1971. 9. "Tainted TurkeysThe Washington Poet, September 24, 1971, 10. "Turkeys, salmon tainted by PCB's," The Evening Star, September 23, 1971. 11. "A contaminant is found in cardboard," The New York Times, September 20, 1971. 12. "If you think DDT's a problem, meet PCB," The New York Times, September 30, 1971. 13. "FIYl studying chance of contamination in containers for food," Thu ' Wall Street Journal, September 28, 1971. 14. Transcript of Proceedings of the Interagency Meeting on Polychlorinated Biphenyls {FCR*s). Food and Drug Administration, I'upiu Linent of Health, Education, and Welfare, Washington, D.C., August 5, 1971, 15. Polychlorinated Tliphenyls--Environmental Impact, A Review by the Panel on i In ..aide, is Trace Substances, March 1972. Environmental Research; 5: 249-.>62, 1972. TIONS 207362 2 JG. Press release on Interdepartmental PCB Task Force, Food and Drug Administration; Department of Health, Ed"i'at<ou, h Welfare, September 15, 19/J, 17, Letter from Eil.ard J. Buffer, Jr., M.D. cf OST to Mr, John Mason, The Monsanto Comjiany, October 15, 1971, 10. Memorandum from John Dean, Counsellor to the President, to Edward J. Burner, Office of Science and Technology, concerning the Freedom of Information Act, October 4, 1971. 19. Polychlorinated Diphenyls and the Environment. Interdepartmental Task Force on PCH'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 Envirotuncntal Health Sciences Meeting ort Polychlorinated Biphenyls (PCB's), Rongemount, North Carolina, December 20-21, 19/1. Proceedings published in Environmental Health Perspectives, Experimental Issue Wo. 1, April 1972, National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina. 22. Monsanto Industrial Chemicals Company, Press Hele.'inc. "Monsanto Releases rc]3 Production Figures to Department of Commerce ", November 90, 1971. 2J. Press Release accompanying the release of the PCB Interdepartmental Task Force Report on I'CB's, Washington, D.C., May 12, 197?,, 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, Sector llroun on Unintended Occurrence of Chemicals in the Environment, Polychlorinated Biphenyls--Propocals for Concerted Action, October 1.4, 3972. 26. Food and Drug Administration, Final Environmental Impact Statement. Rule Making on rolychlor.inated Biphenyls, Department of Health, Education, and Welfare, December 15, 1972. MQNS 207363