Document Xz8g8YM2Beqxg5gpVe4mzDY5w

INTRODUCTORY REMARKS John L. Buckley, Ph.D. I would like to call to order the final morning of our conference here and I would like to tell you also that I have won an additional brass ring. I will be chairman of the session this morning, not because I planned it that way, but because Dr. Jim Brydon, who had agreed to serve in this capacity and did his best to get here, could not make it. He left Ottawa late yesterday afternoon, having appeared before the Treasury Board in the mom* ing and the Senate in the afternoon, and he made it as far as Toronto, where apparently there were electrical difficulties and so Jim will about this time be turning around to go back to Ottawa instead of coming here. I would like to explain to you what I have in mind in the way we are going to try and operate. It is not all that difficult or complex. It rather follows the statement in the program. We will have a series of speakers, each of whom has prepared remarks and that will be followed by discussion among the speakers and in response to com ments or questions from the floor. "1 Pages 409 and 410 are blank. GENE 005961 411 774609' _J A REVIEW OF FEDERAL AND STATE GOVERNMENT ROLES IN CO NTRO LLING IMPACTS OF PCB's ON THE ENVIRONMENT A. Karim Ahmed, Ph.D.* Abstract Polychlorinated biphenyls (PCB's) have found ex tensive application in a large number o f industrial prod ucts since they were first commercially used in the 1930's. Presently their use in the United States appears to be principally restricted to dosed electrical systems, such as capacitors and transformers, though several tens o f millions o f pounds are used each year as an insulating fluid in these products. Numerous studies now clearly * indicate the contamination o f PCB's in die environment. Residues o f PCB's are detected in many different aquatic and animal species. They are found in high concentra tions in river bottoms, and in samples o f commercial and sport fish collected from the Great Lakes region and in several rivers in die East Coast. They are found in amounts greater than die Food and Drug Administra tion 's tolerance lim it o f S ppm. The roles o f the Federal and State governments in controlling the manufacture and use o f PCB's are ex amined. I t is concluded that, in most cases, little or no regulatory activities have been initiated by government agencies in recent years to address die problem, in spite o f the heightened concern over die potential threat o f PCB's on the environment and to public health. Only in the past few months have several Midwestern States bordering the Great Lakes and the State o f New York taken measures to control the discharge o f PCB's from known sources. To cope with the problem, several recommendations have been urged, which include: the complete phaseout o f the manufacture and use o f PCB's, a ban on their import and export, the development o f a consumption inventory, an accelerated program o f monitoring and surveillance, ' a moratorium on river bottom dredging, promulgation o f the PCB toxic effluent standard, a sig nificant lowering o f present FDA tolerance lim it on PCB's, and Congressional passage o f die Toxic Sub stances Control A c t IN T R O D U C T IO N Polychlorinated biphenyls (PCB's) were first intro duced into commercial use over 45 years ago, and for a S ta ff Scientist, Natural Resources Defense Council, New York, New York. long time they were considered to be relatively nontoxic substances. Their potential threat to the environment was not recognized until 1966, when the Swedish scien tist, S. Jensen, observed the presence of PCB's in fish and wildlife samples while analyzing for chlorinated hydrocarbon pesticide residues (refs. 1,2). Since that initial discovery, PCB's have been detected in numerous aquatic and animal species, and have been noted in high concentrations in industrial waste discharges, river bot tom sediments, food packaging materials, and in food products, such as poultry, fish, and dairy products. A large variety of industrial applications have been found for PCB's, since they are endowed with a number of desirable chemical and physical properties. They are chemically stable, nonflammable, and essentially non soluble in water. They also possess a high dielectric con stant and are relatively viscous materials with a low vola t i li t y . Thus, they are used as heat-exchange fluids and as a dielectric medium in electrical capacitors and trans formers, They have been used as hydraulic and lubricat ing fluids, and are used in gas turbines and vacuum pumps. In the past, they were extensively used as plasti cizers in plastic products, as coatings in textile products, and in paints and varnishes. They were also used as sea lants, as extenders in pesticides, and as an ingredient in caulking compounds, adhesives, printing inks, and car bonless duplicating paper (refs. 3,4,5). In 1971, over 106 million pounds of PCB's were produced in the industrial countries of the world, with a third or nearly 40 million pounds being manufactured in the United States (ref. 4 ). During the late 1950's and into the 1960's, U.S. domestic sales o f PCB's increased nearly threefold, reaching a peak of approximately 72 million pounds in 1970 (ref. 5 ). Prior to 1970, about 60 percent of U.S. domestic sales was fo r closed electrical systems, such as capacitors and transformers. Another 25 percent was used as plasticizers and in the production of carbonless duplicating paper (ref. 5). Since Septem ber, 1970, when Monsanto Company, the sole manufac turer of PCB's in the United States, restricted its sale of PCB's to closed electrical systems, the U.S. consumption has been reduced considerably. It is important to note, however, that,these reductions occurred mainly with the use of PCB's as plasticizers, and as hydraulic and lubri cating fluids and other miscellaneous uses. The bulk of PCB's, as mentioned above, had been used in electrical systems, and it is still being used almost exclusively by 412 774610 GENP 005962 L manufacturers of large power and small ballast capaci tors, and electrical transformers, as the preferred dielec tric fluid. E N V IR O N M E N TA L C O N TA M IN A TIO N OF PCB's Residues of PCB's in environmental samples have now been reported in numerous studies conducted dur ing the past 10 years. They have been analyzed in wild life and fish samples in Holland, Germany, and in the Baltic Sea (refs. 6,7). O ff the coast of Scotland, PCB residues were found in several marine species, .the con tamination presumably having arisen from sewage wastes being dumped into the open sea (ref. 8). Unlike the almost ubiquitous presence of chlorinat ed hydrocarbon pesticides in the environment, PCB res idues are generally found in areas associated with high industrial and urban activity. Little or no detectable amounts of PCB's were found in wildlife sampled in re mote, nonpopulated areas, such as the Gulf of California and Cape Crozier, Antarctica (ref, 9 ), Similarly, rivers and lakes without known industrial discharges are gener ally found to be uncontaminated with PCB's, such as has been shown for several watersheds and small lakes in the upper Midwest and in Canada (refs, 10,11). On the other hand, PCB's in increased amounts are detected in the Eastern and Western coastal regions in highly urbanized areas, such as the Chesapeake Bay, San Fransisco Bay, and the Puget Sound, or in regions where industrial dis charges are known to occur, such as Escambia Bay, Florida, and the Hudson River (refs. 9,12,13,14), Studies on plankton species in the marine environ ment have shown them to contain detectable amounts of PCB's. Zooplankton sampled off the Eastern continental shelf area were observed to contain PCB levels ranging between 0.07 and 3 ppm (ref. 15). Plankton species col lected in the Gulf of Mexico and the Gulf of St. Lawrence have been found to contain PCB residues as high as 1 ppm and 3 ppm, respectively (refs. 16,17). Tuna caught off the Atlantic seaboard are shown to contain PCB's with levels of 0,36 to 1.5 ppm (ref. 18). Considerably high concentrations of PCB's are noted in several predatory birds, with values from 30 to 900 ppm in the livers of heron, 65 ppm (wet weight) in peregrine falcons, 190 ppm (whole body weight) in white-tailed eagles, to 93-470 ppm (wet weight) in the livers of cor morants (ref. 8, 9, 19, 20). Similarly, a number of studies have shown relatively high levels of PCB's in the eggs of wild birds, ranging from 1 to 44 ppm (refs. 18, 19,21). _ An important impact of PCB's on the environment has been contamination of 'sport and commercial fish eries in the Great Lakes region. Levels of PCB's in lake trout and coho salmon from Lake Michigan show an alarmingly increasing trend since 1972, in the average range of 10 to 25 ppm, well above the present Food and Drug Administration's maximum allowable concentra tion of 5 ppm for fish and shellfish (see figure 1) (ref. 22). On the other hand, DDT levels for the same species of fish show a decreasing trend since 1970, when DDT consumption in the United States was curtailed (figure 1). It is rather discouraging to note that even with the restriction of domestic sales of PCB's to closed electrical systems since the early 1970*s there has been no corre sponding decrease in PCB levels in commercially impor tant fish species. Fish samples collected by the Wisconsin Department of Natural Resources last year showed extensive con tamination of several species of fish in Lake Michigan (ref. 23). These include Chinook salmon, coho salmon, brown trout, tiger trout, lake trout, whitefish and carp. Generally, the residue levels ranged well above 5 ppm, with lake trout (up to 43.8 ppm) and carp (up to 51.6 ppm) showing the highest concentration values. In the Upper Fox River fish sampled at one station earlier this year by the Department showed high concentration of PCB's in white suckers (32.7 ppm), carp (21.4 to 45.8 ppm, average 35.9 ppm) and northern pike (average 15.4 ppm). Samples analyzed by the Department in 1973 showed similar residues of PCB's in a number of fish species in several reaches of the Mississippi River. These data are. summarized in table 1. An interagency Task-Force on PCB's, formed of Federal and several State agencies of Minnesota and Wisconsin, sampled fish in the Mississippi River during the early summer of this year and found similar levels of PCB's in several fish species: carp (up to 33 ppm), walleye (up to 9.8 ppm), white bass (up to 4.3 ppm). Generally, PCB values were found at higher levels in samples collected south of the Minneapolis-St. Paul metropolitan area (ref. 24). More surprising is the detec tion of PCB residues in lake trout sampled last year in Lake Superior by the Great Lakes Environmental Con taminants Survey (GLECS), which showed residue levels ranging between 0.5 and 12.7 ppm in theSiscowet (fat) variety of trout. The lean trout variety had lower PCB residues, though the larger size fish often had residue levels close to or above 5 ppm (ref. 25). The Division of Fish and Game of the Common wealth of Massachusetts has in the past occassionally sampled PCB levels in fish in several rivers and streams in the State (ref. 26) and high levels have been detected in several species. White sucker samples collected in 1971 in the Housatonic River showed mean PCB levels of 15.10 and 69.30 ppm at tw o sampling stations near the General Electric plant in Pittsfield, Massachusetts, which GENP 005963 413 774611 fc96S00 dHHO \ TRENDS IN ODT LEVELS LAKE MICHIGAN FISH TRENDS LAKE INMICHPICGSAN LEFIVSEHLS z t9 H . u Vi \ Figure 1. PCS and D D T trends in Lake Michigan fish (ref. 22). Species Table 1. PCB's residue in fish species in Mississippi River, 1973 (ref. 23) Station PCB(ppm) Walleye Largemouth bass Northern redhorse Carp Lake Pepin Prescott Wabasha Trempealeau Lake Pepin Trempealeau La Crosse Lake Pepin Prescott Lake Pepin Prescott Wabasha La Crosse 11.9 - 31.4 7.21 - V I. 1 3.84 - 9.00 3.16 - 6.34 1.65 - 10.5 1.74 - 5.92 1.49 - 4.24 3.45 - 8.53 1.01 - 16.2 5.49 - 11.2 0.57 - 20.44 4.31 - 10.5 1.95 - 4.05 PCB average 21.9 9.04 5.85 4.98 4.90 2.94 2.62 5.94 5.71 7.69 8.36 7.83 2.94 manufactures electrical transformers. Though it was de termined by the State agency that the contamination of the fish was due to discharge of PCB's from the General Electric plant, there has been no further monitoring of the Housatonic River since 1971, and there is no indica tion whether abatement procedures used by the plant were effective. From the data collected by the agency, it is also clear that in 1972 there was extensive contamina tion of a large variety of fish species in nearly all the rivers that were sampled in the State, with mean PCB residue levels ranging between 1.11 and 197.0 ppm {see table 2). To date, the most contaminated fish sampled in this country are found in the upper reaches of the Hudson River, near and below two General Electric capacitor plants in the Fort Edward-Hudson Falls area. Earlier sampling by the Federal EPA last year had shown yellow perch and shiner minnows to contain average PCB resi dues of 17 and 78 ppm, respectively, w ith one rock bass sample containing 350 ppm (ref. 27). It appears that the two General Electric plants had been discharging approx imately 30 pounds of PCB's per day into the river, though in recent months there appears to have been a reduction of daily discharges to less than 10 pounds. The most recent fish samples collected by the New York State Department of Environmental Conservation con firm the earlier findings. The composite PCB averages of fish caught near the plant show typical values well above 20 ppm, with one American eel sample yielding residue values of 403.4 ppm of Aroclor 1016/1242 (ref. 28). These findings are partially summarized in table 3. A t the same time, the New York State Department of Environmental Conservation sampling of fish species of recreational and commercial importance in the lower Hudson also shows high residues o f PCB (ref. 28). Strip ed bass caught near the Albany area showed total PCB residue values ranging between 11.08 and 89.76 ppm.' PCB residues in fish caught in the lower reaches of the river have higher concentrations o f Aroclor 1254, indi cating long-range transport of the previously used higher chlorinated mixture of PCB discharged by industrial activities in the past. Striped bass sampled near the West Point and Tappan Zee area of the Hudson River (50 miles north of New York City and several hundred miles south of the Fort Edward-Hudson Falls area) show total PCB residues ranging between 1.16 and 7.54 ppm. Sim ilarly, a sample of American shad in the Poughkeepsie area showed PCB residue levels of 9.0 ppm. Of equal concern is the accumulation of PCB in sediments of the river bottoms. PCB's, like most chlori nated hydrocarbons, are highly insoluble in water and tend to settle op river sediment quite readily, being ad 12sorbed on silt and fine particles in river bottoms (ref. ). Data collected by the United States Geological Sur vey (USGS) on the Hudson River during the years 1973-74 show the presence o f PCB's in the water and in the bottom sediments of the river (ref. 2 9 ). Values rang ing between 0.3 and 3.0 ppb PCB have been reported in water samples collected at several stations on the Hudson River. These include locations near Poughkeeps ie, Waterford, Chelsea, and Rhinebeck. 415 774613 UU5965 Table 2. Mean PCB concentration (ppm, dry weight) in fish collected in Massachusetts rivers and streams (ref. 26) Stream and station Town No. and species Aroclor (ppm) Rank * 1972 1971 M illers Deerfield Merrimack #1 Connecticut Merrimack 2 Chicopee Westfield Blackstone L ittle Ware Athol Deerfield Tyngsboro Northampton Haverhill Ludlow Westfield M illville Westfield Thorndike Aroclor 1248 1 White sucker 5 Fallfish 5 Pumpkinseed 5 Fallfish 3 Alewives 1 Eel 1 Banded k i l l i f i s h 5 Pumpkinseed 5 Pumpkinseed 5 White sucker 5 Golden shiner. 5 Pumpkinseed 197.0 23.8 19.1 17.7 13.3 13.3 11.9 10.1 9.41 3.32 1a 25 346 54 62 73 81 97 10 Blackstone M illville Aroclor 1260 5 White sucker 1 21.3 ' Aroclor 1254 Charles #2 Concord Taunton Quaboag Cambridge Concord Taunton Palmer 5 Pumpkinseed 5 Bluegill 5 Bluegill 5 Redbreast sunfish aNo fish could be collected in previous years. . 8.3 5.96 3.13 1.11 11 22 33 4- On the other hand, PCB concentrations analyzed from the bottom sediments of the river showed consider ably higher values characteristic of the insoluble nature of PCB's. The U5GS data are summarized in table 4, More recently, the U.S. EPA conducted water and sediment analysis for PCB's in the vicinity of Fort Edward, near the GE plant. WatBr samples collected immediately south of the GE outfalls had PCB values of 2.2 to 3.1 ppb. The sediments contained 540,000 to 2,980,000 ppb (540 to 2,980 ppm) PCB, with 6,600 ppb being detected several miles downstream of the discharge pipes (ref. 27). These very high concentrations o f PCB's in the sedi ments of the Hudson River for which dredging is proposed are particularly troubling in light of the fact that the highest concentrations are likely to exist in the deep navigation channel. PCB is associated more with finer grain particles than with particles of larger mean grain-size diameters. This was clearly observed in exten sive studies carried out In a study conducted by the State of Maryland Department o f Natural Resources in conjunction with Westinghouse Electric Company in the Chester River (ref. 12). The study concluded as follows: Laboratory and field studies by other work ers as well as the present study have indicated that the relatively water-insoluble chlorinated hydrocarbons readily adsorb to the surfaces of suspended clay minerals, and, in turbid waters, are found mainly attached to the suspended 416 O ' 7?* G i4 O' Species Table 3. Composite PCB residue in fish species sampled near the Fort Edward-Hudson Falls area of the Hudson River (ref. 28) Station PCB, ppm (Aroclor 1242/1016) Rock bass Walleye Yellow perch White sucker Brown bullhead Largemouth bass Smallmouth bass Fort Edward Fort Edward 5 miles below GE Fort Edward' 5 miles below GE Fort Edward 5 miles below GE S tillw a te r Waterford 5 miles below GE S tillw a te r Waterford 27.35 ' 104.21, 81.12, 9.88 157.27 61.10,236.4, 1-28.3 84.13,' 35.5, 88 82.9, 8.8 51.39, 29.7, 36.03, 78.0, 57.5 10.3, 154.3 20.3, 36.0 73.24, 85.30 24.85, 14.31, 8*.99 27.0, 36.0 Date 7/74 9/74 7/74 9/74 7/74 9/74 8/75 7/74 Table 4. PCB's concentration in Hudson River sediments, USGS (ref. 29) Station PCB in sediments (ppb) Chelsea Chelsea Poughkeepsie Poughkeepsie Waterford Waterford Roger's Island, south of Glen Falls Winebrook H ills 3,200 1,800 11,000 3,600 13,000 640 . 18,000 0.1 particulate matter. In the Chester River Study, the inverse correlation between mean grain-size diam eter o f the sediments and chlorinated hydro carbons content [including PCB] suggest th at a m ajor route o f transport o f these compounds in to the Chester River is attached to the suspended sediments that sweep into the tower river from Chesapeake Bay. The sediments are distributed in the bed of the Chester River in accordance to their grain size and the local current velocity regimes. The fine-grain materials (silts and clays) are thrown into suspension in the shallow, shore line areas by wind-driven and tidal currents. These materials tend to collect in the deeper channels o f the river, and, as is suggested b y the ,core data the fine-grain sediment areas in the deeper channels and submerged terraces probably "represent the m ajor sinks'w fo r chlorinated hydrocarbons in the Chester River. (Emphasis added.) The above observatioh of the transport and adsorp tion properties of several chlorinated hydrocarbons, including PCB's, has been further confirmed by a recent ly completed study in the Upper Chesapeake Bay area (ref. 30). Thus, it has been abundantly demonstrated 417 774615 GENP 005967 that not only are PCB's adsorbed on fine-grain particu lates, but they are also found in highest concentrations in the deeper channels of the river, where the channels act as "sinks" for the insoluble hydrocarbons. Thus, the very areas where dredging operations are being proposed are the most contaminated. T O X IC IT Y OF PCB's--A BRIEF APPRAISAL Effects on Aquatic Species PCB's, as a class of compounds, are extremely per sistent and nonbiodegradable substances, and tend to bioaccumulate in the aquatic environment by factors of a few thousand-to several hundred-thousand-fold. PCB's (Aroclor 1254) have been shown to concentrate over 20,000 times the water levels in Crustacea, 10,000-to 50,000-fold in certain estuarine fish species, to as much as 200,000-fold with fathead minnows (Aroclor 1242 and 1254) (ref. 31). The most serious effect of PCB's on aquatic species is their ability to interfere in reproductive process and hatchability.of fish eggs. It appears that the thresholds for whole salmon egg mortality is about 0.5 ppb (ref. 32). Similarly, the production and hatchability of fat head minnow eggs was adversely affected by 0.9 ppb of Aroclor 1254 (ref. 3 3 ). Pinfish and spot were unable to survive at 5 ppb of Aroclor 1254 (ref. 34) and many aquatic invertebrates were clearly affected at concentra tion ranges of 1 to 10 ppb PCB, including blue crabs, pink shrimp, and oyster (ref. 14). Studies by Hansen and his colleagues at EPA's Gulf Breeze Environmental Research Laboratory have indicated comparable mortal ity to several aquatic species exposed to Aroclor 1016 (ref. 35). These findings show that acute 96-hour LC50's (or EC50's) for oyster, brown shrimp, and grass shrimp were 10.2 ppb, 10.5 ppb and 12.5 ppb, respectively. It thus appears that the substitution of the lower chlori nated homolog mixture, Aroclor 1016 (chlorine content, 41%), does not diminish the impact of PCB's on the aquatic environment. Based'on the high lethality of PCB's to marine and freshwater aquatic species, the National Academy of Sciences-National Academy of Engineering Committee made the following recom mendation: Aquatic life should be protected where the maximum concentration of total PCB in unfilter ed water does not exceed 0.002 microgram p e r' liter [0.002 ppb] at any time or place, and the * residues in the general body tissues of any aqua tic organism do not exceed 0.5 microgram per gram [0.5 ppm] (ref, 31). E ffece on Humans and Animats The toxicity of PCB to humans has been clearly 1 demonstrated. In 1968 a severe form of skin disease was diagnosed in Japanese families that consumed rice oil contaminated with Kanachlor 400 (PCB with 48 percent chlorine content) (refs. 36,37). A total of 1,057 poison ing cases have been recorded to date in Japan (ref. 38). The disease is characterized by swelling of the upper eyelids, visual impariment, acne-like formations, and heightened pigmentation of the skin (ref. 36). Patients with this disease also exhibited neurological disorders and showed signs of hearing loss. Several babies born of women patients had many of the symptoms of the dis ease, which indicated a placental transport of PCB, and most fetuses were born smaller than the national aver age. Another disturbing feature of this disease was the observation that most patients recovered very slowly, which suggested that PCB was retained in the human body over a very long period (ref. 38). It should be noted here that human contamination with PCB's is not isolated. PCB's have been detected in human adipose tissue in such widespread occurrence th a t, over 40 percent of the U.S. population contains 1 part per million (ppm) or more (ref. 39). A number of studies have conclusively shown the effect o f PCB's on the reproduction of several animal species. A t 100 ppm in the diet of experimental rats, PCB (Aroclor 1242 and 1254) caused a reduction in the number of offspring that were born (ref. 3 6). Similarly, in another study, dietary levels of as little as 20 ppm of Aroclor 1254 caused a decreased number of titters to be bom to female rats (ref. 36). In a reproduction study carried out with minks, dietary levels of less than 1 ppm of PCB's caused a marked depression on the ability of minks to reproduce (ref. 4 0 ). The effects of PCB on the reproduction of pheas ants and chickens have also been demonstrated. Aroclor 1254 has a noticeable effect on both the production and hatchability of pheasant eggs (ref. 41). With chickens, dietary levels of as little as 10 ppm of Aroclor 1242 and 100 ppm of Aroclor 1254 caused thinning of eggshells, reduced egg production, and reduced hatchability (ref. 42). In this context, it is important to note that homo logs of PCB with lower chlorine content may have a greater effect on reproduction than biphenyls with high er chlorine content. In a recent review article on the toxicology of PCB, D r. Renate Kimbrough o f th Center for Disease Control in Atlanta, Georgia, stated: The results obtained from the reproduction studies in birds particularly seem to indicate that 896500anao 418 774616 the lower chlorinated biphenyls affect reproduc* tion more than the higher chlorinated biphenyls, and it is very important to determine whether the lower chlorinated biphenyls that have been suggested as replacements for presently employ ed chlorinated biphenyls have an effect on repro duction (ref. 36). In an extensive series o f studies carried out by D r. James Allen and his colleagues at the University of Wisconsin Medical School, PCB's fed in the diet of rhe sus monkeys caused significant effects that mimicked both the symptoms of known human toxicity and repro duction failures in experimental animals. When female rhesus monkeys were given 25 ppm of Aroclor 1248 for a period of 2 months, severe symptoms of facial swelling and skin eruptions were manifested (ref. 43). A t lower dietary levels of 5 ppm and.2.5 ppm (Aroclor 1248), similar clinical symptoms were observed after a few months, and more significantly, these low levels of PCB caused marked effect on reproduction. After three matings with male monkeys, only 12.5 percent of the 5 ppm PCB dietary group and 37.5 percent o f the 2.5 ppm group were pregnant as compared to 90 percent pregnan cies with a comparable control group (ref. 4 4 ). A t the same time, fetuses that were bom were significantly smaller in size and continued to ingest high PCB levels from the nursed milk of their mothers (ref. 4 5 ). These effects at low PCB levels are particularly important to note, since the present Food and Drug Administration tolerance lim it for PCB residue in fish and shellfish is 5 ppm (ref. 46), and were based on an. assumption of a higher no-effect level. Of serious concern is a recent study conducted by a group of research investigators at the Center for Disease Control, Atlanta, Georgia, the U.S. Environmental Pro tection Agency, the National Cancer'Institute, and the John's Hopkins University School o f Medicine (ref. 4 7 ). They observed that when Sherman strain female rats were fed 100 ppm of PCB (Aroclor 1260) for about 21 months, 26 of 184 of the experimental animals exam ined had malignant liver tumors (hepatocellular carcin oma), whereas only 1 of 173 control animals had the same disease. A t the same time, 146 of the experimental and none of the control'animals had tumorous lesions (neoplastic nodules) in the liver. Other toxic effects of PCB that have been reported in the scientific literature include: (1) increase in the biological activity of certain hydroxylating enzymes in the liver and increased activity in the rat; (2) induction of liver porphyria in several animal species; (3) interfer ence with the immune defense mechanisms o f rabbits; (4) neurological disorders in rats; (5) increased PCB resi due in fatty tissues, serum, and milk; and (6) teratogenic effect in the chick embryo (refs. 4 8 ,4 9 ). IMPACT ON RECREATIONAL AND COMMERCIAL FISHERIES One of the most illustrative examples of the impacts of PCB contamination on the environment is an exami nation of its effect on sport and commercial fisheries on the Hudson River. The Hudson River is a productive breeding ground for fish, not only for resident species such as white perch, but also for migratory oceanic species like striped bass, shad, and herring. The shortnose sturgeon, which has been classified as an endanger ed species, is also an inhabitant o f the Hudson River (ref. 50). Striped bass are the most economically important of the fish that spawn in the Hudson since the species sup ports a major recreational and commercial fishery. For that reason, too, it is a species o f particular concernbecause of the high levels of public consumption of Hud son River striped bass and the economic dependence of commercial fishermen on the species. The weight in 1970 o f the striped bass commercial catch in the New England Region plus New York State (including the Hudson River) was 2,780,000 pounds (ref. 51). The weight in 1970 of the striped bass sport catch in the North Atlantic (which includes New York State) was 45,844,000 pounds (ref. 52). Hudsonspawned striped bass are a major component of the Atlantic stock. Though estimates have varied, there is no doubt that the contribution is substantial. The staff of the Nuclear Regulatory Commission (ref. 53} has taken the position that: 1. The Hudson River stock is the major source of striped bass caught in the Hudson River, the western half of Long Island Sound, and the New York Bight (Bamegat Inlet, N J ., to Moriches Inlet, N .Y .). In this " Inner Zone" of influence the NRC staff estimates that more than 50 percent o f the sports and commercial landings are made up of Hudson-spawned striped bass and uses a figure of 90 percent for its own estimates (ref. 53). 