Loading...
HomeMy WebLinkAboutSmuggler Superfund - Blood Lead Exposure to young children 1998 Univ of Concinnati Final Reportw 1, low mm BLOOD LEAD SURVEILLANCE AND EXPOSURE OF YOUNG CHILDREN TO ELEVATED SOIL LEAD AT THE SMUGGLER SUPERFuNiD SITE, AsWEN CO. FINAL REPORT ' Prepared by: The University of Cbreinriiti Prepared for: Pith County, FeteOh eirt , U S Eft Reoa� VIIT !ra October, 199$ ` A � OCT ; 1998::; ._ EMARONMEWAL HEALTH ASPEN J PITKfN Mr w wr TABLE OF CONTENTS Page I. Executive Summary II. Workplan 1.0 Background................................................5 2.0 Study Objectives ............................................. 6 �« 3.0 Rationale .................................................. 6 3.1 Health Effects of Elevated Blood Lead 6 3.2 Benefits of an Independent Lead Study ..................... 8 4.0 Study Design ............................................... 9 4.1 Overview ............................................. 9 4.2 Sample Size ........................................... 9 4.3 Sampling Frame ....................................... 11 4.4 Selection of Study Participants .............................. 11 4.5 Activities Proposed for Fall, 1996 ............................ 13 4.6 Activities Proposed for Fail, 1997 ............................ 13 4.7 Timetable for the study ................................... 13 5.0 Methods..................................................14 5.1 Review of Protocol for Census .............................. 14 5.2 Overview of Protocol for Residential Environmental Sample Collection ...................................... 14 nA 5.2.1 Hiring and Training of Environmental Technicians ............ 17 5.2.2 Environmental Survey in Temporal Order of Events ........... 17 5.3 Overview of Protocols for Environmental Sample Collection 18 5.3.1 Interior Household Surface Dust ........................ 18 5.3.2 Handwipe Sample Collection .......................... 18 5.3.3 Exterior Surface Dust and Soil ......................... 19 5.3.4 Quality Assurance Plan for Environmental Samples ............ 19 v 5.4 Environmental Sample Analyses ............................. 19 5.4.1 Environmental Sample Analysis Reference Methods ............ 19 5.4.2 Acid Digestion for Analysis by Atomic Absorption ........... 20 5.5 Overview of Protocol for Blood Collection, Lead Analysis and Quality Control ..................................... 20 5.5.1 Sample Collection ................................ 21 5.5.2 Sample Analysis ................................. 21 5.5.3 Quality Assurance Plan for Blood Lead Analysis ............ 21 5.6 Overview of Protocol for Clinic Interviews ...................... 21 5.7 Data Management Procedures .............................. 22 5.8 Data Analysis......................................... 23 5.8.1 Descriptive Statistics .............................. 23 5.8.2 Inferential Techniques ............................. 23 5.9 Reporting of Results from the Blood Lead and Residential Environmental Survey ................................... , 23 III. Results and Discussion 6.0 Blood Lead Levels....................................... 24 6.1 Influence of Age................................... 24 6.2 Impact of Altitude/Hematocrit on Blood Lead .................24 6.3 Comparison with Previous Surveys ......... .............. 24 7.0 Environmental Lead Levels................................. 25 8.0 Hand Lead as an Exposure Indicator ........................... 25 9.0 Comparison of `96 and `97 Lead Exposure Data ................... 26 IV. Summary of Results and Conclusions................................34 V. References................................................. 35 VI. Appendices A. Biological Sample Collection Protocol B. Consent Forms C. Data Collection Forms D. Individual Result Report Forms E. Environmental Sample Collection Protocol F. Influence of Altitude on Hematocrit, Blood Lead and Body Lead Burden G. Aspen Individual Data Listing for 1996 and 1997 H. Project Investigator and Key Personnel I. Executive Summary In the early 1980's elevated levels of lead were found in residential areas in and around the Smuggler Trailer Court. In 1986, the site was placed on the Superfund National Priorities List. i In 1990, the Agency for Toxic Substances and Disease Registry conducted a blood lead study to examine the impact of environmental lead exposure on residents of the area. This survey found no evidence of excessive lead exposure at that time. However, the number of children residing in the area was quite small. Therefore concerned parties had limited confidence in making assurances to the community that the true risk was low and would remain so in the future. The Smuggler Mountain Technical Advisory Committee reviewed these data in 1993 and recommended a two year blood lead assessment be conducted to confirm that there were no remaining excessive health risks at the site. A legal consent decree stipulating the guidelines under which such an assessment should be performed was agreed upon by EPA and Pitkin County. The University of Cincinnati was retained by Pitkin County to conduct a follow-up study beginning in October, 1996. The main objectives of the study were: to re-evaluate lead exposure following recent remedial actions which included capping the berm and limited soil removal, to assess the transfer of lead from soil to the interior of homes to estimate the relative importance of various exposure pathways to identify any children with blood lead levels equal to or above 10 µg/dl Properties/homes in and around the Smuggler Trailer Court were randomly selected to yield a geographically representative sample. In addition all families with children less than 84 months of age were invited to participate in the study. A total of 40 properties were evaluated and 18 individuals, including 14 children less than 84 months old, were screened for possible blood lead elevation. Blood lead screening results reaffirmed the low blood lead levels previously reported for children at this site. Their average blood lead was 2.7 ,cg/dl (range = 1.5 to 5.9 µg/dl) which is identical to that reported in the most recent national survey. Sixty blood samples collected from young children between 1990 and 1997 have yielded a maximum blood lead level of 8.4µg/dl, i.e., none have exceeded 10 µgldl which is the EPA and Centers for Disease Control level of concern. Elevated levels of lead in soils and street dusts were detected and 43 percent of the children surveyed in 1996 had unusually high levels of lead in dust recovered from their hands. Apparently some of the children are coming in contact with these elevated sources of lead in soil and dust but it is having little or no significant impact on their blood lead levels. Repeated blood lead monitoring of young children in the area with 40 of the most contaminated sites at the Smuggler NPL site showed no increase in blood lead levels over the national background level of about 2.7 µg/dl. 4 II. Workplan 1.0 Background The Smuggler Mountain site, located one mile northeast of the city of Aspen, CO., Pitkin County, has historically been an area of le4d and silver mining and milling. The mines, once a source of employment for the surrounding community are now inactive and essentially abandoned. These mining activities generated tailings and waste which were intermixed with native soil and spread across areas where residential development eventually took place. The Hunter Creek Condominiums, Smuggler Trailer Court and the Centennial Condominiums were all constructed on top of and adjacent to surrounding tailing and waste piles. In the early 1980's elevated levels of lead and cadmium were found in these residential areas within and surrounding the city. In 1984 the site was proposed for the Superfund National Priorities List (NPL) and in 1986 placed on the Superfund List. Much controversy exists regarding the risk to human health from metals in soil. In particular, there is uncertainty regarding the bioavailability of metals present in mining waste, and therefore uncertainty regarding human exposure. In several studies conducted in mining and milling communities, correlation has been demonstrated between soil lead and blood lead of young children. Weak indirect correlations have also been seen, where in soil lead is correlated with house dust lead and house dust lead is correlated with blood lead. The Smuggler Mountain Technical Advisory Committee in 1993 suggested a two year blood lead (PbB) assessment should be conducted to confirm that there were no remaining excessive health risks at the site. A soil bioavailability study conducted by EPA indicated a higher than expected bioavailability of 35 percent, further substantiating the need for this assurance. Finally, a legal consent decree stipulating the guidelines under which such an assessment should be performed was agreed upon between EPA and Pitkin County. �1 2.0 Study Objectives The specific purpose of this investigation was to access lead exposure and low blood lead in children residing at the Smuggler NPL site in Aspen, CO. Data were used to develop a final remedial action that Drotects long-term health at the site. Secondarily, the amount of lead transferred from the soil into the interior of the residences was assessed to estimate the relative importance of exposure pathways. The main objectives of the study were as follows: .v 1. To re-evaluate lead exposure following recent remedial actions at the site (e.g., capping the berm) and to estimate future childhood exposure to yard -soil lead. 2. To identify any children with elevated blood lead levels (> 10 ,ugldl). 3.0 Rationale 3.1 Health Effects of Elevated Blood Lead Children are known to be particularly susceptible to lead poisoning. Lead has been shown to cause developmental problems in children when they are exposed to high enough concentrations of lead over long enough periods of time. The effects are most pronounced for prenatal exposure and for young children whose bodies are developing rapidly. The toxicity of any substance depends on the magnitude, duration, and route of exposure. Magnitude of exposure must be based not on the total concentration of substance present, but on the concentration of bioavailable substance present. To be bioavailable, the substance must be present in a chemical form which can be readily transported into and absorbed by the body. There must also be a pathway present for transfer from the environment to the child, i.e., the substance must be accessible. Primarily for these reasons, there is considerable uncertainty related to the health effects of lead from mine tailings. Previous studies conducted at other mining and milling sites have demonstrated that blood lead levels of populations living in areas with elevated soil lead concentrations are no higher than those of other populations in the United States. Several studies have been performed in the past several years that have not shown a strong correlation between soil lead levels and blood lead levels in children at these sites. A previous study of children residing near the Smuggler Mountain site, where the average soil lead concentration was 1,370 mg/kg (ranging from 135 - 11,676 mg/kg), found the arithmetic mean blood level to be 3.0 µg/dl. That study, conducted by the Agency for Toxic Substances and Disease Registry and the Colorado Department of Health, found no association between lead -containing mining wastes in soil and blood lead levels. Similarly, in Butte, Montana (Bornschein et al. 1992), children who lived at residences with high soil lead T concentrations (ranging from 2,500 - 8,500 mg/kg) had average (geometric mean) blood lead levels of 3.5 tzg/dl. Finally, in a 1989 study in Midvale, Utah (Bornschein et al. 1991), children's average blood lead levels were 5.2 pg/dl, where concentrations of lead in residential surface soils obtained in the study conducted by the University of Cincinnati ranged from 58 to 666.5 mg/kg. . The most accepted method of measuring actual exposure to and uptake of lead in children's bodies is through use of blood lead measurements. Several other methods, such as bone lead, can also be used; however, there are problems with the other methods, such as the difficulty in obtaining samples. A difficulty with blood lead measurements lies in their interpretation. Blood lead levels rise and fall as exposures rise and fall; but since lead is retained in various body compartments for differing lengths of time, a single measurement reflects both current and long-term exposure. Despite this concern, the data show that if a child is exposed chronically to lead sources, blood lead levels do provide a useful indication of lead exposure over the preceding months. According to ATSDR, blood lead levels can provide information regarding the relative level of exposure at more remote