Document 3evjprDxNeEorj5958exXw8Ra

pRoP/T a ui,r\ 8!J- s/s r STLCOPCB4078615 / 332040 0S>N STLCOPCB4078616 ) t, : xA V STLCOPCB4078617 c .;/ ; ' Z : <ZL /) ld^ P ~T l 'p t Ze^t N ^ vr- O D ~?y<. -t __ /Jl P sv s >? DSW 332042 STLCOPCB4078618 DS\N 332043 STLCOPCB4078619 {js'~ v-M Q> STLCOPCB4078620 7//7 //y/'K' - ' i^ 77i'tri'rirTl'//tl A f/ZU/) Jptf* yms. W- LI' >#/*A -f -f- c yfcAy* Sh <L /) i. v' ' *' . C" / w 0 / L X DSW 332045 STLCOPCB4078621 /f' .~r^ t' DSW 332046 STLCOPCB4078622 rTnWVi 0 For the last fifteen years there has been growing world wide concern regarding the persistence of chlorinated pesticides (particularly DDT) and their universal pre sence in man, food, animals, fish, birds, air, water, and soil. DDT and its metabolites have been found in virtually every living organism and matter around the globe--including penguins in the Antarctic and the polar ice cap. As analytical techniques for measuring .the residues have improved, interfering substances have become apparent and raised doubts as to the quantitative validity of reported concentrations. Gas chromatograph techniques, making possible determination in the parts per billion and parts per trillion range are particularly sensitive not only to DDT but also to its metabolites DDE, the insecticides Dieldrin and Aldrin, and polychlorinated biphenyls (PCB's), isomers of which have similar reten tion times ("peak locations") in the gas chromatogram. Identification of some of the major Interfering sub stances as PCB's was announced by Professors Widmark and Jensen, of the Institute of Analytical Chemistry at Stockholm in November, 1966. With the identification (confirmed by mass spectroscopy) Widmark and Jensen announced finding PCB's in fish, birds, eggs, nr1 Samples analyzed were all from Sweden and the Swedish coastal areas. Subsequently, PCB's were identified in fish and wild life in Great Britain (1967), the Rhine River and Netherlands estuaries (March, 1969) In August of 1968, Professor Risebrough of the Univer sity of'California at Berkeley presented a paper at a private meeting of toxicologists indicating he had found PCB's in fish and wildlife along the coast of California. The'first reference in the American public press followed the publication of Risebrough's paper in Nature, February, 1969. At that time the San Fran cisco Chronicle carried a "scare" story concerning PCB's after an Interview with the author. In the last six months, PCB's have been reported in: a. Milk in Georgia b. Waters of Lake Michigan c. Fish in Connecticut d. Sea food along the Gulf Coast (toxic--fatal to shrimp at Pensacola) DSW 332047 ' STLCOPCB4078623 SHY 1. EVIDENCE OF PROBLEM (Continued) e. Electric dishwashing compounds f. Milk in Maryland g. Bald eagles from the mid-west and h. Mother's milk (rumor--not confirmed) in Denver. After lnvestlgation--not complete in all cases--the committee has concluded: 1 - 1. That the identification of the PCB's as contam1 inants of the environment is certain; 2. There is no question as to the non or low bio . gradability of the PCB's--particularly the higher chlorinated members of the series in eluding Aroclors 1254 and 1260 and probably 1248; 3- The possibility of natural origin of the PCB's (such as biological or chemical degradation of other chlorinated hydrocarbons by natural processes or metabolism in the eco-system) is so remote that it is not a satisfactory expla nation of their presence; 4. As discussed in the following section, these may he significant toxicological effects in some species of living organisms; and, 5. Aroclors 1254 and 1260 are the compounds wlrich" a'rer'found_and--rep"6rted in the literature by the AroClor trade-names or as the "biphenyls with,predominantly 5 to 8 chlorine atoms". We believe-that references to Aroclors 1242 and 1268 (and chlorinated terphenyls) in several letters received reflect early non definitive efforts of the analysts. l I j i t If \ } i DSW 332048 STLCOPCB4078624 _-aaeA: (> i 2. -TOXICOLOGICAL ASPECTS - ' A. Man--Data available at present indicate that PCB's may be "moderately toxic" to man. Safe industrial . usage has been based on a recognition of possible ; toxic effects and control of' exposures to minimize { the hazard. There have been a limited number of ! cases of occupational disease where workmen have I been exposed to excessive vapor inhalation or repeated and prolonged skin contact with subsequent ' development of skin manifestations("chloracne") or j more serious involvement of the liver and kidneys. i. ! B. . Animals--Chronic toxicity data for animals (which I would allow a better extrapolation of "safety" | levels for humans) has been meager. In May, 1969 chronic (two year) feeding studies In rats and ; dogs were initiated