2. In the " Outer Zone" of influence, extending from Maine to Cape May County, N J . (less the Inner Zone), Hudson-spawned striped bass constitute some where between 10 and 50 percent of the sports and commercial fishery. The average annual commercial catch of striped bass for the years 1961-1969 in the Inner Zone was 268,200 pounds (ref. 53). Using the NRC's 90 percent figure. GENP 005969 419 774617 241,400 pounds represent the average annual commercial catch in the Inner Zone attributable to Hudson River striped bass. The average annual commercial catch in the Outer Zone is 1,969,000 (ref. 53), 50 percent of which is 984,500 pounds. The annual total for commer cial catch of Hudson River striped bass is therefore esti mated to be about 1,200,000 pounds. In 1970, a pound of striped bass would bring a com mercial fisherman $.26/lb on the average. The retail price would be, at a minimum, three times that amount. Striped bass is now selling at SI /lb in New York. Using this retail value of $1 /lb, the value of commercial catch of Hudson River striped bass appears to. be in the range of $1.2 million per year. In 1970, the striped bass sports catch exceeded the commercial catch in the North Atlantic (which includes New York State) by a factor of 16.5 (ref. 53). Assuming an annual commercial catch of 1,200,000 pounds of Hudson River striped bass, one can extrapolate to a sports catch of 21,200,000 pounds. This amount repre sents a little less than 50 percent of the 45,844,000 1970 sports catch of striped bass in the North Atlantic and, therefore, is, if anything, an underestimation of the Hudson River sports catch. In sum, something on the order of 22,000,000 pounds o f Hudson River striped bass are probably consumed each year, if we combine these commercial and sports catch figures. Moreover, the problem is even more serious than the above information would indicate. The striped bass is a migratory fish with stock from various sources (e.g., the Chesapeake, Delaware, and Hudson) intermingling. Since there is no way to distinguish origin of a striped bass, the entire North Atlantic stock may be contaminated. An indication of the magnitude of the total Great Lakes fishery problem from PCB contamination can best be seen by evaluating the value of sport and commercial fisheries for the State of Michigan. The sport fisheries in the Great Lakes are comprised of coho and Chinook salmon, steelhead, brown and take tro u t This fishery is known collectively as the salmon fishery. This is the fishery most substantially effected by PCB contamina tion. Value of sport fishery in Michigan is determined by multiplying the number of angler days by $15 per day. In the Great Lakes contiguous with the State of Michi gan in 1974. there were 3.1 million angler days devoted to the anadromous and Great Lakes fishery. The total value of this sports fishery is estimated at $ 46.5 million. Another determination is a total value o f the fishery to resident and nonresident fishermen. Michigan has deter mined this to be $24 to $30 million--a somewhat lesser figure but still quite substantial. The value o f the total Great Lakes sport fishery would be substantially larger when data from other States are Included (ref. 54). The commercial fishery in the Great Lakes has been on recent decline due to overfishing, so the value is,sub stantially less than the sport fishery. In 1974, the num ber of pounds caught totalled 14,524,079, with an estimated value of $3,814,840. The commercial species most affected by PCB con tamination has been observed to be chubs. These fish are caught commercially in Lake Michigan and Lake Supe rior. Their 1974 catch and value are recorded in table 5. As the above table indicates, chubs represent approximately 32 percent and 54 percent of the com mercial fishery, respectively, in these two lakes. Any significant decrease in the availability of chub popula tion to the commercial fishery will have a negative impact on the fish-related economy of the region. It is possible that a decreased chub population would elimi nate commercial fishery from the Great Lakes altogeth er. FEDERAL AND STATE GOVERNMENT ROLES Since the early 70's, when it was increasingly realiz ed that widespread contamination of PCB's had occurred in this country, a number o f events highlight the role that the Federal and State governments have taken, or have failed to take, in addressing this problem. A Federal Interdepartmental Task Force was convened in 1972, which concluded that because of the highly persistent nature o f PCB's and their bioaccumulation in the food chain, they posed a serious threat to human health. They recommend restricting the use of PCB's to closed electrical systems, such as electrical transformers and capacitors (ref. 5 6 ). However, as mentioned before, Monsanto Company had begun restricting its domestic sales for such exclusive purposes since the fall of 1970, and it is not clear what the Task Force's recommenda tions issued in May, 1972, had to do with the voluntary move made earlier by the company as has been suggested in recent remarks by an official o f a Federal agency (ref. 57). In July, 1973, the Federal Food and Drug Adminis tration established tolerance limitation in a variety of food products as follows (table 6): Toxicity data obtained during the past year that show severe reproductive failure in low concentrations of PCB in primates (5 and 2.5 ppm), and the recent demonstration of carcinogenicity with Sherman strain rats (refs. 44,47), clearly indicate the need to substanti ally revise the present FD A tolerance limitations of PCB's in foods. This in turn will have the effect of com pletely changing the definition of " unacceptable" levels of PCB's in fish and poultry, to be. at times almost all 420 GENP 005970 774618 Lake Michigan Lake Superior Table 5. 1974 commercial fish catch and value in Lakes Michigan and Superior (ref. 55) Chubs Catch (lbs) Value ($) Total Fish Catch (lb s) 1,154,067 1,011,234 780,793 464,499 10,924,961 1,529,736 Value ($) 2,496,208 826,592 Table 6. FDA tolerances for PCB in food and food packaging (ppm) (ref. 46) Product Tolerance level (ppm) M ilk a Dairy product Poultry . Fish and s h e llfis h 0 Eggs Infant and ju nior food Complete and finished animal feed Animal feed components Paper food-packaging material 2.5 2.5 5.0 5.0 0.5 0.2 0.2 2.0 10.0 ` a0n fa t basis. ^Edible portion. inclusive of many species that inhabit the polluted lakes, streams, or feedlots, in this country. In spite of the deficiencies of the present tolerance standards, the FD A has in recent months taken seizure action against several fish shipments earmarked for com mercial markets in Lake Michigan, since they exceeded the present 5 ppm guideline (ref. 61). Similarly, the FDA seized a shipment of carp this summer in Lake Pepin on the Mississippi River (ref. 58). In view of a recent legal decision that clearly allows the FDA to define pesticide residues in foods as an indirect food additive, the FDA is expected to enforce its guidelines more forcefully in the future. FD A officials -in the Great Lakes region have warned that chubs, coho salmon, and lake trout may be disallowed in interstate commerce, since they continue to contain high residue levels of PCB's (ref. 61). It is apparent that with a more thorough monitoring and surveillance program, nearly all species of fish in the Great Lakes region and in several rivers in the East coast area will be essentially unavailable for human consumption for many years to come. One of the great ironies of the present situation is that over 3 years ago the Federal Water Pollution Con trol. Act (FWPCA) directed the Federal Government, specifically the Environmental Protection Agency (EPA) to take swift action to reduce the discharge of PCB's and other toxic water pollutants to safe levels. The fact that today there is no meaningful national program to regu late PCB discharges is a result of the Federal Govern ment's disappointing failure ;to carry out the FWPCA as Congress wrote it or, for that matter, to take any other strong regulatory action. 421 774619 GENP 005971 The Congressional authors of the FWPCA believed that the "hazards posed by toxic substances" made their effective regulation "especially urgent" (ref. 59). Ac* cordingly, they established in the act a "national policy that the discharge of toxic pollutants in toxic amounts be prohibited" (ref. 60) and added to the act a far-reach ing special provision, Section 307(a), to insure that this goal was fully implemented. If Section 307 (a)'s manda tory deadlines had been met, toxic pollutant effluent standards covering PCB's and other toxic pollutants would have been promulgated by EPA roughly 2 years ago and complied with by dischargers about 1 year ago. Yet, to date EPA has failed to promulgate a single stand ard under this provision. State officials have also expressed dismay over the EPA's failure to promulgate toxic substances effluent standards. John Hesse of the Michigan Department of Natural Resources in recent comments at a regional con vention, stated: I want to mention that the delay in this standard [effluent standard for PCB] has weak ened the states attack on industrial sources and is long over-due. (ref. 61) It is instructive to review the events leading to the current situation. Section 307(a) of the act requires EPA to first develop a list of toxic water pollutants. For the substances on this list EPA must subsequently develop and enforce strict effluent standards, standards which must protect the users of the waters with an "ample margin of safety" (ref. 60). EPA began inauspiciously by failing to meet FWPCA's January 1 2 ,1 9 7 3 , deadline for publication of the list of toxic pollutants. When 4 months later the list had still not been published, the Natural Resources Defense Council brought suit chal lenging EPA's default. That suit ended on June 19, 1973, when the U.S. District Court ordered EPA to publish the list "on or before August 31, 1973" (ref. 62). The list published by EPA as a result of this court directive, though inadequate in many respects, did in clude PCB's along w ith eight other pollutants, Section 307(a) also requires that prior to promulgat ing final standards for substances it has listed, EPA must first propose such standards for public comment and then hold a formal hearing on them. Standards for the nine substances, PCB's included, were in fact proposed by EPA on December 27, 1973. The required hearing began a month later and continued through May, 1974. Under Section 307(a) EPA is mandated to promulgate final standards not later than 6 months after publication of proposed standards, or "immediately" if EPA chooses to modify the proposed standards as a result of the hear ings (ref. 60). Yet, despite this requirement, 2 years have elapsed without the promulgation by EPA of a single standard under Section 307(a). This failure to develop final standards is being chal lenged in a law suit brought in the District of Columbia (ref. 63). The NRDC and the Environmental Defense Fund (EO F), plaintiffs in the suit, are claiming that the EPA's omission is contrary to FWPCA's requirements and are seeking a ruling establishing court-ordered dead lines for final EPA action on toxic pollutant effluent standards. In affidavits filed in this law suit, EPA has stated that the record of the original hearing "could not justify or support the promulgation of either the origin ally proposed standards or any specific modification thereof" (ref. 64). In support of this conclusion, EPA claims that the evidence at the hearing was inadequate to permit the agency to determine "what level of each of the toxic pollutants would provide an ample margin of safety as required by Section 307(a) of the A ct." EPA also states that it was unable at the hearings "to either assess or respond to " industry evidence "tending to show" that the proposed standards would have substan tial economic repercussions on the regulated industries (ref. 6 4 ). Accordingly, EPA now intends to repropose, i.e., to propose new toxic pollutant effluent standards, and to begin the hearing process again. The agency states that under its new schedule it "expects" to propose new standards for PCB's in late February, 1976 (ref. 65). EPA has also informed the parties to the law suit that these new PCB standards, unlike the original standards, will be limited to dischargers who manufacture PCB's or use PCB's in castings, electrical transformers and capaci tors. Behind this record of delay lies a series of complex problems which deserve to be examined in a far more comprehensive manner than we can undertake here. Our own judgment, based on our work in this area over the past 3 years, is that several underlying factors are princi pally responsible for this failure o f Federal regulation. We offer them for further examination and discussion. First, EPA has not had during this period a strong institutional commitment to doing something about the problem of toxic water pollutants. Partly this is a reflec tion of the historic concerns of the sanitary engineering profession, concerns which still dominate much of EPA's thinking, and partly it results from the failure o f EPA leadership to assign priority attention to this problem during the formative period o f the agency's programs. Even as Congress was developing the act, EPA informed the House Public Works Committee that "we do not endorse the provisions of Section 307 relating to toxic substances" (ref. 66). Subsequently, the resources EPA allocated to the toxic pollutant problem were miniscule r-t;t4P 0059T2- 422 774620 in comparison with the need, and this pattern continued despite the fact that it was repeatedly criticized. As late as March, 1975, EPA's priorities in the' water pollution area completely neglected control of toxic pollutants. In a discussion of priorities for fiscal year 1976, EPA failed to mention toxic pollutants in a table listing the agency's first, second, and even third priorities for the coming year (ref. 67). A second factor has been the very large and well financed efforts by the dischargers of toxic pollutants to oppose development of standards under Section 307(a). Approximately 35 major corporations and industry groups challenged EPA's proposed standards in the for mal hearing that was held in early 1974. The talents of many of the country's best paid lawyers and scientists were at the disposal of the PCB, mercury, and cyanide dischargers, and it seems almost certain that far more resources were spent picking apart EPA's proposed standards than EPA had used in developing them. One theme developed by the dischargers at these hearings was the potential economic impact of meeting the proposed standards. Evidence was introduced at the hearings to show that the technology to meet some of the standards was not available or that where it was available it could only be installed at substantial ex pense. It was also contended that the proposal would force segments of major industries to shut down. EPA, though it has never rigorously investigated these claims, has nevertheless acted on them to the point that concern over economic dislocations has become a major inhibit ing factor within the agency, overshadowing any concern with public health and environmental quality. Environ mental organizations have urged EPA, unsuccessfully, not to delay standards development on these grounds, pointing out the self-interest in such claims of hardship and also EPA's obligation to implement the act as Con gress wrote it. If a discharger believes that a variance from a Section 307(a) standard is justified in light of economic hardship, that plea, environmental groups have urged, should first be addressed to Congress, since Sec tion 307(a) does not now contain a variance provision. But the absence of such a variance provision should not be used to justify inaction, or inadequate action, by EPA. Because of recent publicity in the media of PCBcontamination in the Great Lakes region and the Hudson River, it is encouraging to note that several States have taken administrative and legislative initiatives to control the discharge of PCB's into lakes and rivers. Earlier this year, the Michigan Natural Resources Commission endorsed the recommendation of the Lake Michigan Toxic Substances Committee, calling for a ban on PCB imports and use in the United States and for a rapid replacement of PCB's in electrical capacitors and trans formers (ref. 61). A t the same time, a bill has been intro duced in the State Legislature to place strict control on the use and sale of PCB's in the State (ref. 61). In Wisconsin, the Division of Health of the State Department of Natural Resources has issued warnings on consumption of large size lake trout and salmon from Lake Michigan and the upper Mississippi River. The Department also held a hearing in August of this year, with a view to developing a strategy to control the sale and distribution of PCB's within the State (ref. 61). In Minnesota, an Interagency Task Force was established, principally to widen the monitoring of PCB's in fish in several rivers and streams in the State (ref. 24). In terms of administrative remedies, the strongest action was taken- this year in New York State, after it was discovered that two G E plants on the Hudson River appeared to be the major dischargers of PCB's in upper regions of the river. The New York State Depart ment of Environmental Conservation on September 23, 1975, issued an abatement order requiring the *G E plants to achieve zero discharge of PCB's by September 30, 1976. Administrative hearings begun on October 6, 1975, are expected to continue for several weeks (ref. 69). A t the same time. Commissioner Ogden Reid of the department publicly cautioned consumers against eating striped bass from the Hudson River and salmon caught in Lake Ontario (ref. 70). On the international front, the Organization for Economic Cooperation and Development (OECD) a few years ago recommended to its member countries, which includes the United States, West Germany, France, United Kingdom, Japan, Italy, and Spain, involved in the production of PCB's, to restrict the commercial use of PCB's to closed systems (ref. 71). Only Japan has taken further strict measures to completely eliminate the use of PCB's in all commercial application, including capaci tors and transformers. It also prohibits the import and export of the compound, and since'September, 1972, there has been a virtual elimination of almost all applica tions of PCB's in the country (ref. 57). CONCLUSION AND RECOMMENDATIONS On August 29 of this year, NRDC and the Hudson River Fisherman's Association requested the Adminis trator of EPA to take immediate and decisive action to curtail the discharge of PCB's into the Hudson River, pursuant to 504 of the#Federal Water Pollution Con trol Act (FWPCA) (ref. 72). Under 504, the EPA is given authority to seek whatever emergency relief is needed to seek abatement with pollution sources pre senting "an imminent and substantial endangerment to GENP 0059TM 423 774621 the health of persons or to the welfare of persons." To date, we have received no indication that the EPA s prepared to take emergency action against PCB dischar gers, and with respect to the G E plants on the Hudson River, it has postponed its permit hearings pending the present State of New York proceedings against the company. At the same time, we are very concerned about the proposal by the U.S. Army Corp of Engineers to under take extensive maintenance dredging in shipping chan nels in the Hudson River. We have called upon the Corp of Engineers to hold public hearings before the agency prepares its final environmental impact statement, since in the earlier draft statement the agency had failed to recognize the problem of PCB contamination of sedi ments in river bottoms (ref. 73). On behalf of three New York environmental and conservation organizations, we have intervened in the administrative proceedings now being conducted by the New York State Department of Environmental Conser vation against the two G E plants in the Fort EdwardHudson Falls region of the Hudson River. We are in general agreement with the State's abatement order of achieving zero discharge of PCB's by September next year. Finally, we are at present, along with the Environ mental Defense Fund, planning to petition the Federal Food and Drug Administration to lower the current PCB tolerance limits on foods and food products in the United States. This is, as mentioned previously, based on recent long-term data that show considerably lower "effect" levels of PCB's on experimental animals. We recommend the following courses of action that should be taken by Federal and State agencies to address the problem of PCB's contamination of the environ ment: 1. A complete phase-out of the manufacture, sale, use and distribution of PCB's in this country, including its use in closed electrical systems; 2. A ban on the import and export of PCB's to and from the United States; 3. Development of a PCB use and consumption inventory, to pinpoint all point and nonpoint discharge of PCB's to the environment; 4. An accelerated program of monitoring and sur veillance of PCB's in fish, wildlife, and foods by State and Federal agencies; 5. A moratorium on all dredging of river bottoms, until a complete study is conducted to examine the resuspension of PCB's in river water from such activities; 6. Promulgation by the EPA of the toxic sub stances effluent standard with respect to PCB's, such that water quality standards in receiving streams be no more than 0.001 ppb; 7. A significant lowering of present FD A tolerance limitation of PCB's in foods to reflect present knowledge of its long term chronic toxicity; and 8. A swift passage of the Toxic Substances Con trol Act, which is still pending in Congress, to provide additional authority to Federal agencies to cope with the manufacture and use of toxic substances. ACKNOWLEDGEMENT The author is grateful to Sarah Chasis, Esq., J. Gustave Speth, Esq., Frances Beinecke, and Eileen Richmond for their assistance in the preparation of this report. REFERENCES 1. S. Jensen, " A New Chemical Hazard," New Scienfist, Vol. 32 (1966), p. 612. 2. G. Widmark, "Possible Interference by Chlorinated Biphenyls," J. Assoc. Offic. Anal. Chem., Vol. 50 ` (1967), p. 1069. 3. M. G. Broadhurst, "Use and Replaceability of Poly chlorinated Biphenyls," Environ. Health Perspec tives. No. 1 (1972), p. 81. 4. 'Polychlorinated Biphenyls. Their Use and Con tro l," published by the Environment Directorate, Organization for Economic Cooperation and Devel opment (OECD), Paris, November 1973. 5. "Polychlorinated Biphenyls -- Environmental Im pact," A review by the Panel on Hazardous Trace Substances (Chairman: Norton Nelson), Environ mental Research, V ol. 5 (1972), p. 249. 6. J. H. Koeman, M. C. TenNoever DeBrauw, and R. H. DeVos, "Chlorinated Biphenyls in Fish, Mussels and Birds from the River Rhine and the Netherlands Coastal Area," Nature, Vol. 22I (1969), p. 1126. 7. S. Jensen, A . G. Johnels, M. Olsson and G. Otterlind, "D D T and PCB in Marine Animals from Swedish Waters," Nature, Vol. 224 (1 9 6 9 ), p. 247. 8. A . V . Holden, "Source of Polychlorinated Biphenyl Contamination in the Marine Environment," Na ture. V ol. 228 (1970), p. 1220. 9. R. W. Risebrough, P. Rieche, D . B. Peakall, S. G. Herman and M. N . Kirven, "Polychlorinated Bi phenyls in the Global Ecosystem," Nature, V ol. 220 (1968), p.464. 10. V . Zitko, "Polychlorinated Biphenyls and Organochlorine Pesticides in Some Freshwater and Marine 424 aBM? 005974 774622 Fishes," Bull. Environ. Contam. Toxicol., V ol. 6 (1970), p. 464. 11. G. D. Veith, "Recent Fluctuation of Chlorobiphenyls (PCBs) in the Green Bay Wisconsin Re gion," Environ. Health Perspectives, No. 1 (1972), p. 51. 12. "Chester River Study," published by Maryland Department of Natural Resources and Westinghouse Electric Co., Annapolis, Maryland, November 1972. 13. D. L. Stalling and F. L. Mayer, 'Toxicities of PCBs to Fish and Environmental Residues," Environ. Health Perspectives, No. 1 (1972), p. 159. 14. T . W. Duke, J. I. Lowe, and A . J. Wilson, Jr., "A Polychlorinated Biphenyl (Aroclor 1254) in the Water, Sediment and Biota of Escambia Bay, Flor ida," Bull. E nviron.. Contam. Toxicol., V ol. 5 (1970), p. 171. 15. R. W. Risebrough, V . Vreeland, G. R. Harvey, H. P. Miklas and G. M. Carmignani, "PCB residues in Atlantic Zooplankton," B ull. Environ. Contam. Toxicol., V ol. 8 (1972), p. 345. 16. C. S. Giam, M. K. Hong, A . R. Hanks, W. M. Sackett and R. L. Richardson, "Chlorinated Hydrocarbons in Plankton From the G ulf of Mexico and Northern Caribbean," Bull. Environ. Contam. Toxicol., Vol. 9 (1973), p.376. 17. D . M . Ware and R. F. Addison, HPCB Residues in Plankton From the G ulf o f S t. Lawrence," N ature, V ol. 246 (1973), p. 519. 18. V . Z itko and P. M. K . Choi, "PCB and Other Indus trial Halogenated Hydrocarbons in the Environ , ,ment," Fish. Res. Board Canada Technical Report V ol. 2 7 2 (1 9 7 1 ), p. 1. 19. I. Prestt, D . J. Jeffries, and N. W. Moore, "Polychlo rinated Biphenyls in Wild Birds in Britain and Their Avian Toxicity," Environ. P oll., Vol. 1 (1970), p\ 3. 20. J. H. Koeman, "PCB in mammals and birds in the Netherlands," PCB Conference I I (S. Lundstrom, ed.) National Swedish Envrionmental Protection Board publication 4E, Stockholm, 1972, p. 35. 21. Y . A . Greichus, A . Greichus, and R. J. Emerick, "Insecticides, Polychlorinated Biphenyls and Mer cury in Wild Cormorants, Pelicans, Their Eggs, Food and Environment," Bull. Environ. Contam. Toxb co l., Vol. 9 (1973), p. 321. 22. J. L. Hesse, "Contaminants in Great Lakes Fish," s ta ff report, Michigan Department of Natural Resources, June 1975. 23. P. Degurse and V . Duter, "Chlorinated Hydrocarbon Residues in Fish From Major Waters of Wisconsin," published by Bureau of Fish and Wildlife Manage ment, Wisconsin Department o f Natural Resources, Report No. 79, Madison, Wise., July 1975. 24. "Preliminary Report on - the Polychlorinated Bi phenyls in Mississippi River and Lake Pepin," by the Interagency Task Force on PCB's, obtained from Minnesota Pollution Control Agency, St. Paul, Aug. 1975. 25. J. L. Hesse, "PCB Situation in Great Lakes Fish," report to the Michigan Water Resources Commis sion, April 1 7 ,1 9 7 5 . 26. P. J. Palermo, "Progress Report, Massachusetts Pesticide Monitoring Program, April 1972 to March 31, 1973," Division of Fisheries and Game, Com monwealth of Massachusetts, Boston, Mass., 1973. 27. R. J. Nadeau and R. Davis, "Investigation of Poly chlorinated Biphenyls in the Hudson River: Hudson Falls-Fort Edward Area," EPA Region II Report, circa, October, 1974. 28. "Monitoring of PCB's in Fish Taken From the Hud son River," published Bureau of Environmental - Protection, Division of Fish 8t Wildlife, New York Department of Environmental Conservation, A l bany, N .Y., October 1975. 29. John Turk, United States Geological Survey, Air bany, N .Y ., (private communication). 30. Thomas Munson, Westinghouse Ocean Research Lab., Annapolis, Maryland (private communica tion). Also from preliminary draft of the Upper Chesapeake Bay study. 31. "Water Quality Criteria," a report of the Committee on Water Quality Criteria Environmental Studies Board, National Academy of Sciences, National Academy of Engineering, Washington, D.C., 1972. 32. S. Jensen, N. Johannson, and M. Olsson, "PCB -- Indications of Effects on Salmon," PCB conference sponsored by Swedish Salmon Research Institute, Stockholm, September 2 9 ,1 9 7 0 . 33. National Water Quality Lab., Quarterly Research Report, Duluth, Minnesota, June, 1971. 34. D. J. Hansen, P. R. Parrish, J. I. Lowe, A . J, Wilson, Jrs., and P. D . Wilson, "Chronic Toxicity, Uptake, and Retention of a Polychlorinated Biphenyl (Aro clor 1254) in two Estuarine*Fishes," B ull. Environ. Contam. Toxicol., V ol. 6 (1970), p. 113. 35. D . J. Hansen, P. R. Parrish, and J. Forester, "A ro clor 1016: Toxicity to and Uptake by Estuarine Animals," Environ. Aeses/cA, V ol. 7 (1974), p. 363. 36. R. D. Kimbrough, 'T h e Toxicity o f Polchlorinated Polycyclic compounds and Related Chemicals", CRC C ritical Reviews in Toxicology, January 1974, p. 445. 37. M. Kuratsune Y . Morikawa, T . Hirohata, M. Nishizumi, S. K oh ch i.T . Yoshimara, et al., "A n Epidemi ological Study on 'Yusho' or Chlorobiphenyls Poisoning", *ukuoka A cta M ed., Vol. 60 (1969), p. 513. 38. M . Kuratsune, T . Yoshimura, J. Matsuzaka, and A . 425 ENP 005975 774623 Yamaguchi, "Epidemiological Study of Yusho, a Poisoning Caused by Ingestion of Rice Oil Contami nated With a Commercial Brand of Polychlorinated Biphenyls", Environ. Health Perspectives, No. 1 (1972), p. 119. 39. H. A. Price and R. L. Welch, "Occurence of PCB's in Humans", Environ. Health Perspectives, No. 1 (April 1972). 40. N. S. Platonow and L. H. Karstad, "Dietary Effects of Polychlorinated Biphenyls on M ink," Canadian J. Comp. Med,, Vol. 37 (1973), p. 391. 41. R. B. Dahlgren, R. L. Linder, and C. W. Carlson, ''P o ly c h lo rin a te d Biphenyls: Their* Effects on Penned Pheasants", Environ. Health Perspectives, No. 1 (1972), p. 402. 42. M. L. Keplinger, 0 . E. Fancher and J. C. Calandra, "Toxicologic Studies With Polychlorinated Bi phenyls", Toxicology & Applied Pharmacology Vol. 19 (1.971), p. 402. 43. J. R. Allen, L. A. Carstens, and D. A. Barsotti, "Residual Effects of Short-Term, Low-Level Expo sure of Nonhuman Primates to Polychlorinated Bi phenyls," Toxicol. & Appl. Pharmacol., Vol. 30 (1974), p. 440. 44. J. R. Allen, "Response of the Nonhuman Primate to Polychlorinated Biphenyl Exposure," Federation Proceedings, Vol. 34 (1975), p. 1675. 45. J. R. Allen, University of Wisconsin Medical School, Regional Primate Research Center, Madison, Wis consin (private communication). 46. Federal Register, Vol. 38, No. 129 (July 6, 1973), p. 18096. 47. R. D. Kimbrough, R. A- Squire, R. E. Linder, J. D. Strandberg, R. J. Montali, and V .W . Burse, "Induc tion of Liver Tumors in Sherman Strain Female Rats by Polychlorinated Biphenyl Aroclor 1260," preprint of study obtained from R. D. Kimbrough, Center for Disease Control, Atlanta, Georgia. 48. "Polychlorinated Biphenyls and the Environment," Interdepartmental Task Force on PCB's, Washing ton, D.C., May 1972. 49. J. R. Allen and /D. H. Norback, "Polychlorinated Biphenyl and Terphenyl-lnduced Gastric Mucosal Hyperplasia in Primates," Science, Vol. 179 (1973), p. 498. 