Document OabV5xqyo6EeJBzOYRE1JjoX

Monsanto Mmmmi Com**v 00 N. UNbw|k iMlmri at. I***. Mis*ri tstaa bm-iooq June 7, 1982 Mr. Ronald Clark Bditorial Page Bditor ST. PAUL PIONEER PRESS 55 E. 4th Street St. Paul, MN 55101 Dear Mr. Clark: Your May 17 editorial on PCB chemicals wrongly assails industry's motives in seeking a review of the latest healtheffects information on PCBs. Contrary to your assertion that "those pushing for the review are eager to resume manufacturing and using PCBs," Monsanto Company, formerly the sole U.S. producer of PCBs, has no intention or desire whatsoever to resume PCB production. Once PCBs had been judged an environmental problem, Monsanto took prompt and responsible action toward them. In 1972, the company voluntarily began phasing out the sale of PCBs for certain uses, and by 1977 had halted all PCB manufacture. This occurred two years prior to the 1979 federal ban on new production of PCBs. Your editorial also states that industry studies of PCB effects "ought to generate more skepticism than optimism." Setting aside the patent unfairness in implying that all industry health-related research is suspect, you and your readers should know that the studies you cited (done by contractors for the Edison Electric Institute and the Chemical Manufacturers Association) are not original research but rather reviews of recent research done primarily by government agencies, universities and nedical schools. Among this work, for example, is a study performed by the National Institute for Occupational Safety and Health involving more than 2,500 electrical equipment manufacturing workers, more than half of whoa were exposed to PCBs on the job in excess of 20 years. This study found no excess deaths among the workers nor any increase in mortality due to cancer, cardiovascular disease or neurological disorders. Similar findings have emerged from other epidemiologic studies. HONS 002196 h ' Mr. Ronald Clark Monsanto feels that an open-minded reading of the complete , scientific record on PCS health effects leads a reasonable ' 1 person to conclude that PCBs, while environmentally long-lived and a potential source of temporary dermatitis, are not human cancer agents nor are they associated with other long-tern serious health effects. In short, the "sign of welcome relief" on PCBs rejected by you is entirely justified in our opinion. Monsanto supports reasonable regulations and disposal requirements for PCBs. Again, we are not interested in going back into the PCB business. But we are concerned about overly xealous controls based upon incomplete science and an hysterical public fear of these compounds out of all proportion to their genuine risks. Sincerely /ec enclosures 4: PCS News Helenes PCS Healtivri&ivixcimental Effects Fact Sheet PCB Regulatory History Fact Sheet PCB Production History Fact Sheet boot 8. 8. Colline L. J. O'Neill HONS 002197 PCBs MINI SYMPOSIUM ISSUES (ion '. > ________________ Session Topic and Issues__ Author* I Analytical Methodologies Dr. Edo D. ' o Current threshold concentrations for identi Pellicxari fication of PCBs in the environment using various analytical methodologies O' Current threshold concentration for identifi- cation of polychlorinated dibenzofurans (con taminants of PCBs) o Heed, if any, for standarized sampling proce- __. dure* to reduce inter-laboratory variability in PCB residue analysis o Identification and measurements of PCBs formed in process streams Discussion period Discussants Dr. Mary S. Wolff II Exposure Studies--Environmental Dr. Brock . Residues and Bioaccumulation . A. Environmental Residues Heely 1. Quantity of PCBs released to environment per year from "totally enclosed systems" and other sources 2. Quantity of PCBs released from leaking ' condensors and transformers 9. Quantity of PCBs released through disposal processes o Efficiency of high temperature PCB disposal o Efficiency of PCB disposal in Indus- ' trial boilers and impact of disposal in wider areas . 4. Dispersal pathways of PCB following envi ronmental release . o Effect of release concentrations of PCBs in Great Lakes, in other open "PCB hot spots" for next 10, 20, 30 years O Impact of anticipated release on PCB . concentrations in edible fish from . these waters .. 