time periods (ATSDR, 1988). Repeat blood sampling over time, such as takes place in prospective childhood lead studies (Bornschein, et al 1985) has revealed a high degree of intercorrelation among repeat sampling. In fact, blood lead levels in 6.5 year olds are correlated (r = 0.72) with lead exposures occurring five years earlier (Hawk and Schroeder et al, 1985; Mushak, 1989). This issue has also been examined in the Cincinnati Lead Study. Blood lead measurements were made at three month intervals in over 300 children. For children over one year of age, the correlation between their blood lead level at a randomly selected age (between 1 year and 6 years of age) and a blood lead obtained one year later is r=0.81. The correlation between this randomly selected blood lead value and their average blood lead from birth to five years of age is also 0.81. Blood lead measurements even reflect to some extent the level of lead exposure incurred during the fetal period. The geometric mean blood lead obtained in a large sample is a reflection of past and current exposures of the average child in the community. Studies which have reported changes in blood lead levels following some form of intervention report rather slow changes in blood lead. For example, Succop et al (1987) estimated the half life of blood lead for 27 month old children following a change of residence from a high lead to a low lead residential environment. The estimated half life was found to be 11 months. Thus if a 27 month old child had a blood lead of 10 µg/dl and then moved to totally lead-free housing, his expected blood lead would be 5 jig/dl after 11 months. If new housing was not totally lead free, the child probably would not reach 5 pg/dI. A recent examination of epidemiological and toxicokinetic evidence (Karam et al., 1993) indicates that under relatively constant exposure conditions, blood lead measurements in a population of young children at a site are stable over time. A major advantage of measuring blood lead levels is that the Centers for Disease Control (CDC) in Atlanta have established action levels which can be used to judge the results of blood lead measurements. Specifically, the CDC has established 10 ,ug/dl (micrograms per deciliter) as the level above which some concern is warranted. Blood lead levels above 15 µgldl are cause for active intervention to locate and eliminate lead sources and/or pathways. Average blood lead 7 levels in children exposed to background levels of lead in air, water, and food typically range from 3 to 6 µg/dl. Although any single blood lead measurement above these values might be cause for some action, blood lead studies are typically evaluated on a statistical basis. If 95 percent of the population exhibits blood lead measurements below 10 µgldl, a significant community wide problem is not generally considered to be present. 3.2 Benefits of an Independent Lead Study A well-designed blood lead study in conjunction with an environmental lead survey provides the best means of identifying lead -related health risks in a community. This independent study conducted in the Smuggler Trailer Court area provided the information needed for a quantitative assessment of potential risks to human health. It provided the site specific data required for use with the uptake/biokinetic (UBK) model which EPA uses to predict blood lead concentrations in a given population based on environmental lead concentration data and assumptions regarding lead intake and absorption. Benefits of conducting the study included the identification of actual health hazards, obtaining site-specific data for use in the EPA blood lead model, improving the scientific database on lead bioavailability, and providing a community service. E:? 4.0 Study Design 4.1 Overview The study employed a cross-sectional design. Environmental and biological measurements were made for each child and his/her resident. Environmental sampling occurred be in and around : residences occupied by study participants. Additional environmental samples were taken from 20% of the homes within the site to establish the possibility of an exposure pathway. Regression techniques were used to relate blood lead measurements to environmental lead measures. The study contained the following components: • Demographic survey • Environmental Survey • Environmental Media Sampling • Blood Sampling and Analysis • Hand Wipe Analysis • Data Analysis and Interpretation • Report Preparation • Community Outreach • Response to Participants r EPA, the State of Colorado, and the Aspen/Pitkin County Environmental Health Department participated in development of the work plan and protocol review. A key component to the success of the project was the participation of the local agencies and community leaders. Participation by the local environmental health department and the support of community leaders encouraged resident participation. 4.2 Sample Size One of the study objectives was to estimate the community mean blood lead for children less than or equal to 84 months of age. If a community geometric mean of 2µg/dl and a geometric standard deviation of the blood lead distribution of 1.7 µg/dl is assumed, then a sample size of 10 will yield an estimate of the geometric mean blood lead with a precision range of 1.3 µg/dl (95 % confidence limits = 1.5 - 2.8). Note that reference to precision is an estimate of the error of the population mean, not reference to analytical precision. The number of children in this neighborhood is limited, thus a less precise estimate of the mean blood lead for this neighborhood was detained . However, it was still possible to identify individuals at risk due to elevated blood lead levels. Thus sampling in a low population area is still warranted. See Table 4.2.1 for precision estimates for other size samples. Table 4.2.1: 95 Percent Confidence Limits for a Geometric Mean Blood Lead of 4 ,ug/dl and Various Sam le Sizes Estimated Geometric Sample 95 % Confidence* Mean Blood Lead Size Limits of the Estimate 10 1.5-2.8 2 µg/dl 25 1.7-2.4 50 1.8-2.3 100 1.8-2.2 200 1.9-2.1 10 2.9-5.4 4 µg/dl 25 3.3-4.8 50 3.5 -4.5 100 3.7-4.4 - 200 3.8-4.2 10 4.4-8.1 6 µgldl 25 5.0-7.2 50 5.3-6.8 100 5.5-6.5 200 5.6-6.3 *Thus calculation assumes a geometric standard deviation of the mean of 1.7 µg/dl. 10 4.3 Sampling Frame Study participants consisted of children, less than or equal to 84 months of age, currently residing in the study area selected. Study enrollment was voluntary. Pregnant women and mothers nursing young infants were invited to have their lead levels checked. Since the number of pregnant or lactating women was limited, obtaining a highly precise estimate of the mean and distribution of blood lead levels for these groups was not possible. This study did not employ a control group selected from outside the proposed study area. By definition, a control group should be identical to the study group in all aspects considered relevant to the key outcome variable, e.g., blood lead, with the exception of the key independent variables (environmental lead measures). The multivariate nature of the childhood lead exposure mitigates against finding true control groups. There is considerable uncertainty regarding soil lead concentrations in any potential control area. The Smuggler area has been influenced by milling and mining operations at various times during the past 100 years. Soils may have become contaminated to a largely unknown degree and in ill-defined patterns as a result of these activities. Furthermore, working parents may have carried metal contaminants home in the form of dust on their clothing, shoes, or automobiles. This could result in the contamination of residential units scattered throughout the area. Thus, it is impossible to select a control area with any certainty that it is not also contaminated to some extent. Selection of a control area in the absence of good g ° residential environmental lead data could result in a spuriously high estimate of background blood lead levels. Most importantly, the purpose of the study was not simply to demonstrate that the average blood lead in a study area is significantly different from a "control" area. Rather, child - specific lead sources in each study area were measured and statistically modeled to determine the relative impact of these sources on the blood lead of residents. Estimates of the impact of various independent variables (soil lead, exterior and interior dust lead, etc.) were developed using regression techniques. 4.4 Selection of Study Participants Since the study area was confined and the number of children small (n=14), a door-to-door census was not undertaken. Study participation was strictly voluntary following a description of the study and signing of an agreement to participate (see Consent Form - Appendix B). Residents living outside the proposed study area were not actively recruited. However, if they requested a blood lead screening test, they were not refused, nor were residents living in the study area who did not have children less than seven years old and who had not been selected for ' environmental sampling. See Figure 4.4.1- Map of Study Area. In addition to actively recruiting families with young children an effort was made to obtain a spatially representative sample of homes for residential lead assessments. To this end, every fifth homeowner on each street was requested to participate. If he or she declined, an adjacent homeowner was approached. This procedure yielded a sample of 38 homes distributed across the study area. Two families living near the trailer court also requested that their homes be sampled. 11 4.5 Activities Proposed for Fall, 1996 The survey planned for the fall of 1996 consisted of a full census of the trailer court in order to identify all age eligible children. A spatially stratefied random sample of mobile homes was selected for full environmental sampling. In addition, all families with at least one age eligible child, were recruited into the study. As result of this strategy, 40 of 136 homes were targeted for sampling, including 10 homes with 14 children. 4.6 Activities Proposed for Fall, 1997 Sampling in 1997 was restricted to 8 homes with age eligible children tested in 1996. Environmental samples were restricted to floor dust, and hand dust. Blood samples were collected on children previously tested plus several sibs not tested in 1996. 4.7 Timetable for the Study The study was conducted in October of 1996 and October of 1997 and took approximately one week to complete. The following is the overall project schedule: Activily Timing Develop Work Plan and QA Plan Aug. -Sept., 1996 Meet with Local Health Dept. April, 1996 Invite EPA Input Aug., 1996 Finalize Survey Forms and Questionnaire Sept., 1996 Complete Sampling Protocols Sept., 1996 Organize Field Office Sept., 1996 Conduct Demographic Survey and Environmental Sept. -Oct., 1996 Sample Collection Conduct Error Checking and Data Entry Oct., 1996 Collect and Analyze Blood Samples Sept. -Nov., 1996 Enter Biological and Environmental Results Dec., 1996 Communicate Results to Participants Jan., 1997 Communicate Results to Community May, 1997 Conduct Follow-up Blood and Dust Survey Sept. 1998 Prepare Report 1998 Submit Final Report Oct. 1998 13 5.0 Methods 5.1 Review of Protocol for Census Two, two -member teams were used in the collection of demographic and environmental data. All technicians underwent thorough training on methods used to obtain reliable and complete data. Appointments were made for each environmental visit. In the event no one was home, the teams made at least three additional attempts to contact the resident on different days and times of day. The following information was obtained by interview during the visit: 1. Current address. 2. Names and ages of all children under six years of age residing at the residence. 3. Pregnant and/or nursing mothers. 4. Duration of residence at current address. 5. Prior address and duration of residency. 6. Type, age and condition of current housing. 5.2 Overview of Protocol for Residential Environmental Sample Collection The environmental survey was designed to sample the various media which might contribute to a child's lead exposure from a variety of non -household and household sources. The media sampled included household interior surface dust, exterior surface dust, and soil. Details of methods development and application in other metal exposure situations can be found in Que Hee et al., 1985; Clark et al., 1985; Bornschein et al., 1985; Bornschein et al., 1986; Bornschein et al., 1989, Butte -SBDOH and UCDEH, 1992, Leadville, 1992 and Bingham Creek, 1994. The principle variables of interest and their units are listed in Table 5.2.1. (Also see Appendix E - Environmental Sample Collection Protocol - for more detail). Figure 5.2.1 shows the type and location of samples collected at each residence. 