Loading...
HomeMy WebLinkAboutSmuggler Superfund - Technical Advisory CommitteeThornas S. Dunlop, Director SMUGGI,ER MOUNTAIN TAC As Environmental ent FINAL REPORT, 1/27/93 Health Departm130 S. Galena AsNn, CO 81611 M '71 I Al, I A/ W Y"' i" U A SMUGGLER MOUNTAIN TAC 2 FINAL REPORT, 1/27/93 PREFACE In 1986 the Smuggler Mountain Superfund Site in Aspen, Colorado was officially placed on the National Priority List. This listing led to a sequence of events typical for superfund sites culminating in a Record of Decision in which EPA proposed certain remedial actions. These events included several Site investigations, including the analysis of soil samples which indicated elevated concentrations of some metals, particularly lead, in the vicinity of residences. While these events were unfolding, an opposition to EPA's actions developed in the community which eventually spread to include most, if not all, of the citizens of the area. one of the catalysts for the opposition was a blood lead survey performed by the Colorado Health Department which found that the blood -lead concentrations in the pre-school children at the Site were below that for the general U.S. population. This, and other information prompted the local government to withdraw from a previously negotiated settlement and put a stop to further progress toward clean-up. In an effort to resolve the differences between the Aspen community and EPA, a meeting was held in Washington, DC on Feb. 28, 1.992 with Senators Wirth and Brown of Colorado, a delegation from Aspen and EPA officials. One of the agreements to emerge from this meeting involved the formation of a Technical Advisory committee consisting of scientists familiar with the issues at stake at the Site. The membership of the Committee ,was agreed upon jointly by Aspen and the EPA. The charge to the Committee was to review documents pertaining to lead and to the Site; to receive testimony from experts representing Aspen and the EPA; and to answer three questions relating to: the level of present human risk, the future human risk, and any public health measures that should be taken. The Committee met in Aspen on Oct. 26, 27, and 28, 1992 to hear the testimony and to decide upon its answers to the three questions. On Oct. 28, 1992, the Committee released its findings at a press conference. These findings are contained in the Executive Summary of this document which was released to the media on Oct. 28. The remainder of the report is a critical review of pertinent information. The format of this report follows the steps in the risk assessment process recommended by the National Academy of Science/ National Research Council Committee on the Institutional Means for Assessment of Risks to Public Health. The purpose of this report is to provide the basis for the SMUGGLER MOUNTAIN TAC 3 FINAL REPORT, 1/27/93 findings and recommendations of the committee contained in the Executive Summary. While the process used to arrive at these findings can be used fruitfully at other sites, it is important to emphasize that the findings are unique to the Smuggler Mountain Site® Indeed, this experience emphasizes the importance of evaluation on a site -by - site basis. The Smuggler Mountain Technical Advisory Committee Willard R. Chappell, Ph.D.,Chair Rufus Chaney, Ph.D. Paul Hammond, DVM, Ph.D. Mary Ellen Mortensen, M.D. Alice Stark, M.P.H., Dr. P.H. Iain Thornton, Ph.D. SMUGGLER MOUNTAIN TAC 4 FINAL REPORT, 1/27/93 PREFACE.................................................Z TABLEOF CONTENTS ................... o .... * .......... o..o4 i. MEMBERSHIP OF TECHNICAL ADVISORY COMMITTEE ..............6 I. EXECUTIVE SUMMARY .......................................7 ii. BACKGROUND .............................................10 II.A. The Site.......o ....................... 000 .............. 10 II.B. The Technical Advisory Committee (TAC) .................11 II.C. The Structure of the Report ............................12. III. HAZARD IDENTIFICATION ..................................13 IV. DOSE -RESPONSE ASSESSMENT ...............................14 V. EXPOSURE, ASSESSMENT ....................................15 V.A. Sources of Contamination ......................... o ..... 15 V.B. Pathways of Exposure ...................................16 V.C. Confounding Factors ....................................19 V.D. External Dose ................ 6 ......................... 21 V.E. Absorption/Bioavailability ..............................21 V.F. Internal Dose ...........................................26 Vi. RISK CHARACTERIZATION .................................. 27 VI.A. Comparison With Other Studies ..........................28 VI.B. Possible Explanations of Differences from Other Sites ...........................29 VI.B.1. Absorption/Bioavailability ............................29 VI.B.2. Attenuated Pathway ...................................31. VI.C. Predictions of EPA's UBK Model ......................... 32 VI.D. TAC's Characterization of the Risk .....................33 SMUGGLER MOUNTAIN TAC FINAL REPORT, 1/27/93 VII. RISK MANAGEMENT ........................................34 VII.A. EPA's Proposed Remediation ............................34 VII.B. Tae's Recommendations .................................35 VIII. REFERENCES ...........................................36 TABLE1 ....................................... o ...... 43 SMUGGLER MOUNTAIN TAC FINAL REPORT, 1/27/93 1. 1 i. MEMBERSHIP OF SMUGGLER MOUNTAIN TECHNICAL ADVISORY COMMITTEE Rufus Chaney, Ph.D. U.S. Department of Agriculture 10910 Dresden Drive Beltsville, MD 20705 Willard R. Chappell, Ph.D., Chair of TAC Professor of Physics Director, Master of Science of Environmental Sciences Program University of Colorado at, Denver Campus Box 136 P.O. Box 173364 Denver, CO 80217-3364 Paul Hammond, DVM, Ph.D. University of Cincinnati Medical Center 3223 Eden Avenue Cincinnati, OH 45267 Mary Ellen Mortensen, M.D. Associate Professor, Clinical Pediatrics The Ohio State University, and Director, Central Ohio Poison Center Division of Clinical Pharmacology/Toxicology 700 Children's Drive Columbus, OH 43205 Alice Stark, M.P.H., Dr. P.H. Director, Bureau of Environmental and Occupational Epidemiology New York State Department of Health 2 University Place, Room 130 Albany, NY 12237 Iain Thornton, Ph.D. Director, Global Environmental Research Centre Imperial College of Science, Technology and Medicine 56 Queen's Gate London, England SW7 5JR SMUGGLER MOUNTAIN TAC 7 FINAL REPORTO 1/27/93 SMUGGLER MOUNTAIN TAC FINAL REPORTP 1/27/93 good nutritional status can reduce soil ingestion and/or reduce lead absorption by children. The areas adjacent to the mobile homes, houses, and condominiums in the study Site appear to be well maintained. Characteristics of the community on this Site suggest that the children are likely to have good nutritional status. Recent estimates of soil/dust ingestion are in the range of 40 to 50 mg/day (median) in contrast to the 200i mg/day used in Superfund Risk Assessments. If these new ingestion rates are used, along with the Environmental Protection Agency's bioavailability assumptions, the children's blood lead concentrations that were observed would have been predicted. The TAC will now respond to the questions posed. We emphasize that the answers are specific to the unique conditions at the Smuggler Mountain Site. QUESTION No. 1: Does the existing site-specific data and scientific literature provide adequate evidence which confirms that the soil lead in the Smuggler Mountain superfund site poses a current realistic health threat (i.e., unacceptable risk of disease or impairment) to any of the residents on or near the Site? ANSWER: The Committee unanimously concludes that the answer is no. QUESTION No. 2: If the answer to question i above is no, is there a reasonable probability of such a threat developing in the future? ANSWER: The Committee unanimously, agrees that there is a possibility ility of a future threat, but the likelihood is small. if the demographics, land use and environmental conditions remain essentially unchanged at the Site, we do not anticipate any future realistic health threat. QUESTION No. 3: Having made this health threat assessment,, what is the TACfs recommended public health action, if any, in order to protect the current and future health of residents from the soil lead effects? ANSWER: The Committee unanimously agrees that since there is a small possibility of future risk, the following recommendations are prudent: 1. A program of blood lead surveillance should be instituted for young children. At a minimum, the frequency of testing and interventions should be consistent with the program for children with low risk of high lead exposure as described on Page 93 in "Preventing Lead Poisoning in Young Children" (CDC, 1991). 