50. U, S. Department of the Interior, "Endangered Species of the United States," Bureau of Sport Fish eries & Wildlife, U. S. Fish & Wildlife Service, 1970. 51. "Fisheries Statistics of the United States," National Marine Fisheries Service publication, 1971. 52. D. G. Deuel, "1970 Salt-Water Angling Survey," U. S. Department of Commerce. ?!OAA, National Marine Fisheries Service, Current Tishery Statistics No. 6200, 1973. 53. Final Environmental Statement (FES), Operation of Indian Point Nuclear Generating Station Unit No. 3, Consolidated Edison Company of New York, Inc., February 1975. 54. "Michigan Great Lakes Trout and Salmon Fishery, 1969*1972"', Fisheries Management Report No. 5, Michigan Department of Natural Resources. June, 1973. 55. J. L. Hesse and N. Fogle, Michigan Department of Natural Resources, Fisheries Divison (private com munication). 56. "Polychlorinated Biphenyls and The Environment", Interdepartmental Task Force on PCB's, Washing ton, D.C., May, 1972. 57. G. E. Schweitzer, Director, Office of Toxic Sub stances, Environmental Protection Agency, in state ments made at a Hearing on PCB's held by the Wis consin Department of Natural Resources, Madison, Wisconsin, August 2 9 ,1 9 7 5 . 58. "Mondale, HHH center PCB Fray", Minneapolis Tribune, August 2 6 ,1 9 7 5 , p. 1-B. 59. Senate Report No. 92-414, 92nd Congress, 1st Ses sion, (1971), p. 61. 60. Title 33, United States Code, R1251 (a) IFWPCA R101 (a) (3); R307 (a) ( 4 ) ] . 61. J. L. Hesse, Michigan Department of Natural Re sources, Lansing, Mich. "Summary of Regulatory Efforts o f The Great Lakes Region Toward The Environmental Control of PCB's (Polychlorinated Biphenyls)", speech presented to the Governor's Great Lakes Regional Interdisciplinary Pesticide Council, Chicago, Illinois, September 1 8 ,1 9 7 5 . 62. Natural Resources Defense Council v. F ri, D.D.C. Civil Action No. 849-73, Decree and Stipulation (June 19,1973). 63. Environmental Defense Fund and Natural Resource Defense Council v. Train, D.D.C. Civil Action No. 75-0172. 64. R. V . Zener, affidavit filed August 1 2 ,1 9 7 5 in E D F and NR DC v. Train, (reference 63). (5 . K. M. Mackenthun, affidavit filed August 1 2 ,1975, in E D F and N R D C v. Train, (reference 63). 66. " A Legislative History of the Water Pollution Con trol Act Amendments of 1972", Senate Committee on Public Works, Serial No. 93-1, 93rd Congress, 1st. Session (1973), p. 1199. 67. B N A Environment Reporter, Current Develop ments, Vol. 5 (March 28, 1975), p. 1893. 68. Lake Michigan Toxic Substances Committee, EPA, et al,, a statement of concern relating to PCB's, draft, 1975. 69. New York State Department of Environmental Con servation, Complaint (File No. 2833) issued against General Electric Co, Sept. 2 3 ,1 9 7 5 . 426 GENP 005976 774&24 70. "Statu Says Some Striped Bass and Salmon Pose a Toxic Peril," New York Times, August 8, 1975, p. 1. 71. Decision of the Council, Organization for Economic Cooperation and Development, on Protection o f the Environment by Control o f Polychlorinated Bi phenyls, adopted by Council on February 13, 1973. 72. Letter to Russell E. Train, Adminstration, U. S. EPA, From NRDC and Hudson River Fisherman's Association, August 2 9 ,1 9 7 5 . 73. Comments of N RDC, Hudson River Fisherman's Association, and Hudson River Sloop Restoration, a proposal for maintenance dredging of The Hudson River by The U. S. Army Engineer District, New York, October 22, 1975. ENP 005977 427 774625 FDA REG ULATIO N OF PCB's IN FOOD John R. Wessel * Abstract Investigations by the Food and Drug Administration (FDA) during the period o f 1969-1971 disclosed that PCB's had become a significant contaminant o f the Nation's food supply. Spillage or leakage o f PCB's from manufacturing equipment or contact with PCB-containing materials were identified as routes of-direct contami nation o f food and animal feed. The presence o f PCB's in the environment was causing the indirect, unavoidable contamination o f certain types o f food, particularly those o f animal origin. In March 1972, the Food and Drug Administration formally proposed regulations to lim it bureau exposure to PCB's from these sources o f PCB's in the diet (the scientific and legal basis for these regulations, which were finalized in July 1973, are de scribed). Presently, the problem o f PCB contamination o f foods, except for certain freshwater fish, has substan tially diminished. Because o f new scientific information on the potential hazards o f PCB's on the public health and the continuing presence o f high levels o f PCB's in certain freshwater fish, the Food and Drug Administra tion has initiated a review o f its temporary tolerance o f 5 ppm in fish. In 1969, the Food and Drug Administration identi fied the presence of PCB residues in milk from several dairy farms in West Virginia. Eventually, the source of contamination was traced to spent PCB transformer fluid that was used as a vehicle for a herbicide. The herbicide-PCB mixture was sprayed along powerline rights-of-way causing dairy cattle grazing,areas to be come contaminated. West Virginia officials were advised that FDA would initiate regulatory action against ship ments of milk containing 5 ppm or more PCB's on a fat basis, As a result, the involved dairy farms were placed under State embargo until it was demonstrated that milk from these farms contained acceptable levels of the con taminant. t mention this incident for several reasons. First, it represented the first documented incident in which an industrial use of PCB's directly contaminated food, in this case animal feed, which subsequently caused resi dues in milk. Second, it represented the first U.S. regula tory action taken because of PCB contamination of *Scientific Coordinator, Office of the Associate Commis sioner for Compliance, Food and Drug Administration, Rock ville, Maryland. food. Third, aside from historical interests, it represent ed a preview and start of what was to become a complex and serious problem. Within the next 2 years, seven other major incidents of PCB contamination of food had occurred in the United States. Not only did these so-called "industrial accidents" present a threat to human health, they also resulted in severe economic losses to the milk, egg, poultry, and feed-producing industries. Since the details on these accidents have been reported (ref. 1), I will not describe the circumstances surrounding each. Suffice it to say that by late 1971, it was quite apparent that spillage or leakage of PCB's from manufacturing equip ment or contact with PCB-containing materials could, and did, directly contaminate food and feed. During the same period, FD A and other regulatory agencies began to routinely test foods for the presence of PCB residues. >t soon became evident that because of their widespread, uncontrolled industrial uses, PCB's had also become persistent and ubiquitous contaminants in the environment, causing the unavoidable, indirect con tamination of certain types of foods. Although scientific information on their hazards was limited in 1971, there was sufficient data for FDA to conclude that the presence of PCB's in food posed a potentially serious public health problem and that regu latory controls were necessary. Accordingly, F D A developed and published a notice of proposed rulemaking in March 1972 (ref. 2) to lim it human exposure to PCB's by dealing with the direct and indirect sources of PCB's in the diet. On July 6, 1973, a final order on the proposed regulations was issued in the Federal Register (ref. 3). The final regulations included two main provisions: First, it banned the industrial uses o f PCB's in estab lishments manufacturing, handling, or storing human food, animal feeds, and paper food-packaging materials. This was done to preclude the direct, accidental contam ination of these articles; The ban did not apply to the use of PCB-containing electrical transformers and capaci tors. The Federal Food, Drug, and Cosmetic Act pro vided the statutory authority for invoking these restric tions as part of F D A regulations on Current Good Manu facturing Practices. This preventive approach means that the industrial uses of PCB's in firms subject to FDA jurisdiction would be considered a violation of the law without first having to demonstrate that products from these firms were being contaminated. GENP 005978 428 774626 The second provision of the FDA regulations was the establishment of temporary tolerance for unavoid able, indirect PCB contamination of milk and other dairy products, eggs, poultry, baby foods, animal feed and feed ingredients, and fish; also, since 1973, FD A has had in effect an action level for PCB's in paper food packaging materials (table 1), Table 1. FDA temporary tolerances for PCB's Commodi ty Milk Dairy products Poultry Eggs Finished animal feeds Animal feed components Fish Infant and junior foods Paper food packaging material Temporary tolerance (ppm) 2.5 (fa t basis) 2.5 (fa t basis) 5.0 (fa t basis) 0.5 0.2 2.0 5.0 (edible portion) 0.2 10.0* aAction le v e l. Prior to the 1972 issuance of the proposed PCB regulations, FDA used guidelines or informal action levels to control the marketing of foods and feeds with excessive PCB residues. The authority to establish the tolerances for PCB's in these consumer products is found in section 406 of the Federal Food, Drug, and Cosmetic Act. This section provides that where the addition of a poisonous or dele terious substance to food cannot be avoided, regulations shall be promulgated to set limits on the quantity of the substance permitted. Section 406 contains three criteria for the setting of these limits: (1) the extent to which a limit is necessary for protection of public health, (2) the extent to which the substance cannot be avoided, and (3) the other ways in which the consumer may be af fected by the same or other poisonous or deleterious substances. In dealing with the problem of unavoidable PCB contamination of foods,* FDA's principal objective was to minimize human exposure from dietary sources of PCB's. At the same time, the agency sought to avoid serious disruption of the Nation's food distribution system so as not to deprive the consumer of a significant portion of his food supply. As a result, it was considered necessary to establish separate and different limits for each type of food shown to contain unavoidable resi dues. Only in this way would overall dietary levels be kept at a minimum and would the public be assured that PCB's', if present in these foods, are generally within safe limits. Thus, the selection of appropriate tolerance levels for PCB's in the different foods represented a "bal ancing" between potential harm to the consumer and economic impact. This balancing principle, which is mandated by section 4 06 of the statute, necessitated the use of subjective judgment regarding available informa tion on the toxicity o f PCB's and on the occurrence of PCB's in the food supply. In other words, while they took into account established, acceptable daily intakes, the tolerance levels were not based solely on A D I's, nor can they be explained strictly in terms of ADI's. Data from FD A total diet studies and surveillance programs fo r 1969-1972 were also important considera tions. These data showed that PCB residues in food were sporadic and that by eating a well-balanced diet, there was only a remote possibility of systematic exposures to PCB's at or above the ADI's over an extended period of time. As a result, FD A concluded that the tolerance levels would provide an adequate margin of safety for the public, provided dietary exposure to PCB's remained sporadic and, in time, would diminish. This approach also allowed FD A to set the tolerance levels high enough to minimize the economic impact that would result from the food and feed industries' compliance with the toler ances. Since issuance of the FD A regulations, the agency has not encountered the types of " PCB-accidents" in volving food or feed that had occurred prior to 1972. Current surveillance data form FD A , the U.S. Depart ment of Agriculture, and others show that with the ex ception of freshwater fish, the presence of PCB's in those commodities subject to tolerances continue to be random and sporadic, but with an overall substantial decline in their frequency and levels. This decrease is precisely what FD A intended when 429 U E N P 00J979 774627 it promulgated the PCB regulations and, as I just men tioned, served as one of the basic premises for the tem porary tolerances. FD A attributes the present situation to several fac tors: 1. Voluntary restrictions instituted by industry with respect to the industrial uses of PCB's. This has resulted in less potential for PCB contamination of the environment and subsequent transfer to food. 2. Regulatory actions initiated by FD A , USDA, and State agencies when excessive levels of PCB's in food were encountered. This has had a salutary effect on industry practices. 3. Efforts of the food and feed industries to conform to Current Good Manufacturing Practices and to market only those products that comply with the tolerances. I wish to emphasize, however, that the present situ ation does not mean that F D A considers PCB's to be no longer a problem. Since occasional shipments of food exceeding tolerance have been encountered during the past 2 years, there is s t^ .a need to monitor foods for PCB residues and to have regulations governing the presence of PCB's in the food supply. Furthermore, and certainly of a more serious nature, is the continued prob lem of PCB's in fish as a result of continued industrial discharges of the chemical into lakes and rivers. Needless to say, reports of PCB levels in freshwater fish from certain waters at 5 to 10 times higher than the FDA tolerance of 5 ppm are reasons for concern, particularly since there is little, if any, scientific disagreement that the regular and consistent consumption of fish at these levels may pose a potentially serious threat to the con sumer. Because of this concern, !FDA recently began evalu ating the adequacy of its current tolerance for PCB's in fish. This evaluation includes a review o f all recently reported studies on the toxicity of PCB's, as well as a review of available data on the current PCB levels in fish and the economic impact that would result from a low ering of the 5 ppm tolerance. If the decision is made to lower the tolerance, a proposed amendment to the existing regulation will be published in the Federal Register along with a detailed explanation of the basis for the proposal. Through this rulemaking procedure, public comment will be solicited and fully considered by F D A before final action is taken and implemented. Obviously, a lowering of the tolerance by FD A will not in itself solve the many problems of pollution of the environment with PCB's. Nor wilt it guarantee that fish available for consumption will comply with the toler ance since only fish involved in interstate commerce are subject to FDA's jurisdiction. Thus, FD A enforcement of a lower tolerance will not necessarily result in addi tional protection for each and every consumer. Further more, even if warnings and advisories are issued by FDA and State officials, there is no assurance that sports fish ermen and, perhaps others, would abide by these warn ings. The same may also be said for foods other than fish since, as long as the chemical is being used in a manner that causes its introduction into the environment, the potential for the indirect contamination of the food sup ply surely exists. For these reasons, the Food and Drug Administra tion urges and will support the Environmental Protec tion Agency and State agencies in the initiation of con trols aimed at the industrial uses and particularly the disposal of PCB's in order to curtail and eliminate further pollution o f the environment and the contamin ation of foods with PCB's. REFERENCES 1. Polychlorinated Biphenyls and the Environment, In terdepartmental Task Force on PCB's, Washington, D.C., May 1972. 2. Commissioner of Food and Drugs, " Proposed Rulemaking on Polychlorinated Biphenyls,'* Federal Register, Vol. 37, No. 54 (March 18, 1972), pp. 5705-5707. 3. Commissioner o f Food and Drugs, " Polychlorinated Biphenyls -- Contamination of Animal Feeds,. Foods, and Food Packaging Material s," Federal Register, Vol. 38, No. 129 (July 6, 1973), pp. 18096-18103. .O 00 o 430 774628 PROGRAMS AND AUTHORITIES OF THE ENVIRONMENTAL PROTECTION AGENCY Walter C. Barber* Abstract The Environmental Protection Agency operates under many constraints, its research and regulatory functions are influenced by Congress, court action, and public opinion. The time and energy required to produce even a simple regulatory action is substantial. A n d what appears to be.a large EPA staff is actually small when the number o f toxic substances and contaminant point sources to be controlled are considered. When creating regulations, EPA must attempt to make them reasonable and enforceable; the regulations then must o f necessity be limited. EPA's role with respect to the Federal Water Pollu tion Control A ct and the Clean A ir A c t is herein ex plained. Recommendations are made that could improve the Federal/State Point Source Regulatory Program: public awareness could be increased among people who use PCB's as to their handling and disposal; there is potential fo r jo in t industrygovernment voluntary label ling and disposal control for PCB's; EPA could focus attention on electric utilities, the major user o f PCB's; jn d finally, local water quality management programs funded under the Federal Pollution Control A c t could be redirected so that they give PCB control greater em phasis. The purpose of my talk is not to tell you again what either EPA has or has not done to. control PCB's or to tell you what we are going to do. Quite frankly, I do not know what we are going to do beyond what you have heard explained in terms of increased monitoring, re search, establishing a 307(a) toxic effluent limitation, and establishing permit limitations for known dis chargers of PCB's. Rather, what I thought I would do today is briefly to review EPA's programs and authorities. I will try to give you a feel for the context of our decisionmaking and the limitations on it so that the non-EPA people here have a better feel for what they can rely on the Federal Government to do in the future and what things they probably ought to think about doing at the State or even, perhaps more importantly, at the local level. Perhaps the overriding concern is that Federal regu lation in the environment (or anywhere else) requires a Director, Standards and Regulations Evaluation Division, OfficB of Planning and Evaluation, Environmental Protection .gency, Washington, D.C. clear understanding of the consequences of regulatory action. The law requires it, the public expects it, and we are making every effort to do t. As a result, the regula tory process is not as responsive and rapid as we might like it to be Dr. Ahmed made some pointed comments about EPA progress in regulating under the Federal Water Pollution Control Act. These comments were fac tually correct, but I think there are probably some rea sons for these things happening, generic reasons associ ated with Federal regulation that we should keep in mind, t do not know that there is a way, even if all the people in the Environmental Protection Agency were replaced, to cha> ige substantially the approach to envi ronmental reguli !on at the Federal level. It is import*. for non-Federal people to remember that the Federal Government is no more than a collec tion of people. The people who are going to regulate PCB'5 are in this room or have been in this room over this 3-day period. So when we say that EPA or the Fed eral Government should do something, in essence we are saying that the people sitting here, who know no more or less about PCB's than you do,, should do something. The Environmental Protection Agency is not a very large organization when you think about the scope of the problems that Congress has asked it to deal with. EPA is asked to regulate tens of thousands of station ary-point sources of air and water pollution, tens of thousands of pesticides that are being used in the envi ronment, and tens and even hundreds of thousands of drinking water supplies. We have programs on radiation noise. Solid waste, and toxic substances. In addition, we have what is considered to be the largest Federal Public Works program in our Municipal Construction Grants effort. We also have a substantial research and develop ment program. There is no army of people to implement these programs. There are fewer than 10,000 people in the Agency with only a couple of hundred in the Regional Office here. When they are divided among the various programs and the number of sources to be con trolled, and the time and energy that goes into taking even some of the most simplistic regulatory enforcement steps is considered, it seems unlikely that EPA will be able to revolutionize regulation or enforcement in the area o f PCB's. Mr. Train has made it clear that he is going to accord a high priority to PCB control, and hopefully, we are going to do substantially better than we have. How ever, we do not have hundreds o f iFederal bureaucrats to 431 i 774629 locate and control all the sources of the PCB's that are going into municipal sewers, being dumped on the ground, and running off into streams and rivers. It is important to remember that our resource allocations fre quently are driven by things that we cannot control. We come under tremendous pressures from the public, the courts, and from the Congress to do or take action in various areas. A year ago, municipal construction grants received a great deal of attention--we were not spending the construction grants money fast enough or building enough municipal treatment works. With regard to regu* lations, our friends at NR DC have served a very valuable public service by encouraging us to' overcome our bureaucratic inertia and to move faster in some areas. But in fact our efforts to accelerate the regulatory proc ess have often resulted in the courts remanding our decisions, doubling the work, with little or no environ mental benefit. The Federal Water Pollution Control A ct, for those of you who have not had an opportunity to read it, is extremely long and complex and has a number of pro visions that would bear on the PCB pollution problem. They overlap, I won't say that they conflict, but they have the potential to conflict in some cases. The act is very demanding in terms of the things which the Federal Government must consider in the process of developing its regulations. When we do not consider them, the courts require us to go back and do so. We are caught somewhat in the middle. I see th legislative history and the nature of environmental laws, Federal Water and Pollution Control Act, and Clean Air Act as essentially having established the purpose of Federal involvement to be a reinforcement for State pro grams, with the State having the basic responsibility. The Federal role is to establish national standards, provide some financial and technical assistance, and to act where a State government is unable or unwilling to enforce the regulations. Because of the way the acts are written, there are some things that EPA can do well. There are other things that the State and local governments cari do much better, and there are still other things that the public can dp. The strength of the environmental program is clearly with the public, and then with the State and local governments and must flow up rather than down. Regulation, either for the control of toxic sub stances, of which PCB's are an example, or fo r the con trol of biochemical oxygen demand, will not be mean ingful and will not have any real impact on the environ ment unless reasonable limitations are applied. I do not kn o w w h a t these reasonable limitations are for PCB's--they may be zero. The reasonableness of a regula tion is determined by technology, economics, and en- forceability. Based on what I have heard over the past 2% days, there are serious questions as to the enforce ability of regulatory actions which go beyond the 20 principal users. EPA's legislative authorities and its principal areas of effectiveness focus on major point sources and dis charges. With PCB's we do not have very many major point source discharges. Although at .least some of those point sources seem to be creating problems, it is not clear to me, based on some of the numbers that were presented, particularly for the Los Angeles area, .that controlling point sources is going to solve even a major part of this problem. We will regulate these point sources, and hopefully we will be able to enforce those regulations so that the contribution from the major point sources will be dimin ished, if not eliminated. Based on quantities of PCB's in existence in the environment, we can say that those that have been produced over the last 30 years have not de graded those that have been imported. It seems some what questionable to me, if not unlikely, that that con trol of major point sources of PCB's is going to solve the fishery problem in the Great Lakes. Let me take about 2 minutes to run through the Federal Water Pollution Control Act and the Clean Air Act, just to tell you where we are with regard to control ling PCB's. Under the Federal Water Pollution Control Act, the Federal government can establish water quality criteria, which we have done. This was done before the current act was passed. We have proposed revisions, and those final revisions have been printed and are creeping their way through the bureaucracy and toward the Federal Register. I expect that they will be published in final form in the next several months. This is a fairly substantial document and includes what we recommend in terms of ambient water quality, which is adequate to protect biological populations. The States in turn have to set the standards based in part on these criteria and in part on their own judgments of the local conditions. Establishment of the standards does not solve any problems because it does not eliminate any discharges. Other sections of the act are designed to reduce dis charges to achieve the standards. Section 304 provides for us to establish technology-based limitations and ef fluent guidelines upon which we base our industrial per mits. Section 307, the toxic substance part, has turned out, at least in our minds, to be a very difficult section of the act to implement. Perhaps it will not be as diffi cult to implement for PCB's as it is for some o f the other toxic substances and we are moving forward on it, al though belatedly. Section 307(b) calls for pretreatment and is signifi cant because a substantial portion of the PCB's reaching 432 tS6S00 774630 our waterways are discharged from municipal treatment works and not from direct discharges on the part of industry. The pretreatment standards are going to pre sent enforcement problems because it is d ifficult for municipalities and essentially impossible for the Federal Government to trace down every discharger of toxic pol lutants to municipal sewer systems. We do not know whether the discharger is throwing pollutants down a manhole under the cover of darkness, whether he is dis charging regularly through drainage in a building, or whether the pollutants are run off through combined sewers from a nonpoint source. Section 311, the hazardous substances section of the act, is designed to protect from spills of hazardous substances. We have had some spills of PCB's, however, it seems clear to me that, unless someone has been hiding a lot of spills, the quantities of PCB's that are in the Great Lakes are several orders of magnitude larger than anything you could attribute to spills into the water. Spills on the land could be another question. However, once again, a few hundred Federal bureaucrats are not going to be able to chase a million capacitors or transformers and find out whether someone is releasing PCB's on the ground. The section 402 permit program provides for e fflu ent limitations for direct discharges to navigable waters. In addition, we have the emergency power provisions of section 504, which were alluded to by Dr. Ahmed. Quite frankly, I do not know what the criteria are for employ ing the emergency powers or what Mr. Train proposes to do in response to the petition. The Clean Air Act might become a significant part of the effort to control PCB's if the numbers for the Los Angeles basin are accurate and representative. With this act, we are in a more difficult position in my opinion than we are with the Federal Water Pollution Control Act. The Clean Air Act is based on ambient standards, as opposed to technology-based effluent or emission lim ita tions. It is unlikely that we could establish, monitor, and enforce an ambient standard for PCB's unless, by some fortuitous happening, most of the PCB's emitted into the air are coming from a few discreet point sources. We can establish new source performance standards for air emissions, which are in fact technology standards, but I do not believe that new air emission sources are going to be the key to the PCB problem. The hazardous air pollutant section in 112 of the Clean Air Act provides for emission limitations which are adequate to protect the public health with an ade quate margin of safety. I have seen nothing in the infor mation presented that alluded to the health effects of airborne PCB's. It seems to be more a question of the airborne PCB's washing into the rivers. I think that we would have a d ifficult time employing section 112. I would like to run through what I personally think might be attractive supplements to the Federal/State Point Source Regulatory program. Based on what I have heard over the last few days, I believe that a substantial ly increased level of public awareness is necessary among the people who use PCB's. Working