14 Table 5.2.1: Key Variables Measured during the Aspen, CO. Study* Name - Type Units Residential interior surface dust lead Residential exterior surface dust at entry Soil lead - house perimeter House type (and condition) House Age Dust loading Social and Demographic Variables: Socio-economic status (Hollingshead 4 -factor) Child's age Age squared (quadratic term) Duration of residency Parental lead -related occupations Parental lead -related hobbies Frequency of child's mouthing behaviors Indoor/Outdoor activity distribution Outcome Variable: Blood lead Handdust lead Continuous Continuous Continuous Discrete Continuous Continuous Continuous Continuous Continuous Continuous Discrete Discrete Discrete Continuous Continuous Continuous µg/g or µglcm2 µg/g or µg/cm2 ILglg years mg/cm2 months months2 months hours µg/dl µg *These represent the major variables of concern. However, many other factors will be measured and can be found on data collection forms in Appendix C. 15 �Ja R U x x o o L � x ■ Lu (n a. ��� • :bo o Q • < '- x '�_ o co U co ■ �' • Bath 4-4 c CD w O fn o C x x c ° � LL �- U cz ................................................................................................................ �Ja R LL o o L � X cz Lu (n a. ��� • x Q • < co • i� CD MM� W CD /n 4-0 V� CD LL o o L � X cz Lu (n a. ��� • x 5.2.1 Hiring and Training of Environmental Technicians Two member teams were used for the collection of environmental samples and the interview of residents for the study. These technicians were University employees who had previous experiences in field -related activities such as this study. Training of this staff occurred the week prior to the start of the field study. All environmental technicians were uniformly trained in the collection of all types of environmental samples. Training occurred in each of the following areas. 1. Project orientation, field office organization, data recording, and safety issues. 2. Soil and exterior dust collection and exterior layout sketching. 3. Interior dust collection and floor plan drawing. 4. Hand dust collection. 5. Blood collection During sample collection, a typical survey required a team to collect both interior and exterior samples. During inclement weather, when it is not possible to collect exterior dust and soils samples, the teams collected interior samples. As weather conditions changed and it became possible to collect exterior samples, the teams made arrangements to collect exterior samples. Initial appointments to survey study homes were made from Cincinnati. Once on site, teams were provided with addresses, names, and all necessary sampling materials. All team members were provided with temporary staff identification badges. 5.2.2 Environmental Survey in Temporal Order of Events: Environmental surveys required 60 to 120 minutes to conduct. Surveys were carried out by a team in the following order: 1. Introduction and preliminary residential walk-through. 2. Interview of parent (Form 12) and child activities questionnaire. 3. Collection of blood from any eligible children or by request. 4. Sketch of interior floor plan and selection of sampling sites. S. Interior surface dust sample collected (one composite floor dust sample). b. Inspection and sketch of layout of exterior. 17 7. Collection of exterior soil cores and exterior dust samples (entry and street). 8. Collection of hand dust wipes. 9. Closing comments to family. 5.3 Overview of Protocols for Environmental Sample Collection 5.3.1 Interior Household Surface Dust interior surface dust was sampled using a small vacuum pump to obtain dust from measured areas (Que Hee et al, 1985). The lead content of the dust was expressed as both µgig (weight content) and tcg/m' (area content). The relative dustiness of the residence was expressed as weight of dust collected per unit area. A composite sample was obtained from three measured areas (625 sq. cm each) in the residence. These areas were meant to represent areas frequented by the children. The areas were: 1. A floor area directly inside of the main entry to the residence. 2. A floor area in the most frequently occupied room (usually living room or kitchen). 3. A floor area in the child's bedroom. Field duplicates were collected at 23 percent of the residences ( n=9). 5.3.2 Handwipe Sample Collection Collection of the hand -dust samples was done at the conclusion of each visit to a residence. Preliminary data indicate that hand dust equilibrates with a given environment within two hours. Therefore, the location and activities of the children immediately preceding the testing are important and were noted. The person collecting the hand -dust samples wore disposable gloves and cleaned his/her own hands with a disposable wipe from a separate container of wipes kept for this purpose before touching the gloves or other equipment. Once the gloves were put on, they were cleaned well, using additional clean wipes. For each residence, where one or more child's hands were sampled, a field blank was taken. This was done in the following manner. Six wipes were removed from the container, handled to simulate wiping a child's hands and then placed in a single bag and submitted for analysis. Dust on children's hands was sampled by wiping each hand of the child with three separate commercial Wet -Wipes. All surfaces of the hand, front and back, up to the wrists, were wiped 18 thoroughly with each of the three wipes. The wipes from each child were composited in a single sealable bag for transport to the laboratory. The total quantity of lead was reported in µg/pair of hands. The materials used to collect hand -dust were as follows: a commercially available wipe which contains a number of ingredients was used (Walgreen's Brand Wet -Wipes). A polypropylene, zip loc bag was used to contain the sample. Fisher Scientific Disposable Latex gloves are worn. 5.3.3 Exterior Surface Dust and Soil Two types of samples were obtained, representing different surface conditions. Soil cores of 2 cm depth were taken in grassy areas. A composite sample of soil cores were taken from grassy yards adjacent to a residence i.e. from the front, back and sides, with 8 to 12 samples per composite. Cores were taken at approximately equal spacings along the sides of the building, at a distance of one meter (3 feet) from the building wall. Small lot sizes and fences in some neighborhoods precluded taking building perimeter samples at a distance of one meter on some properties. Composite surface dust samples were taken with a vacuum apparatus on paved areas, and other hard surfaces near building entries, e.g., at front and rear entrance Field duplicates were collected at 23 percent of the sample sites. 5.3.4 Quality Assurance Plan for Environmental Samples Details of the quality control plan for environmental samples, including sample custody and specific routine procedures to assess data precision, accuracy and completeness are found in a separate document: "Blood Lead Surveillance and Exposure of Young Children to Elevated Soil Lead at the Smuggler Superfund Site, Aspen, CO. Quality Assurance Plan". As part of the quality assurance plan for this study, 23 percent of the homes surveyed were randomly selected for resurvey. One or more randomly selected homes were resurveyed each day during the environmental assessments. Upon completion of the routinely scheduled survey, the survey team at the preselected house undertook a complete resampling of the home. Since sampling teams were randomly assigned to survey homes, different teams conducted the resample each day. A comparison of data from initial versus repeat sampling at those homes yielded a measure of the reproducibility of the environmental data. 5.4 Environmental Sample Analyses The interior dust, exterior dust, soil and handwipe samples were fowarded to the Hematology and Environmental Laboratory at the University of Cincinnati for analysis. These samples were analyzed by atomic absorption spectroscopy (AA). Details for the analysis of these samples were found in "The Hematology and Environmental Laboratory's Quality Assurance Plan" which is available upon request. 5.41 Environmental Sample Analysis Reference Methods Environmental samples were analyzed by atomic absorption (AA) or (XRF). Method validation 19 includes cross checks with inductively coupled plasma emission spectroscopy (ICP) or AA. Unless otherwise noted, the methods were consistent with EPA Test Methods for Evaluating Solid Waste Vol. IA: Laboratory Manual, Physical/Chemical Methods. Method 3020 & 3050 Preparation of samples for total metal determination by graphite furnace AA (3020) direct aspiration AA (3050) or 1CP (3050). Method 5010 & 2000 Basic analytical methods for analysis by inductively coupled plasma atomic emission spectroscopy (6010) or atomic absorption (2000). Method 7420 & 7421 Lead analysis by direct aspiration (7420) or graphite furnace (7421). 5.4.2 Acid Digestion for Analysis by Atomic Absorption Weigh an aliquot of 100 mg sieved, dried soil or dust into a tared, acid -washed 100 ml beaker. Add 25 ml 7N HNO3, cover and digest gently at 95' degrees C for two hours, stirring occasionally. if excessive foaming occurs, remove from the heat periodically until foaming subsides. Maintain at least 25 ml in the beaker by adding 7 N HNO3 as necessary. Cool. Filter through a plastic funnel with Whatman No. 54 filter paper into a 100 ml beaker. Rinse filter and labware with IN HNO3 to effect a quantitative transfer. Place the covered samples on a hot plate and take down to dryness at 95°C. Add 3 ml of 1N HNO3 to redissolve arsenic. Gently heat on hot plate for 5-10 minutes. Cool. Pour the sample into 10 ml cylinder. Add 3 rinsings of the original sample beaker to the cylinder. Dilute to 10 ml volume. This portion of the sample was delivered to the Analytical Laboratory for GFAAS analysis. Samples were diluted with 1.0 M nitric acid to bring the sample concentration within the linear range of the instrument. After samples were analyzed, the lead concentration was calculated and the results reported in ppm. 5.5 Overview of Protocol for Blood Collection, Lead Analysis and Quality Control Whole blood samples was collected by a trained pediatric phlebotomist for the analysis of lead and hematocrit. For these analyses, a maximum of 2 ml of blood was obtained by using venipuncture blood collection techniques. One person was designated to oversee the collection and record keeping of these samples, make the necessary preparations for analyses, and be sample custodian. 20 5.5.1 Sample Collection Venipuncture samples were drawn using a 23 gauge butterfly apparatus attached to a 6 ml disposable syringe. Blood was immediately dispensed into a K3EDTA containing pediatric vacutainer tube by insertion of the needle through the top of the tube. The tube itself was then inverted several times to mix the anticoagulant. All blood sample collection equipment was prescreened for possible lead contamination. 5.5.2 Sample Analysis All samples were analyzed for lead in triplicate using anodic stripping voltommetry (ASV). Analyses were conducted at the University of Cincinnati using the method of Roda et al., 1988. Quality control samples prepared in the Cincinnati laboratory were included in all analytical runs. These samples consisted of human blood samples with lead content determined by isotope dilution -mass spectrometry, the definitive lead method. Samples whose duplicate lead values differed by more than 3 gg/dl were reanalyzed. This occurred in less than 2 percent of the samples. 5.5.3 Quality Assurance Plan for Blood Lead Analysis Details of the quality control plan for blood lead analysis including sample custody and specific routine procedures to assess data precision, accuracy and completeness can be found in the "Blood Lead Surveillance and Exposure of Young Children to Elevated Soil Lead at the Smuggler Superfund Site, Aspen, CO. Quality Assurance Plan and The Hematology and Environmental Quality Assurance Plan" which are available upon request. (Also see Appendix G - Overview of Blood Lead QC Plan - for more details.) 5.6 Overview of Protocol for Clinic Interviews Staff involved in interviewing parents were experienced interviewers who had undergone specific training with respect to the questions and information being sought for this study. Examples of information obtained during the interview include the following: 1. Parental occupation and education. 2. Recent major renovation at current or prior address (if during last twelve months). 3. Frequency of childhood habits such as mouthing behavior and pica. 21 4. Use of tailings or mine waste as fill material at any site on the residential lot. 5. Lead -related hobbies or occupations. 5. Time spent at day care centers or secondary residences. 