2. Although the Committee unanimously agrees that there is no need for soil removal from the Site, the berm (the mound of waste material adjacent'to the mobile home park and the Smuggler tennis courts) deserves special attention. Because SMUGGLER MOUNTAIN TAC FIVAL REPORT, 1/27/93 101 of extreme contamination of the berm, it should be capped and covered with clean soilo then planted with appropriate vegetation. Monitoring should be instituted to ensure the integrity of the cap and actions taken, if necessary, to correct any breach of the integrity. As an interim measure, the surrounding fence should be extended to completely enclose the berm. Common -use areas, such as Molly Gibson Park, presently comprised of exposed mine waste, should be appropriately covered. 3. If owners wish to have vegetable gardens, these should be planted in raised beds with at least 12 inches of clean soil. 4. Soil testing should be made available upon request by residents. 5. proposed changes in Site use should be reviewed by the City and County Health Departments to evaluate possible changes in soil exposure to young children. 6. If studies demonstrate that lead -bearing materials at this Site have or can be made to have very low bioavailability, the above recommendations should be reviewed and, perhaps, modified. SMUGGLER MOUNTAIN TAC 10 FINAL REPORT1 1/27/93 The Smuggler Mountain site has supported mining and milling operations, primarily for silver and lead, since 1879. Most of the activity occurred between 1879 and 1918. The operations at the Smuggler, Molly Gibson, and Free Silver mines and the Cowenhoven Tunnel have resulted in mine and mill (tailings) waste which were deposited between the western side of Smuggler Mountain and the Roaring Fork River. Some of these waste materials were leveled when residential development took place and lie under or adjacent to these developments. The Smuggler Mountain geology is characterized by glacial, alluvial, and colluvial sediments overlying sedimentary bedrock. Outcrops of limestone, dolomite, sandstone and shale are common on the slopes of Smuggler Mountain and contribute to the abundance of calcium carbonate in the native soils which provide for a natural buffering capacity and relatively high Ph values in the soils (ICF Clement, 1986). The Site is approximately 110 acres in size and is about 1 mile northeast of downtown Aspen, Colorado in Pitkin County. Aspen is at an altitude of 7928 feet above sea level. The average annual precipitation inAspen is 19.2 inches. The total annual snowfall is 147 inches. In 1981, David Boon, then a graduate student at Colorado State University (CSU), took samples of soils in and around the area of the Smuggler Mobile Home Park (Boon and Soltanpour, 1992).. The purpose of the sampling was to test the fertility of the soils. Several routine soil tests were conducted. These tests indicated that the soil pH values ranged from 7.0 to 8.0 (saturated pastes), with a mean of 7.5 indicating that nearly all the soils tested are calcareous. In addition, a routine metals analysis on the soils performed by the CSU laboratories, found very high levels of some metals, particularly lead, zinc, , and cadmium in some of these samples. These results came to the attention of the local government and recommendations were made to the site residents regarding cautionary steps to avoid exposure to the contaminants. In 1983 EPA visited the site to determine if it qualified as a superfund site under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) , often referred to as the Superfund Act. In 1984 EPA proposed the listing on the National Priority List (NPL) of the Smuggler Mountain site and in 1986 the site was officially listed on the NPL. There were two "operable units" (OU) defined within the Site. OU -1 consisted of approximately 75 acres, primarily the residential areas at the base of Smuggler Mountain. OU®2 was approximately 35 acres, exclusively containing the Smuggler Mine and surrounding mine property. It is OU®1 that is the focus of this report. SMUGGLER MOUNTRIN TAC FIXIAL REPORT, 1/27/93 Since 1986 EPA or its contractors have carried out the site investigations mandated by CERCLA and developed a Record of Decision (ROD) which outlined the selection of the site remedy. This ROD has undergone revisions described in two Explanation of Significant Differences (ESD) issued in 1989 and 1990. The proposed remedies include the excavation of contaminated soils and the use of a geo-textile liner covered with 1 foot of clean fill and topsoil. I II.B. The Technical Advisory Comaittee (TAC) In 1990 Pitkin County repealed settlement ordinances between local government, EPA, and the State of Colorado because of -the iesire of local citizens and local officials to more clearly understand the health risk question prior to accepting a remedy. The EPA decided to withdraw plans for Site clean-up for two year�* to allow for the completion of studies to better clarify the health risk. on Feb. 28, 1992, EPA representatives, Senators Wirth and Brown of Colorado, and a delegation from Aspen met to discuss a number of community concerns relating to the Smuggler Mountain Site. At this meeting the various parties agreed to the formation of a Technical Advisory Committee (TAC) that was to consist of scientists familiar with the issues involved in the dispute. This committee would convene and review various site specific and lead related documents and provide an independent assessment of the health risk resulting from the presence of high concentrations of mM tals in the soils at the Site. in particular, the TAC would be asked to answer the following three questions: 1. Does the existing site specific data and scientific literature provide adequate evidence to confirm that the soil lead in the Smuggler Mountain Superfund Site (Site) poses a current realistic health threat (i.e., unacceptable risk of disease or impairment) to any of the residents on or near the Site? a. If so, what is the primary evidence and the main rationale for attributing a current realistic health threat to the soil lead on the Site? b. Also, what comprises this health threat (spectrum of potential risk) stemming from exposure to the soil lead? 2. If the answer to question number one above is no, is there a reasonable probability of such a threat developing in the future? a. If so, please provide information outlined in parts a. SMUGGLER MOUNTAIN TAC 171 FINAL REPORTO 1/27/93 and b. in question I above. b. If not, provide a summary of . the evidence and rationale to support this conclusion. 3. Having made this health threat assessment, what is the TAC's recommended action, if any, in order to protect the current and future public health of the residents from the lead? The Technical Advisory committee has been asked to consider several questions regarding the level of health risk from the Smuggler Mountain Superfund Site. The executive summary provides the Committee's answers to the questions posed above. This report is meant to provide a more detailed explanation of the logic behind these Answers. Because the questions relate to the issue of human health risk, the format of this report will follow the categorization of risk assessment adopted by the National Academy of Sciences /National Research Council (NAS/NRC) Committee on the Institutional Means for Assessment of Risks to Public Health (NAS, 1983). The characterization of the potential adverse health effects of human exposures to environmental hazards. The NAS Committee stated that risk assessments contain some or all of the following four steps: Hazard Identification, Dose - Response Assessment, Exposure Assessment and Risk Characterization. The NAS Committee further observed that Regulatory actions are based on two distinct elements, risk assessment, and risk__management. Risk assessment is the use of the factual base to define the health effects of exposure of individuals or populations to hazardous materials and situations. Risk management is the process of weighing policy alternatives and selecting the most appropriate regulatory actions, integrating the results of risk assessment with engineering data and with social, economic, and political concerns to reach a decision (NAS, 1983). The three questions that the Technical Advisory Committee has been asked to address involve both risk assessment (Questions I and 2) and risk management .