5. Populations specifically exposed and ' ' exposure trends e Recent data concerning concentrations and stability of PCBs in various eco logical environments, and the decay ' ' half-lives of these systems Dr. Mark Helancon Continued- MONS 002198 JCifcSystems, J;tc. PCBs MINI SYHPOSIUM ISSUES--continued Melon Bo. Session Topic and Issues Authors Discussants ' . ' . ' B. 6. o Background levels of PCBs in the at- sraspbertc, terrestrial and aquatic com partneats of the environment o Average residence tines for PCBs in the three environmental compartments or, conversely, the degradation rates in alrt water and soil o Assuming no further release of PCBs, anticipated decay rate in food supplies, - background levels and human tissue 6. Comparison of expected field levels of PCBs to effect levels in mammals 7. Probability of PCB transformer/condensor fires forming TCVDs and PCDFs; impact of seed fires Bloaccumulation Dr. Mary Jo 1. Bloaccumulation rates of PCBs in fish, Vodicnik wildlife and humans ' 2. Excretion rates of PCBs in fish, wild life and humans 9. Impact of PCB bloaccumulation in plants 4. General description of biotransformation patterns . 5. Likelihood of acute lethality resulting from food chain accumulation of PCBs in aquatic environment 6. Likelihood of acute lethality resulting from food chain accumulation of PCBs in terrestrial animals 7. Recent data on bloaccumulation and persis- tance of PCBs in food chain ' Discussion period Dr. Hark Melancon m Exposure Studies--Industrial Processes Estimation of PCBs incidentally formed in various process streams - Worker exposure streams .. Potential for environmental release e Relative importance of release compared to ' existing environmental pools of PCB Discussion period " Dr. Kent Hodges Dr. Robert Kaley Wealth Effects--Epldemilogy e Studies of sports-fishermen la Hichigan vh< have consumed high concentrations of PCBs in Contaminated fish Dr. William Dr. Renate R. Caffey Kimbrough . continued- 2 HONS 002199 ifcSystems, Jac rcat MINI SYMPOSIUM ISSUES--continued Ion Me. Sen ion Topic end Issues ______________ Study on Michigan farmers exposed to PCBs frost silos coated with PCBs ' Recent reviews of "Yusho incident" O Other Incidents involving PCB exposure Recent studies on PCBs in human tissues Half-lives of PCBs in humans Discussion Period Author* Discussants . ' V Health Effects--Laboratory Studies Dr. Seymour A. Reproductive Effects Fries* 1. Relevance of studies on reproductive Dr. Stephen effects in Rhesus monkeys (Allent et al.) Safe for humans 2. Other recent studies demonstrating repor- ductive effects . o Dosage levels ' o Species ' o Types of abnormalities o Incidence o Types of abnormalities o Incidence -- ' o Severity o Number of effect levels o Significance levels for parameters S. Significance of animal reproductive studies and conclusions about potential effects of PCBs on human reproduction B. Carcinogencity 1. Recent studies on carcinogenicity of PCBs e Dose-response relationships over time - . Statistical significance - 2. Consensus of scientific opinion on carcin ogenicity of PCBa in animals and humans PCBs as "initiators" or "promoters" Mode of action for reported carcino- . genic effect (and specifically arene side formation) .. 3. Significance of animal studies to human * 'population C. Mutagenic Effects 1. Recent studies on mutagenicity of PCBS o Mutation frequencies e gtatistical significance ' O Proposed mechanism of action and eval- nation of their appropriateness ' ' o Sensitivity of test method Dr. Renate Kimbrough Continued- MOMS 002200 JCifeSystems, Jitc. KBs HIHI SYMPOSIUM ISSUES--continued Session Ms. ________________ Session Topic snd Issues '_____________ Authors Piscusssnts __ . _ ' . ' ' B. 8, 2. Conclusions o Mutagenic potential of PCBs Significance of aniswl data to huaian population . Other Health Effects 1. Placental transfer rates 2. Kate of entrance of PCBs into huaian breast 3. Potential target organs in humans o Neuroendocrine effects on thyroid, adrenals, gonads and