7. Time spent at community playgrounds. Many other questions were asked and examples can be found in Appendix C. 5.7 Data Management Procedures Numerous procedures were utilized for insuring the validity of the collected data. Staff were trained in appropriate procedures for completing forms. One member of the research team completed the form, while a second member reviewed the form for errors. Forms used for this survey can be found in Appendix C. The forms were then forwarded to the data auditor who verified the legibility and completeness of the entries. Forms were then delivered to the data entry personnel. Data were be entered into Macintosh PC's for storage and preliminary analysis. Data was be entered and re -checked twice, each time by a different staff member. Computerized data files were pre-processed (checked) for certain types of data entry errors. A computer program was used to check the accuracy of identification information (subject identification number; data; child's age in months; etc.), presence of possible missed entries, and completeness of the file. The pre-processed data were then entered into the permanent (disk) data base and were concatenated with any data already resident to the data base. A range check was performed to locate serious entry errors. A printout of the newly entered data was then provided to each of the project personnel who initiated the paper forms. Reviews of the newly entered data for each form type was then performed, and any errors in the data residing in the permanent data base corrected. All changes to the permanent data base were thoroughly documented. Before major statistical analyses were performed on any of the data, univariate analyses of the frequency distributions was reviewed. These descriptive statistics provide valuable information for choosing the best variable specification (transformation of the observed frequency distribution, e.g. log, square root, etc.) for each variable in the data base. The techniques also aided in discovering possible spurious outliers or errors that were not identified by one of the previously mentioned data entry procedures. 22 5.8 Data Analysis 5.8.1 Descriptive Statistics The frequency distribution of blood lead and the environmental data was plotted for visual inspection. Frequency histograms revealed that the distributions of lead in blood and lead in environmental samples were distributed log -normally. Blood lead and environmental lead data were transformed to their natural log equivalent and estimates of the sample geometric mean and geometric standard deviation obtained. These distributions were compared to available national norms (Mahaffey et al., 1982); National Health and Nutrition Examination Survey III - expected summer, 1993; and The Centers for Disease Control Guidelines (Preventing Lead Poisoning in Young Children, 1991) and other surveys. Simple bivariate correlations among the exposure variables, covariates, confounders and dependent variables were then calculated. 5.8.2 Inferential Techniques The small sample size in both the 1996 and 1997 precluded rigorous hypotheses testing due to low statistical power. Therefore it was not possible to derive exposure pathway models or carry out even simple multiple regression analyses. Analyses were limited to simple t-tests and correlations. 5.9 Reporting of Results from the Blood Lead and Residential Environmental Survey Parents of the children tested were notified in writing of the blood lead results. Interior surface dust lead and exterior soil core lead concentrations were provided to families in summary reports prior to the public release of the final report. Forms used to report individual results to parents can be found in Appendix D. 23 III. Results and Discussion 6.0 Blood Lead Levels 6.1 Influence of Age There were a total of 14 children less than 84 months of age living in the Smuggler Trailer Court at the time of this study. All of these children from 10 families participated. In addition, 30 other families living in or near the trailer court participated in the environmental screening phase of this study. The average blood lead among the young children was 2.7 µg/dl (range = 1.5 to 5.9 ,ug/dl). Older siblings and adults had comparably low blood lead levels (see Table 6.1). A resurvey of these children in 1997 found that the average blood lead had fallen to 2.1 µg/dl (range = 1.3 to 2.9 µg/dl). Individual data for both 1996 and 1997 are reported in Appendix G. There was no significant age trend among children less than 84 months of age. 6.2 Impact of Altitude/Hematocrit on Blood Lead Many sites in this country, where children are exposed to waste from mining, milling and/or smelting activities, are located at high elevations in the western U.S. Aspen, CO at an elevation of 7,981 feet above sea level, is such a community. At these high elevations, the body responds to the lower oxygen concentration by producing more red blood cells in order to increase the ability of the blood to carry oxygen. This has consequences for the distribution of lead in the body, as well as for how we interpret the health consequences of a given level of lead in the body. About 95 percent of all lead in blood is bound to red blood cells. As the percentage of red blood cells in whole blood (hematocrit) increases, the number of binding sites for lead increases. Thus, the higher the hematocrit, the higher the blood lead concentration, even though the amount of lead bound to a single red blood cell remains the same. To illustrate the impact of this effect, assume two identical children, with identical lead exposures. One child lives at sea level with a hematocrit of 35 percent and a blood lead of 8.5 Mcg/dl, the other living in Aspen at 7,981 ft. would have a hematocrit of 42 percent and a blood lead of 10.2 µg/dl (20 % higher). Health scientists interpret a blood lead of 10 µgldl as being a level of concern based on numerous developmental studies carried out in communities at or near sea level, where children have hematocrits of about 35 %. We do not know if chronic blood lead levels of 10 ,ug/dl in children living at high elevation pose the same risk as that which has been studied at sea level. Conversely, children with chronic anemia have lower hematocrits (30-35 %) and might be at greater risk than would otherwise be inferred from a chronic blood lead level of 8 or 9 µg/dl. Physiologically based pharmacokinetic modeling might shed some light on this issue (see Appendix F). 6.3 Comparison with Previous Surveys It is informative to compare the 1996 and 1997 blood lead surveys with previous surveys conducted at this site, as well as with a recent national survey. The ATSDR conducted a comprehensive assessment in 1990. That survey of 28 children less than 6 years old found no children with blood lead levels above 10 jg/dl, while the group average was 2.6µg/dl. This low average blood lead level was unexpected given the high levels of lead in soil and exterior dust. 24 There were no recent national survey data available in 1990 and this value of 2.6 µg/dl was thought to be far below the national average. In 1992, the University of Cincinnati retested children from two families. Again the blood lead levels were quite low. No further systematic survey took place until 1996-97. The results of the earlier surveys and the current surveys are shown in Table 6.3. As can be seen, the average blood lead level remains low. In 1994, the results of a national survey were released (Pirkle et al. 1994). These results indicated that the children living in the Smuggler Trailer Court were in fact typical of young children participating in the NHANES III survey. 1 7.0 Environmental Lead Levels Environmental data collected during the 1996 survey are presented in Table 7.1. Two trends are apparent: (1) homes surrounded by soils with lead greater than 1000 ppm have higher levels of lead in entry dust and floor dust than other categories of soil lead and (2) soils and street dust lead y have higher concentrations of lead than exterior entry dust which is in turn higher than the interior floor dust. The floor dust lead loadings and exterior entry dust lead loadings are substantially lower than the proposed EPA/HUD standard of 50 µglft' or 540 µglm2. The highest observed floor dust lead loading was 367 µg/m' found in unit #3 in 1996. Street dust lead and entry dust lead loadings were also highest at this unit, 4784 and 202 µghn , respectively. The child residing in this unit was 29 months old and had the highest observed blood lead of 5.9 µg/dl. Despite the high soil lead and street dust lead levels, children's blood lead levels are low and stable over time, perhaps in part due to the very low levels of lead in floor dust. It should be noted that these mobile homes contain no lead paint and are well maintained. Table 7.2 illustrates the degree of association among various sources of lead in the environment and indicators of lead exposure, i.e., hand dust lead and blood lead. Correlation among environmental sources is high as was expected based on previous studies at similar sites. The environmental sources were not significantly associated with hand dust lead or blood lead. This is due to the small sample size and lack of statistical power. The correlations are positive and of a strength similar to that seen at other sites. It is likely that if more children lived at this site and participated in the survey it would have been possible to demonstrate that lead in soil and dust was having a small but measurable impact on children's blood lead level. Children living in homes with soil lead above 1000 ppm appear to have blood Ievels which average about 0.5 µg/dl higher than children exposed to less than 1000 ppm. 8.0 Hand Lead as an Exposure Indicator The hand dust lead data presented in Table 7.1 was surprisingly high given the low blood lead levels seen in the children. In 1996 six of 14 children tested had hand dust lead levels above 10 µg. There is no standard for hand dust lead. However, studies by the University of Cincinnati indicate that hand dust lead greater than 10 Ag/pair of hands is likely to be associated with a blood lead level above 10 µg/dl in young children. Table 8.1 shows average hand dust lead and blood lead levels and their correlation at sites investigated by the University of Cincinnati. In general, as average hand dust lead increases, average blood lead increases. However, the data from Aspen appear to be anomolous. Based on a group average hand dust level of 8.8 µg (Table 7. 1), average 25 blood lead levels would be expected to average 10-11 µgldl. Instead the average blood lead level in 1996 was 2.7 µgldl, a level which is usually associated with average hand dust lead levels of 2-3 µg. The correlation between hand dust lead and blood lead was also weaker than expected in 1996 (r=0.20). A review of records indicated that several children were sampled immediately prior to leaving home for preschool and several others were sampled immediately after returning home from preschool. This is not the normal protocol which calls for children to be sampled after remaining indoors for about one hour. The necessary deviation from protocol might have introduced a greater than normal amount of variability in hand dust lead, thereby reducing the association with blood lead. u These data clearly indicate that the children living in the Smuggler Trailer Court have come in contact with lead in dust and soil near their homes. However, this exposure is not resulting in the expected blood lead elevations, either due to a low hand-to-mouth activity or a dietary condition which is reducing lead absorption. In either case, there is no evidence that lead in soil and dust is causing elevation in blood lead levels which pose a health threat. 9.0 Comparison of `96 and `97 Lead Exposure Data Table 9.1 summarizes the change in exposure levels which were observed between the 1996 and 1997 surveys. This analysis is based on 13 children in 8 homes which participated in both surveys. Floor dust lead, hand lead and blood lead all declined in the second year of the survey. The hand dust and blood lead levels declined by about 25 percent, while floor dust lead concentrations (ppm) and loading (µg/m) declined by about 45 percent. The blood lead and dust lead concentrations declines were small but statistically significant. 