principally with labor and the management of industries using PCB's, we must try to improve the level of awareness about proper handling and disposal. I see potential for a joint industry/government voluntary labeling .and disposal control program, which would be substantially more restrictive than what we have now. Given the magnitude of the problem, it would appear that both the industry and the affected labor unions might be sympathetic in trying something along those lines to avoid the problems caused by unknowledgeable dumping of PCB's. It seems to me that we have a major resource in our electric utilities, who apparently use the predominant share of PCB's in closed electrical systems. Electric u tili ties are fairly sensitive to public concern, and I would think that the electric utilities as a group or perhaps even individually might be sympathetic to mounting a signifi cant labeling and waste-handling campaign, which they would subject to some public scrutiny. Lastly, we are spending substantial sums of money on funding local water quality management agencies un der section 208 of the Federal Pollution Control Act. It seems to me that, w ith what is likely to be millions of dollars available in the Great Lakes basin for water quality management, the people who live here might be well served by having the 208 agency work on the PCB problem in addition to BOD reduction, waste load allo cations, and sediment laws. If in fact the PCB's remain the dominant concern in the Great Lakes basin, then maybe the 208 agency could help track down the apparent myriad of small discharge sources, to educate dischargers, and to help put controls on them. GENP 005983 433 774631 U.S. FEDERAL AGENCY ROLES AND ACTIONS: THE DEPARTMENT OF THE INTERIOR Nathaniel P. Reed* Abstract The Department o f the interior warns that its assess ment o f the impact o f polychlorinated biphenyls upon national fish and wildlife resources, as determined by the National Pesticide Monitoring Program, reveals environ mental hazards. The evaluation o f data from the moni toring program has demonstrated a serious detrimental impact by PCBs upon national fish and wildlife re sources and restoration programs. The Department o f the Interior recommends immediate toxic substances legislation for control o f domestic and imported sources o f toxic substances. During the past 2 days numerous repcrts have been given describing the uses and sources of PCB's, their occurrence in various components of the environment, and their real or potential threats to the health of our natural resources. The documentation of the widespread contamination of our environment by this group of com pounds demands that we elevate our recognition of PCB's from a local concern to a national and global leveL We must immediately respond to the dangers posed by PCB's; they represent an ubiquitous degenerative influ ence on our national health and well-being. The reasons for this concern are simply stated: Our food and water supplies are contaminated; our health is threatened; and we are faced with "environmental stress" about which we know comparatively little! The PCB problem is a national problem that the U.S. Fish and Wildlife Service has identified in both re search studies and in the National Pesticide Monitoring Program, As earlier papers pointed out, PCB residues were found in all of the fish samples from 100 stations located in major river systems throughout the United States, and in almost all the bird samples taken since 1970. I am deeply shocked by the pervasiveness of PCB's; they are literally everywhere. And I am very troubled by the exceedingly high levels found in fish from all our drainage systems; and I do not mean just the Hudson v and the entire Great Lakes' system, but the Merrimac and Connecticut Rivers of the Atlantic Coast, the Mississippi, Missouri, and Ohio Rivers of the Midwest, the Columbia River system in the Northwest, the Sacra mento in the West, Rio Grande River and other Gulf Coast streams, and even the Yukon in Alaska! #Assistant Secretary for Fish, W ildlife, and Parks, De partment of the Interior, Washington, D.C. Fish are not alone in absorbing sizeable quantities of PCB's. The birds we are monitoring are equally suscep tible. Waterfowl carry the highest residues in the Atlan tic flyway, followed in descending order by the Mississippi, Pacific, and Central flyways. Further, all starlings collected since 1970 contain PCB residues. It is one thing to trot out all these scientific facts and figures identifying quantitative residues in various terrestrial and aquatic organisms; it is quite another to assess the broad impact of PCB's upon our environment and natural resources. What are the effects of pesticides, heavy metals, and hazardous substances such as PCB's and what do they mean to our fish and wildlife habitat? Cleansed of all the details, the facts, simply stated, are that we are in trouble. My department has spent millions of dollars, and is programming millions more in these times of fiscal austerity, on programs aimed at reinvigorating our wildlife resources, and protecting and restoring numerous threatened and endangered species. The omnipresence of PCB residues in our environ ment looms as a very dark cloud casting an ominous shadow upon all of our fish and wildlife resource pro grams which depend on environmental quality and healthy habitats. In particular, PCB's pose an immediate threat to our efforts to preserve and protect threatened and endangered species. Under present conditions PCB's may very well pull the rug out from beneath us by des troying marginal species in spite of our best efforts for preservation. Consider the Atlantic salmon, a species we are striv ing to reintroduce into our northeastern rivers. Atlantic salmon egg mortality has been associated with a thres hold concentration of about 0.5 ppm of PCB. Our scientists tell me that this threshold concentration in the eggs would be equivalent to residual PCB levels in whole fish of 2.5 to 5.0 ppm, comparable to unhealthy levels found in many species throughout the United States. I cannot justify a salmon restoration program in any northeastern river system where the fish will be subject ed to PCB residues. Other recent tests show that rainbow trout eggs containing as little as 2.7 ppm of the PCB, identified as Aroclor 1242, and 90 ppb of D D T complex caused 75 percent mortality--and about 60 to 70 per cent of the surviving fry were deformed. Another test demonstrated that fish bioaccumutated more than 40,000 times the concentration of PCB in the water. I think the fish are telling us something. They are stating unequivocally that our rivers and streams are sick. We should not need a clarion call to realize that our GENP 005984 434 774632 rivers and lakes--the very lifelines of our environ m ent-are in mortal danger. 1 am aware that it took many years of research be fore we could identify the effects of D D T, dieldrin, and other organochlorine pesticides in birds and mammals. We know that the reproductive success of bald eagles has been greatly reduced in Maine and along the shores of Lake Michigan where high residues of DDE, dieldrin and PCB are present in eagle eggs. Similarly, the once abundant osprey population of Long Island Sound has suffered a near total decline as a result of chemical toxicants. Although our extensive work on PCB-fed ducks revealed little reproductive loss or eggshell thinning at environmental levels of PCB, I hope we don't have to repeatedly demonstrate the dif ferences in susceptibility among wildlife species before we establish the imminence of a hazard requiring drastic national action. Remember that while we found quail and pheasant resistent to DDE thinning of eggshells, mallard and black ducks, american kestrels, screech owls, and brown pelicans were all highly susceptible. It pains me to remind you that the ban on D D T was not imposed until long after its threat to wildlife was proved, and action was taken only when studies showed the potential hazard to human health. I suggest that we cease to quibble over scientific niceties and respond to the ailing resources around us. In this day and age, we should not need to be told that if the health of our natural resources is impaired, then human health is next around the comer en route to the sick bay. We are meeting on the shore of one o f a series of lakes that represents the world's greatest single fresh water resource; appropriately, they are called the Great Lakes. But how do we measure their greatness? Their immense area and volume are sufficient to characterize them as "great." They can also be considered "great" because of their esthetic and recreational value. Perhaps we could even classify them as "great" based on the amount of municipal and industrial waste they hold. The list of attributes for these lakes is long and varied but regardless of the criteria used, the conclusion remains the same--the lakes and everything contained therein truly constitute a "great" resource. The lakes' fisheries are particularly important both as utilizabie and renewable resources and as* indicators of .the health of our Great Lakes. I am convinced that fish and wildlife are the true barometers of the quality of our environment. In my capacity as the steward of fish and wildlife for the Department of the Interior, and as a commissioner on the Great Lakes Fishery Commission, I have an overwhelming concern for the protection and management of Great Lakes Fishery resources. During this century, the fisheries of the Great Lakes have suffered from heavy fishing, relentless predation by the parasitic sea lamprey, the influx of other nonnative species like the alewife, and the diminished quality of habitat as a result of waste disposal, uncontrolled shore line development, and numerous other water polluting activities. In recent years, however, we have taken significant steps at great financial cost to stop the decline of Great Lakes fisheries and to restore them to their former pro ductivity. As a first step in this restoration, we under took the control of the parasitic sea lamprey. Our co operative efforts with the States, Provinces, and the Canadian Government achieved success in all th Great Lakes except Lake Ontario, where intensive control programs are now undery/ay. After 17 years and 33 million dollars, the sea lamprey, with a continued sustained control effort, no longer represents a major threat to the fisheries of the upper Great Lakes. The dissolution of the lamprey threat has allowed a successful State and Federal re stocking program involving more than 150 million lake trout, splake, coho salmon, Chinook salmon, atlantic salmon, and kokanee. Additional millions of rainbow, brook, and brown trout have also been stocked. These stocked salmonids have fed heavily on the plentiful alewife and have rapidly grown to trophy size. The resulting sport fishery of these salmonids, when combined with the existing sport fisheries on other species, currently contributes approximately 350 million dollars annually to the Great Lakes States and the Pro vince of Ontario. All our efforts are for naught if these fish cannot be harvested--and we now face this stark possibility. A sig nificant portion of these fish contain PCB residues in excess of the current 5.0 ppm action level established by FD A . As a result,- warnings have been issued about the consumption of large lake trout and salmon from Lake Michigan. To varying degrees a similar PCB problem exists in Lakes Superior, Huron, and Ontario. Although contamination by PCB's is particularly evident in salmonids, the problem is also present in com mercial species such as carp, chubs, smelt, and alewives. Carp from Lake Michigan have already encountered mar ketability problems because of PCB's, and chubs appear to be at or just below the 5.0 ppm action level. But if the current level were lowered to I or 2 ppm, then virtually all species would be restricted and essenti ally the entire Great LakeS' fishery would be curtailed. The current guidelines of 5.0 ppm has already tabled any serious consideration of commercially utilizing the salmonid populations in the near future. PCB's present a major problem in the future maintenance and growth of GENP 005985 435 774633 commcrical fisheries. These fisheries today have a dock-side value of about $19 million annually and a total economic contribution to the United States and Canada of possibly S95 million annually when process ing, shipping, and retailing are included. We must now consider the expenditure of millions of dollars for controlling sea lamprey and stocking salmonids in the Great Lakes in the light of continued contamination of the fish stocks with unacceptable levels of PCB's. There are overriding reasons in favor of continuing our program. These include aspects of biology, economics, and ecology. The lake trout restora tion program exemplifies these considerations. More than 17 years were required to restore lake trout to its present abundance in Lakes Superior and Michigan. If we stop our current programs, it is almost certain that the sea lamprey would reestablish itself and the salmonid populations and the fisheries dependent upon them would collapse, thus wiping out the past Federal invest ment of many years and millions of dollars and. a Great Lakes economy worth several hundred million dollars. Although we know considerably more now than we did 17 years ago about lamprey control and salmonid stock ing programs, it would still require at least 10 years to recontrol the lamprey and rebuild the lake trout stocks. Why so long? The reason is a simple biological one--it takes 7 years for a lake trout to mature to an adult, spawning fish. There are few overnight solutions to natural resource restoration projects. Obviously, the quickest and most economical solution to the problem is to eliminate PCB's from the environment. With PCB's in the lakes, the entire program of restoring self-sustaining stocks of lake trout in the Great Lakes, or in fact all salmonids, is in serious jeopardy. And yet if we cannot eat these fish, I cannot justify spending millions of dollars contributed by the American taxpayer. We cannot wish this problem away. Nothing short of immediate drastic action will enable us to raise any thing better than lakes full of eunuchized fish. With the present preponderance of PCB's, the lifespan of the Great Lakes fishery will be limited to a single generation. The Great Lakes are a virtual "sink" for PCB's! It takes more than 50 years for water to turn over in Lake Mich igan; there is no fast flushing action by mighty rivers or ocean energies to mitigate the lakes' absorbance of toxi cants. Moreover, with more than one-third of the United States population and an even greater proportion of the Canadian population living near the lake shores, tons upon tons of PCB-infested materials are daily deposited into the Great Lakes receptacle. Transformer fluids, plas tic bottles, hydraulic fluids, carbonless paper, ink, and other PCB-loaded wastes alt find their way into the lakes, where the percentages of PCB's amalgamate mal ignantly. As soon as the food chain absorbs these wastes, the poison is off and running. The tiny invertebrate fingernail clam has demon strated an inordinate capacity to concentrate poisonous PCB residues and pesticides and heavy metals, which may ultimately spell the extinction of one of America's favorite waterfowl, the canvasback, which feeds vora ciously on the clam. The clam was once common in the Detroit River and Lake St. Clair, habitats that used to attract major flights of canvasbacks. The dieoff of fingernail clams on the Illinois River in 1956 spelled the end of that favorite spot for the canvasback. The canvasback represents a valuable waterfowl resource struggling against many odds as a declining species, but I foresee little succor for a population which winters and breeds in areas heavily infested with PCB's. No dollar values can be assigned to endangered species, and even our society of technological whizzes cannot rejuvenate a species when its sole environmental niche is so totally contaminated with toxicants. The complete disappearance of Atlantic salmon from Lake Ontario during the early part of this century and blue pike fr.om Lake Erie in the early 1960's have served as classic examples of man's impact on Great Lakes fishes and their environment. Currently we appear to be losing certain species, such as cisco and chubs, that are native inhabitants of the deepwater portions of Lakes Superior, Michigan, and Huron. Even restoration of self-sustaining populations of lake trout is in doubt in Lake Michigan because of an apparent lack of natural reproduction in the lake. Possible reasons for these species' decline are num erous and complex. Although we have yet to pinpoint the interaction of dynamic ingredients, our scientists are certain that toxic substances such as PCB's are playing an important role. The potential effects of PCB residues in excess of 20 ppm in adult, spawning lake trout cannot be ignored. I think I have gone far enough in detailing the prob lems that we face with this contaminant in the protec tion and management of Great Lakes fishery resources. The potential impact of PCB's on the future manage ment of the lakes' multimillion dollar sport and com mercial fisheries is tremendous, especially if the FDA lowers its guidelines, or if average PCB concentrations in fish increase. Past attempts to control point sources of PCB's into the environment have failed to bring about any measur able reduction in the contamination of Great Lakes fishes. D D T levels in Lake Michigan fishes and mercury levels in Lake St. Clair fishes, however, have declined from between 50 and 87 percent in the past 4 to 5 years as a result of controls on their use. Why haven't PCB GENP 005986 436 774634 levels responded similarly? Do they behave so differently from D D T and mercury in the environment that we can- >t reasonably expect to have observed some decline by tnis time? We will never know>unless the flow of PCB's to the environment is stopped. I remind you that it was commonly thought that decades might elapse before D D T and mercury would decline to satisfactory levels in the great Lakes. It appears highly probable that the pri mary cause for the failure of PCB's to decline in Lake Michigan fish is that their sources have not been cur tailed to any significant degree. To sum up, the insidious character of PCB's is now self-evident and presents a very serious problem to all of us. These pollutants affect the very care o f State and Federal fisheries restoration programs throughout the United States. Here in the Great Lakes, PCB's have the potential of severely damaging multimillion dollar sport and commercial fishing industries. We urgently need an. effective program of control capable of rapidly eliminat ing the release of PCB's into the Great Lakes and our other national watersheds. Because of my deep concern with the problem, I support the recommendation of the Lake Michigan Toxic Substances Committee for a "na tional ban on all domestic and imported PCB's destined for use other than in transformers and capacitors, and [recommend] that the critical or essential use of PCB's in transformers and capacitors be immediately and criti cally reviewed in light of current potential replacement oducts." There must be at the same time an immediate and intensive evaluation of proposed replacement products to determine their suitability for industrial use and the hazards associated with their potential loss to the envi ronment. For the immediate range, our goal must be the elimination of all sources of PCB's in the environment within 3 years; for the long haul, however, we must vigorously pursue legislation that will preclude new "PCB's" from being discharged into the environment. I have addressed you on my professional concerns as they apply to fish and wildlife. Now let me speak to you as a citizen. I have demonstrated that the Fish and Wild life Service's pesticide monitoring program acts as a bell wether for measuring the future environmental impacts of toxic substances upon mankind. I reiterate that onethird of the population of the United States lives within the drainage area of the Great Lakes. The domestic water supplies for many millions of people are drawn from these Great Lakes--the same lakes whose fish pop ulations are so contaminated with chemical toxicants that they are unfit for human consumption even under the present, outdated FDA regulations. We are all aware that EPA is considering the estab lishment of PCB limits fo r water quality in the vicinity of 1 ppt (trillion), which is truly startling when we real ize some of the lakes may already exceed 10 ppts right now. The passage o f an effective toxic substances act and the complete control of PCB importation are imper ative to the health of the American people. A piecemeal approach to toxic substances control would only delay and hamper our efforts to stringently regulate the occur rence of poisons in our environment. Philosophically, we must consider man's role in his environment. Thoreau urged that we "probe the earth to see where our main roots run." The health of our fish and wildlife acts as a pulse indicator for human health. As this conference has shown, all medical and environ mental gauges indicate this pulse to be unsteady and irregular. The irony o f our position today is that our left hand is spending millions of dollars and thousands of man-years to establish a crucial resource while our right hand renders each new growth of this resource malig n a n t Our new resource will not only self-destruct but w ill place die human population in mortal danger. As a final thought let me stress that we should consider all alternatives. Since drastic action is needed, we should not be afraid to step back from industrial efficiency if we can step forward to environmental health. Quite frankly, I am thoroughly disgusted by the gnashing of teeth, wailing, and rubbing of hands. To the agencies which have the enforcement responsibilities, a word on behalf q f the bewildered but concerned Ameri can people--G ET ON W ITH IT I GENP 005987 437 774635 U.S. FEDERAL AGENCY ROLES AND ACTIONS: NATIONAL INSTITUTE OF OCCUPATIONAL SAFETY AND HEALTH Richard A. Rhoden, Ph.D.* Abstract \ NtOSH activities regarding PCB'shave included: {1) the issuance o f a background information document on PCB's for the occupational health community; (21 the decision to develop recommended workplace standards to be forwarded to the Department o f Labor; and (3) plans for conducting retrospective m ortality studies o f workplaces where PCB's are processed. N /O S H is equipped to perform onsite retrospective mortality studies o f workplaces, b u t as yet no facilities handling PCB's have requested an analysis. To date NIOSH activity in regard to PCB's has consisted of three undertakings. On the 3rd of this month, our Office of Occupational Health Surveillance and Biometrics issued a PCB background information document. Its purpose was to inform the occupational health community of current knowledge concerning industrial uses and the toxicity of PCB's. I have a few copies of that document with me and others may be obtained by writing to our Rockville, Maryland, offices. (I might add right here that NIOSH would welcome any technical input from members o f the audience with regard to case studies, hygiene surveys, workplace levels, and so forth.) In a second action of NIOSH, it has been decided that criteria for our recommended workplace standards will be developed and forwarded to the Department of Labor Occupational Safety and Health Administration with formal development efforts to commence in March of next year. This will be an in-house effort, in contrast to the case with many of our criteria development efforts. It is anticipated that the final finished document will be transmitted to OSHA in late 1976 or early 1977. The Center for Disease Control has kindly made Dr. Kimbrough available to aid us in this effort. A t present, U.S. workplace standards for PCB's consist of environmental limits, time-weighted averages of .5 mg/m3 for Aroclor 1254 and 1 mg/m3 for Aroclor 1242, with skin notations. NIOSH is acutely aware of its responsibility to insure that its recommended workplace practices will not result in. increased contamination of the general environment. "Senior Research Reviewer (Pharmacologist), Office of Research and Standards Development, National Institute of Occupational Safety and Health, Washington, D.C, The NIOSH division of field studies and clinical investigations will conduct a retrospective mortality study of an as yet unselected workplace where PCB's are processed or handled. A cross sectional medical surveil lance of current workers at that facility is a possibility. Such surveillance would be conducted by the medical investigations branch of that division. To our knowledge, no such studies have yet been undertaken. A complete industrial hygiene survey will also be conducted at the selected facility, including personal air sampling, and checks of breathing zones of w o rk e rs , housekeeping, and other work practice monitoring. The environmental investigations branch will conduct the personal hygiene survey. The mortality study to which I referred will be conducted by the biometry branch. Mr. David Brown, an epidemiologist with that branch, is here and is ready and willing to discuss the protocol with interested people. The mortality study will consist o f first, cohort selec tion--that is, determination that the selected facility has existed for at least 25 to 30 years so that sufficient time has elapsed for cancer induction and so forth. Next is cohort size determination; the cohort must be large enough to insure detection of low-incidence events. And there will be a personnel record evaluation; the person nel records must be comprehensive enough to permit followup and determination of employee work history. Once a facility is selected for. study, personnel records will be microfilmed and encoded into a data bank. The followup to determine the vital status of the cohort is then undertaken. That is, cause of death and so forth and the findings are analyzed using modified life tables in order to determine any excess mortalities and the specifics thereof. Attempts are then made to correlate the mortality experience with workplace exposure levels, as ascer tained from work history data. Section 20A7B of the Occupational Safety and Health Act of 1970 authorizes the Department of Health, Education, and Welfare to make inspections and question employers and employees as provided in section 8 of the act in order to carry out its functions and responsibilities. The field investigations are conducted hopefully in the spirit of government, management, and labor cooper ation. Section 20A 6 of the Occupational Safety and Health Act of 1970 charges the Department o f Health, Education, and Welfare with the responsibility for evaluating the potential toxicity of the materials used or GENF 005988 438 774636 found in the workplace. That is upon receipt of written request by employers and employee representatives. NIOSH is the agency which provides these onsite toxicity determinations. I found upon checking with the responsible NIOSH division that no such requests have been received to date from any facility that can be identified as a PCB facility. I have a few health hazard evaluation forms with me and I also have a few NIOSH mailing list forms and with that I'll dose. Thank you. GENP 005989 439 774637 PROPOSED CANADIAN REGULATORY MEASURES FOR PCB'S Maurice F. Millson, Ph.D.