Document em1KMVYxDqG2gGG39kRXM0vOe

fD G E N E R A L ^ ELECTRIC CORPORATE RESEARCH ANO DEVELOPMENT dfrt a R/r ? ,, f 2. S' SCHENECTADY. N Y. 1 D I A L C O M M 8* 2Ii:* Building K-l, Room 3B35 January 24,- 19 79 Ccr\ Ta Ti JT Coe JS Nelson FAIRFIELD Subject: Proposed Research on the Differentiation of Toxic from Non-Toxic Forms of PCB Dear Jerry and Jim, Last weeX you suggested that I amplify upon the proposed PCB/-CD: research program outlined in my letter to Dr. Casey of January 16. Accordingly, I should like to indicate, first, what I think could e accomplished by having such a program; second, what its technical con tent might consist of; and third, what it might cost to do the job right. I. Program Objectives A. The primary objective of this program would be to generate information needed to present OSHA with a non-controversial and face- saving alternative to NIOSH's proposed 1 yg/m3 p c b standard, and thus to avoid an expensive, highly publicized, and possibly unsuccessful legal battle to keep our plants open. ' --? B. Secondary objectives would be to defuse the chronic threats of PCB-related lawsuits resulting from old deposits in dumps or river bottoms, or past exposures to employees, customers, or the general public; and to reduce our public image as a major contributor of tcxi material to the environment. II. Assumed Situation at OSHA My proposed strategy for achieving th'e primary program objective assumes that somewhere in OSHA there exists a decision-making indi vidual who is confronting this set of facts: A. NIOSH has selected from the scientific literature a large number of alarming statements related to the bioeffects of PCBcontaining mixtures, written a 224-page criteria document that re sembles a political manifesto and a legal brief as much as it does a scientific treatise, and called for a thousana-fold reduction in the permissible exposure level, i.e., down to 1 yg/m^ (about 1 ppb) t This document has been sitting in his office, and in those of the lab and environmental activists, since September, 1977. 783204 V- Proposed Research on PCB -- 2- B. These activists are known to regard the p r o m u l g a t i o n of ultra-stringent standards as the primary test of Agency'com m i t t m e n t , efficacy and machismo- In the case of the ambient w a t e r quality standard, EPA fought* for six years to get the 1 p a r t p e r trill i o n P Cl standard in place, and finally made it. Sooner or later, p r e s s u r e or OSHA to implement the NIOSH 1 yg/m^ proposal will be inevitable. C. Recent experience w i t h acrylonitrile and b e n z e n e has shown, however, that ultra-stringent standards that go beyond the bounds of any conceivable economic justifiability may not stand up legally. D. OSHA does not relish big legal fights, nor does it have the legal staff to engage in more than a very few of them. Further, it has no assurance that the forthcoming generic carcinogen rules can actu ally help avoid such fights in situations with as many unusual elements as that presented by PCB. The above elements present what many politicians would describe as a "no-win" situation. OSHA's decision maker has responded by de laying action on the NIOSH proposal for at least 18 months, but he c a n 't delay indefinitely w ithout an explanation. I therefore presume that he would welcome a face-saving compromise, and suggest positioning ourselves to approach him along these lines: III. Proposed Approach to OSHA A. If we can get our show together before O S H A issues its p r o posed standard and starts public hearings, we should go down for a visit and make these points: 1. The proposed standard would force the closing and demoli ticn. of most US capacitor and transformer manufacturing plants, none of which have used PCB's for 2-3 years. GE and other manufacturers would be forced to fight this vigorously, and would anticipate a fair rreasur* of public and press support for their position. 2. The NIOSH criteria document specifically called attention to the need for additional research on the health effects associated with chronic exposures to PCB's and on the contaminants in cor?j?ercii2 PCB preparations. General Electric is actively p u r s u i n g both of these lines of research, both in its cwn laboratories and through collaboration with Dr. Selikoff's group at Mt. Sinai. . G E N P 01039 783205 Proposed Research on PCB -3- 3. The preliminary indications are that these studies w i l l denon strata the need for a standard that w i l l be differentiated a c c o r d i n g -o the measured or presumptive levels of toxic impurities in the PCB. Such a standard could be even more rigorous than that proposed by N10SH for some PCB mixtures, but more like the present ACGlH and International standards for others. Overall, it would permit at least as great protection of occupational health withput need for mis sive demolition of old plants. 4. Accordingly, we would propose that OSHA deter standard setiir until the ongoing research studies have been completed and the re sults made available for public scrutiny. Such a delay would not produce an obvious health hazard, since PCB manufacture and import in to this country was discontinued 18 months ago, and; the opportunities for occupational exposure are rapidly declining. i B. If OSHA moves first, hits the Federal Register w i t h a p r o posed standard, and initiates public hearings, we should expand the above lines of argument to include legal as well as prag m a t i c issues, for example: , l 1. OSHA has always recognized, as a matter of stated policy, th: substances having generically similar chemical formulae can still te very different in terms of toxic hazard. It has never pr o p o s e d to regulate any chemical substance, for either toxicity or carcinogen:ri- except on the basis of biological