26 Table 6.1 Blood Lead Levels (ug/dl) Smuggler Mountain Site (1996), Table 6.2 Hematocrit Levels (%) N Geometric Mean GSD Mininum Maximum less than 36 mo. 4 2.57 1.80 1.5 5.9 36 mo. - 84 mo. 10 2.80 1.35 1.5 4.3 less than 84 mo. 14 2.73 1.46 1.5 5.9 7 yr. - 18 yr. 2 2.24 1.12 2.1 2.4 greater than 18 yr. 2 2.57 1.79 1 1.7 1 3.9 Table 6.2 Hematocrit Levels (%) 27 N Artithmetic Mean S.D. Mininum Maximum less than 36 mo. 4 40.5 2.89 37 44 36 mo. - 84 mo. 10 42.3 2.45 39 46 less than 84 mo. 14 41.8 2.61 37 46 7 yr. - 18 yr. 2 41.5 0.71 41 42 greater than 18 yr. 2 49.5 0.71 49 50 27 Table 6.3 Comparison of Aspen Surveys with Recent National Blood Lead Survey Data (Pirkle et al. 1994) 'Pirkle, J.L., Brody, D.J., Gunter, E.W., Kramen, R.A., Paschal, D.C., Flegal, K.M., Matte, T. D. (1994). The decline in blood lead levels in the United States: The National Health and Nutrition Examination Surveys (NHANES). Journal of the Amer. Med. Assoc. 272:284=291. bresample of 3 children tested in 1990 and one child born since 1990 28 Average Blood Lead % Greater than 10 ,ug/dl NHANES III: 1-5 yr. olds (N = 2392)a 2.7 ggl dl 4.4% Aspen Surveys: 1990 (N = 28) 2.6 0 1992 (N = 4)a 3.3 0 1996 (N = 14) 2.7 0 1997 (N = 14) 2.1 0 'Pirkle, J.L., Brody, D.J., Gunter, E.W., Kramen, R.A., Paschal, D.C., Flegal, K.M., Matte, T. D. (1994). The decline in blood lead levels in the United States: The National Health and Nutrition Examination Surveys (NHANES). Journal of the Amer. Med. Assoc. 272:284=291. bresample of 3 children tested in 1990 and one child born since 1990 28 Table 6.4 1990 versus 1996-97 Aspen Blood Lead Survey acategories based on soil lead characterization obtained in earlier surveys and shown on Pitkin Co. GIS map dated 4/16/96. 29 Average % Greater than Blood Lead 10 ,u /dl 1990 ATSDR Study Soil Lead less than 500 ppm (N = 9) 3.6 0 Soil Lead 500-1000 ppm (N = 14) 2.4 0 Soil Lead greater than 1000 ppm (N =4) 3.9 0 1996 U.C. Study' Remediated Soils (N = 5) 2.5 0 Low Lead Soils (N = 4) 2.9 0 Partial Soil > 1000 ppm (N = 0) -- -- All Soil > 1000 ppm (N = 5) 3.3 0 1997 U.C. Study Remediated Soils (N=7) 2.0 0 Low Lead Soils (N=3) 1.9 0 Partial Soil >I 000 ppm (N=0) -- -- All Soil > 1000 ppm (N = 4) 1 2.5 1 0 acategories based on soil lead characterization obtained in earlier surveys and shown on Pitkin Co. GIS map dated 4/16/96. 29 Table 7.1 1996 Aspen Data Summary' Property Type' 'All values reported as geometric means 'Categories based on soil lead characterization obtained in earlier surveys and shown on Pitkin Co. GIS map dated 4116196. 30 All Partial Abated Low All Soil Lead Soil Lead Soils Soil Properties > 1000 > 1000 Lead Ppm PPm SamleT pe Units n=17 n=11 n=5 n=7 n=40 Foundation Soil 916 446 337 262 540 PPM Street Dust ppm 812 322 322 127 423 Street Dust Lead Loading �cglm2 599 252 273 106 320 Exter. Entry Dust Lead Conc. ppm 521 257 86 245 300 Exter. Entry Dust Lead Loading uglm2 227 62 59 132 120 Floor Dust Lead Conc. ppm 365 188 148 194 239 Floor Dust Lead Loading 4g/m2 153 74 69 63 91 Floor Dust Loading mg/m2 420 393 477 322 383 Hand Dust ,ig 11.7 --- 6.0 10.0 8.8 Blood Lead (N) 4gldl 3.03(5) --- 2.41 (5) 2.81 (4) 2.73 (14) 'All values reported as geometric means 'Categories based on soil lead characterization obtained in earlier surveys and shown on Pitkin Co. GIS map dated 4116196. 30 Table 7.2 Correlations Among Environmental Lead Sources and Indicators of Children's Lead Exposure (1996 Survey) *statistically significant (p C .05) 41997 survey r=.36; p=0.19 '1997 survey r=.41; p=0.13 31 Exterior Entry Dust Floor Dust (ppm) Hand Dust (ppm) Blood Lead (ug/dl) Foundation Soil —(PPM) .67* .58* -.10 .28 Street Dust .56* .50* .17 •37 Entry Dust - .61 * .35 .32 Floor Dust - - • 23 .42a Hand Dust - - - 20' *statistically significant (p C .05) 41997 survey r=.36; p=0.19 '1997 survey r=.41; p=0.13 31 Table 8.1 Comparison of Average Hand Lead and Blood Lead Levels of Children < 36 Months of Age at Different Sites eN=14; p=.46 ep=0.13 32 Hand Lead Blood lead Age Correlation Gig) ,u dl (months) r Sandy, Utah (1994) 2.3 3.2 18.5 0.08 Bingham Creek, Utah (1994) 2.7 1.5 20.9 0.23 Magna, Utah (1994) 3.1 4.2 16.5 0.47 Telluride, CO (1986) 3.3 6.8 22.0 0.43 Aspen, CO (1996) < 36 mo. (N=4) 4.7 2.6 24.1 .20" 36-84 mo (N=10) 11.2 2.8 66.2 Aspen, CO (1997) 36-95 mo (N=14) 5.4 2.1 69.8 0.41b Cincinnati Soil Lead Abatement Study (1989-1991) 5.7 10.0 19.4 0.41 Cincinnati Child Development Study (1982-1985) 6.4 11.0 13.8 0.56 Trail, B.C. (1992) 8.9 11.0 20.6 0.28 eN=14; p=.46 ep=0.13 32 TABLE 9.1 Comparison of `96 and `97 Aspen Exposure Data 'N=13 bN=8 `based on homes and children with two consecutive measures (N=8) 33 Geom. Mean Decline' Variable units 1996 1997 Aviz. %v value PbB (pg/dl)' 2.8 2.1 -0.7 25 .03 PbH (µg)a 7.1 5.4 -2.1 28 .59 PbD (ppm)b 160 115 -85 43 .04 PbD (µg/M2)b 61 43 -38 47 .12 'N=13 bN=8 `based on homes and children with two consecutive measures (N=8) 33 IV. Summary of Results and Conclusions 1) Blood lead screening reaffirmed the low blood lead levels previously reported for children at the Smuggler Mountain site (mean blood lead = 2.7 µgldl in 1996 and 2.1 µg/dl in 1997) . 2) Blood lead levels at the Smuggler site are comparable to levels obtained in a recent national survey (NHANES III) of 2400 children 3) 60 blood samples, collected between 1990 and 1997 yielded a maximum blood lead level of 8.4 ,ug/dl, i.e. none exceeded the CDC level of concern 4) 13 children sampled in both 1996 and 1997 revealed that the average blood lead levels are not only low, but stable within individuals (average decline _ -0.7 µg/dl) 5) 20 percent of 46 exterior dust samples contained lead greater than 1000 ppm and 20 percent of 40 floor dust samples contained lead greater than 500 ppm 6) 43 percent of children tested had unusually high levels (> 10 µg) of lead in dust recovered from their hands, indicating contact with lead from soil and dust 7) Homes with lower residential soil lead levels had lower levels of lead in exterior entry dust and interior dust 8) Although elevated environmental lead levels are present at this site and children are in contact with this lead, repeated screening of these children shows no impact of this exposure on blood lead levels of children at the site. 34 V. References Agency for Toxic Substances and Disease Registry (1988) . The Nature and Extent of Lead Poisoning in Children in the United States: A Report to Congress. U.S. Dept. Health and p Human Services. Doc. No. 99-2966. 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 Substances in Environ. Health. 11:322-332. Bornschein, R.L., Clark, C.S., Grote, J., Peace, B . , Roda, S . , and Succop, P., 1989. Soil Lead -Blood Lead Relationship in a Former Lead Mining Town. In: Proceedings of the Lead in Soil: Issues and Guidelines Monograph. Society of Geochemistry and Health. Bornschein, R., S. Clark, W. Pan, et al., 1990. Midvale community lead study. Final Report. University of Cincinnati, Department of Environmental Health, Cincinnati, OH. Bornschein, R.L., Clark, C.S., Pan, W. and Succop, P., 1991. Midvale community lead study. Soc. Geochem. Health Chem. Spec. Bioavail. 3:149-162. Bornschein, R.L., Clark, C.S. et al. 1992. Butte -Silver Bow Department of Health and University, Department of Environmental Health. The 1990 Butte -Silver Bow County Environmental Health Lead Study Final Report. Chaney, R.L., 1991. Soil lead chemistry in relation to bioavailability of lead in soil and dust. In: Proc. Symp. Bioavailability and Dietary Uptake of Lead. R. Cothem and R.W. Elias (eds.). Research Triangle Park, NC. Clark, C.S., Bornschein, R.L., Succop, P.A., Que Hee, S., Hammond, P.B., and Peace, B., 1985. Condition and type of housing as an indicator of potential environmental lead exposure and pediatric blood lead levels. Environ. Res. 38:46-53. Karam, H.S., Beck, B.D., Goodman, G., and Steele, M.J., 1993. The Value of Blood Lead Measurements in Children in Estimating Past, Present, and Future Exposures to Lead: Application to Risk Management Decisions at Superfund Sites. Society of Toxicology Annual Meeting, 1993. 35 Mahaffey, K. R., Annest, J. L., Roberts, J. and Murphy, R.S., 1982. National estimates of blood lead levels: United States 1976-1980 - New England J. Med. 307:573-579. Mushak, P. (1989) Biological monitoring of lead exposure in children: overview of selected biokinetic and toxicological issues. In Lead Exposure and Child Development. v. Smith, M.A., Grant, L.D. and Sors, A. I. (eds.) Kluwer Academic Publishers, Boston, p. 129-145. O'Flaherty, E., 1993. Physiologically -based models for bone seeking elements. IV. Kinetics of lead deposition in humans. Tox. Appl. Pharmacol. 118:16-29. Pirkle, J.L., Brody, D.J., Gunter, E.W., Kramer, R.A., Paschal, D.C., Flegal, K.M., Matte, T.D., 1994. The decline in blood lead levels in the United States. The National Health and Nutrition Examination Surveys (NHANES). J. Am. Med. Assoc. 272:284- 291. Preventing Lead Poisoning in Young Children - A statement by the Centers for Disease Control, 1991. U.S. Dept. Health and Human Services. Que Hee, S.S., Peace, B., Clark, C.S., Boyle, J.D., Bornschein, R.L., and Hammond, P.B., 1985. Evolution of efficient methods to sample lead sources such as housedust and handdust in the homes of children. Environ. Res. 38:77-97. Schroeder, S.R., Hawk, B., Otto, D.A., Mushak, P. and Hicks, R.E. (1985) Separating the effects of lead and social factors on I.Q. Environ. Res. 38:144-154. Smuggler Mountain TAC, 1993. Final Report. Smuggler Mountain Technical Advisory Committee, Aspen, CO. Succop, P. A., O'Flaherty, E.J., Bornschein, R. L., Clark, C. S., Krafft, K. M., Hammond, P. B. and Shukla, R. (1987) A kinetic model for estimating changes in concentration of lead in the blood of young children. In Lindberg, S.E. and Hutchinson, T.C. (Eds.) Proceedings of the International Conference: Heavy Metals in the Environment, New ' Orleans, Vol. 2, 289-291. APPENDIX A Biological Sample Collection Protocol Protocol for Blood Collection, Lead Analysis and Quality Control Whole blood samples will be collected by a trained pediatric phlebotomist for the analysis of lead and hematocrit. For these analyses, a maximum of 2 ml of blood is obtained by using venipuncture blood collection techniques. One person is designated to oversee the collection and record keeping of these samples, make the necessary preparations for analyses, and be sample custodian. Sample Collection Venipuncture samples will be drawn using a 23 gauge butterfly apparatus attached to a m 6 ml disposable syringe. Blood is immediately dispensed into a K3EDTA containing pediatric vacutainer tube by insertion of the needle through the top of the tube. The tube itself is then inverted several times to mix the anticoagulant. All blood sample collection equipment is prescreened for possible lead contamination. Sample Analysis All samples will be analyzed for lead in duplicate using anodic stripping voltommetry (ASV). Analyses will be conducted at the University of Cincinnati using the method of Roda et al. 1988. Quality control samples prepared in the Cincinnati Laboratory will be included in all analytical runs. These samples consist of human blood samples with a lead content determined by isotope dilution -mass spectrometry, the definitive lead method. Samples whose duplicate lead values differ by more than 3 [4g/dl will be reanalyzed. This is expected to occur in less than 2 percent of the samples. Quality Assurance Plan for Blood Lead Analysis Details of the quality plan for blood lead analysis including sample custody and specific routine procedures to assess data precision, accuracy and completeness will be found in the "Blood Lead Surveillance and Exposure of Young Children to Elevated Soil Lead at the Smuggler Superfund Site, Aspen, CO Quality Assurance Plan" and "The Hematology and Environmental Quality Assurance Plan" which are available upon request. (Also see Appendix I - Field and Laboratory Quality Control Results) Overview of Protocol for Interviews Staff involved in interviewing parents will be experienced interviewers who have ` undergone specific training with respect to the questions and information being sought for this study. n� Examples of information obtained during the interview include the following: 1. Parental occupational and education. 2. Recent major renovation at current or prior address (is during last twelve months) . 3. Frequency of childhood habits such as mouthing behavior and pica. 4. Use of tailings or mine waste as fill material at any site on the residential lot. 5. Lead -related hobbies of occupations. 6. Time spent at day care centers or secondary residences. 