* Abstract A systematic approach to the development o f regu lations intended to reduce environmental levels o f PCB's involves three aspects: the nature o f die problem, the ways o f reducing the severity o f the problem, and the recognition o f those ways in formulating the regulations. Six regulatory packages are outlined. The Canadian legis lative base on which to impose these packages is indi cated, along with preparatory steps underway in antici pation of the coming into force o f the Environmental Contaminants Act. The contrast between the purposes for which D D T and PCB's have been used leads to the conclusion that presently measured PCB residue levels in the environ ment should not be expected to decrease, in response to Monsanto's imposed decrease in usage, a t a rato compar able to that at which D D T residues have decreased. The title given in the program is a bit optimistic. It sounds as if we made up our minds to pass information out, whereas in fact we are here to gather evidence in order to decide exactly what regulations we need. I shall deal only with an approach to regulations intended to affect the situation in the open environment, not regula tions of food or other direct threats to humans. In this presentation I plan to follow a systematic objective approach to development of regulations, and it involves three aspects: the nature of the problem, the ways of reducing the severity of the problem, and how to recog nize those ways in formulating practical regulations. From the regulatory point of view, the nature of the problem is that there are dangers posed to living things by the presence of PCB's in their environment and levels do not seem to be decreasing. The dangers are a combi nation of the inherent toxicity of various PCB's and the exposure of susceptible species to those PCB's. Since we cannot change the toxicity of the types of PCB's, we can reduce the severity of the problem only by reducing the exposure. Exposure incurred by PCB's in the environment is a little different from normal exposure. I think Dr. Kimbrough touched on this. For humans, one talks of exposure in terms of intake, whereas in the environment we normally talk in terms of the residues of PCB's in an organism or in a sediment. And it is those residues that 'Environmental Assessment Coordinator, Environments! Contaminants Control Branch, Ottawa, Canada. we need to reduce as far as the environment itself is concerned. As a consequence, that would affect the intake of humans. We can reduce the residue levels by restricting the permitted range of uses of PCB's, by re stricting losses of PCB's into the environment from any permitted uses, or by restricting the proportion of per sistent homologs in the PCB's that get into the environ ment This brings us to the third aspect: how to recognize, it in the formulation of alternate regulations, the three ways of reducing the residue levels. I have put together six alternative regulatory packages of increasing severity with regard to those three ways. The first package prohibits all uses other than in transformers and capacitors, and couples that with con trols on disposal of industrial sizes of capacitors and transformers, the PCB's in Them, and manufacturing wastes in making them. The second package prohibits all uses other than transformers and capacitors. It puts a restriction on the higher chlorinated PCB's, meaning more than four chlo rines, in capacitors and puts controls on disposal of industrial material. The third package prohibits all uses other than transformers and capacitors. It restricts higher chlori nated PCB's in any capacitors, with an additional restric tion on the medium chlorinated PCB's (more than three chlorines) in small capacitors because of their disposal. There are controls on disposal of industrial materials, recognizing that small capacitors are inherently unregulatable as far as disposal is concerned. The fourth package prohibits all uses other than transformers and large capacitors, with a restriction on the higher chlorinated PCB's (more than four chlorines) in the capacitors, and has the disposal controls. This package would remove PCB's from small disposable capacitors. The fifth package prohibits all uses other than for transformers and capacitors, and places a restriction on any PCB's with more than four chlorines. That would wipe out Aroclor 1254. It would probably not entirely wipe out the use in transformers; I think Westinghouse has always used a brand of 1242 for certain trans formers. The sixth package is total prohibition of PCB's. To any of those six there could be slight modifications. We might have to permit the use of PCB's in research; if we're going to allow them at alt then we should allow GENP 005990 440 774638 their use in research, otherwise we'll never know any more about them. We could permit their use as a chemical inter mediate. Somebody may have reason to use 4,4,-dichlorobiphenyl for conversion to something else. And with sufficient restrictions on the conversion efficiencies and the disposal of waste, it might be possible to allow them to do that. We could add an **xtra restriction on the concentration of the chlorinated dibenzofuran in any fluid in which it appears to be a problem or in any fluid in which it's possible to remove it or prevent it from being there in the first place. We are currently involved in examining the evidence on which to decide what package of regulations should be recommended to those who make the final decision. How we could legally impose the chosen set? We have the traditional fields of pollution control: waste water, air pollution, solid waste disposal, and just as in the United States, in Canada there is much legislation. We have 10 provinces, all with different laws and regula tions. We have the Federal Government. Between them they could cover the whole range if everyone used its authority to pass, impose, and enforce the laws that are available. It is generally recognized, as you already heard from EPA's point of view, that those sort of laws are not adequate for the proper control of PCB's. That does not mean they are not useful in conjunction with other legis lation on products. Canada almost has a law on products--the proposed Environmental Contaminants Act. It is Bill C25 at the moment and whenever a civil servant speaks of a bill he has to be careful to say he means the proposed act, because if one talks of the act, the legislature gets rather upset that you are taking it for granted. The reason that Jim Brydon is not here today is that yesterday he had to appear at a Senate committee hearing, and my under standing from phoning back this morning is that the committee passed the bill. Now whether it passed it with one amendment I am not sure. It passed the bill, which means it will go to third reading in the Senate next Tuesday, and then all it requires is the signature of, or Royal Assent from, the Governor General or whoever is acting for him. A t that point it is on the statutes books but not-in force. It comes into force on a date to be fixed by proclamation. When that will be I do not know. Various people are pressing for an early proclamation; certain others feel you need time to get organized before you proclaim the act, otherwise you can get into serious problems with handling paper. In addition to that possibility of controlling prod ucts, the provinces have constitutional power, if they care to use it, to pass laws to control in detail all indus trial activities within their boundaries. They can tell industry it must do this and it may not do that. Thev can control them in detail. They recognize that the regu lation of products is better done at the national level in order to avoid fragmenting the markets and ending up with 10 different classes of laws. The Contaminants Act implicitly recognizes provincial power and requires the Federal Government to consult the provincial govern ments before putting in any regulations, in fact, before publishing the proposed regulations. The consultation is to determine whether any particular province prefers to deal with the problem itself. I do not imagine that any province would want that option for PCB's, or else they would have handled it already. How to apply the new act when it becomes available to the six packages? It contains an information gathering power, which gives us the right to demand all kinds of information if there is reason to believe a significant danger exists. Those involved with a nominated sub stance must identify themselves, and on request must identify what their involvement is. The act contains three powers of prohibition. Because of the nature of its constitution base, it may only prohibit. It may not regulate in a management sense merely because we feel it better that way. The activities that can be prohibited are those liable to injure health or the environment. With respect to something such as PCB's, this could involve prohibition of willful release into the environment and prohibition of import, manufacture, processing, sale, or use for pre scribed uses. Another prohibition is that on incorpora tion of a substance into a product beyond a certain specified concentration or proportion. I should point out the possible strange regulations on proportions of chlorine in PCB's. If we wish to regu late them, it would not be by naming allowable propor tions of specified substances by product, but by naming classes of substances and prohibiting them for certain uses. We can name substances or classes of substances with some limitation on the tyoe of class. These classifi cations are nowhere near as broad as some of those in the draft UJ5. toxic substances bills. If we'combine the three powers of prohibition in the new act with the conventional pollution control powers of the federal and provincial governments, you can see that we could put in any of those six packages on PCB's. In regard to what we actually intend to do, there is no secret that the earliest regulation that would be put forward would be very simply restriction to no PCS use other than for transformers and capacitors, with the possible exception of research and maybe chemical intermediates. . In effect that would initially confirm Monsanto's E N p 005991 441 774639 1971 curtailment of sales. And it would not disrupt the market for electrical uses at the moment. It would dis rupt whatever other markets there are that we do not have a handle on. We know some people are using PCB's. We don't know where they got them from. We have suspicions about who might be using them. Our informa tion gathering power could be used, when in force, to find out who is using them. To go beyond the curtail ment to transformers and capacitors, I cannot tell you what we shall do because we have not made up our minds. We would have to consult other government agencies or the Federal agencies. We would certainly have to discuss the action with electrical equipment manufacturers as to timing if or when we go beyond that one step. To go to regulations on composition of fluids by prohibiting higher chlorinated PCB's, and certain chlo rinated dibenzofurans, we would have to be able to specify analytical procedures. The procedure would have to be developed and would have to stand up to interna tional comparisons; you do not do that overnight. People do not agree, for good scientific reasons, particu larly on the chlorinated dibenzofurans as to exactly what are you measuring when you go through different procedures. We have put together a good deal of information on the situation in Canada because we would have to be prepared to state the basis for a regulation. By we I mean a task force from the National Health & Welfare and Environment Departments, and the environment, health, and agriculture ministries of the province of Ontario. (Ontario controls the whole northern shore of the Great Lakes other than Michigan.) Several members of the task force are at this meeting; when we get back we shall debate our impressions of the data reported here, the opinions reported here, what we already know. We were not all of the same opinion the last time we met as to exactly what the evidence justified. We came here with open minds, but I doubt whether we shall reas semble all with one opinion. We shall be better in formed, maybe a bit wiser, and a bit more scared about difficulties. I cannot describe the Contaminants Act to you in a few minutes. It does require publication of any proposed restriction after it's been discussed with the provinces and before it comes into force. It provides for the crea tion of a board of review if a notice of objection is lodged. For this reason we would have to be prepared to submit to a board the evidence on which we claim to have become satisfied that the substance constitutes a significant danger to health or the environment. That is the basis of the act--the Governor-in-Council, meaning the Federal cabinet, has to be satisfied that a significant danger exists. This means that we would have to con- vince other departments whose interests are in promot ing economic development and so on, that the danger is enough that the Federal Government as a whole should become involved. That would prevent arbitrary and capricious decisions. We have come here partly to find evidence on the more perplexing points, in particular, the degree of per sistence in the environment of the different PCB's. When they appear, one does not know for sure whether it is because they just came into that location or because they are persistent, or even which ones do persist. On a personal level, everyone is worried that the Monsanto restrictions of 1973, '71, and '72 have not caused a significant decrease of levels of PCB's; that is, there has been no significant decrease in the levels of the persistent P C B 's -1 2 5 4 ,1260. I do not expect to see the persistent PCB's decrease in the 1970's in the biological accumulators, the fish and birds, and in sediments, which are nonbiological accumu lators. If you look back to DDT,.use dropped off from about 1963 around the Great Lakes and more or less ceased about 1968, '69, and '70. Five years later, after argument, people accepted the fact that D D T and DDE were, decreasing. A ll the D D T ever manufactured was intended to be spread into the environment within 1 to 2 years of its manufacture. Five years after stopping its production and use, a decrease in the environmental level has been shown. Almost all the PCB's ever made were intended to be kept somewhere because they were long-life products, and so they have not yet reached the open environment, let alone begun to show decreasing levels. One member of our task force, as a matter of fact, happens to analyze from time to time his invoices, and the carbonless copy paper invoice is still in use. It has not been manufactured for 3 years. So not only has it not yet appeared to go out of company files into the disposal system; it is not yet even in the company files--it is in the stock of un used paper, What I do expect to decrease, if only we had the evidence, are the so-called less persistent PCB's--the 1242's or call them what you will. No one seems to have evidence or data on 1242 types in biota or sediments going back 5 years. Most people do not have any evi dence for it at all, because either it is not there or they have not looked or the system cannot pick it up. There is same hope that one group in the Wildlife Service may be able to go back to some of its samples and determine the trichloro, tetrachloro levels over the last 3 years, and certainly over the next 3 years it can obtain samples and follow the trend if it exists. If that one does not decrease by 1980 or before, we have a bigger problem than any body thinks. 442 GENP 005992 774640 PCB's IN FOODS: A LOOK A T FEDERAL GOVERNMENT RESPONSIBILITIES Joseph Highland, Ph.D.# Abstract Our growing concern over the continued contamina tion o f food supplies by polychlorinated biphenyls (PCB's) reflects an ever increasing knowledge o f the ex treme health hazards posed bymthese compounds. PCB's are both subacutely and chronically toxic, and have recently been shown to cause severe chronic effects a t dietary intakes as lo w as 2 .5 ppm in nonhuman primates (refs. 1-4). To data, a no-effect level fo r PCB's in non human prim ates has n ot been established. Federal sampling and surveillance programs have continually demonstrated the presence o f PCB's in our food supply. N o t only have the existing tem porary toler ances fo r PCB's established b y the FD A been insufficient to protect the public health, b u t recent evidence also indicates they must now be considered both obsolete and inappropriate. A new regulatory posture is needed which takes into account recent evidence o f chronic effects caused by tow level dietary intakes o f PCB's and, more im portantly, new evidence (ref. 5) substantiating the carcinogenicity o f these compounds. Such a regulatory approach is mandated by the FDA 's responsibilities under the Food, Drug, and Cos m etic A c t I t must involve the establishment o f a zero tolerance level fo r PCB's in food to be achieved b y means o f a phased reduction to zero (using appropriately set temporary tolerances) determ ined by the levels o f PCB's presently found in the environm ent Such tempo rary tolerances must be sufficient to m inim ize the risks to public health and must be based on a level o f risk which has been assessed using appropriate statistical models to account fo r the p otential carcinogenic risk posed b y any given residue level. Appropriate regulatory action is long overdue. PCB contamination o f food clearly poses a potential health hazard. The longer action is delayed, the longer society w ill involuntarily be required to endure such health hazards. THE NEED TO REGULATE The need to regulate the levels of PCB's in the food supply is brought about by our knowledge of the health hazards posed by the ingestion 6f these compounds. Director of the Toxic Chemicals Program, Environmental Defense Fund, Washington, D.C. Are PCB's Toxic? PCB's are considered to have a low acute toxicity (ref. 6). In adult rats, the oral LD50 ranges from 4-10 g per kg body weight. In weaning rats, an oral LDJ0 for Aroclort 1254 of 1,295 mg per kg body weight and 1,315 mg per kg for Aroclor 1269 have been reported (ref. 7). However, a low acute toxicity does not mean the absence of health hazards. On the contrary, PCB's are subacutely and chronically toxic at relatively low dose levels (ref. 8). The chemical nature of PCB's in part may help explain why they are subacutely and chronically toxic rather than being acutely toxic. They have a low solubili ty in water but are highly soluble in fat (ref. 9). There fore, they tend to accumulate and concentrate in the body's fat stores rather than being rapidly metabolized and excreted. It appears that the metabolism and excre tion of PCB's, especially o f those Aroclors with high chlorine content, are even slower than for some of the most persistent pesticides, such as dieldrin and D D T (ref. 6). Thus, after ingestion. PCB's persist in the body for long periods of time and thereby may elicit chronic effects. - Bioaccumulation o f PCB's in Tissue From both animal and human data we know that PCB's accumulate in adipose tissue. Animals continuous ly fe'd PCB's show a steady buildup of these compounds in their tissues; to date, no known upper lim it for PCB storage has been found. Steady-state levels of dietary PCB's were reported for certain but not all tissues in rats fed 100 ppm Aroclors 1 2 4 8 ,1 2 5 4 , and 1262 for approx imately 10 months (ref. 8). Once these levels were reached, they appeared to remain relatively stable for a long while even after dietary exposure to PCB's ceased. Rats fed PCB's for 58 days showed levels in their adipose tissue 5 times greater than their daily dietary intake (ref. 10). When the dietary exposure was for 240 days rather than 58 days, levels of 10 times dietary intake were noted. If PCB feeding was curtailed after 58 days and the levels in tissue measured after 71 days on a PCB-free diet, adipose tissue still showed 80 percent of the highest TThe term A ro d o r is Monsanto's trade name fo r the PCB's it produces. Monsanto is the sole U.S. producer o f PCB's. The last .two digits of the four-digit number indicate the percent chlorination of the product (e.g., Aroclor 1260 contains 60% chlorination). Other trade names fo r PCB's manufactured outside the United States include: Kinaclor (Japan), and Clophen, Flendor, Phenodor, and Sorol (Europe). 443 GENP 005993 774641 level previously measured while the levels in the brain showed no decrease but remained relatively constant. As noted above, significant levels of PCB's have been found in the adipose tissues of humans as well. It is estimated that levels of 1 ppm PCB or more exist in 30 to 45 percent of the general U.S. population (refs. 11,12). In a few cases, levels as high as 200 and GOO ppm have been reported. Moreover, as the PCB's continue to be consumed, the composition of the residues stored in the body no longer directly reflect what has been in* gested (refs. 10,13*15). This is due to differences in the body's retention of various PCB homologs. The more highly chlorinated homologs, which tend to be more chronically toxic, are retained longer. Therefore, the toxicity of the PCB's stored in tissues may actually in crease and the mobilization and metabolism of a given amount of stored PCB can produce a more severe toxic effect than the ingestion of an equivalent amount (by weight) of a commercially produced PCB mixture. Toxicity o f PCB Metabolites It is not only the direct toxic effects of PCB's with which we must be concerned, but also the effects of their metabolites as well. Many times metabolites are more toxic than the parent compound. In fact, in the case of the PCB metabolite 5-hydroxy-2,4,3, ,4,*tetrachlorobiphenyl, this has been shown to be the case (ref. 8) . The nature of PCB metabolites not only warns us of possible increased toxicological risks, but also of the types of toxicological responses that may be expected. The metabolism of PCB's by monkeys (primates like man) occurs by way of the formation of an epoxide intermediate (ref. 16). Aromatic hydrocarbons such as PCB's, metabolized via this intermediate, often produce cancer, birth defects, mutation, and cell death in experi mental animals (ref. 17). The Toxicity o f PCB's in Humans In response to PCB poisoning several adverse effects have also been observed in man. in 1968 over 1,000 Japanese experienced PCB poisoning after consumingrice oil contaminated with Kanechlor400 (refs. 18,19). In addition to causing headaches, swelling of eyelids, temporary loss of vision, and many other symptoms, PCB's stored in the adipose tissue o f pregnant women were passed through the placental wall and into their fetuses. As a result, 9 of the 10 live-born babies had unusually greyish, darkened skin, and most were born underweight. The importance of these observations can not be underestimated, especially in light of very recent findings reported by Allen and coworkers on the effects of low-level exposure of nonhuman primates to PCB's (refs. 1-4). The effects seen in these monkey studies are similar in appearance and persistence to the symptoms of the human poisoning already discussed. Moreover, these symptoms were documented at levels of dietary intake of as low as 2.5 ppm. To date,a no-effect level for PCB's in monkeys has not been established. Carcinogenicity o f PCB's Although carcinogenicity in primates in response to the dietary intake of PCB's has not yet been observed, it has been reported for both mice and rats'(refs. 5,8). The World Health Organization has reported that Kanechlor 500 and Aroclor 1254 are carcinogenic in mice and in duce both benign and malignant liver cell tumors follow ing oral ingestion. Most recently, a team of research in vestigators from the Center for Disease Control, Atlanta, Georgia, the U.S. Environmental Protection Agency, the National Cancer Institute and Johns Hopkins University School of Medicine reported that 26 of 184 experimen tal animals (rats) fed 100 ppm of Aroclor 1260 for approximately 21 months developed hepatocellular carcinomas. Only 1 out of 173 control animals devel oped this lesion in the same period of time. Moreover, 146 of the experimental animals but none of the con trols had tumorous lesions (neoplastic nodules) of the liver. Appropriate regulatory action with regard to the presence of PCB's in food- must take into account the following factors among others: the bioconcentration of these compounds in human tissues; the selective nature of this process which can lead to more severe toxic effects than those expected from the ingestion of the original PCB mixtures; the toxicity of the PCB metabo lites; the severe chronic effects observed in nonhuman primates from dietary ingestion of low levels of PCB's; and the demonstrated carcinogenicity of PCB's in two animal species. PCB's IN FOOD The first evidence that food supplies had become contaminated with PCB's was reported in 1966, when fish from various Swedish waters were shown to contain PCB's (ref. 20). Since then, PCB's have been identified as contaminants in food supplies around the world. They have been found in pike taken from a lake in Finland, mollusks and marine fish from Scottish waters, a wide variety of fish caught in the St. John River system, wild life in California, and in trout and salmon taken from Lake Michigan (refs. 8,21). More recent findings indicate that contamination by PCB's continues to be wide spread. Within the last few months, striped bass caught tn the Hudson River have been found to contain as much as 90 ppm PCB's, while pike caught in the Baltic Sea were shown to contain 0.31 ppm PCB in their muscle O o Ox \D sO JS> 444 774642 and up to 190 ppm in their ovaries (refs. 22,23). More over, plankton from the Baltic Sea, upon which manv fish fetid, contained levels of 25 ppm PCB in their fat (ref. 24). Federal Sampling and Surveillance Programs fo r Chemi cal Residues in Food The Federal government currently conducts three separate programs in which the contamination of foods by PCB's is measured. These programs include: the FDA Pesticide Surveillance Program, the FD A Total Diet Pro gram, and the USDA Surveillance Program. The FD A Pesticide Surveillance Program, which began in 1968, was developed to gather information on the levels of pesticides (including PCB's) In foods and animal feeds based on a statistical sampling program designed to cover specific geographical regions of the United States. The program is intended to assure the safety of the human food supply by screening and removing shipments of foods containing PCB's or pesti cides irt excess of established tolerances. Commodities covered under this testing program include dairy prod ucts, eggs, fish, animal feeds, fruits, vegetables, and processed foods, In the FD A Total Diet Program, the levels of pesti cides, PCB's, and trace heavy metals in the diet are meas ured. Bimonthly, a diet approximating that which would be consumed in a 2-week period by a hypothetical 15- to 20-year-old male is collected at retail stores in five regions around the United States. The foods are cooked or prepared in the appropriate manner and then divided into 12 basic food composite classes. These include meat, fish, poultry, leafy vegetables, etc. Each composite is then analyzed for contaminants. The USDA Surveillance Program consists of periodic sampling and analysis of meats and poultry from chemi cal contaminants including PCB's. Samples are taken from federally inspected slaughterhouses. The Levels o f PCB's Found in Food A summary of the findings, with respect to PCB's, of the survey and surveillance programs described above are listed in tables 1 through 3. It represents a compila tion of data gathered from Federal sources (refs. 8,20,25). Although the data are incomplete, it is clear that PCB's continue to contaminate our food. Results of the pesticide surveillance program appear to indicate an in crease in the extent of contamination, while those of the USDA surveillance program indicate a decrease. This apparent conflict may be explained by the fact that dif ferent foods are sampled in these programs and it is quite possible that contamination of some foods has de creased while increasing for others. The apparent decrease in the levels of PCB's report ed in the FDA total diet survey between FY 73 and the first half of FY 74 must be viewed with caution. During the first half of FY 74, the average PCB levels for milk and other dairy products, for eggs and egg products, and for animal feed ingredients were equal to or greater than those reported for FY 73. Then why the apparent de crease? In large part this reflects an apparent decrease in the numbers of fish that were found to be contaminated with PCB's. In FY 73, 62.2 percent of the fish samples examined contained PCB's in the range of trace amounts to 123 ppm. In the first half of FY 74 only 35.3 percent of the samples checked were contaminated and the levels found ranged from trace amounts to 9.70 ppm. How ever, the fish data reported for FY 73 included mostly freshwater fish, where the contamination with PCB's has been shown to be the greatest, while during the first half of FY 74 the F D A samples consisted mainly of marine fish. Since the samples are not comparable, the apparent decrease observed is more probably a reflection of the difference between PCB contamination of freshwater and marine fish than an indication of a decline in PCB's in fish generally. In addition to these observations, numerous specific incidents of PCB contamination of food have been re ported by the FD A and USDA. A summary of these has been compiled by Wessel (ref. 20). A few examples fol low. In 1970, the Campbell Soup Company detected high levels of PC8's (26.8 ppm on a fat basis) in chickens grown in New York State. As a result, 140,450 chickens were destroyed. In July* of 1971 Monsanto Chemical Company 'informed the Food and Drug Administration that large amounts of fish meal might have been contam inated with PCB's during pasteurization from a leak in the heating system at their East Coast Terminal in Wilmington, North Carolina. An investigation by the FDA revealed that the leak had begun in April of 1971 and had continued through July 1971. Contamination of the fish meal was verified, and as a result, over 123,000 pounds of egg products and 88,000 chickens were de stroyed. That same year, the FD A was notified that high levels of PCB's (20 ppm) had been found in Swift and Company turkeys. As a result, approximately 1 million birds were kept from market. These incidents and the results of the Federal surveillance programs demonstrate that the contamination of food by PCB's is not a new phenomenon. It is a continuing problem, which has resulted in part from the continued indiscriminate dis charge of PCB's into the environment, and one which GENP 005995 445 774643 Yoar 68-71 FY 73 FY 74 Table 1. FDA total diet survey Number of composite food samples Percent contaminated 900 6% 360 6% 360 4% Levels of contamination trace--0.36 ppm trace--6.0 ppm trace--0.05 ppm Table 2. FDA pesticide surveillance program Year Number of samples Percent contaminated Levels of contamination 68-71 FY 73 FY 74 15,000 7,882 . 1,723 3.22 4.02 5.42 "detectable" {fis h , speci fic a lly : 1-10 ppm) "detectable" "detectable" GENP 005996 Year Table 3. USDA surveillance program Number o f samples Percent contaminated * Levels of contamination 71 FY 73 (poultry only) FY 74 (poultry only) 4,175 . 1,037 574 4% 2.6% <1% trace-- 15 ppm tra c e --4 ppm 1.