(Question 3). Therefore, the TAC has decided to structure the report in terms of the four steps of risk assessment defined by the NAS Committee and risk management. SMUGGLER MOUNTAIN TAC 13 FINAL REPORT61 1/27/93 The National Academy of Sciences Committee (1983) defined Hazard Identification as: Ae process of determining whether exposure to an agent can cause an increase in the incidence of a health condition (cancer, birth defect, etc.) - it involves characterizing the nature and strength of the evidence of causation. The adverse effects of lead on human health have been known for centuries. As noted in the CDC (19 91) document, lead has, been shown to have an adverse effect on virtually every system in the body. These effects include (CDC, 1991; Davis, J., 1992) effects on the heme system (f rank anemia, reduced hemoglobin production, increased urinary ALA, erythrocyte protoporphyrin elevation, and ALA -D inhibition) , ef f ects on the central and peripheral nervous systems (encephalopathy, slowed nerve conduction velocity, and ef f ects on cognitive development) , renal system ef f ects (chronic nephropathy), reproductive effects (delayed physical development, and low birth weight) , cardiovascular ef f ects (elevated blood pressure), and gastrointestinal effects (c6lic)o These and other adverse health effects (e.g., decreased hearing acuity) have been demonstrated, to a greater or lesser degree of certainty, in occupational and/or environmental health studies on humans. Therefore, as noted by Houk (1992), we have a greater confidence in the human health hazards presented by lead than we do f or those compounds where only animal studies are available. On the other hand, while human studies involve the species of interest, there are many possible confounders and covariates involved that can make proper interpretation of such studies fifficult. in the case of lead, however, the fact that there have been several such studies (Davis, J., 1992) with similar results lends additional credibility to these findings. Moreover, as noted by Davis, J. (1992), experimental studies of laboratory animals have "'demonstrated parallels in the developmental neurotoxicity in lead in children, primates and rodents." As noted by CDC (1991) lead is "particularly harmful to the developing brain and nervous system of fetuses and young children." Of particular concern are the adverse effects on development involving decreased IQ, hearing acuity and growth, at very low blood lead levels. Several studies (Davis, J., 1992) in Boston, Cincinnati, Cleveland, Port Pirie, Australia have shown decreased cognitive ability and other neurobehavioral effects in young children attributable to lead exposure. The cognitive effects may be substantial, e.g., an average I.Q. drop of 7.2 points going from an integrated postnatal blood lead of 0.5 Amol/L (10µg/dl) to 1.5 Amol/L (30 Ag/dl) (McMichael, et al., 1988). The general consensus among experts seems to be that the risk of adverse effects on the central nervous system becomes apparent as the 24 month or integrated 2 year blood lead profile rises above 10 Ag/dl. SMUGGLER MOUNTAIN TAC 14 FINAL REPORTI 1/27/93 In addition to the vulnerability. of children because of the development of the central and peripheral nervous system, the apparent higher absorption and retention of lead by children also supports the conclusion that the target group for lead toxicity are pre-school age children. Thus, there is considerable evidence that lead is a hazard and that the group most at risk is that of pre-school age (generally less than 6 years) children. The NAS Committee defined Dose -Response Assessment as: The process of characterizing the relation between the dose of an agent administered or received and the incidence of an adverse health effect in exposed populations and estimating the incidence of an effect as a function of human exposure to the agent. The CDC document (1991) indicates that there are several dose - response curves for lead depending on the adverse effect of interest. The more obvious and dramatic the effect, the higher the threshold. EPA's Air Quality Criteria Document (US EPA, 1986) Viscusses some of the dose response relationships for specific ­ffects such as erythrocyte protoporphyrin, coporphyrin in urine znd ALA -D in blood. The blood lead level has long been used as a measure of internal dose and/or internal exposure. While there are some disadvantages to the use of blood lead as an internal dose (e.g., the half-life of lead in blood is on the order of 30 days, and therefore may not give a measure of cumulative dose), both animal and human studies have shown that blood lead increases with external dose, and the response increases with increasing blood lead.: Moreover, as noted in the Butte study (Bornschein, et al., 1992), there is a high correlation among blood leads measured at different times in a given child. As noted by CDC (1991) and Davis, Jr (1992), there are several adverse effects which have an "apparent" threshold blood lead level at or below 10 Ag/dl. While these effects are subtle, and not apparent on clinical examination, they are demonstrable in large epidemiological studies which compare the results for relatively large numbers of children with low exposures to relatively large numbers of children with higher exposures® Since the history of lead has been a decrease in the blood lead concentration defined as the level of "concern," due to the development of increasingly sensitive measures of exposure and effect, it would not be surprising to see another lowering of the level of "concern" sometime in the future. SMUGGLER MOUNTAIN TAC 15 FINAL REPORTOP 1/27/93 TNomittee defined Exposure Assessment as; The process of measuring or estimating the intensity, frequency, and duration of human exposures to an agent currently present in the environment or of estimating hypothetical exposures that might arise from, the release of new chemicals into the environment. Tn its most complete form, it describes the macfnitude, duration, schedule, and route of exposure; the size, nature and classes of human populations exposed- and the uncertainties in all estimates. f SMUGGLER MOUNTAIN TAC if FINAL REPORT, 1/27/93 V.B. Pathways of Exposure5- The primary pathway of interest for lead exposure at Smuggler Mountain is presumed to be the ingestion of soil and dust by children. As noted by CDC (1991): Rs a part "of normal play and hand-to-mouth exploratory aFtivities ' young children may inhale or ingest lead'from soil or dust. ingestion of dust and soil during meals and playtim,e activity appears to be a more significant pathway than inhalation for young children (EPA, 1986). The pathway from soil lead to blood lead is discussed in the Butte report (Bornschein, et al., 1992). It involves a complex interaction between outdoor soil lead, indoor house lead, lead on the hands of children, and, finally, blood lead or internal exposure or dose (blood lead is sometimes considered to be a measure of'internal exposure and other times to be an internal dose measure). Several studies have documented this pathway in different settings. Ono of the key factors in estimating the risk of this exposure pathway is the amount of soil/dust ingested by young children. EPA uses a default value of 100 mg/day for children in its Uptake Biokinetic (UBK) Model, but as a matter of policy uses 200 mg per day for evaluating the risk at superfund sites (Porter, 1989). As recently as 1985, on the basis of experimental evidence it could be concluded that an average value of 100 mg per day was appropriate and supported by the best available research in respec to children between 1 and 4 years of age. This value was based o the results of studies by Binder et al. (1986), and Clausing, e al. (1987) using elements such as Aluminum, silicon, and titaniu as stable markers. This f igure of 100 mg per day conf irme estimates proposed in rather an arbitrary fashion in a series o earlier publications. LaGoy (19empted to use these result as a basis for a risk assessment and concluded that a value of 10ii mg per day could be used as a soil ingestion rate for an averag child between 1 and 4 years, with a maximum rate of ingestion o 500 mg per day. He selected the higher value on the basis o prudence rather than scientific merit. With regard to infants i the first year of life, he concluded that 50 mg could be used as a estimate of the average soil ingestion rate. For older childre and adults he then assumed that soil ingestion would be reduced at least 50% and suggested 50 mg per day as an average with maximum of 250 mg per day. It is emphasized that LaGoy's estimate of soil/dust ingestion by children of I 'to 4 years of age wer based on the results of experimental studies available at tha time, but the values for younger and older children and adults wer derived mainly by making,intuitive assumptions. More recent experimental work has since been undertaken to SMUGGLER MOUNTAIN TAC 1.7 FINAL REPORT, 1/27/93 Calabrese et al. (1 990) providethe first published estimates if amounts of soil ingested by adults, using data collected as part of the validation exercise for the study reported above in children. They refer to