hypothalamic- pituitary axis hepatotoxicity e Others A. Dermal and inhalation absorption rates in humans 5, Significance of observed persistent chloracne and skin pigmentation changes 6. Relevance for humans of studies by Allen et al. in demonstrating learning disabili- ties in Rhesus monkeys and low PCB dosages 7, Evidence of detrimental effects on learn- ing in species other than monkeys 8. Other health effects observed for PCBs o Effect Species o Bose Statistical significance Discussion period ' ' a* VI ' ' Environmental Effects A. Recent studies on ecotoxlcity of KBs in various fish and wildlife species 1. Reported effects 2. IDSOs 3. Statistical significance B. Impact of impaired reproduction on phyto plankton, daphnid and fish populations - I. Potential for population changea 2. Potential for cosaaunity disruption C. Reproductive impairment in exposed birds . I. Residues in bird eggs -- ' 2. Behavioral alterations 3. Relative contributions to impaired repro Auction Dr. Richard Dr. Mark Hunter Melancon I continued4I MUMS 002201 i/sj l. H1NI SYMPOSIUM ISSUES--continued Cion .___ 8lon Topic nd Iooueo___________________________________ ' 9. Relative sensitivity of mammalians to rcpro- ductlve and lethal effects of PCBs ` 1. Hlnk -- R. Felines - S. Primate* 4. Rodents ' 5 Others R. Modes and rates of absorption for fish and wildlife F. Coaparison of field concentrations of PCBs and reported effect levels for reproductive and % other chronic effects in fish, birds and aamaals of economic importance 1. Water, sediment and food chain concentra tions . . 2. Modification of PCBs* toxicity by meta . holism in mammals or fish ' C. Significance of mutagenic effects studies in animals on fish and wildlife population R. Significance of carcinogenic effects studies in animals on fish and wildlife population I. Discussion period Author* ___ VII ' * Risk Assessment Dr. Robert o Health and environmental implications of James current environmental and human tissue concentrations of PCBs o Relationship of environmental and human ' tissue concentrations of PCBs to exposure ' o Possible environmental concerns for safety of monochlorinated biphenyls and other low . - chlorinated isomers e Impact of analytical uncertainties for PCB residue analyses on risk assessments o Potential synergistic activity of PCBs with ether chemical groups, and estimates of numbers of chemicals in each group for which " synergism may exist " e Concern for increased susceptibility to disease in populations of animals after PCB exposure Discussion period Discussants Dr. Roy Harbison 5 MONS 002202 Monsanto MOWMIIIU INSWTHML CWMCALS OO. 00 N. UlO(|l St. L*Ms, Mloaoort 03167 *: 014} 664-1000 April 15, 1982 Nr. Barry Shearman, HP, Huddersfield East House of Commons WESTMINSTER London, England SW1A OAA - Dear Mr. Sheerman: Hr. Dan Bishop, Director of Public Affairs of Monsanto Europe, SA, asked that I respond to your letter of March 26. It is difficult to present the scientific evidence relating to the health, toxicity and environmental effects of PCB's in a few pages; however, the task of reviewing the data from the thousands of studies (over 5,800 since January, 1976) is not impossible. Recent thorough reviews of the health and toxicity effects of PCB's, with particular emphasis on data obtained and published since 1975 when the Toxic Substances Control Act was being drafted, have been conducted by several indepen dent reviewers, including the scientific staff of the Department of Medicine and Environmental Health of Monsanto Company. Results of these reviews have been published and were submitted to the U.S. Environmental Protection Agency. Results of these reviews, including an extensive scientific review of more than two dozen health studies dealing with human exposures to PCB's, fail to show a link between the chemical and human cancer (see attachments). The human epidemiology studies have shown that while exposure to PCB's can cause temporary akin problems, there are no clinically observable long-term health effects, including the occurrence of cancer. All of the occupational studies of health effects agree that there has been no