7. Time spent at community playgrounds. Many other questions will be asked and specific questions can be found in Appendix C. APPENDIX B Consent Form UNIVERSITY OF CINCINNATI CONSENT TO PARTICIPATE INv A RESEARCH STUDY Childhood Lead Exposure Study at the Smuggler Superfund Site, Aspen, CO. Institutional Study Number INVESTIGATOR INFORMATION: R bell L Bomschein, Ph.D. Principal Investigator Name INTRODUCTION Sponsor Study Number 51'558-0526 Telephone No. 241hr/dav-work, Before agreeing to participate in this study, it is important that the following explanation of the proposed procedures be read and understood. It describes the purpose, procedures, benefits, risks discomforts and precautions of the study. It also describes alternative procedures available and the right to withdraw from the study at any time. It is important to understand that no guarantee or assurance can be made as to the results. It is also understood that refusal to participate in this study will not influence standard treatment for the subject. I, have been asked to participate in the research study under the direction, of Sandy M. Roda and the supervision of Dr. R.L. Bomschein. Other professional persons who work with them as study staff may assist or act for them. I will be one of approximately 15 subjects to participate in this trial. PURPOSE: The purpose of this research study is to determine the amount of lead to which I and my family are exposed. This will require the measurement of lead in my blood or my child (children), . My home will be surveyed to determine levels of lead in soil, dust and water in and near my home. Dust wipe's from the hands of my child (children) will be taken and also analyzed for lead. DURATION: My participation in this study will last for approximately one year. PROCEDURES: I have been told that during the course of this study, the following will occur: A small amount of blood, about two teaspoons will be drawn in order to permit measurements of lead, hematocrit and blood count. I known that my child may cry for a moment when his/her finger or arm is pricked to obtain blood for the lead measurement. There tivill be collection of environmental samples from the inside and outside of my home. Such samples may include indoor dust, exterior dust, water, handwipe and paint. I understand that my child (children) will receive a small gift and I will receive a cash payment in the amount of $25 for participating in the project. EXCLUSION: Families living outside the designated study area are excluded from this study. RISKSIDISCOMFORTS: I have been told that the study described above may involve the following risks and/or discomforts and safeguard and or precautions to avoid them: The risk of simple venipuncture, (sticking needle into vein to draw blood) include: commonly, the occurrence of discomfort and/or bruise at the site of the puncture; and less commonly, fainting, the formation of a small blood clot or swelling of the vein and surrounding tissue, and bleeding from the puncture site. I have also been told that no risks are associated with the survey of my residence for lead sources. I will be participating in the protocol for approximately one year. If there is a significant variance from the stated time period, I will be notified. If I am a woman and I am or should become pregnant, there is no risk to me or my fetus by participating in the study. There also may be risks and discomforts which are not yet known. BENEFITS: I have been told that the benefits of participating in this study may be: Notification of blood lead levels as well as environmental lead results. Second, the health department will be notified if high levels are found so that appropriate actions can be taken. My family physician will also be notified if my child's blood lead level is greater than 10 Ag/di. ALTERNATIVES: There are no alternative procedures or course of treatment that might be available. - NEW FINDINGS: I have been told that I will receive any new information during the course of the study concerning significant treatment findings that may affect my willingness to continue my participation. CONFIDENTIALITY: Every effort will be made to maintain the confidentiality of my study records. The Aspen/Pitkin Environmental Health Department will be allowed to inspect sections of my medical and research records related to this study. The data from the study may be published; however, I will not be identified by name. My identity will remain confidential unless disclosure is required by law. FINANCIAL COSTS TO THE SUBJECT: Funds are not available to cover the costs of any ongoing medical care and I remain responsible for the cost of nonresearch related care. Tests, procedures or other costs incurred solely for purposes of research will not be my financial responsibility. If have questions about my medical bill relative to research participation, I may contact Dr. R.L. Borrmschein (513-558-0526) COMPENSATION IN CASE OF INJURY: The University of Cincinnati Medical Center follows a policy of making all decisions concerning compensation and medical treatment for injuries occurring during or caused by participation in biomedical or behavioral research on an individual basis. If I believe I have been injured as a M result of research, I will contact Dr. R.L. Bornschein (513-558-0526) or Mr. Gary Harris, Chairperson, U.C. Medical Center Institutional Review Board (513-558-5259). I have been told that in the EVENT OF INJURY resulting from the research procedures in which I am to participate, no form of compensation is available. Medical treatment may be provided at my own expense or my health care insurer (e.g., Medicare, Medicaid, Blue Cross/Blue Shield, etc.) which may or may not provide coverage. PAYMENTS TO PARTICIPANTS: INSTITUTIONAL STUDY NUMBER: SPONSOR STUDY NUMBER: If requested by the E.P.A. all environmental data collected at my home including my address may be reported to the appropriate E.P.A. representative. I HAVE READ THE INFORMATION PROVIDED ABOVE. I VOLUNTARILY AGREE TO PARTICIPATE IN THIS STUDY. AFTER IT IS SIGNED, I WILL RECEIVE A COPY OF THIS CONSENT FORM. Subject Signature Date CHECK BOX IF VERBAL ASSENT OBTAINED BY INVESTIGATOR Legal Representative Parent Date Signature of Person Obtaining Consent Date Signature of Investigator Date Witness Signature Date APPENDIX C Data Collection Forms I Dwelling ID Number FORM 01 -Housing Survey Street No. 1 Street Name ,1. Observations: 1 -Structure occupied by residents. 2 --Cannot find address. 3=No structure on lot. 4 --Structure is vacant. 5=Structure not a dwelling. 6=Under const'n. 7=Occup'd no pp. 8-Occup'd nt veri 2. What is the full name of the head of household at this - (dwelling)? Family name: First name: 3. What is the head of household's phone number? '4. Interviewee: What is your full name? - Family name: First name: 5. Interviewee: What is your phone number? -6. Relationship to head of household: El 1=Same, 2=Spouse, 3=Relative, 4=Other Specify: 8 7. How long has the family lived at this address? EER R=Refused, X=Unknown (--Yr M), Z=>999 M 48. Do you rent, own, or lease this (dwelling)? 1 --Own, 2=Rent, 3 --Lease, 4 -Other, 5=Owns home, not property, R=Refused, X=Unknown 9. Do you live here: 1=All year, 2=Seasonally, 0 3 --Occasionally, R=Refused, X=Unknown 10. Does the owner or manager live in this (building? house? mobile home park?) 1=owner, 2=Manager, 3=Neither, R=Refused, X=Unknown Apt No. 11. Please tell me the owner/manager's name? Family name: First name: 12. Please tell me the owner/ manager's phone number'? 13. How many children live here who are no more than 72 months of age (up to age six)? R=Refused, X=Unknown Bom on/after 1111188 14. How many children We here who are older than socE] and not older than 18 years of age. 15. Are there any pregnant women living here? 1=yes, 2=no, 3=possibly pregnant, 4=more than 1 R=refused, X=unknown. 16. Is there someone living here who is nursing a El baby? 1=yes, 2=no, R=refused, X=unknown, 4=more than 1 17. Are there any other children brought into this residence for babysitting on a regular basis? 1=yes, 2=no, R=refused, X=unknown. 18. Is there another family that lives here with you? El 19. Mailing address: P.O. Box 0 20. Mailing address: , Utah 84_ — 21. Year house was constructed: 22. Housing type: 1 mingle family, 2=multi family, 3=mobile home, 4 -double wide, 5 --business, 6=business/residence, 7=other 23. Forms completed: 1=01, 2=01 & 17, 3=01, 03, & 17 4--01, 02, 03, & 17, 5=01, 02, & 17 Call Record Date Day of week Time Response code and explanation Response codes: NA=no answer, H=retusea, c;=compierea, Crs=can bat;evi to apP., CSA=call back appt.(record appt. date/time), H=hazard to staff (dog,waming signs, hostility), B=phone busy, INT=need interpreter (specify language) Date of interview: ` - Interviewers: & rllesn - -- - -- FORM 03 -Family Questionaire Dwelling ID Number Family Name First Name Now I have a few questions to ask about each of the people In the household. m 1. How many adults, age 18 and older, and children, under 18 years, live here? Adults, Children, Children, less than 72 months, age 18 and older. between 6 and 18 years. bom on/after 1111/88. 2. Children up to 72 months, bom on or after 1111188: No. Last Name First Name Sex Q.O.B. Race Day/Preschool 1-Al.,ti. a Amarin�n i1-:ifkor ' bex: M or r mace. YY-YY111tC, n=na1n11, --v...wq .-. .�... ....._.._-.. _ _ Day Care/Preschool: Enter name of day care or preschool if child attends, otherwise enter N=No# Applicable 3. Pregnant womardwomen: Employment status: 1=employed full time, 2=employed part time, :s=unempioyea kiempurdr11Y1 4=unemployed homemaker, 5=full time student. 4. Nursing mothers: No. Last Name First Name D.O.B. 5. Older siblings, 6 to 18 years: No. Last Name First Name Sex D.O.B. 6. Other adults, 18 years and older. No. Last Name First Name Sex eye" Race I Emp. Sta. School Name Emp. Status Date of interview: Interviewers: & Use other side of form for notes Phase y„ P1Vr i..1■ 11 11 1\Ifi \/\/VI1 ■ a I a lVvry FORM 04 -Recruitment Tag Number Dwelling ID Number Family Name First Name Resident Phone Resident Address Apt.# Owner Phone Owner Address Owner Name Contact Phone Contact Name Children under six: # Children (under 6): # Preg. Women: # Nursing Mothers: Name Birthdate Potty Trained yes 1 no yes / no yes / no yes 1 no yes / no 1. Family planning to move within six months: Li 3. Permission from owner to collect exterior Li samples: y 1=yes, 2=no, 3 --unknown, 1=yes, 2=no, 3=unknown, 4=other (specify): 4=other (specify): ® 2. Caregiver's response to participation in 4. Caregiver's response to participation in blood environmental sampling: collection: 1=yes, 2=no, 3 --unknown, 1=yes, 2=no, 3=unknown, 4=other (specify): 4=other (specify): Call Record Date Day Time Response Date Day Time Response Environmental Schedule Record Date Day Ttme Response Date Day Time Response Response codes: C -completed, PC= partially completed; H=hazard to staff (dog, warning signs, hostility), LF=Left flyer, INT=need interpreter (specify language) Phase FORM 45 -Interior Dust Sample Collection .:a Tag Number Dwelling ID Number Family Name First Name Samples collected by Area(sgcm) CC: N Custody transfer. N Resident Phone Resident Address Apt.# Owner Phone Owner Address Owner Name j N N Sample log number - Di QC Sample log number N Field Blank log number N Appointment(s): DatedTime: DatetTime: DatelTme: N N N N N N Total area sampled " sq cm Date samples collected Surface Samples collected by Area(sgcm) CC: N Custody transfer. N From QC: N To NA Date I N Date/Time: Note: Area is calculated by muttiplying number or grids sampled by 625 sq cm. Subsample Locat'n Surface # Grids Area(sgcm) Child No 1. Entry N V2 N N NA 2. Most -01 ml I N j N N NA Bedroom 1 Bedroom 2 Bedroom 3 Location(room code): 1=Living'room, 2=Kitchen, 3=Dining room, 4=Entry hall, 5=9edroom, 6=Family room, 7=Other Surface choices: 1=Vinyl, 2 --Carpet, 3=Wood, 4 --Painted, 5 --Concrete, 6=Other Note: Most -utilized room is the room most -utilized by children <6 years of age. Project staff followed Protocol SL35C: Signed: Date: a Use reverseside for notes. Pre weight Post weight Net weight V1 N N N V2 N N N V3 I N j N N Location(room code): 1=Living'room, 2=Kitchen, 3=Dining room, 4=Entry hall, 5=9edroom, 6=Family room, 7=Other Surface choices: 1=Vinyl, 2 --Carpet, 3=Wood, 4 --Painted, 5 --Concrete, 6=Other Note: Most -utilized room is the room most -utilized by children <6 years of age. Project staff followed Protocol SL35C: Signed: Date: a Use reverseside for notes. Phase A01r-14 1 r 1 rUlr %-.Vut4 i i r-nv%JG- 1 Tag Number FORM 08 -Exterior Dust & Soil Sample Collection Exterior Dust Samples Appointment(-,): Street dust samples Date/Time: DateMme: DatelTime: Exterior entry dust samples Entry sample log number -Xi 0 C Sample log number N Distance - bldg to street feet Subsample number Entry -1 Entry -2 Entry -3 Entry location Texture Surface type Number of grids Texture Total number of grids Street surface type Number of grids Driveway surface type Total nun-tber of grids Entry location: 1=Front, 2=Lett siae, j=mignt slue, 4=11ear Surface type: 1 --Concrete, 2=Asphaft, 3=Brick, 4=Hardpack, 5=Gravel, s=Other, 7=No drive Texture: 1=Rougtvbroken, 2=Smooffilintact Sample location descriptions: Street sample log no. - Y1 Q C Sample log no. N Subsample number Street -1 Street -2 Sample location Surface type Texture Number of grids Total number of grids Street surface type Driveway surface type Location: 1=Intersection or onve ana -,trees 2=intersection of walk and street Exterior dust samples Date of collection Samples collected by Custody transfer From To Date Entry 1: Entry 2: Entry 3: Street 1: Street 2: Project staff followed protocol SL08C: Signed: Date: Phase Dwelling ID Number AW -CIM / t'l 1 MIN LruuV4 1 I i FORM 10 -Environmental Questionaire Family Name First Name Date of Interview: I Interviewer. I ��* =_: .1 - =1 1. Type of structurelbuilding (rate entire building): 1=Apartments below grade, 2=Apartments on grade, 3=Apartments above grade, 4=Single family, 5 --Single family with apartments, 6=Duplex, 7= Mobile home, 8=0ther(Specify): Questions'. 