*25 ppm 446 7746^ must be eliminated because of the severe health hazards posed by these compounds. THE ESTABLISHMENT OF TOLERANCES Existing Tolerances In partial recognition of the health hazards posed by PCB's, the FDA proposed the following temporary toler ances (in ppm) for the levels of PCB's which would be permitted to contaminate food: 1. Milk (fat basis) 2.5 2. Dairy products (fat basis) 2.5 3. Poultry (fat basis) 5.0 4. Eggs 0.5 5. Complete and finished animal feeds 0.2 6. Animal feed components 2.0 7. Fish and shellfish (edible portion) 5.0 8. Infant and junior food 0.2 9. Paper food-packaging material 1.0.0 The FD A contends that these tolerances are sufficient to protect the public health. However, careful considera tion of the available evidence indicates clearly that this conclusion is unwarranted and unsupported by the facts. The Toxicological Basis fo r Calculation o f The "Accept* able D ietary In ta k e " o f PCB's The F D A has calculated what is termed an "accept able daily dietary intake" for PCB's. Even if the validity of such a concept is assumed, the basis for establishing such a level must be evaluated in order to determine whether the temporary tolerances that have been pro mulgated sufficiently lim it PCB intake. In this connec tion the FDA's final environmental impact statement for rulemaking on PCB's (ref. 26) indicated that both animal and human toxicological data were used to establish an allowable dietary intake. According to data avilable at that time, long-term animal studies showed no-effect levels in dogs and rats of 10 ppm for Aroclors 1242, 1254, and 1260. Employing the standard 100-to-1 safety factor, a no-effect level for man based on data derived from dogs was calculated to be 2.5 pg/kg body weight/day. From the data on rats, a 3 pg per kg body weight figure was obtained. Therefore, the allowable level of PCB ingestion in man was figured to be 0.175 mg per day for a 70-kg individual. However, according to Dr. H. Blumenthal, Acting Director, Divi sion of Toxicology, Bureau of Foods, FD A (ref. 8), in the time since these calculations were made, there have been two important observations concerning PCB's which alter our understanding. These observations make the allowable daily intake previously calculated obsolete. First, the recent studies cited earlier in this paper dealing with experiments on nonhuman primates were reported, indicating that the rat and dog are relatively insensitive to many of the toxic effects of PCB's. As stated previously, a no-effect level for PCB's has not yet been determined for monkeys. Second, recent work by Allen (ref. 1) indicates that the use of gross observations of toxicity are not reliable in the study of PCB's. Allen observed that routine toxicological evaluations of rats fed 100 ppm Aroclor 1248 for 1 year revealed no abnor malities in growth, mortality, and hematology. However, more sophisticated tests showed that these rates had drastically altered fat and cholesterol metabolism as well as changes in liver size and structure. Therefore, even if one were willing to accept an allowable human daily dose for PCB's calculated from animal toxicological data, one would have to question seriously the basis for the FDA's 1972 calculations. The human toxicological data used to determine the allowable daily dose came from the accident at Yusho described earlier in this paper. The reasoning put forth, by the FD A (ref. 26) was as follows: Since 2,000 mg was reported to be the average total dose causing an effect in the Japanese, it is possible that 200 mg total dosage PCBs (applying a safety factor of 10 to 1 as above) may be tolerated over a much more protracted period of time without overt adverse effect if daily exposure is held to minimal levels. This would permit ingestion of 4 fig per kg body weight per day in a 70-kg man. Since the low est total dose producing an effect in man in the Japanese incident was 500 mg, a similar 'analysis leads to an allowable protracted inges tion of 1 pg per kg body weight per day as derived from a 70-kg man. On the basis of these data, the FD A arrived at an allow able dose of PCB's (for a 70-kg man) of between 70-280 pg/day, although the significance of these calculations is very questionable. Particularly suspect are the estimates that had to be made of actual doses received by the Japanese, as well as the arbitrary assumption that a safety factor of 10-to-1 is sufficient to determine a safe level of intake for a "protracted period of tim e." In addition, the calculations fail to consider the potential long-term effects caused by stored PCB residues. Recent evidence from controlled feeding experiments of non human primates which demonstrated severe chronic effects from low-level intakes of PCB's raises the ques tion of whether similar effects might also be seen In man under the appropriate conditions. The "Acceptable D aily D ietary In ta k e " Can Readily Be Exceeded The FDA's acceptable daily PCB intake of 75-210 pg/day for a 70-kg man seems questionable at best. As PFP 014458 447 774645 Dr. J. Wessel, Scientific Coordinator, FDA, has pointed out (ref. 20), " it is quite clear that the acceptable daily PC8 intake of 75-210 pg/day could easily be exceeded by an adult consuming some of the heavily contamin ated foods in his diet." Table 4 below, taken directly from the testimony of Dr. Wessel (ref. 20), illustrates this point clearly. As Dr, Wessel concludes, "Even when PCBs are pres ent at the tolerance level, it would be possible for an adult, with normal dietary habits, to exceed 175 pg of PCB per day." Adults with "normal dietary habits" are not the only people unprotected. Perhaps at even greater risk are those targe groups within the population, such as sport fisherman or people on special diets, who consume above-average quantities of PCB-contaminated foods, or nursing babies who ingest PCB's in their mothers' con taminated milk and who, for biochemical reasons, have a very limited capacity to metabolize foreign chemicals such as PCB's. Dr. A. Kolbye, Jr., Associate Director for Science, Bureau of Foods, F D A (ref. 27), and Dr. H. Blumenthal, Acting Director, Division of Toxicology, Bureau of Foods, FD A (ref. 8), are clearly correct when they say respectively: "Infants or young children could also readily exceed the tolerable daily exposure," and "Thus, the best evidence indicates that children would be more susceptible to the poisoning caused by un metabolized PCBs, since they have not developed effec tive ways of eliminating them from the body." 77ie Need fo r Reevaluation o f PCB Tolerances Is A p parent The FDA's temporary tolerances for PCB's in food are both inadequate and inappropriate. They fail to pro tect the populace even if one accepts the concept of an acceptable daily dose, because the dose calculated in 1972 is now obsolete in light of more recent findings. More importantly, however, the appropriateness of any "acceptable daily dose" for PCB's is highly questionable Type of food Table 4. Relative contribution to acceptable daily intake (175 yg/g by foods subject to PCB temporary tolerances) Serving of food Equivalent Temporary amount PCB tolerance (ppm) in food Relative contribution to ADI Milk 800 ml (3.5 cups) 2.5 (fa t basis) 0.1 (whole product) 80 yg 46% Cheese 100 g (3.5 oz) 2.5 (fa t basis) 0.6 (whole basis, assuming 25% fa t) 60 yg 35% Poultry 200 g (7 oz) 5.0 (fa t basis) 0.5 (whole basis, assuming 10% fa t) 100 yg 58% Eggs 100 g (2 eggs) 0.5 50 yg 29% Fish 200 g (7 oz) 5.0 1000 yg 580% Packaged food 100-200 g 10 ppm (3 .5 -7 .0 oz) (packaging) 10-60 jiga 6-35% aBased on 1971 FDA Survey that 10 ppm PCB in packaging can resu lt in-migration of 0 .1 -0 .6 ppm PCB to packaged food. 448 774646 GENP 005997 in light of the evidence demonstrating in experimental animals the carcinogenicity of these compounds. Since there is, at the present time, no scientific evidence that any level of intake of a carcinogen is safe, the entire concept of an acceptable daily dose for a carcinogen such as PCB is self-contradictory and scientifically unsupportable. A new regulatory posture is therefore needed. A PROPOSAL FOR APPROPRIATE REGULATION Responsibility Under the Law The FDA's responsibility and obligation to protect the public health against hazardous substances in the food supply were established by Congress in the Food, Drug, and Cosmetic Act, Section 409 of the act em bodies in the Delaney Amendment the explicit Congres sional policy to prohibit all carcinogenic additives in food. Since "food additive" has recently been judicially interpreted to include any substance whose use can reasonably be expected to result, directly or indirectly, in its becoming a component of food,* the policy under lying the Delaney Clause is applicable to PCB's in food. In addition, Section 406 of the act authorizes the estab lishment of tolerances for poisonous and deleterious sub stances in food. An appropriate regulatory policy with respect to the contamination of food by PCB's must therefore take cognizance of these expressions of legis lative intent. A Regulatory Approach Consistent With the Health Hazards Involved Consistent with the foregoing expressions of Con gressional policy and with the evidence that PCB's are both ubiquitous in the food supply and carcinogenic in laboratory animals, the FDA should and indeed must establish a zero tolerance for the levels of PCB's permit ted in food. New' FD A regulations pertaining to PCB's must start w ith the premise that elimination of PCB's from the food supply is the ultimate goal. This does not mean that all food supplies currently contaminated with PCB's must be immediately condemned and confiscated. Such an effort would be impracticable and irresponsible. It does mean, however, that within a reasonable period of time, PCB contamination of food supplies will no longer be tolerated. In the interim, a temporary toler ance, sufficient to minimize the risks to public health, must be established, and then progressively reduced to zero. Such a regulatory posture would also require the EPA to carry out, in a reasonable and appropriate man ner, its responsibilities with respect to environmental 'U n ite d States v. Ewing Bros. Co., 502 F.2d 715 (7th Cir. 19741. contamination by PCB's and to stop the indiscriminate discharge of PCB's into the environment. The method used to establish temporary tolerances for PCB's is very important. PCB's have been shown to be carcinogenic in two species of laboratory animals. In light of this evidence, it is clear that the routinely applied 100-to-1 safety factor for toxic substances is completely inappropriate. The F D A has already indi cated (ref. 27) its intention to adopt the Mantel-Bryan method (refs. 28,29) of statistical analysis to establish the required sensitivity of the testing method in cases where carcinogenic additives or drugs are intentionally added to animal feed or administered directly to ani mals. The F D A has adopted this position in an attempt to satisfy the intent of Congress as expressed in the Delaney Amendment. Temporary tolerances for PCB's, established using the Mantel-Bryan or other (ref. 30) ap propriate statistical procedure, would be consistent with this policy. Any values so obtained could not be con sidered a "safe" level since neither the Mantel-Bryan pro cedure nor any similar statistical method is intended to be used to establish "safe" levels of exposure to environ mental carcinogens in food. Oh the contrary, they are used to relate the dose of a carcinogen ingested to the probability of the induction of cancer. The establishment of temporary tolerances must be viewed in light of the potential carcinogenic hazards posed by PCB's. The rapid reduction to zero of such -tolerances is the only reasonable and responsible action that can be taken. Appropriate regulatory action is long overdue. Any additional delay in reducing dietary levels of PCB's can only result in increased exposure of the population to potentially disastrous health risks which neither they nor their elected representatives have under taken to assume. REFERENCES 1. J. R. Allen, "Response of the Nonhuman Primate to Polychlorinated Biphenyl Exposure," Federation Proceedings, Vol. 34 (1975), p. 1675. 2. J. R. Allen, L. A . Carstens, and D . A. Barsotti, "Residual Effects of Short-Term, Low-Level Ex posure of Nonhuman Primates to Polychlorinated Biphenyls," Toxicology and A pplied Pharmacology, Vol. 30 (1974), p. 440. 3. D. A. Barsotti and J. R. Allen, "Effects of Poly chlorinated Biphenyls on Reproduction in the Primate," Federation Proceedings, V ol. 34 (1975), p. 338. 4. D . A. Barsotti, R. J. Marlar, and J. R. Allen, "Re productive Dysfunctions in Rhesus Monkeys Ex posed to Low Levels of Polychlorinated Biphenyls GENP 005998 449 774647 (Arodor 1248)," Food and Cosmetics Toxicology, in press. 5. R. D. Kimbrough, R. A. Squire, R. E. Linder, J. D. Strandberg, R. J. Montali, and V. W. Burse, "Induc tion of Liver Tumors in Sherman Strain Female Rats By Polychlorinated Biphenyl Aroclor 1 2 6 0 /' in press. 6. R. D. Kimbrough, 'T h e Toxicity of Polychlorinated Polycyclic Compounds and Related Chemicals," C R C C ritical Reviews in Toxicology (January 1974), p. 445. 7. R. E, Linder, T . B. Gaines, and R. D. Kimbrough, 'T h e Effect of Polychlorinated Biphenyls on Rat Reproduction," Food and Cosmetic Technology, Vol. 12 (1974), p. 63. 8. H. Blumenthal, Testimony on PCBs in Paper Food Packaging Materials, available from the hearing clerk's office, FDA, Washington, D.C. (Docket No. 75 N-0013). 9. J. R. Allen, D. H. Norback, and I. C. Hsu, 'Tissue Modifications in Monkeys as Related to Absorption, Distribution and Excretion of Polychlorinated .Bi phenyls," Arch. Environ. Contam. Toxicol., Vol. 2 (1974), p. 86. 10. A . Curley, V . W. Burse, M. E. Grim, R. W. Jennings, and R. E. Linder, "Polychlorinated Biphenyls: Dis tribution and Storage in Body Fluids of Sherman Rats," Environmental Research, Vol. 4 (1971), p. 481. 11. H. A. Price and R. L. Welch, "Occurrence o f Poly chlorinated Biphenyls in Humans," Environm ental Health Perspectives, Vol. 1 (1972), p. 73. 12. A. R. Yobs, "Levels of Polychlorinated Biphenyls in Adipose Tissue of the General Population of the Nation," Environmental Health Perspectives, Vol. 1 (1972), p. 79. 13. B. Bush, C. F. Tumasonis, and F. D. Baker, 'T o x ic i ty and Persistence of PCB Homologs and Isomers in Avian Systems," Arch. Environ. Contam, Toxicol., Vol. 2 (1974), p. 195. 14. G, Bagley and E. Cromartie, "Elimination Pattern of Aroclor 1254 Components in the Bobwhite," J. Chromatography, Vol. 7 5 (1973), p. 219. 15. D. L. .Grant, W. E. J. Phillips, and D. C. Villeneuve, " M e ta b o lis m o f a Polychlorinated Biphenyl (Aroclor 1254) Mixture in the Rat," Bulletin Envi ron. C ont Toxicol., Vol. 6 (1971), p. 102. 16. A . M. Gardner, J. T. Chen, J. A . G. Roach, and E. P. Ragelis, "Polychlorinated Biphenyls: Hydroxylated Urinary Metabolites of 2,5,2',5' - Tetrachlorobiphenyl Identified in Rabbits," Biochem. Biophys. Res. Commun., Vol. 55 (1974), p. 1377. 17. D. M. Jerina and J. W. Daily, "Arene Oxides: A New Aspect of Drug Metabolism," Science, Vol. 185 (1974), p. 573. 18. M. Kuratsune, T . Yoshimura, J. Matsuzaka, and A. Yamaguchi, "Epidemiologic Study on Yusho, a Poisoning Caused by Ingestion of Rice Oil Con taminated with a Commercial Brand of Poly c h lo rin a te d Biphenyls," Environmental Health Perspectives, Vol. 1 (1972), p. 119. 19. M. Kuratsune, "An Abstract of Results of Laborato ry Examinations of Patients with Yusho and of Animal Experiments," Environmental Health Per spectives, Vol. 1 (1972), p. 129. 20. J! R. Wessel, Testimony on PCBs In Paper Food Packaging Materials, available from the hearing clerk's office, FDA, Washington, D.C. (Docket No. 75N-0013). 21. G. Veith, "Baseline Concentrations of Polychlorin ated Biphenyl and D D T in Lake Michigan Fish, 1971," Pesticide Monitoring Journal, Vol. 9 (1975), p. 21. 22. R. Hanley, "PCB in Fish Stirs New State Study," The N ew York Times, September 1 6 ,1 9 7 5 . 23. R. R. Linko, J. Kaitaranta, P. Rantamaki, and I. Eronen, "Occurrence of D D T and PCB Compounds in Baltic Herring and Pike from the Turku Archipel ago," Environmental P ol/u t., Vol. 7 (1974), p. 193. 24. R. R. Linko, P. Rantamaki, and K. Urpo, "PCB Residues in Plankton and Sediment in the South western Coast of Finland," Bull, o f Environmental Contam. Toxicol., Vol. 12 (1974), p. 733. 25. P. E. Cornetiussen, Testimony on PCBs In Paper Food Packaging Materials, available from the hear ing clerk's office, FDA, Washington, D.C. (Docket No. 75N-Q013). 26. "Supplement To The Final Environmental Impact Statement Rule Making on Polychlorinated Bi phenyls," FDA (1973), p. 7. 27. A . C. Kolbye, Jr., Testimony on PCB In Paper Food Packaging Materials, available from the hearing clerk's office, FD A , Washington, D.C. (Docket No. 75N-0013). 28. N. Mantel and W. R. B ryen ," 'Safety'Testing of Carcinogenic Agents," Journal o f the N ational Cancer Institute, Vol. 27 (1961), p. 455. 29. N. Mantel and M. A . Schneiderman, "Estimating 'Safe' Levels, a Hazardous Undertaking," Cancer Re search, Vol. 35 (1975), p. 1379. 30. D. G. Hoel, D. W. Gaylor, R. L. Kirschstein, U. Saffiotti, and M. A . Schneiderman, "Estimation of Risks of Irreversible Delayed Toxicity," Journal o f Toxicology and Environmental Health, Vol. 1 (1975), p. 133. GENP 005999 450 7 74648 CONCERNS AND RECOMMENDATIONS OF THE NATIONAL MARINE FISHERIES SERVICE REGARDING APPROACHES TO CONTROL THE POLYCHLORINATED BIPHENYLS PROBLEM Thomas J. Billy* Abstract AREAS OF CONCERN The views o f the National Marine Fisheries Service concerning what can and should be done to f 1) prevent PCB's from further polluting the environment, (21 pro tect consumers and lim it human exposure, and (3) avoid unnecessary adverse p ub licity having a severe economic im pact upon die fishing industry are described. Specific environmental, consumer,and fishing industry concerns are discussed and recommendations made, in light o f these concerns. IN T R O D U C T IO N On the occasion of this conference, the National Marine Fisheries Service (NMFS) would like to express its views concerning what can or should be done to (1) reduce the amounts of PCB's reaching the environment, (2) limit human exposure, and (3) avoid unnecessary adverse publicity. In earlier sessions, we have heard presentations on: 1. Health effects and human exposure, including the available toxicological information. 2. The uses, sources, and identification of PCB's. 3. Discussion on the environmental fate and occur rence, including the ecological effects of exposure. 4. The availability and economics of substitutes. 5. The impact that the PCB pollution .problem has already had on people and their livelihoods. During this session of the conference, presentations have been made on what can be done to reduce the amounts of PCB's reaching the environment and to limit human exposure. Federal and State roles and responsi bilities have been described and the recent Canadian regulatory measures have been presented. With this information and data base and with the approaches and responsibilities for control outlined in this session, I would li.ke to express our concerns and recommendations, as the Federal Agency with the pri mary responsibility for the management and utilization of our Nation's marine fishery resources. 'C hief, Fishery Products Inspection and Safety Division, National Marine Fisheries Service, National Oceanic and Atmos pheric Administration, Department of Commerce, Washington, D.C. Our concerns can be put into the following three categories: 1. Aquatic environment, 2. Consumers of fishery products, and 3. Fishing/seafood industry. Let us take a brief look at each of these areas. 1. Environmental Concerns Effective, comprehensive controls to prevent the pollution of the environment from the manufacture, sale, use, and disposal of PCB's in the United States have not been implemented to date, resulting in the continu ing contamination of the ecosystem and the consequent occurrence of PCB residues in a number of fish species and other foods. 2. Consumer Concerns We believe responsible regulatory action has been taken already to deal with the public health issue, and we fully support the current 5.0 ppm temporary toler ance for PCB's in fishery products. However, our con cern is that certain information being presented at this conference and other pressures could result in precipi tous further regulatory actions that are not based upon the full and complete information necessary to justify such actions. No change in the present tolerance should be con templated until full and proper consideration has been given to: a. New, conclusive toxicological information. b. The role of the specific species in the diet. c. Probable further decreases in PCB levels over an extended period of time. d . , Direct economic impact to the fishing industry as well as the overall economic impact. e. A lte r n a tiv e government and industry ap proaches for assuring consumer protection. Finally, there is concern that some of us in this room may fail to recognize our responsibility to insure that information reaching the public be completely fac tual, not speculative, and that it be presented fairly so as to prevent unnecessary confusion oh the part of con sumers and the resultant severe economic impact on the fishing industry. 3. Seafood Industry Concerns There is a lack o f recognition by some that an indus try depends upon the natural resources which we are GENP 006000 451 774649 discussing, and we have imposed a serious problem on them that is not of their making. The seafood industry is concerned about the safety of their products and has been and continues to be willing to take responsible ac tions to protect public health. However, NMFS is concerned that the lessons from the past in over-regulating or implementing unnecessary regulatory actions will not be heeded, R E C O M M E N D A T IO N S In light of these concerns as well as the available information, the National Marine Fisheries Service recommends the following: 1. That Federal and State governments take immediate steps to implement effective controls to prevent the poi* lution of the environment by PCB's under the many authorities available to them. These controls should con sider the manufacture, sale, use, and disposal of PCB's and other similar hazardous substances. 2. That current tolerance for PCB's in seafood should be maintained unless new and complete information warrants consideration of specific actions to selectively deal with specific problems. 3. That release of unnecessary or irresponsible adverse publicity or other actions that will have a direct impact on all seafood sales should be avoided. In summary, let us not once again lay ourselves open to the criticism of having only single purpose goals. Let us evaluate all risks, costs, and benefits and then take further regulatory actions, based on the greatest net good to society. 452 774650 THE ROLE OF THE COAST GUARD IN PCB POLLUTION CONTROL Lt. Cmdr. J. A. MacDonald* Abstract In order fo r die Coast Guard to act in protecting the e n viro n m en tth e substance to be controlled must be designated as a harm ful o r a hazardous polluting sub stance by EPA. To this date, PCB's have n o t been o ffic i ally established as such. Public awareness is also crucial in helping the Coast Guard fu lfill its role--handlers must learn that PCB's are hazardous and treat diem according ly , and those who detect spills should report them prom pdy. The Coast Guard's role in protecting the environ ment from PCB pollution is defined in Section 311 of the Federal Water Pollution Control Act of 1972 as amended. That role is to prevent transportation-related spills of oil and hazardous polluting substances from entering the navigable waters of the United States or the contiguous zone, and to enforce the provisions estab lished in Section 311. In order for the Coast Guard to initiate actions to respond to this role, PCB's must be designated by the Environmental Protection Agency as a harmful or hazardous polluting substance,' and a determination made as to the amount that is hazardous. A fter this is determined, the Coast Guard will address the problem in three basic ways: detection of spills, prevention of spills, and enforcement of statutory sanctions for such spills. Increased public awareness will help to reduce and mitigate the effects of PCB spills. As soon as the public Chief, Pollution Prevention and Enforcement Branch, U.S. Coast Guard. is aware that PCB's are hazardous, and that special pre cautions should be taken in their handling and transpor tation, the number of spills involving PCB's will certainly decline. Detection is exceedingly difficult because PCB's are a relatively colorless liquid. Oil, on the other hand, is ~ more easily detected although even certain oils present problems for us from time to time. It may be possible that some form of tagging, such as the utilization of dyes, would assist in the detection of PCB spills. Prevention also ties'back into public awareness. If the stevedore handling a transformer containing PCB's on a pier in Seattle had been aware that the transformer contained a hazardous polluting substance, he might have been more cautious while handling that trans former, and the resultant spill might have been averted. Enforcement is predicated upon an illegal spill being detected and reported to the proper authorities. We must ascertain that a spill took place, establish its cause, and identify the responsible party so that penalty assessments and statutory sanctions can be invoked. To reduce and mitigate the effects of a spill after it has taken place, we would deal with it in a manner some what analagous to the manner in which we deal with oil spills. Response teams capable of dealing with spills of any number of hazardous substances o f various mag nitudes would assist in the containment and cleanup. Unfortunately, with PCB's these actions are made very difficult by the physical properties of the liquid. There are some hard questions that need answering immediately. The Coast Guard, EPA, and other agencies will address them, as soon as practicable. I would re emphasize, however, the fact that our future actions in regard to PCB's are predicated upon its establishment as a hazardous polluting substance. I GENP 006002 453 774651 \ CONSIDERATIONS BY THE DEPARTMENT OF TRANSPORTATION Alfred W. Grella* A b s tra c t The Departm ent o f Transportation (D O T} has nine categories fo r hazardous materials. Packages containing these substances are to be labeled by category and ham died accordingly. PCB's are n o t presently classified as conventional toxic materials and are therefore n o t regu lated under D O T criteria. The department is now consid ering whether to develop a generic category o f "hazard ous wastes" and/or sim ilar categories fo r environmental ly hazardous materials, which would possibly include materials such as PCB's. I have just a few remarks which would point out some o f the thinking in DOT, some of the concerns we have, and some reasons why we do not have any regula tory criteria at the present time for transportation requirements for PCB's. It is important at the outset to point out that the current standards and philosophies in regulating hazardous materials in transportation are based on considerations o f preventing acute hazards caused by release of hazardous materials from their packaging. This philosophy is common to ooth the inter national and the domestic transportation requirements. Another way o f saying this is that ws do not regu late materials from a standpoint of the long-term effects from chronic hazards. In transportation hazardous mate rials are grouped or categorized into approximately nine classifications. The hazardous material may either be listed by name and classification or under a generic head ing by classification. The regulations, for the most part, provide test criteria for persons to test a material to determine its classification, if the material is not already listed. If it is regulated under these criteria, then packaging, marking, and labeling requirements are prescribed, and sometimes carrier stowage requirements are indicated. For -these purposes, the "conventional" poison classification criteria relate to the effects of animal tests against oral, inhalation, and skin-absorbtion criteria. It is clear that the PCB's that we are aware of are not present- 'C hief, Technology Division, Office of Hazardous Materials Operations, Materials Transportation Bureau, Department o f Transportation, Washington, D.C. ly regulated as "conventional" toxic materials. There fore, they are not regulated in transportation under our present DOT criteria. Previously there has never been a statutory defini tion of "hazardous materials." Recent legislation, as recent as January of this year, resulted in the Transpor tation Safety Act of 1974, Public Law 93-633. In sec tion 103, paragraph 2, "hazardous material" is defined as "a substance or material in a quantity and form which may pose an unreasonable risk to health and safety for property when transported in commerce." Therefore, it appears, for the first time, that we may have some sort of a basis to look at criteria other than the acute hazard, if such action appears appropriate. And the same consideration is coming up more and more when we talk about the generic term, "hazardous wastes." Many hazardous wastes may already be regu: lated now as hazardous materials. There are also many types of hazardous waste that may not be quite toxic enough or quite corrosive enough or quite flammable enough to be regulated. But they still may be objection able with respect to release to the environment. The other area is carcinogenic materials in general, which do not meet the conventional toxicity criteria. So in these three areas-PCB's, hazardous wastes, and carcinogenic materials, we are starting to take a long look at whether there is a need for some degree of regu lation in transportation. The question would then arise: What should that degree of regulation be? Certainly, packaging requirements might have to be addressed and, certainly, considerations for labeling. This will give you some idea of the things we are thinking about. We have not formed any actual, concrete plans. We are following very closely what the other agencies are doing and are maintaining as close contact as possible with those 'agencies. The UN Group of Experts on Dangerous Goods, which is the international body that develops regulations for the transport of .hazardous materials, has been debating the subject of PCB's and environmental pollut ants for several years and has not been able to come to agreement as to whether they should undertake to regu late environmental hazards at all or whether this should be left to the environmental groups. 