this as a pilot study and to the, results as being of a preliminary nature, as they are based on only 6 adults (3 males and 3 females aged 26 to 41 years) over a 3 week period. They reported median values ranging from 1 to 65 mg of soil/dust ingested per day, depending on the element used as a tracer, (i.e., 1 mg per day if silicon was used, 52 mg if aluminum was used, 65 mg if yttrium was used and no ingestion at all if zirconium was used). The average of the four median tracer values is 30 'Tag per day. However, the very limited nature of this study is noted together with the disparity between the estimates, for adult soil/dust ingestion according to the tracer element used. Davis, et al. (199o) published the results of a population - based estimate of soil ingestion in 104 normal children between the age of 2 and 7 years, using the elements aluminum, silicon and titanium as stable markers. Aluminum provided a median value of 2,5 mg of soil ingested per day, silicon 59 mg and titanium 81 mg per day. In the'light of the findings of Calabrese et al. (1989), it appears that titanium can no longer be accepted as a reliable tracer. Van Wijnen et al. (1990) studied soil/dust ingestion in 1 to SMUGGLER MOUNTAIN TAC 18 FINAL REPORT, 1/27/93 5 year old children in the inner cities and suburbs of Amsterdam and Utrecht, Netherlands, by measuring titanium, aluminum and acid - insoluble residue in soil and feces. They attempted to correct the results for non -soil sources of these elements by using data for parallel hospitalized children. The "limiting tracer method" that they adopted at all times uses the lowest of the three separate estimates to calculate soil ingestion. For around "200 children sampled from day-care centers, geometric mean soil intakes ranged from 0 to 90 mg per day. For children younger than 1 year, these estimates were lower, ranging up to 30 mg per day. It is noted that this study assumed a daily average stool (feces) dry weight of 15 g. on the basis of the later findings of Thompson and Burmaster (1991) outlined below, it is likely that the use of this figure in calculations of soil ingestion will lead to an excessive value, over estimating soil/dust ingestion by as much as a factor of 2. Thompson and Burmaster (1991) published a re-evaluation of data collected by Binder et. al (1986). This re-evaluation used actual stool weights, rather than the assumed figure of 15 g used by Binder. The result of this more detailed and accurate approach was to lower both mean and median soil ingestion values by a factor of 2.' Using the elements aluminum and silicon, which seemed to provide the most reliable data, these authors calculated an overall average median soil ingestion rate for children of 59 mg per day. On the basis of the above it is now proposed that previous estimates of 100 mg per day as an average soil/dust ingestion rate for children were too large. The reason for these estimates were due to incomplete experimental procedures used in the early investigations. In the light of more recent evidence, it would seem reasonable to assume a median value of approximately 50 mg per day for children within the age groups of I to 7 years. In calculations on lead ingested as dust and soil, the U.S. E.P.A. (Porter, 1989) assumed that children ingest twice as much dust as adults. While it may be argued that this is based on intuitive rather than experimental procedures, nonetheless it may be assumed that adults certainly would not be expected to ingest more soil/dust than children (although it should be noted than in some sub -cultures, deliberate soil ingestion has been practiced). This assumption is supported by,the results of Calabrese et al. (1990), where on the basis of very limited evidence a median value of 30 mg per day was estimated. In conclusion, on the basis of the evidence available at this time, the following assumptions of median soil/dust ingestion values are recommended as being reasonable: 5.0 mg per day for the 1 to 7 year old child, 25 mg or less per day for children under 1 year of age, 25 mg per day for adults. SMUGGLER MOUNTAIN TAC 1.9 FINAL REPORT, 1/27/93 A 0 v.c. Confounding Factor3 A substantial and consistent literature exists (stark et al 1978, Stark et al 1982, Chatterjee and Geltman 1972, Lansdown et al 1974, Nullian et al 1956, Rennert et al 1970, Rummo et al 1979, Schroeder 1989, Schroeder et al 1985) which identifies a set of demographic and behavioral factors that are associated with blood lead concentrations in children independent of environmental exposure levels. The characteristics associated with increased blood level concentrations are those that tend to impair the ability of a family to provide the necessary care, and supervision for a young child. These characteristics are not always, directly SMUGGLER MOUNTAIN TAC 20 FIVAL REPORTO 1/27/93 SMUGGLER HOURTRIN TAC 21 FXNAL REPORT, 1/27/93 Moreover, these differences are all in the direction (e.g., Aspen residents earn higher wages) that would tend to lower the amount of exposure by the Smuggler Mountain children (Bornschein, et al., 1992). I SMUGGLER MOUNTAIN TAC 22 FINAL REPORTI 1/27/93 lead ingested with meals could be due in part to a co -precipitation of lead with calcium -phosphate formed in the duodenum. This last suggestion was based on research conducted to clarify the role of diet constituents on absorption of 203Pb by human volunteers. If the test meal contained about 50% of the daily Ca intake, Pb absorption was reduced from 60% on fasting to 5-15%; if the test meal contained about 50% of the daily P intake, Pb absorption was reduced from 60 to 45%; but if both were present in the test meal, absorption was reduced to as low as 1.5% (Blake and Mann, 1983; Heard et al., 1983; Heard and Chamberlain, 1982). Bioavailability of dietary Zn was reduced in cow's milk compared to human milk because higher Ca in cow's milk than human milk caused extensive coprecipitation of Zn when acid treated cow's milk was raised to the pH of the small intestine (Nelson et al., 1987) ., One would expect Pb coprecipitation to be much more extensive than Zn coprecipitation, but this has not been studied (see discussion of pyromorphite formation below). in a series of papers by Ruby, et al. (1992), Davis, A., et al. (1992), and Hemphill, et al. (1991), the bioavailability of lead in soils and other materials from the Butte, MT area was investigated both theoretically and in laboratory animal studies using rabbits. The predominant lead forms in these samples were found to be lead sulfide, lead sulfate (anglesite) and lead sulfides with rinds of anglesite. More than 80% of the soil lead in these samples occurred as either anglesite (60-70%) or sulfide (10-25%) (Ruby, et al., 1992). Besides the evaluation of chemical speciation of Pb in the soil materials, these authors conducted in vitro bioavailability assays which attempted to simulate the conditions of the stomach and then the small intestine. They looked at the kinetics of release of Pb from the soil materials and from pure minerals, and found that PbSO4 and PbS could not dissolve rapidly enough to have high bioavailability. They have not reported fully on the effects of soil properties on Pb solubility in the simulated small intestine phase of the assay, but noted rapid and strong adsorption/precipitation of Pb after raising the pH of the simulated gastric compartment. The authors concluded that the lead in these materials had a very low bioavailability. An extensive laboratory animal study using rats was performed by Battelle (1991) (see also Freeman et al., 1991; Freeman et al., 1992) using mining waste soils from the Butte, MT area. These materials were reported to contain 28% anglesite, 17% galena, 284 coronadite (a manganese lead mineral; may be simply Pb adsorbed on Mn02) and 22% lead phosphate in one case and 53% anglesite and 24 % galena (taking only the major phases) in the other case. Varied %-soil were mixed into purified diets and fed for 30 days. Bone, blood, and liver were analyzed for Pb. In contrast with the linear dose -response pattern seen with pure Pb -compounds, tissue Pb concentrations approached a plateau with increasing soil dose. These materials were found to have a low bioavailability (about 9% of Pb -acetate, and Pb -acetate is presumed to be equivalent to food Pb) in these studies as well. One of the most important conclusions from this work is the shape of the blood Pb vs. soil SMUGGLER HOUVTAIN TAC 23 FXNAL REPORT" I 1/27/93 SMUGGLER MOUNTAIN 'SAG 24 FINAL REPORT, 1/27/93 SMUGGLER MOUNTAIN TAC 25 FINAL REPORTP 1/27/93 one of the issues that has arisen in doing laboratory animal studies of bioavailability is the choice of the appropriate animal model. Weis and LaVelle (1991) have noted that coprophagy and different feeding behaviors