2. Lowest level of dwellingtapartmentlspace occupied ❑ by family: B=Below grade, 1=0n grade, 2=2nd story, 3 --3rd story, etc. 3. Is there commercial or industrial space in the building? 1=yes, 2=no, 3=unknown, R=refused 4. Is there a sandbox or play area for children on ❑ the property? 1=general play area, 2=none, 3=unknown, 4=sand box, 5 --play area & sand box 5. Do you have a flower garden at your residence? Uyes, 2=no, 3=unknown 6. Do you have a vegetable garden at your residence?❑ - 1=yes, 2=no, 3=unknown, 4=not yet, but plan to 7. Do you grow any fruit? 1=yes, 2=no, 3=unknown S. Do you grow food crops inside or in portable planters: Uinside, 2=in planters, 3 --both, 4=neither Tag Number 9. If inside or in planters, is the soil from: ❑ 1=your yard, 2=bagged soil, 3 -combination, N=not applicable, 4=Other(Specify): 10. Do you grow anything other than beans, ❑ carrots, lettuce, cabbage, or tomatoes? 1=yes, 2=no, N=not applicable. If yes, what? 11. Of the vegetables grown, which types have you found difficult to grow? 12. Do you use any old insecticides or herbicides ❑ containing arsenic? 1 --yes, 2=no, 3=unknown, N=not applicable If yes, list type and brand: 13. Has soil been hauled in and placed on ❑ your garden or yard? 1=yes, 2=no, 3=unknown, N=not applicable If yes, where did it come from: 14. Does your child play in the garden (e.g., while you are working in the garden)? 1=yes, 2=no, 3=unknown, 4 --no garden 1 S. How many days per year does your family spend away from the Aspen area? -Continue questions on page -2- APPENDIX D Report Forms Sent to Participating Families ASPEN/PITKIN COUNTY LEAD EXPOSURE STUDY RESULTS Family Name Family ID Number D., itho .if T.'nvirnnmant/rl .CmmnIP.0 C'nllortod at Your Hobe: LEAD* Environmental Community Community YOUR LEAD Sam le Type Units Lead Average Lead Range a RESULT Floor Dust g/m, 0.38 0.14-1.05 Loadinge Floor Dust Lead ppm 239 50-757 Concentration Floor Dust Lead µg/mz 91 11-410 Loading' Outside ppm 300 61-1385 Entry Dust Lead Concentration Outside Entry Dust ,ug/m2 120 4-1552 Lead Loading Street Dust Leadd ppm 423 106-5601 Concentration Street Dust ,ugW 320 44-4784 Lead Loading Soil Lead Concentration ppm 540 115-2199 * Summary of Aspen/Pitkin County Lead Study results from 40 homes. ppm = part per million = amount of lead per gram weight of samples a g/m2 = grams of dust per square meter area of dust collection µgW = micrograms of lead per square meter area of dust collection **** = not collected or not measured a 90% of the sample results fall within this range. b Weight of dust collected from one square meter (about one square yard) of floor area. ° Amount of lead detected in the same one square meter sample described above. Current Housing & Urban Development maximum acceptable level is 100 µg/ff(about 1000 µg/m). d Dust sample collected at the street curb in front of the house. 10, � N eC Oo x o ed z A o U U APPENDIX E Environmental Sample Collection Protocol I. ORGANIZATION Environmental samples will be collected by two -person teams. Interior dust, and administering the environmental questionnaire will be performed by an interior team; exterior dust and soil samples will be collected by an exterior team. Interior and exterior environmental sampling teams will visit single-family, detached residences concurrently. When adverse weather conditions or staff availability prevent a single visit, the exterior samples will be collected at a different time by the exterior team. In the case of a multi -family residence, the exterior samples may be collected at a different time from the interior samples. Interior and exterior environmental visits will be scheduled by a project staff person. Environmental visits will be scheduled at specified times based upon the availability of environmental teams and the convenience and availability of the study participants. A scheduling log book will be maintained by the staff person in charge of environmental scheduling. At the beginning of each day, the list of environmental visits scheduled during the day will be given to the staff person in charge of environmental team assignments. Preparation of collection forms and sample containers can then begin for the scheduled visits. Some flexibility should exist in the scheduling to accommodate unexpected changes in the plans of the study participants. Even though a telephone call will be made to remind each family of the scheduled visit, some families may find it impossible, due to unexpected circumstances, to keep that appointment. The environmental sampling teams will leave, with their assignments, from the project field office each day. Prior to lunch, dinner, and at the conclusion of the day, each team will return to the field office to error check collection forms and transfer custody of environmental samples to the Project Manager in charge of the field office. That Manager will retain custody of the samples until they are shipped to the appropriate lab for analysis. At that time, custody of the samples will be transferred to the analytical -lab personnel who will retain custody during analysis. For quality control, 10% of the residences will be re -sampled; duplicates of each type of sample will be collected at these households. Residences to be treated as QC visits are identified by random selection, prior to the scheduling of environmental visits. The monitoring teams will alternate in the collection of the quality control samples. II. TRAINING ENVIRONMENTAL TECHNICIANS Two -member teams will be used for the collection of environmental samples and the recruitment of families into the study. Environmental technicians will be uniformly trained in the collection of all types of environmental samples. The training will consist of demonstration, lecture, discussion, and field practice in the following areas: " 1. Project orientation, field office organization, data recording, and safety issues; 2. soil and exterior dust collection; 3. interior dust collection, completion of the environmental questionnaire, and floor plan drawing; and III. INTERIOR ENVIRONMENTAL VISITS Preparation for the interior environmental visit begins at the field office. The environmental team will be given a daily assignment at the beginning of each day. Once the assignment is received, the environmental team members will check the accuracy and completeness of the data on each environmental sample form. The Dwelling ID Number and other idents ing information should be identical on all the environmental forms: FORM 05, FORM 06, FORM 08, FORM 09, and FORM 10 (see Appendix D). After checking these items for accuracy, the environmental team will then calibrate the sampling pump. The sampling pump should be calibrated to a flow of 2.5 liters per minute. After the necessary calibration of equipment, the environmental monitoring team should then use a checklist (Attachments I and II) to make certain all equipment and supplies are packed and ready for use. At this point, the monitoring team is ready to go into the field. The interior monitoring visit begins with an introduction to the resident of all members of the environmental monitoring team or teams. All members should wear appropriate identification. If the residence to be monitored is a single family, detached residence, both the interior and exterior teams should be present. All members should be introduced to the residents along with a short explanation of the monitoring process (see Attachment III for script). After the introduction and the explanation, the exterior monitoring team will proceed to collect the exterior dust and soil samples. The interior monitoring visit can be divided into the following tasks: 1) Sketching a floor plan of the residence. 2) Collection of interior surface dust samples. 3) Administering the environmental questionnaire. 3 The most efficient way to accomplish these visits is to have one team member do the introduction and administer the environmental questionnaire while the other team member collects the dust samples, and sketches a floor pian. At the completion of the collection of the interior samples, a final discussion with the resident is appropriate. This discussion will include a "thank you" for participating in the project and allowing the collection of samples. If there is any reason to return at a later time, that should also be stated to the resident; and, if possible, an appointment should be scheduled. Reasons for return visits might include the need to collect a particular sample which was unavailable at the initial visit. I. INTERIOR SURFACE DUST The interior surface dust sample will consist of a composite of at least three sub -samples taken from the following areas in the residence: 1) An area adjacent to the main entrance. 2) A floor area in the room most -utilized by the subject child. 3) A floor area in the subject child's bedroom. Additional sub -samples may be added to the composite sample. These sub -samples will be taken from bedrooms occupied by additional subject children. The main entry sample is collected by placing the template on a carpeted surface immediately inside of the entry door. If carpeting is not present in this area, the most likely place to find an adequate surface dust loading would be the area immediately adjacent to the main entry door. The identification of sample sites from the most frequently occupied room and the child's bedroom will be determined partly by the floor covering present in those rooms. If the floor is carpeted, an adequate sample can readily be collected from almost any pathway in the room. A pathway might consist of an area immediately inside of a doorway into the room or an obvious pathway from one side of the room to the other. In rooms where there is no carpeting, the most likely place to find an adequate supply of surface dust would be an area immediately adjacent to a wall. Very often on floors with hard surfaces, dust will migrate to the edges; therefore, that is the most likely place to collect the dust. Interior surface dust is collected by using a personal monitoring pump connected by Nalgene tubing to a three-piece air monitoring cassette with a 0.8 micron poly cellulose acetate filter. A collection nozzle is connected to the air monitoring cassette by means of a short piece of Nalgene tubing. The collection nozzle is a piece of acrylic plastic tubing crimped on one end to form an opening of approximately 1.3 by 0.1 cm. To facilitate the collection of the interior dust sample, a template is used. The inside of the template measures 25 cm X 25 cm. 4 The dust sample is collected by placing the template on the identified sampling area. The pump is then turned on and a visual check is made to make certain that the flow rate is 2.5 liters per minute. The collection apparatus is held at about a 45 degree angle to the surface (floor) and moved from one side of the template area to the opposite. This sweeping motion in " the same direction is repeated until the entire area has been "vacuumed" with the collection attachment. The procedure is repeated in a direction 90 degrees from the initial direction. A third coverage of the area is then completed in the same direction as the initial coverage. The rate of movement from one side of the template to the other should be approximately 1.5 - 2 seconds per stroke. As each sub -sample is collected, its location should be indicated on the floor plan which was completed earlier. Care should be taken to note the total number of areas sampled. At the completion of the sample collection, the dust cassette will be removed from the collection device and the end plugs will be replaced. The dwelling ID number and the sample number should be written on the side of the cassette with permanent ink. The FORM 05 -Interior Dust Sampling -Residential work sheet should be completed at the time the dust sample is collected. As part of the QC program for the Aspen study, two additional interior dust samples will be collected at the 10% sample of QC residences. The two samples include a wet wipe and high volume sample (HVS) , co -located with the dust sample collected with the personal monitoring pump. The wet wipe sample will be collected according to the HUD Clearance Method (HCM). The HVS sample will collected in a 125 ml bottle attached to a high flow rate, teflon - coated cyclone, powered by a Dirt Devil vacuum. 