454 774652 OBSERVATIONS ON AND SUMMARY OF SESSION V II Albert Kolbye, M.D., M.P.H., J.D.* It has been a very interesting meeting and we have heard a lot of interesting data, opinions, and some rhetoric. I would like to make a few quick points that I think we should all keep in mind, because personally I feel once again we in FDA are the straight men in a bad joke. We are asked to mediate decisions that involve many parameters, not the least of which concerns human safety very directly. We are asked to interpret data and to come up with limits on human exposure oyer time. We have previously dealt with environmental contaminants. We have a few that we unfortunately have experience with that are biologically persistent and for which experimental data show that there are varying degrees of carcinogenic potential: at least in animals. I should like to talk about a guideline for a moment, because a guideline or a tolerance or however you wish to think of it represents a level in a particular food. What is really important in the long run is what the exposure dose is that humans receive and how they receive it. The major point that I am trying to make is that we feel the average consumer is fairly well protected against the hazards of PCB's. But if one eats food with a high percentage of contaminating residues, and if one eats that particular food commodity frequently, one's ex* posure dose quite obviously goes up. As far as I can see, the people who in this country bear the greatest poten tial risk are selected sport fishermen, "sport fisher people," who, if they are catching and retaining and consuming with a high degree of frequency certain species of fish from certain geographic locations, have higher exposures than do the rest of usjn this country. One of the decisions we have to make is what incre mental degree of protection will be afforded to the pub lic by a dcrmentai change in our guidelines. But please "Anociat'e Director for Sciences, Bureau of Foods, Food and Drug Administration, Washington, D.C. remember once again that a guideline itself represents a judgment concerning dietary intake, which also repre sents a judgment about the frequency of food consump tion. And it is a little difficult sometimes to draw a bright line in a gray zone and I believe you can expect reasonable people to differ somewhat in their opinions about where that bright line should be drawn. I woujd like to say one other thing about a guide line, because it would appear from time to time here and there that there has been some confusion about the meaning of a guideline with reference to cooperative action by various governmental sectors regarding the en vironment. An FD A guideline involving an environ mental contaminant, in food is not, and I repeat, is not equivalent to permitting pollution. It does not give license to pollute. Some people seem to have thought in the back of their minds that as long as fish did not exceed such and such a level of PCB's, a certain amount of PCB's entering the aquatic environment was per missible. That thinking is now obsolete. The ecological criteria as far as I can see, with re spect to wildlife, are some of the most sensitive indi cators with respect to substances like PCB's, and I think, as was mentioned earlier, we should take note of such data in terms of our overall cooperative efforts to pro tect the environment. I .think health and environmental education should be undertaken for the public land in particular for cer tain people who are concerned with disposal of solid waste) as to what containers are likely to contain PCB's and the proper identification and disposal of transformer fluid, etc. I would also tike to make one note. Let us not unduly focus on the polychlorinated biphenyls. There are other environmentally persistent compounds of con cern, and a recent episode has led us to fully appreciate that the polybrominated biphenyls are also of concern. Thank you very much. GENP 006004 455 7 653 / 21 November 1975 Session V ili: SUMMARY SESSION John L. Buckley, Ph.D. Session Chairman 457 KJ\ Preceding page blank 774654 \ SUM M AR Y OF SESSION I DR. J. G. VOS ( Rijks Instituut voor de Votksgezondheid, Bilthoven, The Netherlands): Recent findings on the biological action of PCB's, such as jcarcinogenicity in rodents and the disturbed reproduction in monkeys, greatly increase our concern of PCB's as a health hazard. In ' summarizing the papers presented in the session on health effects, one is confronted already in Dr. Kuratsune's paper with the problem of PCB's and chlorinated dibenzofuran impurities. In the "Yusho" disease, one is struck by the persistence of symptoms present in patients, although there is a shift in the pattern, a decrease over the years in the skin lesions but a persistence of hypersecretion of Meibomian glands. In "Yusho" patients, increased urinary excretion of 17-ketosteriods was noted, as was an increase in serum triglyceride levels. Changes in the menstrual cycle were observed in a high per centage of female patients. Mean blood levels in "Yusho" patients were 7 ppb. This level conflicts with the high PCB concentrations in blood of work ers who are occupationally exposed yet who, for the most part, show no indication of adverse effects. A possible explanation for this difference was the relatively high concentration (5,000 ppm on PCB basis) of chlorinated dibenzofurans (including 2,3,7,8-TCDF) in rice oil. Apparently furans were formed in the PCB during its use as a heat exchang er, since the level of chlorinated dibenzofuran in Kanechlor KC-400 was approximately 17 ppm. O f particular significance was the relatively high con centration of chlorinated dibenzofurans versus PCB's in the liver of some patients who died, when compared with adipose tissue values. Further studies are required to solve the dilemma of the importance of furans in the etiology of "Yusho" disease; and in a wider context, to get information on possible changes in composition or concentrations of chlo rinated dibenzofuran and other contaminants in used PCB's and on their fate in the environment During the 1971 PCB conference, there was some concern on a bladder tumor that was found in a rat by Dr. Kimbrough. Now we know that this tumor apparently developed spontaneously. But as we heard from Dr. Kimbrough, in recent studies cer tain PCS mixtures induce tumors in rats and mice. A spectrum of lesions are induced in livers of rats fed 100 ppm Aroclor 1260 for 21 months: hyper plastic or neoplastic nodules in 80 percent of the treated animals and in none of the controls, and hepatocellular carcinomas in 14 percent of the ex- perimental animals and in one out of 173 controls. Mtastass were not observed. However, hepato cellular carcinomas were not found in the chronic study in rats, as reported by Dr. Calandra. A possi ble explanation can be the small number of animals used in this study. Evidently, this question has to be solved. Hyperplastic nodules were seen in 25 to 50 percent o f rats fed 100 ppm Aroclor 1242, 1254, or 1260. These three mixtures did not appear to be mutagenic or teratogenic. No-effect levels based on 2-year studies in rats and dogs and reproduction studies in rats were 10 ppm. As reported by D r. Allen, adult monkeys and in particular the females are very sensitive to PCB's. When Rhesus monkeys were fed 2.5 or 5 ppm A ro clor 1248--that is, approximately 0.1 or 0.2 mg/kg body weight/day--skin lesions consisting of acne of face and neck, edema, and hair loss developed in some females already after 2 months. All females exhibited these changes after 6 months, but males were more resistant. Disturbances in reproduction were present in females and not in males. Menstrual cycles were irregular within 4 months. The concep tion rate in the 5-ppm group was decreased. Because o f resorptions and abortions, the birth rate was re duced and the infants born were small. F ifty per cent of them died before weaning, showing typical lesions. These effects on reproduction may be due to an estrogen/progesterone imbalance. Female rhesus monkeys on a PCB diet had increased urinary levels of ketosteriods. By comparing the reports of Drs. Kuratsune and Allen, one is struck by the similarity of lesions present in "Yusho" patients and those produced ex perimentally in the monkey, with the exception of the effect on serum triglycerides. Both species seem also to be equally sensitive in a quantitative way. Dr. Matthews studied the effect of chlorination on tissue distribution and excretion of PCB isomers in rats. Each of the PCB's studied was removed rapidly from blood to liver and muscle. Redistribu tion to skin and adipose tissue increased with in creasing chlorine concentration, whereas elimination via urine or feces was highest with the low chlorina ted isomers. A fter 6 weeks, 85 percent of the 2,4,5,2',4',5'-isomer was still present in adipose t i s s ue and s k i n , w hile the residue of 2,4,5,2<,5<-isomer was only 5 percent. Significant excretion occurs only after metabolism to polar compounds. The necessary factor could be the pre sence of two adjacent unsubstituted carbon atoms GENP 006006 Preceding page blank 774655 that facilitate the formation of arene oxide inter mediates, os was also reported by Dr. Allen in his study with the 2,5,2'5,-isomers in the monkey. Dr. Lcobichori reported on the influence of position and degree of chlorination of chlorobiphenyl isomers on the hepatic function in the rat. Substitution at the 4 and 4* positions, irrespective of chlorination at other positions, enhanced the activities of endoplasmic reticulum bound enzymes 0- demethylase and aniline hydroxylase. This is probably due to their higher persistence. For en zymes less discretely localized in the liver cell, such as carboxyle.sterase and sulfobromophthalein -glutathion conjugating enzyme, the position of chlorine atoms appears of less importance. Purified unsubstituted biphenyl did produce enzyme induc tion, though enhanced effects were noted when one or more chlorine atoms were present. As can be concluded from the report of Dr. Biocca, biological effects of symmetrical heXachlorobifenyl isomers differ not only quantitatively but also qualitatively. Such comparative studies are necessary for the ultimate goal--that is, the under standing of the biological effects produced by com plex mixtures that endanger human health, mixtures that are different from those formulated commer cially. Of the three isomers tested in mice, 3,4,5,3*, 4',5'-HCB was most toxic, followed by 2,4,6,2*,4',6 '-HCB and 2,4,5,2',4',5*-HCB, respectively. Liver weights were increased by all three isomers. Severe thymus atrophy and a decrease in a- and 7 -globulins were produced only by 3,4,5,3',4',5'-HC B. In a study in chickens, these isomers along with 2,3,4,2 \3',4'-H C B and 2,3,6,2',3',6'-HCB were given at 400 ppm in the diet for 3 weeks. Again, 3,4,5,3',4* ,5'-HCB was most toxic and was lethal even at 3 ppm. Chickens exhibited pronounced edema, thy mic involution, and marked liver pathology. How ever, chickens that were fed 100 ppm died earlier and had only mild-liver pathology. The 2,4,6,2',4* ,6 r-HCB was less toxic (no deaths at 400 ppm) but caused marked liver pathology and highest liver w e ig h t increase. The toxicological effects of 3,4,5,3',4\5*-HC B differ qualitatively from the other HCB isomers studied, and resemble the lesions produced by 2,3,7,8-TC DF. Dr. McKinney reported on metabolism studies of HCB isomers in the chicken using low resolution mass spectrometry. When metabolites were detect ed, the three basic reactions were isomerization, reductive dechlorination, and oxidation with and without chlorine loss. Siginificant metabolites were not detected in excreta of chickens fed 2,3,4,2',3', 4 \ 3 ,4 .5 .3 \4 \5 '-, or 2 ,3,6,2\3\6'-H C B . Metahydroxylation followed by parahydroxylation of the same ring are favored processes for 2 ,4 ,5 ,2 ',4 \ 5*-HC8. Further oxidation could give quinone. The presence of a metabolite with a trihydroxypentachlorobiphenyl structure indicated that dechlorina tion can be concomitant with hydroxylation. A dibenzofuran metabolite was not detected. In the case of 2 ,4 ,6 ,2 \4 ',6 f-HCB, several re a c tio n types occurred: dechlorination, isomeri zation, and dibenzofuran formation. This isomer had lowest effect on body weight, did not give a high liver residue, but produced most severe liver pathology despite the dibenzofuran formation. In contrast, 3,4,5,3',4',5*-HCB accumulated most in liver and fat, was most toxic with "fu ran"-type ef fects, but metabolites were not detected in the ex creta. However, one has to consider in the case of 2,4,B,2\4\6**H CB and possibly 3,4(5 ^ ' l4 'r5*-HCB the possibility of covalently bound metabolites that may be of toxicological significance. A good corre lation, which may have predictive value, was ob-` served between the retention indices from gas chro matography with the adipose tissue concentration. An exception was the 2,4,6,2',4\6'-isom er, which had the smallest retention index but relatively high tissue accumulation. The strong ortho effect could be responsible for this discrepancy. Dr. Moore reported on the first toxicity studies with 2,3,7,8-TCDF. Marked thymus atrophy and the presence of edema are seen in chickens dosed daily with 1 pg/kg. Only mild liver pathology was present at the 5-pg dose level, which produced 100 percent mortality. The LD S0 in guinea pigs after a single oral dose was approximately 7 pg/kg body weight. In chicken and guinea pigs, 2,3,7,8-TCDF is lethal at dose levels that are less than one order of magnitude higher than that of 2,3,7,8-TC DD and share a number of biological effects. Mice and rats are more resistant to TC D F . A single subcutaneous dose of 6,000 pg/kg did not reduce body weight but gave thymus atrophy and mild liver toxicity in mice. No effect was noted in rats intubated with 1,000 pg/kg body weight. Clearly, more research is needed with different chlorinated dibenzofurans isomers in order to assess their health hazards. s 1 460 774656 SUM M ARY OF SESSION II M R. D A V ID G A R RETT (Environmental Protection Agency, Washington, D.C.): (n Session II , Dr. James Mieure, who is research group leader, Mon santo Industrial Chemicals of St. Louis, spoke of PCB's, their properties and mixtures, and presented physical and chemical properties of commercial Aroclor products. Dr. Stephen Safe, Associate and Professor, De partment of Chemistry, University of Guelph, Ontario, presented an overview of analytical identif ication and spectroscopic properties. Key among the points stressed were that sophisticated methods and equipment are available for identification and quan tification of PCB's at extremely low levels. Dr. Robert Durfee, Vice President o f Versar, Inc., presented topical information on the manufac ture and uses of Aroclors in the United States and also gave a vivid description of the use of Aroclors in the manufacture of closed electrical systems--in particular, capacitors and transformer products. In addition he presented an overview of PCB's uses in investment casting waxes and the casting process it self was reviewed. Thomas E. Kopp of the Office of Toxic Sub stances in the Environmental Protection Agency re viewed past, present, and possible future regulatory activities of EPA concerning PCB's. in the water environment He discussed proposed voluntary stan dards being prepared by N EM A, ANSI concerning labeling and safeguards for handling askarels and askarel-containing equipment Then, Mr. Stanton Kleinert, who is Chief of Surveillance for the Wisconsin Department of Natu ral Resources, discussed sources of PCB's in the State of Wisconsin, emphasizing the probable role of intermedia transfer from air to water and describing some possible sources of contamination for food and water. And lastly in this section, Mr. John Hesse, Supervisor of the Toxic Material Unit, Department of Natural Resources in Michigan, described uses of PCB's and'losses to the environment of Michigan. Mr. Hesse also emphasized PCB losses to air and the probably significant transfer of these PCB's into the water medium. Data was presented on PCB concen tra tio n s in municipal treatment effluents and sludges, which undoubtedly contributes to the con tinuous cycling in the environment of these persist ent pollutants. . Some of the salient points generally brought forth in the meeting either presented or implied were that PCB losses to air could be an important contributor to the problems we encounter in water. Disposal of PCB's waste to municipal sewage treat ment does not necessarily curtail the cycling and environmental damage from PCB's. And undoubted ly there should be a greater sense of accountability among users of PCB's and a closer control of inven tory. Additionally, there is presently no corrective UJS. authority which could regulate importation of PCB's and PCB-containing products, nor other seri ous environmental contaminants which are not pes ticides, drugs, and the like. And lastly, judging from estimates of PCB's already contaminating the environment and its in habitants, the task of cleanup is monumental, even if we had proven technology with which to accom plish this task. Thank you. GENP 006008 SUM M ARY OF SESSION III . DR. IA N C. T . NISBET: Eleven major points came out in the course of our session on transport and accu mulation of PCB's in the environment. 1. We know almost nothing about chlorinated dibenzofurans, except that they are present in Aroclor 1242 and 1254, and we learned during Session I that they are formed in use and they are formed by metabolism. We know nothing whatsoever about their subsequent behavior in the environment 2. PCB's themselves remain universally distributed in the environment Although some releases have been curtailed, othr releases 'continue. These in.elude releases from manufacturing, leaks from sup posedly closed systems, scrapping of PCB's manu factured before 1971 and of materials containing them, and use in nonclosed systems of material that is either imported or diverted from other uses. 3. Surprisingly large quantities of PCB's which match Aroclor 1254 or 1260 are still being found in air and :n dry fallout and precipitation. It is difficult to account for these quantities in terms of known past uses, and accordingly we may have to look for a significant current source of air emissions. Perhaps this may be air emissions from transformers, or dis posal of scrap materials from them. 4. There is circumstantial evidence that PCB's that are now trapped in large quantities in sediments in lakes, rivers, and estuaries will remain available for resuspension and will continue to move slowly downstream. We do not have any precise infor mation about their persistence or about the time it will take them to move downstream into the sea, but we believe that it is to be measured in years, if not decades. 5. Although PCB levels have decreased consider ably in some components of the environment such as terrestrial birds or the mussels collected off California, as yet there is no clear indication of a consistent decline in PCB residues in fish. We should not expect a rapid decline, because of the long re tention time of PCB's in the environment and in human tissue. 6. In addition, many items containing PCB's have service lives of 10 to 20 years before they are dis carded, so that we are still experiencing releases of materials manufactured before 1971. 7. Because of time lags in response we may not yet have reached peak levels in some compartments in the environment. I am thinking here particularly of estuaries, where levels of PCB's may continue to increase as sediments are transported downstream. 8. Most human exposure to PCB's in the diet is via fish, although there is some human exposure via other routes, such as milk, meat, and by inhalation in the air. The information from the FDA total diet program suggested that the dietary exposure of an average adult in the United States is of the order of 10 micrograms per day. However, an average for PCB's has little meaning because of the very wide variations in individual consumption of fish and enormous variations in the contamination levels. 9. Individuals who have a dietary preference for freshwater fish will take in much more than the average--in some cases at least a hundred times as much as the average. Breast-fed^infants appear to have extremely high dietary intakes of PCB's, aver aging about 50 times higher than that of their mothers on a milligram per kilogram basis. The breast-fed infant appears to be one of Dr. Kolbye's special consumers who is imprudent enough to eat the same diet every day. 10. Monitoring of PCB residues in human fat in the United States and Canada shows that the median PCB concentration is of the order of 1 ppm. Again there are enormous variations, at least a hundred fold variation between the highest level recorded and lowest level detectable. 11. Finally, although tetrachlorobiphenyls are more easily degraded in the environment than pentachloro- or higher chlorinated compounds, the tetra chlorobiphenyls are nevertheless accumulated and retained by fish. Accordingly there are significant human intakes of tetrachlorobiphenyls, even though they are not retained in significant quantitities in human tissues. Therefore, release of either Aroclor 1016 or 1242 into aquatic systems will lead to some human exposure to tetrachlorobiphenyls. SUM M ARY OF SESSION IV DR. D O N ALD I. M O U N T (Environmental Protection Agency, Duluth, Minnesota): Among and between the birds, mammals, and aquatic organisms there are marked differences in sensitivity to PCB.'s. Even so, these differences are not large when compared to species differences found for other pollutants. Like wise, there are differences in the toxicity of various Aroclors and isomers of PCB's that are real but not large. While increasing chlorine content increases tox icity in warm-blooded animals, increasing chlorine content decreases toxicity of PCB's to aquatic ani mals. This observation is exceedingly important In determining the future actions to be taken on PCB's. Increased chlorine content seems to increase biological half-life and bioconcentration in all ani mal groups, but the evidence is not entirely clear cut on this point. To generalize, we can say that in mcst cases acute lethal toxicity in birds and mammals occurs 462 774658 from 10 to 100 ppm in the food, while more sensi tive species may suffer death from 1 to 10 ppm in the food. Concentrations of about 5 ppm in bird eggs produced death. And concentrations of PCB's from .5 to 5 ppm in food produced reproductive or growth effects. For aquatic animals, water concen trations of 10 to 100 micrograms per liter are acute ly lethal. Concentrations of 1 to 10 micrograms per liter produced chronic reproductive or growth ef fects and water concentrations of 1 to 10 nanograms per liter (ppt) produced residues of biological or public health significance. Direct uptake from water into aquatic orga nisms is very significant and appears to produce con centration factors on the order of one hundred thousand or more times. Water uptake supplement ed by food intake results in concentration factors of five hundred thousand or more times. The metabolic pathways, biological half-life, and selected isomer concentrations appear to be dif ferent, especially between cold-blooded and warm blooded animals and for various mixtures and iso mers of PCB's. Enzyme systems of poikilotherms are vastly different among the various groups and are also different from the enzyme systems of the homeotherms. Measurable harmful effects of PCB's in the envi ronment on organisms are not abundantly docu mented, and for the most part the effects that have been found are limited to subtle ones except for specific instances such as in mink and certain bird populations. Based upon laboratory toxicity data and contamination levels found in the environment, one would predict only subtle effects to occur. This is not to say they are not significant. The greatest concern continues to be residues as they affect the organisms carrying that residueespecialiy in the eggs and sex products-and as they effect the higher consumers. Apparently water con centrations will have to be kept in the range of .1 to .5 nanograms per liter if unacceptable residues are to be avoided. And the evidence to date is uncon vincing that 1016 is an acceptable substitute as far as aquatic organisms are concerned. SUMMARY OFSESSION V DR. NICHOLAS AJ A SHFORD (Massachusetts Institute of Technology, Cambridge, Massachusetts): While the effects of PCB's and their possible control are being pursued it is quite necessary arid natural that development of substitutes and their economic and health implications also be examined. In what fol lows, my purpose is to summarize the conference section dealing with economics and substitutes for PCB's. I shall present the summary in an order dif ferent from that in which the participants^appeared, so as to follow a logical sequence most meaningful to the substitute issue. Duncan McArthur from the Foster Snell operation presented an analysis of the PCB case which was part of a larger study (called "the Snell Report") of the probable effects of a Toxic Substance Control Act. In the PCB analysis, they addressed the direct and secondary impact of a complete banning of PCB's in the absence of tech nological breakthroughs and new substitutes. They postulated this prohibition would be effected over a period of 76 months, 38 months of which would be consumed with hearings and the promulgation of standards, with 38 months remaining for the tech nological response to eliminate the use of PCB's. The analysis focused on transformer and capacitor manufacturing having a volume capacity of 45 million pounds in 1973. On this basis, they calculate a one-time cost to society of $13.7 million, $8.8 million of which would affect the secondary users. Thereafter, an annual cost of $110 million per year was anticipated, of which $16.5 million fell upon primary users and $93.3 million on the secondary. There was no detailed examination of the health and economic benefits to be derived from a banning of PCB's. Dr. Dale Hattis from MIT's Center fo r Policy Alternatives reported on an examination o f both economic and environmental health changes that may have occurred as a result of the past partial withdrawal of the product from commerce by Mon santo. One of the factors covered was the increase in fire insurance premiums, estimated as possibly in the tens of millions of dollars and which presumably represented the increased risk as viewed by the in surance industry. It is important to note that die methodology was restricted by the availability of information on the nature of substitutes. This points out the complication of trade secrecy and 463 774659 GENP 006010 proprietary information, which, while presumably legitimate for other reasons, does complicate the assessment of costs and benefits. Two surprises appeared in the study. One had to do with the use of PCB's in paint systems. It wa? noted that a major group of substitutes evolved which were more economical than the PCB's which they replaced. This evidences a common inertial re* sistance to technological change even when it could be anticipated to be more beneficial (in a strictly economic sense) than technology already in use. A secondary benefit which should result from the de creased use of PCB's is a reduction in the threat to sport fishing. A calculation of recreational value could be very large even compared with the alterna tive recreational activities which occur as second best choices on the part of sport fishermen. The enormous size of die valuation inferred for sport fishing makes it easily the largest o f the defined costs of unrestricted PCB disposal. A third participant, Richard Rollins, spoke for the Electronic Industries Association, which is con cerned for the manufacturers and users of capaci tors. He cited the issues of flammability and reliabil ity, and he urged the development o f less toxic sub stitutes, This latter remark was consistent with one very clear message embodied in remarks by the group, namely that his industry was much more concerned with the environmental consequences than cost increases in the product He stated that there are no commercially available substitutes in AC capacitors, including the substitutes presented at this meeting, which are acceptable fo r safety and reliability. One interesting point made was that since the components of capacitor-grade PCS (Aroclor 1016) are not what are found in the environ ment, protection of the environment might not profitably be served by attacking the issue of capaci tor use and disposal. It appeared to him that PCB contamination must be coming primarily from some other industrial source. Dr, E. J. Inchalik for Exxon Chemical reported on capacitor substitutes based on diisononylphthalates with a flashpoint of 430 Fahrenheit and which are essentially already developed, but not yet fully proved and tested for health and environmental effects. The Prodelec operation from France presented an approach which is an incremental modification of previous technology. For transformer use, they recommend keeping trichlorobiphenyl in mixtures with chlorobenzene. Both compounds o f course, being chlorinated, have problems in that regard. Secondly, for capacitors they propose a mixture of dichlorobiphenyls and their alkylated derivatives, a commercial mixture of which is called chloralky* lene. These products are now being examined by an institute in Bonn for environmental behavior and he indicates that tests already show there is more biodegradation and tower toxicity for these com pounds than for their PCB counterparts. M r. David Wood from Monsanto Company d escribed