activities clearly m a n i f e s t e d by th< substance itself. j 2. The available literature,on PCB mixtures indicates a very wide range in toxicological properties, including tumorigenicity. This is borne out both by experiments with laboratory animals as well as occupational health experience in American industry. Simply state* some* PCB mixtures are dangerous and some are not. > 3. From the time of the very first study of ]occupational il l ness caused by a PCB mixture, back, in 1933, it w as recognized that th characteristic symptoms of PCB poisoning were produced by infre quently-appearing impurities in the PCB. Since 1970 it has been kr.ow that the significant toxic impurities in the few cases studied vsr; the-polychlorinated dibenzofurans (PCDF's), a family of m a terials -ha can be formed in PCB's by certain types of unusual' thermal and/or * photochemical exposure. The NIOSH criteria document specifically h [T !Z 783206  GENP 010396 Proposed Research on PCB -4- pointed out the need for further studies of such impurities. On going research at Mt. Sinai, NIEHS, and GE its e l f should p e r m i t ui. ambiguous resolution of the role of PCDF's in PCB toxicity, enable us to sort out the toxic PCB mixtures from the non-toxic o n e s , and thu permit an appropriate regulatory response for each; in accord with usual OSHA policy. 4. We therefore p r o p o s e that the hearings be r e c e s s e d until these current research studies have been completed. XV. Research Studies Needed to Support the Suggested Approach A. Technical O b j e c t i v e . The objective of the p roposed research program would be to pr o d u c e two manuscripts Cor subdivisions there:f, if necessary) s both written as if directed at an external scientific and/or medical audience; and b o t h meeting the a c c e p t e d technical aid scholarly standards for publication in reputable refereed journals. One of these studies w o u l d be primarily chemical; it w o u l d describe a: original analytical chemical investigation of the d i s t r i b u t i o n of icn- PCB impurities, including PCDF's, in various sorts of industrial aid laboratory PCB samples, and show how the results c o r r e l a t e d wi t h re ported levels of toxic activity. The other study would be primarily medical; starting from existing data on the health status of the Capacitor worker population, augmented by additional epidemiological and control studies as required, it w o u l d develop statistics or the incidence of various forms of morbidity and mortality in this special population that was heavily exposed to purified FCB's. B. The chemical study w o u l d includes 1. A critical review of the available toxic o l o g i c a l literature, showing the wide range of activities reported for various PCB's (already complete up to 1976) . 2. Experimental w o r k to demonstrate the f e asibility of dolce quantitative analyses for families of impurities (e.g., PCDF's, di phenyl ethers, biphenols, terphenyls, etc.) via minor m o d i f i c a t i o n c the existing perchlorir.ation procedure; also to establish the sensi tivity and precision of the assay. 3. Quantitative analyses of several dozen PC B mixtures: e.g., acceptance samples from H u d s o n Falls, b e f o r e and a f ter fulle r ' s e=rt: 783207 Proposed Research on PCB -5- treatment if appropriate; specimens of used and unused transformer Pyranol; random laboratory samples that had been stored in glass; and samples of PCB's that had been used for reported animal toxicity studies if we can get them 4. Qualitative analyses on a few representative samples, done with high resolution GC-mass spec, to identify the major individual species responsible for the generically-qantitated families. 5. Data interpretations and discussion as required, to point out (a) the probable origins of the various impurities found and (b) the correlations between the observed trends in impurity levels and the reported manifestations of toxicity. C. The medical study can be less sharply delineated at the mor because w e have not had access to the available data compilations at either Hudson Falls, Corporate Headquarters, or Mt. Sinai. Thus, tie work to be done would have to involve: 1. Assessment of available data banks, covering b o t h Hudson Falls capacitor Workers and suitable control p o p u l a t i o n s , in o r d e r -o determine which'ferns of epidemiological statistics and statistical comparisons could be conveniently assembled within a year. 2. Development of any necessary joint authorship agreements with the present possessors of the. data, whereby w e w ould agree to help with the work of compilation, statistical analysis, and manuscript preparation in return for having the buried data made available and sharing the credit. a. 3. Direct participation in the allegedly on-going Mt. Sinai matched cohort-pair study of capacitor worker health, if it would ap pear* helpful in getting .the 30b done. 4. Writing reports giving statistical information o n incidence < (a) suspected manifestation- o f a c u t e toadLcity, (b) chronic health effects, and (c) various causes of death for both capacitor workers and control populations. CiJtiNP 0103 783208 Proposed Research on PCB -6- D. Anticipated Findings. The remarkable scientific paradox presented by PCB is the following; On one hand, PCB mixtures were wid e l y used in American indus t r y for over 40 years, w i t h m a s s i v e w o rker exposure, resulting (as w e now know from the u n p u b l i s h e d Mt. Sinai studies) in correspondingly massive uptake into the workers * bodies, but with total absence of significant health effects at lease 99% of the. time. ' T h e few episodes of toxic mani f e s t a t i o n s that were noted got reported because they were "news," i.e., recognized by unusual events rather