clinical illness associated with PCB exposure other than dermatitis (skin disorder). Studies of non-occupationally exposed populations have found neither dermatitis nor other clinical evidence of exposure-related effects. e unit gf Monsanto Company HONS 002203 Mr. Marry Shearman Pag* 2 April 15, 1982 Thaaa conclusion* ar* based on an extensive review of published and unpublished epidemiologic studies which have been performed by a number of scientists in the United States and abroad, including those from Federal and State governmental agencies, universities and medical schools. In addition, thorough reviews of the scientific and technical literature, relating to health effects of test anisials exposed to PCB's, by several independent bodies show that PCB's are not "deadly toxins" as occasionally misrepresented in the news media. On the contrary, as pointed out in the attached summary report, any. inpact of PCB's on the environment is so slight as to be totally insignificant. The report of the U.S. science body of the National Research Council of the National Academy of Sciences ("Polychlorinated Biphenyls", National Academy of Sciences, Washington, DC, 1979) sums up even the most recent reviews: "Although PCB's have been detected in the U.S. population, there have been no documented cases of PCB intoxication of humans other than those related to industrial exposure. Effects, when detectable, have been subtle rather than overt." (Page 122) With respect to the letter of Dr. D. J. Roberts on the subject of PCB destruction research funding, there are other areas of error in fact other than PCB health effects or in insinuations based upon partial facts. For example, the U.S. EPA Industrial Environmental Research Laboratory at Cincinnati, Ohio, published a draft document in June, 1981, discussing "High-Temperature Degradation Characteristics of Hazardous Organic Wastes -- A Laboratory Approach." In these studies, pur* PCB's were degraded under a series of controlled incineration conditions. The EPA report noted that "no dioxin structures were observed' as reaction/degradation products of the PCB's tested. Dr. Roberts states correctly as noted also in the National Academy of Sciences report that Aroclor* brand PCB's may have contained contaminant polychlorodibenzo furans at trace levels (i.e., up to 2.0 ppm). Dr. Roberts insinuates that this may poae a significant health risk. However, the HOMS 0022* Nr. Barry Shearman Pegs 3 April IS, 1982 racant health reviews prepared for U.S. EPA took this contaminant isaua into account in their evaluation of PCS health effects. Ute reviewers stated: "It is our independent professional opinion that 'any exposure to PCB's' does not pose a significant health risk to humans. these conclusions are based upon data of the primary exposure to commercial grade PCB's." In most animal and human epidemiology studies reported in the literature which were reviewed, the form of PCB material that the subjects were exposed to was 'commercial" PCB's and its concomitant impurities, if any. Lastly, Dr. Roberts states his interest is to seek funding for research programs on methods for disposing of PCB's, particularly hydrodechlorination reactions. I sympathize with his efforts to solicit sponsorship. This area is a very active and fertile one for PCB disposal methods. Currently, in the U.S. no less than five commercial process es for dechlorination of dilute PCB's in transformer fluids have been approved or are being tested by EPA. Three of these processes are available for commercial hire now. Enclosed are several summary packages of information on the PCB issue for your use. I have chosen summaries so as not to deluge you with tons of paper; however, details are available. I'll be happy to attempt to answer other questions you may have on this subject. jh enclosures: Ecology A Environment, Inc., Executive Summary Report for Chemical Manufacturers Association CMA Comments to ANPR (46 TED. REG. 16096) , Pages 7-1B Edison Electric Institute Comments on Use of PCB's, Tol. I, Pages 7-14 80-015 Package cc: Hr. D. R. Bishop - MONSANTO EUROPE, SA bcc: C. J. Larsen MQNS 002205