might make rats and rabbits less than ideal, for such experiments. Coprophagy can be partly prevented by different cage designs and other devices. Another possible confounding factor is the time required for ingested 'material to pass through the GI tract, or GI Transit Time. It would be expected that this time would be shorter for small animals than for large animals (Mordenti and Chappell, 1989). For example, the gut beat duration for mammals follows this behavior, (Adolph, 1949). if this were the case, there would be less time for materials to dissolve as they passed through the gastrointestinal tract of a rat than for that of a small child. On the other hand, young swine have about the same body mass as an 18 - month -old child. However, information regarding GI transit times in species of widely varying size is largely unavailable. There have been,however, some recent studies of GI transit time for humans and some laboratory animals using gamma scintigraphy. Davis, et al. (1986) found that the major factor affecting transit time in humans was the presence of food which SMUGGLER MOUNTAIN TAC 26 FINAL REPORTP 1/27/93 tended to slow the transit. In another study using pigs (Hossain, et al., 1990 the authors found that, although pigs have many similarities regarding GI tract with humans, the gastric emptying time in pigs is much longer than for humans (it should be noted however, that the pigs were ingesting capsules that were roughly 10x20 mm in size). In summary, while some very interesting work on bioavailability has been presented, there are still many unresolved questions as these studies relate to the Smuggler Mountain situation. The animal studies used material which is demonstrably different from the Smuggler Mountain tailings and soils in mineral composition. In addition, all of the animal models have deficiencies in the relationship to humans. The arguments based on geochemical models, while interesting, are not convincing in the absence of animal testing. Thus, no conclusions can be drawn concerning the relative bioavailability of lead in the Smuggler mountain tailings and soils. V.F. internal Dose. At the present time the accepted measure of internal dose or internal exposure is blood lead (CDC, 1991). During August and September, 1990, a blood lead survey of the residents of the Smuggler Mountain site was carried out by the Colorado Health Department with funding from the Agency for Toxic Substances and Disease Registry (ATSDR) . This survey was carried out using a methodology common to several other studies which have been done recently, with the notable exception that no soil or dust samples were collected in conjunction with the study. (The soil lead data used was collected in conjunction with a previous study.) I The door-to-door census phase of the study identified 65 children aged 6 months through 14 years. Forty-nine of these children (75%) participated in the study. The geometric mean blood lead (PbB) for the 28 children aged 6 through 71 months who participated was 2.6 pg/dl, with an arithmetic mean of 3.0 Ag/dl and a geometric standard deviation of 1.66. For the children aged 6 years through 14 years the geometric mean PbB was 1.8 Ag/dl. -of 143 randomly selected adults, 76 (47%) submitted to blood lead testing and the geometric mean PbB was 2.9 Ag/dl. of the children tested, only one had a blood lead greater than 10 Ag/dl. This 14 year old male with a PbB of 13.4 Ag/d1 was retested 3 months later and found to have a PbB of 2.1 Ag/dl. In the report, several possible sources of exposure for this subject were mentioned, including leaded gasoline and mine tailings exposure while riding his motorcycle. Later investigations revealed that leaded gasoline was used in the motorcycle and that the subject frequently rode the motorcycle over tailings material. It was suggested that because after being warned of the exposure, the subject avoided the tailings area, that the much lower blood lead on the retest was due to a curtailed exposure. BMUGGL I ER MOUNTAIN TAC FINAL, REPORT, 1/27/93 WA However, there are other explanations of the elevated blood lead on the first test, including contamination during sample collection; namely, Pb -containing dirt on the skin, dust contamination of the blood collection materials (needle, syringe, or contamination of the tube into which the blood was drawn. it is possible, but less likely that laboratory error may account for the high blood lead. The Centers for Disease Control Laboratory performed the blood lead analyses. This laboratory is highly reliable and has established and conducts a national PbB proency testing program. A major strength of the CDH study is that the PbB determinations provide a means to characterize health risk to children living on the Smuggler Mountain site. Results can be interpreted using the large body of research on the human toxicology of Pb, without having to extrapolate from animals or t The CDH report includes a lengthy discussion of the study limitations. Notably, the results represent only a single measure of PbB, reflecting relatively recent exposure. Serial blood leads would be necessary to more accurately draw inferences about chronic ..... and Pb body burden in each childo Apparently, historical blood lead data were not available in the study. participants. However,while it is true that blood leads relate to relatively recent exposure (the half-life of lead in blood is approximately 30 days) , the time at which the study was conducted (late summer/early fall) is the period during which the highest blood leads tend to occur (U.S.E.P.A.0 1986). As noted earlier, soil sampling on the Site was not done at the same time as the blood lead survey, thereby limiting the value of the soil samples in interpreting the blood lead concentrations. While the report contains. the results of correlation analyses between blood lead and soil lead concentrations, these results should be viewed with considerable skepticism. In addition, other potential pathways of Pb exposure in the study participants were not evaluated, such as lead-based paint, lead concentrations in play area soils, hand dust, interior dust, drinking water, or dietary sources. T I he committee concludes that, in spite of the lack of environmental data, the blood lead survey was well-planned, well - implemented and the results representative of the community at that time. Moreover, because of the time period, it is unlikely that blood leads at other times of that year would be higher than those found in the study, unless exposure changed significantly. The NAS Committee defined risk characterization as: The process of estimating the incidence of a health effect under the various conditions of human exposure described in SMUGGLER MOUNTAIN TAC 28 FINAL REPORT, 1/27/93 exposure assessment. it is performed by combining the exposure and dose -response assessments. The summary effects of the uncertainties in the preceding steps are described in this step. Three other blood lead studies have been conducted recently in Colorado communities where mining, milling and/or smelting activities took place in the past. These sites were Leadville, Telluride, and Clear Creek/Central City. Table 1 summarizes the results of these studies. The comparison with the Telluride and Leadville studies suffer because of the time lag. Bornschein (1992) has pointed out the overall decline in blood leads with time. The CDH (1992a) report .on the Smuggler Mountain study points out numerous differences between the Leadville and Smuggler Mountain Sites, which probably invalidates any direct comparisons between the two sites. These sites differ in the nature, extent and recency of mining activities and presence of smelter operations. They also differ with respect to the extent of contamination, the quality of soil cover, and the possible presence of lead-based paint. Furthermore, the Leadville study population appears tobequite different in terms of age of housing, income status, ethnicity and, perhaps, nutrition (CDH, 1992a) . These differences underscore the importance of considering site-specific characteristics that may influence exposure and/or human health risks. The studies in the Clear Creek/Central City site and the Smuggler Mountain site were carried out at virtually the same time. In both cases there was only mining and milling. Although the median and maximum soil lead concentration values are significantly higher at the Smuggler Mountain site than at the Clear Creek/Central City site, the blood leads at Smuggler Mountain are significantly lower (geometric mean of 2.6 gg/dl versus 5.9 µg/dl). It is important to note that both studies used the protocol developed in the Leadville study, with the exception -that no soil samples were collected in the Smuggler Mountain study