at our consultant's Industrial . Bio-Test Laboratories In Chicago. A three generation , rat reproduction study is also underway. The purpose j of the research is to make available to the U. S. Food and Drug Administration and other federal and state agencies data which will confirm that the levels of PCB's being found in nature--and particularly in human food--do not constitute a serious threat to the public health. C. Fish--The proven presence of pesticides (and PCB's) in fish is beginning to cause concern for two reasons. In Sweden and other Scandinavian countries where fish make up a large portion of the daily diet, > the use of DDT'has been temporarily or permanently | banned. Similiar action has been taken in several j states in the United States and bills have been presented in Congress to outlaw the sale and use of } DDT. This summer the U. S. Food and Drug AdminisI tration seized and destroyed Coho Salmon caught in ! Lake Michigan because of DDT content. This highlights the particular problem with fish which can concentrate/accumulate persistent chlorinated^ hydrofcarbons~Tn their tissues. For examp 1 e, rout~ raised in water containing 1 part per billion will contain 1 part per million in their tissues in six weeks. Other marine species exhibit a similar "con centrating" propensity. Although no scientist has maintained that these accumulated levels in fish are toxic per se, the question of the desirability of having such fish In the human diet has caused concern-- and In some minds, alarm. DSW 332049 i ! j ;J j j i j ; ; 1 i [ jf I | j STLCOPCB4078625 .bp: . . ... kiUtaidSB raW &i 2. TOXICOLOGICAL ASPECTS (Continued) A second consequence of _the chlorinated pesticide presence in fish, is the alleged effect on species of coastal and other fish-eating birds. There is evidence interpreted by a number of scientists (and seized upon by the conservationist-pseudo-scientists) * that several species of birds face elimination or absolute extinction because of persistent chlorinated ' hydrocarbons in fish which make up the major portion if not all of their diet. Included In the United States are the Peregrine Falcon and the brown peli can. (At a meeting in October, 1969* of the Associ ation of Official Analytical Chemists, will be a paper presented entitled, "The Determination of PCB's in Two Bald Eagles". This is based on work done by the Fish and Wildlife Laboratories of the U. S. Department of the Interior at Patuxent, Maryland. Now the emblem of the heritage of the United States is threatened^) D. Birds--The effect in birds appears to be due to an upset of enzyme metabolism in the liver leading to the laying of eggs with thin or no shells at all. On Anacapa Island, near Oxnard, California, only three of one thousand brown pqj^can eggs were found this year with shells and onlyAbird was born. This was due allegedly to anchovies--the main diet of the pelican--containing "DDT and hundreds of parts per million of PCB's". Preliminary results from studies at Industrial Bio Test Laboratories indicate that 100 ppm of Aroclors 1242, 1254 and 1260 in the diet of white leghorns causes a reduction in egg shell thickness and an effect in 6hick embryos which prevents hatching. E. Shrimp--In August, 1969, West Florida State Univer sity at Pensacola reported to our Pensacola Plant that PCB's (Aroclor 1254) had been found in the Escambia'River below our outfall. The amount was reported as 40-45 parts per billion one quarter mile below the plant and 1 ppb at the bridge over the river as it enters Pensacola Bay. fi , The Gulf Breeze Laboratories of the Bureau of ft \ Commercial Fisheries (U. S. Department of JjabexObr) at Pensacola next reported that 40 ppb"'<kiiled baby shrimp in 96 hours. Further study indicated that 5 ppb killed 18 of 25 baby shrimp in 18 days. Plant investigation revealed that one to three gallons per day of Aroclor 1254 was being lost to the river from the use of Pydraul AC in air compressors. . DSW 332050 STLCOPCB4078626 -iiai Aim life 2. TOXICOLOGICAL ASPECTS (Continued) . P. Summary of Toxicity Considerations a. The PCB's are "moderately" toxic to man. A * ` ` . probable safe level for Aroclor 1254 and 1260 in the diet will be something less than one part per million. - b. Although only "moderately" or "slightly" toxic to adult birds and fish on the basis of acute exposure, the "safe long term" or "chronic dose" is less than 100 ppm insofar as reproduction is . concerned. c. * In the case of shrimp, the "safe" or no effect" . level for Aroclor 1254 is less than 5 parts per billion. _ It thus appears that, while we may be able to show some kind of reasonable numbers for "safe levels" of Aroclors 1254 and 1260 (and other lower chlor inated biphenyls)in some species, there