than ordinary, everyday experience. On the other hand, there is equally no doubt at all that many real episodes of poisoning by PCB mixtures have occurred. Typically, these did not simply involve an occasional susceptible individual: when chloracne appeared at all, lots of people got it. There is also no doubt that many laboratory animals have been killed or made sick by PCB mixtures, often at doses that make the very survival of 19 37-15T7 era electrical workers incomprehensible. It is our expectation that the proposed chemical and medical investigations will finally provide a satisfying exp l a n a t i o n for this mystery, both by providing adequate documentation for the low level o significant'health effects in a chronically-exposed population, anc also by identifying the origin of the actual hazard. I expect that w will be able to demonstrate a very low level of PCDF and other oxycsr ated impurities in the electrical-grade PCB's which went into both capacitors and transformers, and.hence were involved in occupational .exposures in the plant. I anticipate that w e wi l l see little PCDF bi appreciable polychlorinated biphenols (hydrolysis products that are toxicologically equivalent to PCB's themselves) in the used transformer PCB's. On the other hand, I think we will see appreciable PCDF levels in PCB specimens that have been subjected to high temper ture treatment or stored in glass in the laboratory, and also in the specimens ** if w e can g e t them - that caused s i gnificant toxic resro in other people's animal tests. When we put the pieces together, I think we'll be able to show*that (a) prolonged occupational-exposur of worker populations to purif i e d PCB mixtures at the 200-2000 ug/'r level, in addition to dermal contact, resulted in various quantifyai low level health effects, and (b) that the various h i g h e r level effs reported in the literature can be shown, either by direct analvtica. evidence or by reasonable.presumption based o a s p e c i m e n his.toryfc to. be corralatable to PCDF-impurity levels. The regulatory impliesfcio obviously, would be that sharp reductions in permissible exposure levels to PCB's in old electrical manufacturing plants are not waranted, nor is there much cause for concern over the wast e s Fro- iiini 783209 Proposed Research on PC8 -7- V such plants (or from p a p e r recyclers) that have w o u n d up in dumps or rivers. Conversely, there may still b e cause for concern over PCB* that have come out of old heat exchangers, as was true for the Yushs incident in Japan and may also be for the PCB's in Lake Michigan to day. V. Proposed Scope and Staffing At the present, we obviously do not know precisely how much tine would be required for the various individual tasks, and hence cannc* estimate how we would allocate effort between, for example, validatin' the precision of the analyses vs. increasing the number of specimens analysed. Such allocations are not of primary importance in deternir. ing project scope, however. The ultimate technical objective is tc produce two manuscripts describing original studies that can stand up to peer review by predictably critical audiences. The generation cf any such a document in an area outside our ongoing research projects requires a substantial fraction of a man-year of competent profess-or effort, or distributed equivalent thereof, pretty much independently of how easily the data turns up. Our critics will be judging us beffort expended as w e l l as coherence of argument. The level of effort I'd propose for a credible study of FC3 impurity levels would be 12 person-months of associate staff analyti chemist or skilled technician effort for the quantitative analyses; 1-2 man-months by our highly competent mass spectroscopist, Dr. W.V. Ligon, for the qualitative analyses and analytical chemical consulta tion, and 1-2 roan-months of my own time (unapplied) for program co ordination and report writing. At the moment, I am assuming that, a credible job on the epidemiological story could be done by our stiff M.D., Dick Lawton, in about 6 man-months. Dick has a repeatedly dempnstrated ability to march into a complicated medical, area, die c the facts, and come up with an impressive review paper. In acditioi some technical support m i g h t be needed, for literature searches an: < compilations. This level of effort at. CRD would result in roughly 150K of s d plied costs for the two studies. Certain short-cuts or task elinin tions could be contemplated* however, they might not be desirable i view of the ultimate objective desired. It is also q u ite li/.sly th CRD might be willing to share some of the cost out of its assessed funds.- However, the proposed project was not included in the aprre 1979 program plan, and I doubt very, much w h e t h e r my m a n a g e m e n t wru3 783210 Proposed Research on PCB - 8- permit me to go ahead with this type of effort unless the great majcri were to be paid for by the operating components concerned. What I'c really like to have to do the job right is 150K in e x t e r n a l support; that is, 50K each from Capacitor, Transformer, and ASBD, and then tc use CRD funds for addressing unanticipated problems and opportunities, e.g., photochemical experiments to demonstrate h o w P C D F could form in old laboratory PCB samples, or enlargement of the epidemiological effort Thus, the decision that you need to make boils down to this: will the Company be better off to spend 150K (from whatever source) on PCB/PCDF toxicity research, so that it will have a strong case to present to OSHA (and other plaintiffs) , or should it take a chance on being able to win on grounds of economic hardship alone? cc: M Aven , EL Simons Best regards, John F. Brown, Jr. Mgr - Life Sciences Branch PHYSICAL CHEMISTRY LABORATORY GENP 010400 783211