as, mentioned earlier. Unfortunately, the only large, nationwide survey of blood leads whose data is available was the NHANES II (National Health and Nutrition Evaluation Survey II) that was performed in the 1970s. The data from NHANES III is not yet available. The US EPA (1989) has a model for predicting blood leads on a regional and national scale. This model was used to predict a "baseline" geometric mean for 2 year old children of 4.2 - 5.2 pg/dl. Thus, the blood lead concentrations found in Aspen are below other sites investigated in Colorado. In fact, -to the knowledge of the TAC members, the geometric mean blood lead concentrations found in the Smuggler Mountain study are less than those reported for any other group that has been studied with one exception. In 1974 SMUGGLER MOUNTAIN TAC 29 FlNhL REPORT, 1/27/93 one possible source f or the dif f erences between the blood lead concentrations Smuggler Mountain and those found at other contaminated sites could be in the relative bioavailability of soil -lead form at the different sites4 However, no research has specifically tested the bioavailability of soil -Pb from Aspen. Based on available information, the bioavailability of Aspen soil - Pb under worst -,case fasting conditions may not be lower than found in other areas for similar soil Pb concentrat ions. The work of Drexler (1992) on soils from Aspen showed that little of the soil Pb was galena or other highly insoluble or rinded (occluded) mineral forms. These latter forms of soil Pb were found to have low bioavailability to rats, rabbits, and in in vi tro bioavailability extraction methods (Ruby et al., 1992; Freeman et al., 1992; Davis, A., et al., 1992). However, other factors which strongly affect Pb absorption in SMUGGLER MOUNTAIN TAC 30 FINAL REPORT, 1/27/93 human volunteers may be important in explaining the low blood -Pb levels found here. First, the presence of food in the gut has been shown to buffer the stomach pH to much higher levels than found in fasting (Malagelada et al., 1977) . Second, the presence of food in the gut has been shown to remarkably reduce the absorption of Pb compared to fasting, from 60-80% absorbed to 1-10% absorbed (James et al., 1985; Heard et al., 1983; Rabinowitz et al., 1980). Besides the role of food in pH buffering and reduction in dissolution of Pb minerals, food constituents can adsorb or coprecipitate Pb. If children in Aspen have better care and receive meals on a regular basis, the timing of food in the stomach rftay prevent them from reaching the high levels of Pb absorption found in fasting humans. James et al. (1985) showed that food consumed at least 3 hours before a Pb dose, or up to approximately 2 hours after a Pb dose substantially reduced Pb absorption, even for • bioavailable soluble Pb salts used in their tests. Thus, consumption of meals on a regular •. three • more time -9 1!er day can interfere with soil Pb risk compared to the worst case inner city •w• unsupervised child who may miss one ♦ more meals taily,. may be malnourished, and who is believed to be at risk when soil Pb exceeds 500-1000 mg/kg (Porter, 1989). Further, adequate Ca nutrition and Fe nutrition can minimize Pb absorption by animals according to many studies. However, few studies have been conducted with humans., and the studies to evaluate effects of Fe or Ca nutritional status on Pb absorption by children have mostly been indirect tests rather than the controlled variable studies which were possible with adults. At least Ca nutrition has been shown to significantly affect Pb absorption by children. Many studies have shown that Fe deficiency in many animal species caused increased Pb uptake (Mahaffey and Michaelson, 1980) . However, the effect of Fe nutritional status remains somewhat confusing, and no clear conclusion is possible regarding children. . Clinical trials were conducted to test whether Fe supplementation of children with high blood Pb could reduce blood Pb concentration. Angle et al. (1975) found a small and nearly significant increase in blood Pb in response to FeSO4 supplementation. Their work even included a double-blind study. Further, in an evaluation of the results of the NHANES-II results, Mahaffey and Annest (1986) did not find a specific effect of Fe deficiency on blood Pb concentration. The effect of Ca nutritional status and Ca level in the diet on Pb absorption has also been studied extensively (see Mahaffey, 1982; Mahaffey and Michaelson, 1980). Work by Six and Goyer (1970), Mahaffey et al. (1973), and Mahaffey et al. (1977) clearly showed that Pb uptake was enhanced much more by deficient levels of Ca than it was decreased by supraoptimal levels of Ca. Mahaffey et al. (1973) also found that the increase in blood Pb due to Ca deficiency was much more pronounced at low Phi intake than at high SMUGGLER MOUVTAIN TAC FINAL REPORT, 1/27/93 Pb intake, indicating dietary Cia in Pb risk - of children may ingest have a high incidence M even more importance for the ro I le of low o children. Although all economic classes low levels of diet Ca, poor urban children *f low Ca intake (Mahaffey, 1982). Further, when Ca and P are at high levels in the diet, Pb may coprecipitate in the intestine. Pb absorption in fasted adult humans was reduced in proportion to Ca level in the diet (Blake and Mann, 1983). It appears that reduction in Pb absorption by humans with normal or high intakes of Ca can be due to 1) reduction in the Ca binding protein/carrier 'in -the intestine; 2) direct competition between Ca and Pb uptake in the intestine; and 3) coprecipitation M f Pb in the intestine. The effect of dietary Ca on blood -Pb levels in children has been assessed in several research studies which attempted to better characterize this relationship. These included the finding that absorption/retention of Pb from pediatric foods was significantly reduced with increasing Ca concentration in the diet (Ziegler et al., 1978). Mahaffey et al. (1986) noted that improved public health measures aimed at increasing intake of Ca and dairy products, particularly in low-income black and white urban dwellers, might reduce Pb risk to urban children. Socioeconomic and demographic factors of the Aspen community indicate that little reduction in blood Pb would be expected from Ca supplementation of Aspen children because they are likely to have adequate Ca nutrition already. Thus, while evidence presented concerning the relative bioava,ilability of lead in the tailings/soil/dust material at the Smuggler Mountain Site was either irrelevant or unconvincing, there are other factors such as the dietary characteristics of the population at that site which would tend to lead to lower absorption of the lead in these materials. VI.B.2. Attenuated Pathway There is a significant difference in the s,oc ia 1 -economic status of the population studied in Aspen compared to the other sites. Unfortunately, the SES data for the Clear Creek/Central City study has not been compiled. But, the CDH (1992a) report on the Smuggler Mountain study does make a comparison with Leadville. It is clear that the Smuggler Mountain population is far more affluent than the Leadville population. While the Clear Creek/central City population was probably somewhat more affluent than that in Leadville, it was certainly more like Leadville than it was like Smuggler Mountain (personal observation, W.R.Chappell) . This relative affluence could be expected to result in child care behaviors, nutritional status and personal and residential hygiene practices that would tend to reduce soil/dust ingestion. As noted in the previous sections, these factors may also impact the kinetics of absorption of lead from the GI tract, binding of lead to both hard and soft tissues and renal excretion. I.Al GGL ER-VMUNTA71-&N-�'O���-2 FINAL REPORT, 1/27/93 SMUGGLER HOURTAXN TAC 33 FXNAL REPORT, 1,/27/93 34 lognormal probability distribution) the probability of finding a child with a blood lead level above 10 pg/dl and 15 pg/dl. These probabilities are 0.4% or 4 in a thousand for blood leads above 10 Ag/dl and 0.03% for blood lead concentrations above 15 Mcg/dl. While the number of subjects in the Aspen study (28) was not as large as in some studies, if the upper 95% confidence limit on the geometric mean obtained by CDH (1992a), which is 3.1 gg/dl, is used (with the same geometric standard deviation), then the probabilities of finding a child above 10 and above 15 ,fig/dl are 1% and 0.1%, respectively. That is, it is unlikely that the risk of a child having a blood lead concentration higher than 10 or 15 µg/dl is higher than 1 in a 100 or 1 in a 1,001, respectively. Two of the questions posed to the Committee involved the issue of present or future realistic health threats. These questions were: QUESTION No. 1: Does the existing site-specif