are other species of life in the ecosystem where a zero to 5 parts per billion limit for. Aroclor 1254' and 1260 (and possibly other more highly chlorinated biphenyls) will be the tolerance level. \ I s' V. sw 332051 STLCOPCB4078627 3. PERSISTENCE OR LACK OF BIODEGRADATION % Evidence for the persistence of Aroclors 1254 and 1260 in the environment includes: .. - a. The chemical stability of most of the chlor inated aromatic hydrocarbons b. The identification of Aroclors 1254 and 1260 in the environment as itemized in Section 1. c. Reports from Sweden indicating the presence of Aroclors 1254 and/or 1260 or competitive equivalent products in the sludge from muni cipal waste treatment plants. d. The lack of data up to now indicating that lower chlorinated PCB's are interfering in the pesticide residue analysis In spite of the equivalent usage of some of them (e.g. Aroclor 1242) and undoubted losses to the environment depending on use applications and ultimate disposal. (Comfort in this conclusion is tem pered by some evidence that the preparation of samples for GC analysis--destroying the DDT and metabolites--may be causing destruction of Aroclor 1242). e. Literature evidence that other lower chlor inated hydrocarbons in a series of compounds (e.g. mono and di-chlorophenols) are subject to biodegradation whereas increase in chlor- . ination makes them more refractory (pentachlorphenol). f. Early reports of research in Monsanto's Ruabon Laboratories that Indicate that Aroclor 1242 is indeed subject to biodegradation in biological waste treatment plants (research scale). DSW 332052 c STLCOPCB4078628 '1. PRESSURES WHICH WILL AFFECT SALES AND USE OF AROCLORS . 1234 and "1260 :' ~! ' As of this date (October, 1969)> there are no restrlc- tions which control the current uses of our Aroclors or PCB's. We are faced instead with pressures being applied relative to persistent chlorinated hydrocarbon pesti cides in general and specifically DDT. The evidence proving the persistence of these compounds and their universal presence as residues in the environment is beyond question. Although the significance of these . . residues is subject to wide difference of opinion among reasonable scientists, the development of "lunatic fringe" post-Rachel Carson has led to a domination of the media by scare publications in the public and scientific press. Only the most myopic individual in the business world could be unaware of the overwhelming interest and influences being directed at preventing contamination of the environment. The principal groups with an apparent avowed mission of providing a world of pristine pure food, water and air include many in aca demic and political fields who recognize the headline value of statements supporting these ideals. In the case of the PCB's as environmental contaminants, the committee believes that Monsanto is faced with a barrage of adverse publicity in all elements of the news media--including those with national coverage. Factual basis will be sparse or non-existent but quilt by association (with DDT) will provide background and prevail. As indicated in the earlier sections of this report, it will be impossible to deny the presence and persistence* of Aroclors 1254 and 1260 at least. The public and legal pressures then to eliminate or prevent global contamination are inevitable and probably cannot be contained successfully. In defense of the chlorinated pesticides, their manu facturers will not be loath to Incriminate the PCB's as being culprits in the development of misleading data relative to their concentrations as residues. Secondly., the manufacturers of competitive products will seize . any opportunity to point out to our customers their potential problems if they continue to use products con taining Aroclors. This has already occurred in the case of our Pydrauls. ' There are pertinent federal lawB and regulations rela ting &o environmental control as discussed in the follov<lng section. DSW 332053 STLCOPCB4078629 ff/J f} 5 LAWS AND REGULATIONS CONTROLLING ENVIRONMENTAL CONTAMINATION A U.S. Department of Health, Education and WelfareX--- i and Drug Administration- f The most pertinent legislation governing the quality of human food is the 195o Act amending the Food, Drug and Cosmetic Act and the regulations which have been estab lished thereunder. Briefly, the requirements relate to food additives - direct and indirect, and control food production and processing to insure a supply free from bacterial contamination and unauthorized chemicals (or levels greater than established "tolerances"). The regulations also Include animal feeds. t No acceptable or "safe" levels for PCB's in human foods or animal feeds have been established. Currently, there has been