two new products, MCS-1238 and MCS-1588, for capacitor usage. He warns that nei ther is fire resistant although they have much better environmental characteristics. Their degradation is more rapid and their accumulation potential in the environment is considerably reduced. Occupational and environmental health considerations indicate a better product with lower acute toxicity. He also announced that they do have candidates with inter mediate fire resistance between PCB's and mineral oil, but did not elaborate on this further. Dr, Dean Branson from Dow Chemical Com pany announced a substitute for use in power capa citors. This compound is called XFS-4169L and is a butylated monochlorodiphenyl oxide. Once again we find that a substitute is like the original, a chlo rinated compound. Its properties are worth noting however. Dielectric losses are lower or slightly lower than for capacitor-grade PCB, while the discharge inception voltage is significantly higher. The size or volume per unit of high-voltage power factor correc tion, called kV A R , is about that of die PCB coun terpart, which means that no redesign is necessary for capacitors. There is little fire and explosion risk indicated by comparing the flashpoints arid firepoints of PCB and XFS. The flashpoint for PCB is 166 centigrade, for XFS 174. The firepoint for PCB is greater than 316 centigrade, while XFS is 199. This substitute is reported to be more reliable and is anticipated to have a reasonable long-term price. The increased expense is estimated to be less than $20 for a 200 kV A R unit. The capacity in the first quarter of 1976 should be in the range of 1 million pounds per year, and a multimillion pound per year volume capability is estimated by the end of 1976. This substitute is more biodegradable by a factor of 45 and the bioconcentration is 30 times less. There is little toxic activity in acute and in 90-day tests, although longer-term tests need to be carried o u t The accumulation in fat is 22 times less. The toxicity in fish is on the order of 20 times less than for PCB's. l\0900dH,a> 464 774660 carried out. The accumulation in fat is 22 times less. The toxicity in fish is on the order of 20 times less than for PCB's. Perhaps the most exciting substitute for use in transformers was announced by Dow-Corning (rep resented by Richard Montgomery). He indicated that the global silicone industry had been looking for a replacement for the transformer fluid PCB's for 5 years, and the technology was now developed for the new fluid. It was to be commercially avail* able in 1976 and had no known environmental problems. Commercial production was available to handle the global market. In the United States there has been field-testing for 4 years and the product is now ready to be used. The product is called Q 2 - 10 90 dielectric fluid, and is a dimethyl silicone which has been used in the military, in Japan, and in a small experiment in Midland, Michigan. He pointed out that this was not very dissimilar to "di-gel," which is used of course for human consumption. It is less flammable than many PCB's with low heat of combustion, high flashpoints and firepoints, and the product is self-extinguishing in case of ignition by violent transformer breakdown. Insurance compan ies have OK'd the substance for use indoors. The cost is higher than PCB's but "not outrageous," giv ing rise to an estimated cost increase of about 6 percent in the transformer equipment. Of course, the fluid itself is more expensive, with a higher per centage increase in cost. PCB transformers now in service can be retrofitted and he believes that the economics are favorable enough to stimulate compe tition. It is worthy to note that unlike the trade industries representing the capacitor users presented at the conference, there was no transformer user or producer represented. It would be interesting to see what General Electric's viewpoint would be on the potential use for this transformer fluid substitute since they have the capability to manufacture sili cone fluids. Their absence at the meeting might leave one with an unwarranted optimism for the use o f these fluids in transformers. One further reflec tion is that we are badly in need of a frank assess ment of flammability risk requirements since the substitute products vary in their flammability over the great range between mineral oil and PCB's. It is not clear what tradeoffs should be made between the fire risks and the safety risks in the industrial setting and the possible damage to humans from substitute products which might get into the envi ronm ent It is also not clear that PCB's flammability characteristics should remain the benchmark for compliance although the insurance industries may see this differently. SU M M A R Y OF SESSION V I MR. CHRISTOPHER M. T IM M (Environmental Protec tion Agency, Region V , Chicago, Illinois): From a very broad mixture of topics and points of views that we were listening to last night, I believe the following four points should be emphasized. First, on top of all the human health and wild life effects that have been documented and thor oughly discussed, PCB's are having a definite and drastic effect on the livelihood and future of the freshwater fishery and fishermen. This is a very real problem to the people in various parts of the conti nent and they see no improvement in the near future. Second, a ban on PCB's and better control of other toxic substances to protect our natural re sources is long overdue. However, the actions of the regulatory agencies such as EPA and FD A must be based on scientific fact in the overall impact on the nation. Third, universally there is a belief that the governmental bodies and agencies for whatever reason are far, far too slow in solving environmental problems like PCB's. This is a frustration to every body. And finally, there is a need to find some way to compensate the people like fishermen whose liveli hood is impacted by environmental pollution which is PCB's. They do not cause the problem, they can not control the problem, and they often cannot find anyone to blame or even talk to about it. But they suffer the consequences of decades of incomplete evaluations and testing of new compounds. Thank you. 465 774661 GENP006012 SU M M A R Y OF SESSION Vl~f MR. CHARLES N. GREGG, JR. (Environmental Protec tion Agency. Washington, D.C.): Because most of you. have heard the discussion this morning, I w ill try not to repeat it, but to provide some insights and perhaps some o f the highlights. I w ill not try to give equal time to the various speakers. First, there is an obvious distinction between physical and technical methods of control, which have been discussed in other sessions, and the regu latory and voluntary actions for achieving those controls that were discussed by this morning's pan el. Second, there' is a distinction between the di rect control of human exposures as, for instance, through limitations on PCB's in fish that can be sold for human consumption, and limitations on use or limitations on emissions into the environment, which in the long run contribute to diminished ex posure. In our present situation, as you were told by the speakers this morning, there are a vast number of Federal agencies w ith roles. Our Government and the Canadian Government both contribute to solu tions of the Great Lakes problem. We have a lot of State Governments with roles to play. One of the major problems will be sorting out roles, and finding adequate cooperation in performing those roles, among the several agencies and units concerned. A further complication is that both in Canada and here we not only have a number of regulatory authorities now, but in each case we are looking for additional authority which it is anticipated will per mit much more finely applied solutions. And at the same time that we plan fo r the future, we do not know for certain what authority we wjli have availa ble for use. One observation I made was that there seemed to be very little real optimism. If we applied all our available resources and used all of our authorities as best we could, ;we could solve in any short time frame the most pressing problem, which appears to be the high levels in fish in a number o f places where they are caught and consumed in substantial quantity. This lack of optimism did not, neverthe less, suggest to the speakers that we should not take action. Everybody-seemed to agree that it was ap propriate to move ahead as best one could with the full range of authorities and voluntary programs available. Also, there was considerable emphasis on nonregulatory action, and increasing communication with people who have the opportunity to affect the flow of PCB's first from industrial situations into the environment and thereafter within the environ ment to locations where they can lead to higher human and environmental exposures. In my view, a voluntary program seems to present a very great op portunity for improvement, perhaps much greater than a strictly regulatory program in the light of some of the difficulties experienced in using our current authorities. Relatively less, it seemed to me, was said by this morning's speakers about just how to control PCB's, particularly how to control, through regula tion, those PCB's which are currently in industrial use or elsewhere in products but not yet released generally to the environment There was some refer ence to controls over disposal, but to my best recol lection, there was no indication that we had any directly applicable authorities with respect to dis posal. Let me touch on a couple of this morning's highlights. Dr. Ahmed of the NR DC asserted that the government had failed to carry out its response b ilitie s adequately, particularly under Section 307(a) of the Federal Water Pollution Control Act. He felt that we had a schedule on which we should have produced regulations a couple o f years ago, with compliance a year ago, and he criticized EPA's lack of attention and priority to toxics in our Water Pollution Control program. He made several recom mendations: a phaseout of the manufacture and use o f PCB's, a ban on exports and imports, develop ment of an inventory of point sources, additional monitoring in fish and elsewhere, a moratorium on river bottom dredging until we have better indica tions of the trouble we stir up, effluent standards that would allow us to arrive at 1 ppt in water, lower FDA tolerance levels, and the passage of the Toxic Substances Control Act. M r. Wessel of the Food and Drug Administra tion referred to its action in 1072 and 1973 to set tolerance levels, indicating that various concerns had to be balanced in setting levels under Section 406 of the Food, Drug, and Cosmetic Act. He indicated that FD A was examining the current tolerance level In fish and considering whether or not to lower I t He said that there would be adequate opportunity for public comment on any proposal that was made. But he felt that this would not solve the PCB prob lem and it would not necessarily prevent consump tion of fish with high levels of PCB's by private fisherman. Gnu? 006013 466 774662 / I Dr. Kolbye of FDA added a discussion of some justify unless we can control the PCB situation. He of the problems in setting tolerance levels, and suggested particularly that since we find great reduc something else I thought was significant: that steps tions in DDT and mercury as a result of regulation, are particularly needed to identify where PCB's are it would certainly be worth a try to see if we can located so we can look to their proper disposal, and reduce PCB levels in the water and in fish by taking education to this end is ni eeded. Hie did feel that the average consumer is fairly well 'protected against all of the regulatory steps we now can. He endorsed the Toxic Substances Control Act, and suggested we PCB's by the current tolerance level, but acknowl edged that there would be higher exposures in some cut off the importation of PCB's. Dr, Rhoden outlined the plans of NIOSH. A 'cases and that this was not a concern to pass over Mr. Billy of the Marine Fisheries Service indi 'lightly. 11 cated their environmental, consumer, and public Mr. Barber of the jEnvironmental Protection Agency, after talking about some of our authorities information concerns.. They recommend not lower ing the FDA level until there has been a sound at i and programs we have undertaken so far, gave con tempt to understand the course to be followed, and si iderable attention to soime of the'i realities involved in EPA decisionmaking: vthe complexity and impli the avoidance of unproductive and unnecessary ad verse publicity. cations of taking various regulatory courses, and the Mr. Grelta of DOT briefly described their incipi fact that there are limited resources in EPA, particu ent program to apply DOT authorities to PCB's, larly people, to handle a| wide array of regulatory though not much has yet been done. Responsibilities. He pointed out the importance of The Coast Guard has a number of functions the State role, and indicated that the Federal GovI emment's role can best be viewed as one way of under the Federal Water Pollution Control Act in the event of. spills, but the Coast Guard representa encouraging the State to find ways to perform a tive told us that until we in EPA have designated great deal of the regulatory and enforcement activi PCB's as a hazardous substance, the Coast Guard is ty. He felt that regulation must represent some sort unable to go forward to use its authorities. He urged of consensus and be enforceable in order to be pro* 1 *i ductive. He felt that a number of PCB problems i i' were difficult to control because of the numbers of public awareness of the needs for good handling and precautions in transportation. Dr. Millson of the Canadian Government urged nonpoint sources. | a systematic approach, and outlined six regulatory | He urged that we try tor more awareness among control packages that Canada was considering. He the people who use PCB's! particularly the utilities, emphasized that Canada does not have a use control and suggested voluntary labeling and use of the act yet, but that such authority together with their planning process under Section 208 of the Federal other authorities would permit them over some peri Water Pollution Control Act, od of time to do a great deal about controlling Secretary Reed described both the environmen PCB's. tal problem caused by PCB pollution and the result Since Dr. Highland spoke last, and I have ing fisheries resource problem. High investment in exhausted my time, with apologies to him I hope restoring the Great Lakes fishery and future invest you remember what he said. ment in this and other fisheries would be hard to GENP 006014 i 467 lt 7 7 4 6 6 ^ CONFERENCE HIGHLIGHTS Richard A. Carpenter* A summary o f this complex and comprehensive^con- ference may be more useful if the informattiyo1n.j .is orga- w In each topic, information can be characterized as nized in the format shown in the accompanying:!igure What is known and generally agreed upon with (figure 1). The presentations have dealt with'three gen a reasonable degree o f confidence. eral topics: 2. Remaining uncertainties and the reasons why a A . The occurrence o f PCB's in the environm ent- lack of understanding continues. Science is sources, rates, routes, and sinks; probabilistic in nature and this concept of B. T h e toxicity o f PCB's--inadvertent human uncertainty must be recognized when technical exposure, laboratory animal experiments, wild information is used in deciding issues of public life, fish, and ecosystems; policy. *N C. The uses and benefits of PCB's to industrial society and the possibilities of control. 3. Finally, the conference discussions have sug gested some courses o f action which are pru- A. - Occurrence in the Environment 1. What is known B. Toxicology C. Uses, Benefits and Control 2. Remaining Uncertainties GENP 006015 3. Prudent Actions j Figure 1. Organization of information about polychlorinated biphenyls. 'Executive Director, Commission on Natural Resources, Nationel Research Council .Washington, D.C. 468 *7 7 4 6 6 4 dent, i.e., could and should be set in motion. tion as to the role of air transport and the recirculation These include setting priorities for obtaining of material that is deposited in rain or in dust back into more information and reducing uncertainties the air so that it is continually redistributed around the through additional research and monitoring. world. The composition change of PCB's in the environ The conference was not designed to produce con ment w ith aging is not well understood; there are ques sensus judgments nr to make recommendations. Thus, tions as to their chlorine content changing and regarding the following summary must be viewed as the responsi formation of diobenzofurans. bility of the author alone. We need a mass balance and a model for transport and removal in order to estimate the time that will be A -1. What is known about the occurrence o f PCB's in required for these materials to eventually move to an the environment ultimate sink in the deep ocean sediments. We have learned what should have been apparent A question has been raised as to the possible conver f from the start-- that any persistent, mobile, and foreign sion of these materials into higher chlorinated com or exotic compound is going to be detected everywhere pounds during sewage chlorination. in the environment. In addition to current production We need to know more about the presence of the and uses, which may result in leaks, a nonpoint source materials in whole water; i.e., are we measuring material situation exists in that about 400 million pounds of on suspended sediments, in very small organisms, in PCB's are already discarded in the environment and sub micelles, or actually dissolved in water? We need to stantial amounts are apparently recirculating in sludge, know about the biological activity of these various forms sediments, in air and dust, and in contaminated orga of occurrence of PCB's in water. nisms. There are about 300 million pounds in industrial A-3. Prudent actions service and this material will be d ifficu lt to contain com What can we do based on this information and pletely as it moves toward disposal. The sediments in uncertainty? We can separate, to some extent, the prob lakes, rivers, and estuaries provide a very large reservoir lem of what is already in the environment from the con of PCB's for contacting aquatic organisms. The material trol of material that has not yet been released. Even if all in dumps (three-fourths of the total discarded) appears manufacture and use were stopped immediately, envi to stay there for the most part. Current processing losses ronmental contamination would remain for some time are important and can be decreased. to come. The PCB problem should be considered in the Eventual removal is to sediments in the deep ocean context of other halogenated hydrocarbons in the envi and we need to know more about the fate of this mate ronment and it should not be separated from investiga rial in th marine environment. tion and control o f the residues o f pesticides and other It is too early to see the effects of the 1972 volun halogenated materials. Work should begin on a more tary action to lim it uses to nondispersive applications, systematic monitoring system and on the use of indica but certainly it was a justified decision and a move in the tor organisms, such as the suggested "mussel watch," on right direction. a worldwide basis. There w ill be occasional catastrophic spills which We can use some ingenuity in devising means of can cause substantial damage to fisheries in the future. cleaning up contaminated water. This problem is of a These will be localized impacts, and will be costly to magnitude that allows one to think about filtration or clean up. adsorption concepts for waters that are somewhat con Incineration is an effective method o f destroying fined. PCB's if the temperature is high enough (i.e., about Ingenuity may suggest ways to make contaminated 2,700 F). fish suitable for use in animal feeds or human consump Analytical procedures now give confidence that we tion. Perhaps segregation of certain organs or particular can measure PCB's qualitatively and quantitatively down methods of cooking would serve this purpose, or some to a few parts per trillion. other way of decontaminating these valuable animals might be found. A-2. Uncertainties about PCB's in the environment There is a real question as to whether the PCB con B- 1. What is known about to xicity tent of the waters of the Great Lakes (particularly Lake The Yusho incident proved the toxicity of used heat Michigan) can be lowered by any degre. of tightening-up transfer fluid to humans at a concentration in cooking of the current use situation, because o f the recirculating oil of about 1,000 ppm of PCB's. But interpretation o f contamination that is already there. There is the ques this incident is confounded by dibenzofuran contamina- GENP 0060 J6 469 774665 tion of the PCB fluid. Industrial hygiene experience is s o m e w h a t rea ssu rin g as to toxicity to humans except th a t the* occasional symptoms and illnesses cannot be re la te d to known exposure doses in most instances. The good housekeeping practiced by some large users and the American manufacturer will probably be better than that of the variety of secondary users. No human deaths have been caused directly, but reports of serious illness and persistent skin problems continue. Exposure of the general public can be controlled by avoiding food (mainly fish) contaminated w ith PCB's. Exposure from environmental contamination or direct -introduction into humans is unlikely. Averages for die tary intake can be misleading since some persons may eat large quantities of fish. Laboratory animals show effects when fed diets containing contamination levels found in fish. Fish are affected at the range of PCB levels found near industrial outfalls into ambient waters, and the occurrence of fin rot in fish near these "hot spots" is a direct confirmation of laboratory tests as to the effects on fish. Ecosystem simplification (fewer species and lower populations) has been found in laboratory experiments to occur at concentrations similar to those in hot spots in natural ambient waters and could be expected to be found at sludge disposal sites. It is hard to find evidence of damage to terrestrial ecosystems. Biomagnification, i.e., the ratio of the PCB content in aquatic organisms to that of the water in which they live, can be as high as several hundred thousand. B-2. Uncertainties as to toxicity There is confusion over the interpretation by patho logists of organ damage. It would be helpful if the highly technical problems of ascertaining carcinogenicity could be worked out by those scientists involved apart from the complexity and emotionalism of a specific issue such as the PCB problem. The effect of dibenzofurans, which may be present as impurities or as metabolites, is still in question. There is a great variation as to the response of d if ferent species in laboratory animal tests. The range of sensitivity is large. More needs to be known as to wheth er the reproductive problem is the most important ef fect. Fat metabolism is not well understood and since a great proportion of the human population is carrying around a few ppm of this material, we need to know more about it. Wildlife to xicity data is poor and we need to know which w ildlife species may react as do chickens and mink. The relationship of to xicity to chlorine content of the PCB's is uncertain. Is the ability to metabolize these compounds (which varies w ith the chlorine content) desirable or not? The possibility of dioxin as a degrada tion product has been raised. We need to know about the equilibrium distribution of these materials between fish and water. Is it possible that depuration can be a help? Are PCB's further accumulated up the food chain after the biomagnification from water to the first orga nism? B-3. Prudent actions based on toxicity knowledge Certainly more experimental work in animals and careful replication of reported tests are necessary. Prior ity should be given to chronic tests in various species, detection of behavior change in animals, and laboratory work at true environmental levels, rather than to greatly increased levels of dose. Obviously it is of great impor tance to determine unequivically whether the PCB mate rials are carcinogenic. We need to coordinate this work with experiments and observations on other halogenated hydrocarbons, particularly the chlorinated hydrocarbons, and to look at combined effects on organisms, communities, and ecosystems. NIOSH should extract the maximum from industrial hygiene data because these human exposures do not necessitate the inferences from animal tests to human toxicology. The widespread occurrence of PCB's in the environ ment constitutes an inadvertent experiment on human populations and the biosphere. A concerted e ffort at monitoring and analysis is indicated in order to gain the most useful knowledge for further decisions concerning toxic substances at low levels in the environment. C-7. What is known about uses, benefits, and control problems We know that about 700 m illion pounds of PCB's have been manufactured, but the current annual produc tion volume is down to 40 m illion pounds from an 80 m illion pound level in 1970. About one quarter of pres ent production is going into small capacitors that are scattered very widely throughout our industrial society. The fire retardant benefits of PCB's are real and important. An abrupt change in the availability of PCB's would be disrupting, but that is unlikely in any event. The estimate of 76 months to reach an end to manufac ture if the Toxic Substances Act existed today suggests that industry will have a substantial transition period. Forty-five years o f use has imbedded PCB's in U.S. industrial practice and it will be costly to replace these unique materials. Alternative dielectric fluids are on the way, but w ill not be suitable as replacements in existing transformers. 470 lUyUOdMdL 774666 C ?. fimnninim/ uneurtain lies Tiiir ilci.isifjn by J:jpiin apparently Hj move further io Himin.'itc tlieM: ^im p o u n d s is u real challenge in the public, inirirl to the regulatory policy of the United States. If that Nation can do w ith o u t PCB's, w hy cannot we? Is a total ban worldwide necessary in order to re duce and eliminate contamination to the North Ameri can environment? An inventory of PCB's in existence is required and this must be international. We need to know more about the changes in PCB's in use, i.e., dibenzofuran formation. How nondispersive are "clos ed" electric systems? We need to reconcile the differences in human food tolerance limits as established by the United States {5 ppm) and Canada (2 ppm) and in alternative proposals from various protagonists on all sides of that question. Cost/benefit analysis will not be very helpful in the PCB contamination problem because of the great num ber of subjective judgments and different value systems involved in arriving at a balance. In any event, the margi nal costs and the marginal benefits are what must be determined. We need to know how to remove PCB's from wastewater, Le., what would be best practicable technology economically achievable in order to get to an effluent standard, and whether that should be 5 ppb, or zero, or what level. We need to know whether 1 ppt is a reason able ambient water standard in view of the large bio magnification factor. C-3. Prudent actions EPA has a responsibility to determine priorities and it needs to review the PCB issue in terms of the total set of pollution problems and the agency's resources. EPA should proceed with effluent standard possibilities in Section 307 of the Water Quality Act (PL 92-500), although such action may end up in court tests. The Endangered Species Act may be a means of cooperative action by other Federal agencies. Voluntary housekeeping by industry can be in creased to a substantial extent, but this requires special attention to the weakest firms, always a problem with voluntary cooperation. Payment of compensation to fishermen may require an act of Congress similar to the experience with heptachlor in milk some years ago. It is my personal opinion that the inadvertent and unavoidable addition of PCB materials to foods could be covered by the Delaney Clause if they are found to be carcinogenic in appropriate animal tests. This conference has addressed a real problem and was not just a demonstration of the prowess of analyti cal chemistry. However, as with any environmental man agement issue, the PCB problem must be put in perspec tive. PCB's will be in the environment for a long time. Fisheries resources in some of the Great Lakes and rivers have been lost. We can protect against any imminent hazard to human health. Ecosystems are resilient but local damage has occurred. Further leaks from the industrial system must be prevented. Internalizing costs will lead the market to produce replacements for PCB's. Human health is most important but environmental quality is a reflection of the ecosystem that we all share. In this case there may be a coincidence, in that if we protect human health adequately, we will have protected the environment. All elements of society are in this together and recriminations are not very helpful. Scientists and engi neers can generate and deliver information for rational enforcement decisions, searching for equity as the inevit able tradeoffs are made. Verified technical facts and their implications must be communicated efficiently to the public through education and information programs. Most importantly, we must use our ingenuity in solving * little parts of the problem when they are all that can be solved as well as in working on an ultimate solution for the problem as a whole. 8 10 9 0 0 N 471 774667