ic data and scientif ic literature provide adequate evidence which confirms that the soil lead in the Smuggler Mountain Superf und Site Floses a current realistic health threat (i.e., unacceptable risk of disease or impairment) to any of the residents on or near the site. ANSWER: The Committee unanimously concludes the answer is no. QIESTION No. 2: If the answer to question I is no, is,there a reasonable probability of such a threat developing in the future? ANSWER: The Committee unanimously agrees that there is a possibility of a future threat, but the likelihood is small. If the demographics, land use and environmental conditions remain essentially unchanged at the Site, we do not anticipate any future realistic health threat. It should be noted that the Committee is not implying there is no risk. As noted above, the risk is small, but not zero. EPA's Proposed Remediation The Record of Decision (ROD) proposed by EPA that describes the remedial actions has been modified at least twice, once in March 1989 and again in May, 1990. The May, 1990 modified -ROD apparently proposes to place a protective cover of clean soil over contaminated areas (those with concentrations >1000 ppm). A foot of clean soil will be put over a geo-textile liner for individual properties. For the condominium area, the depth of the clean soil will be 6 inches. several institutional controls are also proposed. SMUGGLER MOUNTAIN TAC FINAL REPO.T, 1/27/93 m SMUGGLER MOUNTAIN TAC 3f FINAL REPORTI 1/27/93 VIII. REFERENCES Adolph, E.F. (1949) Quantitative relation in the physiological constitution of mammals. Science 109: 579-585. Angle, C.R., Stelmak, K.L., and McIntire, M.S. (1975) Lead and iron deficiency. Trace Subst. Environ. Health 9:377-386. Barnes, R.M. (1990) Childhood soil ingestion: how much dirt do kids eat. Anal. Chem. 62: 1032A -1033A. Battelle. (1991) Bioavailability of lead in mining waste soil: a dosed feed study using Sprague -Dawley rats. Report to Arco Coal Company,. Feb., 1991. Battelle Study No. SC900006'. Columbus, Ohio. Bellinger, D.C., Needleman, H.L., Leviton, A., Waternaux, C., Rabinowitz, M.B., and Nichols, M.L. (1984) Early sensory -motor development and prenatal exposure to lead. Neurobehay. Toxicol. Seratol, 6:387-402. Bellinger, D., Leviton, A., Waternaux, C., and Allred, E. (1985) Methodological issues in modeling the relationship between low' level lead exposure and infant development: examples from the Boston Lead Study. Environ. Res. 38: 119-129. Binder, S., Sokal, D. and Maughan, D. (1986) Estimating soil ingestion: the use of tracer elements in estimating the amount of soil ingested by young children. Arch. Environ. Health. 41: 341- 345. N Blake, K.C.H., and Mann! M. (1983) Effect of calcium and phosphorus on the gastrointestinal absorption of 203Pb in -man. Environ. Res. 30:188-194. Boon, D.Y. and Soltanpour, P.N. (1992) Lead, cadmium and zinc contamination of Aspen garden soils and vegetation. J. Environ. Qual. 21:82-86. Bornschein, R.L., Succop, P., Dietrich, K.N., Clark, C.S., Que Hee, S.., and Hammond, P.B. (1985) The influence of social and environmental factors on dust lead, hand lead, and blood lead levels in young children. Environ. Res. 38: 108-118. Bornschein, R.L., Succop, P.A., Krafft, K.M., Clark, C.S., Peace, B. and Hammond, P.B. (1986) Exterior surface dust lead, interior house dust lead, and childhood lead exposure in an urban environment. Trace Subst. Environ. Health 20:322-332. Bornschein, R.L., Clark, C.S., Grote, J., Peace, B., Roda, S., and Succop, P. (1988) Soil lead -blood lead relationship in a former lead mining town. In: B.E:. Davies and B.G. Wixson, eds. Lead in soil: issues and guidelines. Northwood, U.K.: Science Reviews Ltd. pp. 149-160. SMUGGLER MOUNTAIN TAC FINAL REPORTO 1/27/93 M Bornschein, R.L., Clark, C.S., and Pan,, W. (1992) The Butte -Silver Bow county environmental health lead study. Final Reporta Butte - Silver Bow Department of Health and University of Cincinnati. Cincinnati, Ohio. Calabrese, E.J., Barnes, R ' , Stanek, E.J., Pastides, H., Gilbert, C.E., Veneman, P., Wang, P., Wang, X., Lasztity, A., and Kostecki, P.T. (19 89) How much soil do young children ingest: an epidemiologic study. Regul. Toxicol. Pharmacol. 10: 113-123. Calabrese, E.J., Stanek, E.J., Gilbert, C.E. and Barnes, R.ffr. (19 90) Preliminary soil ingestion estimates: results of a pilot study. Regul. Toxicol. Pharmacol. 12: 88-95. Chatterjee P. and Gel,tman, J.H. (1972) Lead poisoning: subculture zztina aaent? Am. J. Clin. Nutr. 25: 324-330. CDC (Centers for Disease Control). (1991) Preventing lead poisoning in young children: a statement by the Centers for Disease Control. Oct. 1991. Atlanta, Georgia. CDH (Colorado Department of Health) . (1990) Leadville Metals Rxposure Study. Colorado Department of Health. Denver, Colorado. CDH (Colorado Department of Health). (1992a) Clear Creek/central City mine waste exposure study, Part I: Smuggler, Mountain Site. Colorado Department of Health. Denver, Colorado. CDH (Colorado Department of Health). (1992b)i Clear Creek/Central City mine waste exposure study, Part II: Clear Creek/C,entral City mine sites. Colorado Department of Health. Denver, Colorado. Chaney, R.L., H.W. Mielke, and S.B. Sterrett. (1989) Speciationj mobility, and bioavailability of Soil Lead. [Proc. Intern. Conf. Lead in Soils: Issues and Guidelines. B.E. Davies & B.G. Wixson (eds.)]. Environ. Geochem. Health 11(Supplement):105-129. Chaney, R.L. (1991) Land application of composted municipal solid waste: Public health, safety, and environmental issues. pp. 61-83. In Proc. 1991 Solid Waste Composting Conference. solid Waste Composting Council, Washington, DC. Chaney, R.L. and J.A. Ryan. (1992) Heavy metals and toxic organic pollutants in MSW -composts: Research results on phytoavailability, bioavailability, etc. pp. Ln H.A.J. Hoitink et al. (eds.) . Proc. International'Compostinq Research Symposium. In press. Chaney, R.L. (1992) Land application of composted municipal solid waste: Public health, safety, and environmental issues. pp. 61-83. In Proc. 1.991 Solid Waste Composting Conference. Solid Waste Composting Council, Washington, D.C. Clausing, P., Brunekref, B., and Van Wijnen, J.H. (1987) A method for estimating soil ingestion in children. Int. Arch. Occup. SMUGGLER MOUNTAIN TAC 38 FINAL REPORT, 1/27/93 Environ. Med. 59: 73-82. Cotter -Howells, J. and Thornton, I. (1991) Sources and pathways of environmental lead to, children in a Derbyshire mining village. Environ. Geochem. & Health 13: 127-135. Davis, A., Ruby, M.V., and Bergstrom, P.D. (1992) Mineralogic controls on arsenic and lead bioavailability in soils from the Butte mining district, Montana, U.S.A. Environ. Sci. Technol. 26:461-468. Davis, J.M. (1992) Current issues in assessing the health risks of lead. The Toxicologist 12:246. Davis, S.S., Stockwell, A.F., Taylor, M.J., Hardy, J.G., Whalley, D.R., Wilson, C.G., Bechgaard, H., and Christensen, F.N. (1986) The effect of density on the gastric emptying of single- and multiple -unit dosage forms. Pharmaceutical Res. 3: 208-213. Davis, S., Waller, P., Buschbom, R., Ballou, J., and White, P. (1990) Quantitative estimates of soil ingestion in normal children between the ages of 2 and 7 years: population -based estimates using aluminum, silicon, and titanium as soil tracer elements. Arch. Environ. Health 45: 112-122. Drexler, J. (1992) Laboratory services at Smuggler Mountain CERCLA Site, Aspen, Colorado. Phases I and II. Feb. 7 and July 1, 1992. Department of Geological sciences, University of Colorado at Boulder. Boulder, Colorado. Freeman, G.B., Johnson, J.D., Liao, S.C., Feder, P.I., Killinger, J.M.' Chaney, R.L., and Bergstrom, P.D. (1991) Effect of soil dose on bioavailability of lead from mining waste to rats. Chem. Spec. Bioavail. 3:121-128. Freeman, G.B., Johnson, J.D., Killinger, J.M., Liao, S.C., Feder, P.I., Davies, A.0.1 Ruby, M.V., Chaney, R.L., Lovre, S.C., and Bergstrom, P.D. (1992) Relative bioavailability of lead from mining waste soil in rats. Fundamental and Applied Toxicology 19:388-398. Heard, M.J. and Chamberlain, A.C. (1982) Effect of minerals and food on uptake of lead from the gastrointestinal tract in humans. Human Toxicol. 1:411-415. Heard, M.J., Chamberlain, A.C., and Sherlock, J.C. (1983) Uptake of lead by humans and effect of minerals and food. Sci. Total Environ. 30:245-253. Hecker, L.H., Allen, H.E., Denman, B.D. and Treell J.V. (1974) Heavy metal levels in acculturated and unacculturated populations. Arch. Environ. Health 29: 181-185. Hemphill, C.P., Ruby, M.V., Beck, B.D., Davis, A., and Bergstrom, SMUGGLER MOUNTAIN TAC 39 FXNAL REPORTO 1/27/93 P. D. (1991) The bioavailability of lead in mining wastes: physical/chemical considerations. Chem. Spec. Bioavail. 