no Indication that the FDA is seriously concerned about the levels of PCB's which have been reported alone or in conjunction with chlorinated pesticide residues. At the same time, the Pesticide Tolerance Branch of FDA has requested (late September) samples of Aroclors 1254 and 1260 for the expressed purpose of initiating acute toxicity studies in laboratory animals. In the past, the FDA has not seized and destroyed food contaminated by the unintentional or unexplained presence of "adulterants" unless there has been some basis for a judgement that the adulterant was toxic or might pose a threat to health. An exception has been milk because of its primary role in the diet of children. Seizure and destruction of milk containing any "adulteration" has not been uncommon. It can be assumed that the finding ofPCB's in milk in Georgia in June and in Baltimore In September has created a new interest in and emphasis on the PCB problem. , = : ! ; f '! [ j B. U.S. Department of Agriculture - Under laws and regulations governing the use of economic poisons which include Insecticides, rodenticides, fungicides, this department, shares with the FDA the responsibility for establishing safe levels or tolerances for these products. It does seize and destroy meats and poultry subject to Inspection under regulations controlling the processing of these foods originally those entering Interstate commerce but more recently, practically all slaughtered and processed items. ? I I ` : As in the case of FDA, the USDA has not established any acceptable or tolerance levels for the PCB's in products subject to their control, . . . ' DSW 332054 -8 - STLCOPCB4078630 C7B LAWS AND REGULATIONS CONTROLLING' ENVIRONMENTAL CONTAMINATION (Continued) ! : 1' ' S. U.S. Department of Interior - Federal Water Pollution Control Administration Under the provisions of the Clean Water Act of 1967* the FWPCA has to approve standards of water quality estab lished by the individual state regulatory agencies. For practical purposes, this has meant that FWPCA has set not only parameters but actual numbers for dissolved oxygen, pH, temperature, solids, etc. including the broad category of "toxic" compounds. As of this date, no limits per se have been promulgated for pesticides including the chlorinated hydrocarbons. This week (October 10), a bill has been introduced in Congress requiring the FWPCA to establish "limits" for pesti cides. Obviously this is associated with the furor over DDT and the persistent chlorinated hydrocarbons. Hearings on the proposed legislation are expected early in 1970 soon after the Congress reconvenes. It is reasonable to expect that the PCB problem will be brought up at these hearings. Further, with the political and public interest in all forms of environmental contam ination, it is likely that the legislation will be broadened to include all persistent chemicals. D. State Legislation - In addition to Federal legislation, all states have regulatory programs governing the adult erations of food, the contamination of intrastate and interstate waters, and the protection of fish, wildlife and natural resources. Up to this point most of the state government agencies which have contacted Monsanto represent water pollution control, natural resources, or agriculture areas of Interest. ' No states have established any "tolerance" limits for PCB's but a number of states have banned or restricted the use of DDT and have expressed more than a casual interest in the PCB's. In expressing such interest, several states (and the Province of Ontario) have pointed out the actions which have been taken against DDT. DSW 332055 STLCOPCB4078631 1/ -2 3- Man - There is no harmful effect known to man or other mammals after 40-years of production. Studies are underway by various sources. 4. Political and Public Emotion - PCB's linked to DDT because PCB's show up in analyses for DDT. Linked with other' permanent chlorinated hydro- \ carbon pesticides. EFFECT ON MONSANTO: 1. Business potential at stake on a worldwide basis: Fluids Plasticizers Total/Year 70 M Lbs. $16 M_ $6-8 M GP 34 M Lbs. $6 M_ $2-3 M GP 104 M Lbs. $22 M _ $8-11 M Gross Profit 2. Legal responsibility. 3. Public image. 4. Effect on other product areas. EFFECT ON CUSTOMERS AND ULTIMATE CONSUMERS: 1. Affects entire electrical industry - capacitors and transformers. 2. Affects food processing. 3. Affects die casters and other "hot metal" working industries. 4. Affects wide range of plastics and adhesive applications. ...... . . .... 5- Affects wide range of paints and coatings. EFFECT ON OTHER PRODUCERS: There are at least six other producers of PCB's ex-USA. Monsanto has discussed problem with two in Europe. No great concern there yet. ' DSW 332056 STLCOPCB4078632