3., 135- 148. Hossain, M., Abramowitz, W., Watrous, B.J., Szpunar, G.J., and Ayres, J.W. (1990) Gastrointestinal transit time of nondisintegrating, nonerodible oral dosage forms in pigs. Pharmaceutical Res. 7: 1163-1166. Houk., V. N. (1992) Assessing environmental risk --scientifically defensible or fantasy? Presented to Division of Environmental Chemistry. American Chemical Society Meeting, San Francisco, California, April, 1992. ICF Clement. (1986) Endangerment assessment for the Smuggler Mountain Site, Pitkin County, Colorado. Prepared for U.S. E.P.A. Region VIII. Helena, Montana. James, H.M., Hilburn, M.E., and Blair, J.A. (1985) Effects of meals and meal times on uptake of lead from the gastrointestinal tract in humans. Human Toxicol. 4: 401-407. LaGoy, P.K. (1987) Estimated soil ingestion rates for use in risk assessment. Risk Anal. 7: 355-359. Lansdown, R.G., Sheperd, J., Clayton, R.E., Delves, H.T., Graham, P.J., and Turner, W.C. (1974) Blood lead levels, behavior, and intelligence: a population study. Lancet 1:538-541. LaVelle, J.M., Poppenga, R.H., Thacker, B.J., Giesy, J.P., Weis, C., O,thoudt, R. and Vandervoort, C. (1991) Bioavailability of lead in mining wastes: an oral intubation study in young swine. Chemical Speciation and Bioavailability 3: 105-112. Logan, T.J., Ma, Q.Y., and Traina, S.J. (1992) immobilization of aqueous and exchangeable Pb by apatite. Agron. Abstr. 1992:47. Ma, Q.Y., S.J. Traina, T.J. Logan and J.A. Ryan. (1991) Lead immobilization in aqueous solution by tribasic calcium phosphate. Agron. Abstr. 1991:248. Ma, Q.Y., Traina, S.J., and Logan, T.J. (1992),Effect of ligands on hydroxyapatite -induced immobilization of aqueous Pb. Agron. Abstr. 1992:47. Mahaffey, K.R., Goyer, R.A., and Haseman, J.K. (1973) Dose - response to lead ingestion in rats fed low dietary calcium. J. Lab. Clin. Med. 82:92-100. Mahaffey, K.R. (1974) Nutritional factors and susceptibility to lead toxicity. Environ. Health Perspect. 107-112. Mahaffey, K.R., T.A. Banks, C.L. Stone, S.G. Capar, J.F. Compton, and M.H. Gubkin. (1977) Effect of varying levels of dietary SMUGGLER MOUNTAIN TAC FINAL REPORT, 1/27/93 Hui calcium on susceptibility to lead toxicity. Proc. Intern. Conf. Heavy Metals in the Environ. 3:155-164. Mahaffey, K.R., and Michaelson, I.A. (1980) The interaction between lead and nutrition. In: Needleman, H.L. ed. Low Level Lead Exposure: The Clinical implications of Current Research, River Press; pg. 159-199. Mahaffey, K.R. Nutritional factors in lead poisoning. (1981) Nutrition Rev. 39:353-362. Mahaffey, K.R. (1982) Role of nutrition in prevention of pediatric lead toxicity. pp 63-78. In J.J. Chisolm, Jr., and D.M. O'Hara (eds.) Lead Absorption in Children: Management, Clinical, and Environmental Aspects. Urban and Schwarzenberg, Baltimore. Mahaffey, K.R., and Annest, J.L. (1986) Association of erythrocyte protoporphyrin with blood lead level and iron status in the Second National Health and Nutrition Examination Survey, 1976-1980. Environ. Res. 41:327-338. Mahaffey, K.R., Gartside, P.S., and Glueck, C.J., (1986) Blood lead levels and dietary calcium intake in I to 11 year-old children: The second National Health and Nutrition Examination Survey, 1976 to 1980. Pediatr. 78:257-262. Malagelada, J.R., Lonqstreth, G.F., Deering, T.B., Summerskill, W.H.J., and Go, V.L.W. (1977) Gastric secretion and emptying after ordinary meals in duodenal ulcer. Gastroenterol. 73:989-994. McMichael, A.J., Boghurst, P.A., Wigg, N.R., Vimpani, G.V., Robertson, E.f., Roberts, R.J. (1988) Port Pirie cohort study: environmental exposure to lead and children's abilities at the age of four years. New Engl. J. Med. 319: 468-475. Mordenti, J. and Chappell, W.R. scaling in toxicokinetics. Inc Batra, eds. Toxicokinetics and N.Y.: Pergamon Press; p. 80. (1989) The use of interspecies A. Yacobi, J.P. Skelly and V.K. new drug development. New York, National Academy of Sciences; National Research council. (1983) Risk assessment in the federal government: managing the process. Washington, DC: National Academy of Sciences. Nelson, L.S., Jr., Jacobs, F.A. and Brushmiller, J.G. (1987) Coprecipitation modulates the solubility of minerals in bovine milk. J. Inorg. Biochem. 29:173-179. Nriagu, J.D. (1974) Lead orthophosphates. IV. Formation and stability in the environment. Geochim. Cosmochim. Acta 38:887-898. Piomelli, S., Corash, L., Corash, M.B., Seaman, C., Mushak, P., Glover, B., Padgett, R. (1980) Blood lead concentrations in a M1\1�,D 61 D�-1 DUZ) 00014001 SXUGGLER MOUNTAIN TAC 41 FIVAL REPS RT$ X/27/93 remote Himalayan population. Science 210: 1135-1136. Poole, C. and'Smythe, L.E. (1980) Blood lead levels in Papua, New Guinea children living in a remote area. Science of Total Envirqn. 15: 17-24. Porter,, J.W. (1989) Memorandum to Regional Administrators, Regioh I -X, regarding Interim Final Guidance on Soil Ingestion Rates. U.S. E.P.A. office of Solid waste and Emergency Response. Rabinowitz, X.B.,, Nopple, J.D., and Wetherill, G.W. (1980) Effect of food int&ke and fasting on gastrointestinal lead absorption in humans. Am. J. Clin. Nutr. 33,01784-1788. Rennert,Welnerf P.; and Maddenj J. (1970) Asymptomatic lead poisoning in 85 Chicago children. Clin. Ped. 9:9-13. RTI (Research Triangle Institute) . (1991) Distribution of lead A9 rats after repeated exposure to lead compounds in feed. Proje Report No. 14. Report to National Institute of Environnment Health Sciences. Research Triangle Park, North Carolina. Z,uby, M.V., Davis., A., Kempton, J.H., Drexler, J.W. and Bergstrojr,- P. D. (1992) Lead bi,oav,ailabilityat, di'ssolution kinetics under simulated gastric conditions. Environ. Sci. & Techo 26: 1242-1248. Rumma, J.H., Routh, D.K.; Rummo, H.J. and Brown, Behavioral and -neurological ef f ects of symptomatic and asymptomatic lead exposure in children. Arch. Environ. Health 34:120-124. Schroeder, S.R., Hawk, B., Otto, D.A., Mushak, P., Hick . Hicks, RE. (1985) Separating the effects of. -lead and social factors. on IQ. Environ. Res, 38: 144-154. Schroeder, S.R. (1989) Child -caregiver environmental factors uelated to lead exposure; and IQ In; Smith, M.A.; Grant, L.D. and Sors, A,.I'. eds. Lead Exposures andChild Development: An International Assessment. Dordrecht/Bostion/London, Kluwer Academic I*-Ublishers; pg. 166-182. Six, K.M. and Goyer,, R.A. (1970) Experimental enhancement of lead toxicity by low dietary calcium. J. Lab. Clin. Med. 76.-933-,942. Stark, A.,D., Meigs, J.W., Quah, and DeLouise, Family operational coi-f actors in the, epidemiology of childhood lead ijvoisoning. Arch. Environ. Health 33:22-'225. Stark, A.D., Quah, R.F., Meigs, J.W-j and DeLouise, E.R- (1982) Relationship of sociodemographic factors to blood lead concentration in New Haven children. J4 Epid. and Comm. Health 36: 133-199t I Steele, M.J., Beck, B-D.r M urphy, B.L., and Strauss, H.S. (1990) Assessing the contribution from lead in mining wastes to blood SMUGGLER HOURTAIN TAC FINAL REPORT, 1/27/93 M lead. Begin. Toxicol. Pharmacol. 11:.158-190. Thompson, K.M. and Burmaster, D.E. (1991) Parametric distributions for soil ingestion by children. Risk Anal. 11: 339-342® Thornton, I., Culbard, E., Moorcroft, S, Watt, J -t Wheatley, and Thompson, M. (1985) Metals in urban dusts and soils. Environ. Technol. Lett. 6:137-144. U.S. Environmental Protection Agency (U.S.E.P.A.) (1986) Air quality criteria forE.P.A. " Report 600/8-83/028aF. Volumes I-IV. Environmental criteria and As sessment Office, Research Triangle Park, North Carolina. U.S. Environmental Protection Agency (U.S.E.P.A.) (1989) Review of the national ambient air quality standards for lead: exposure analysis and methodology. U.S. EoP.A. 450/2-89-011. Appendix C. Van Wijnen, J.H. , Clausing, P. , and Brunekref, B. (1990) Estimated soil ingestion by children. Environ. Res. 51: 147-162. weis, C.P. and LaVelle, J.M. (1991) Characteristics to consider when choosing an animal model for the study of lead bioavailability. Chemical Speciation and Bioavailability 3:113- 119. Withey, JoR. (1987) Approaches to route extrapolation. In: R. Tardiff and J.V. Rodricks, eds.Toxic substances and human risk: New York, New York. Plenum Press. p. 287. Woefel, A., and A.J. Carlson. (1914) The solubility of lead sulphide ores and of lead sulphide in human gastric juice. J. Pharmacol. Exper. Ther. 5:54:9-552. Ziegler, E.E., B.B. Edwards, R.L. Jensen, K.R. Mahaffey, and S.J. Fomon. (19-78) Absorption and retention of lead by infants. Pediatr. Res. 12:29-34. I `P/^96 >, 4-) ' >r-1 4-) E -i U 4-4 o >1 ra >4 .4 to-) Cl ro U) .H 41 a 0 .ru 0 0 0 0 t3m rd u 4J M-4 m -H 0 fa 0 0 0 r-1 4-) (d 4Jr-4 9 z 0 H P4 0 ol 4) 4-) P4 O'd 041 co U) 44 0 fd �4 0 4 V4 4-) :j E-1 4 Ln 0 P P44 0 0� LO C%] W. 0) La tp y.-0)0 4-) r-1 P-1 ra) co 0 04 04 co cq ter 104 P4 Ln 0 ro (d P04 104 LO 0 TA 0 .H V1 0) E-4 4 z M. 14 rd 04 4 P P4 P4 H 19V ko 4-zJ En Phi 0 Ol r -A I co U) W (N (1) If LO 41 z