2. HANDWIPE SAMPLE COLLECTION Collection of the hand -dust samples is done at the conclusion of each visit to a residence. Preliminary data indicate that hand dust equilibrates with a given environment within two hours. Therefore, the location and activities of the children immediately preceding the testing are important and should be noted. The person collecting the hand -dust samples must wear disposable gloves. The person collecting the hand -dust samples will clean his/her own hands with a disposable wipe from a separate container of wipes kept for this purpose before touching the gloves or other equipment. Once the gloves have been put on they also should be cleaned well using additional clean wipes. For each residence, where one or more child's hands may be sampled, a field blank is taken. This will be done in the following manner. Six wipes are removed from the container, handled to simulate wiping a child's hands and then placed in a single bag and submitted for analysis. Dust on children's hands is sampled by wiping each hand of the child with three separate 5 commercial Wet -Wipes. All surfaces of the hand, front and back, up to the wrists, are wiped a thoroughly with each of the three wipes. The wipes from each child are composited in a single sealable bag for transport to the laboratory. The total quantity of arsenic is reported in µg arsenic/pair of hands. The following materials are used to collect hand -dust: a commercially available wipe which contains a number of ingredients is used (Walgreen's Brand Wet -Wipes). A polypropylene, zip-loc bag is used to contain the sample. Fisher Scientific Disposable Latex gloves are worn. IV. EXTERIOR ENVIRONMENTAL VISITS As with interior environmental visits, preparation for the collection of the exterior dust and soil samples begins at the field office. The environmental team will be given an assignment for the morning or the entire day. Once the assignment is received, the environmental team members will check the accuracy and completeness of the information on the environmental sampling forms. After FORM 0$ -Exterior Sampling -Residential has been error checked, the checklist should be used to make certain all equipment and supplies are packed and ready for use. At this point, the monitoring team is ready to go into the field. The exterior monitoring visit to a single family detached residence will begin in the same manner as the interior monitoring visit. The team members should introduce themselves to the residents of the property and explain the nature of the environmental sampling. If the team goes out jointly with an interior monitoring team, then the introduction of both the exterior and the interior teams will take place at the same time. If the exterior monitoring takes place at a different time from the interior monitoring, then the monitoring team members should introduce themselves and explain the nature of the environmental sample collection. As part of this introduction, the environmental monitoring team should also thank the residents for participating in the study. For multi -family dwellings, no introduction is necessary unless there is an on-site manager for the apartment building or complex. In the case of multi -family dwellings, permission to obtain samples will have been obtained from the owner or manager prior to sending the environmental team to the apartment complex. This information should be conveyed to the on-site manager, if present. Two types of environmental samples will be collected from the exterior of residences by the exterior monitoring team. These environmental samples are soil and exterior dust. Either sample can be collected first, but it is probably more efficient for both team members to work on the collection of each type of sample. T Prior to the collection of any exterior environmental samples, a sketch will be made of the property and building. This sketch will include such things as the perimeter of the parcel, the location of sidewalks, the location of the house on the parcel, the location of active gardens, and the location of bare soil areas. The sketch of the house should be a diagram of the perimeter of the house, plus the location of entrance doors. The location of exterior dust samples and soil samples will be indicated on this sketch. 1. EXTERIOR DUST Two composite exterior dust samples will be collected, an entry sample and a street sample. The entry sample is a composite sample from two separate areas. The two entry subsamples will be collected from the front and side or rear entrances to the residence. In the case of apartment buildings, the samples will be collected from the two entrances most likely used by the study participants who live in that particular building. The street composite sample will consist of a subsample collected from the intersection of the driveway and the street curb and a subsample from the curb area closest to the sidewalk leading the front entry of the residence. If there is no sidewalk leading from the street to the front door, the curb area to be sampled should be the area immediately in front of the front entry to the residence; or alternatively, the curb area closest to the front door. The entry dust sample is collected by first selecting an area with the heaviest loading of dust nearest to the door. The area with the heaviest loading is most commonly the intersection of the first porch step and the sidewalk. Once the heaviest loading has been identified, the template will be placed over an area that includes that loading and the perimeter of the template will be drawn on the surface with the carpenter's chalk. The template is removed and the dust is loosened, if necessary, by means of the stiff bristled brush. Once the material is loosened, then it can be brushed into a pile within the defined area with the paint brush. This pile is then scooped up with the scoop and the paint brush and deposited in the appropriate sample bag. After the bulk of the material is collected in this fashion, the portable vacuum cleaner is used to vacuum the area defined by the chalk lines. The first step in using the vacuum is to place a piece of filter material in the collection cassette. After the filter is in the cassette and the hose is connected to the cassette, and the collection attachment is connected to the hose, then the vacuum can be turned on. The sample is collected by passing the collection nozzle across the designated surface area from one side to the other at the rate of 3 to 4 seconds for each pass along the long axis of the sample area. Repeated passes are made at the same rate until the entire area is vacuumed one time. A second collection is made of the same area in a direction 90 degrees to the initial direction. The rate of movement should be the same. A third collection is made in the same direction as the initial collection. 7 In some cases where there is an extremely high loading, it may be possible for the filter to 3 clog prior to the completion of the collection of the total sample. Visual checks of the filters should be made occasionally during the collection process and, if it appears that the filter is covered with dust, then it should be emptied. This is accomplished by removing the hose and the collection cassette from the vacuum cleaner and dumping the contents of the cassette into the sample bag without taking the cassette apart. Tapping on a hard surface will dislodge most of the material from the filter surface. This should also be dumped into the collection bag. Both sub -samples should be collected in this fashion. After they are collected, the hose is cleaned in the following manner. The vacuum cleaner is allowed to remain running and the hose is lifted into a completely vertical position above the vacuum. With the vacuum running, the operator taps the side of the hose with the paint brush. The hose is tapped from it's highest point to it's lowest point a total of three separate times. This process dislodges most of the dust from the sides of the hose. After this process, the filter cassette is dumped into the bag. The dust remaining in the collection device is brushed into the sample collection bag by means of the paint brush. The filter surface is also brushed into the collection bag. Additionally, the vacuum cleaner is taken apart and the interior of the top part of the vacuum is brushed with the paint brush into the bowl of the vacuum cleaner. The bowl is then brushed with the paint brush and any dust remaining in the bowl of the vacuum cleaner is brushed into the sample bag. Sufficient effort must be expended to collect and save as much of the dust from the vacuum cleaner and parts as is possible. Once the surface dust is brushed into the sample collection bag, the vacuum cleaner is cleaned by utilizing several wet wipes to wipe the interior of the vacuum cleaner bowl and the motor assembly. On a dry, sunny day, the dampness remaining from using the wet wipe should air dry rapidly. On a cool, sun -less day, the vacuum bowl may require drying with a paper towel. Removing the moisture from the vacuum cleaner will prevent dust from the next sample collection from adhering to the vacuum cleaner. The final step in the collection of the exterior dust sample is the final check of the data entered on the sample collection sheets, FORM 08 -Exterior Sampling -Residential. The monitoring team should make certain that all of the data has been entered onto the sheets. The vacuum and other equipment are then packed to be transported to the next sampling site. 2. SOIL COLLECTION Soil samples will be collected with a coring device. The device may be used in either of two ways. There is a "T" handle which can be attached to the top of the coring device which allows the operator to push the coring tool into the ground. The coring tool can be twisted as it is pushed into the ground to allow the cutting edge of the soil corer to cut through roots and packed earth. The other method of using the coring tool is to attach a hammer device to the top of the coring tool. To utilize the coring tool in this manner, the hammer device is first attached to the top of the coring tool and the tool is placed on the ground where the sample is to be collected. The hammer is then raised and allowed to fall while it is guided by the operator's hands. This method may be the most appropriate because of the compacted nature of some of the soils in the Butte area. At each residence occupied by a participating family, we will collect a composite soil sample from the four sides of the residence. Three sub -samples will be collected from each side where soil is present. The samples will be collected at a distance of three feet from the exterior wall of the residence. Spacing along a side may depend upon the position of sidewalks, vegetation, or other obstacles. If there is a sidewalk along an entire side of a M house, the sample will be collected along the edge of the sidewalk which allows for the least deviation from the designated three foot line. These perimeter samples are collected by driving or pushing the coring tool into the ground approximately 2 to 2 112 inches. The tool is then moved gently from side to side to Ioosen the plug of earth. The tool is then pulled from the ground and the soil sample is pushed by means of a pencil or finger so that the upper part of the soil plug lies between the 2 cm marks made on the coring device. The top 2 cm of the soil sample are then cut from the core by means of the spatula provided for that purpose. The top 2 cm are then transferred to a blue sample bag. All 12 sub -samples are collected in this manner. There are three additional types of samples to be collected from residential parcels. A composite sample should be collected from bare soil areas in a yard. In addition, a composite sample from all garden areas should also be collected. These composite samples are collected in the same manner. There should be a minimum of twelve sub -samples for a garden area or areas, and twelve sub -samples from any bare area or areas in a yard. For example, if there are two bare areas in a yard, then a minimum of six sub -samples should be collected from each bare area. If there are six bare areas in a yard, then twelve sub -samples should be collected, two from each bare area. The same procedure is to be followed for garden areas. The final type of soil sample collected will be the sand box or dirt play area sample, if present. If there is sand in the sand box, a grab sample can be taken. If there is no sand in the sand box or dirt play area, then twelve core samples will be taken. Bare -area and sand box samples will be placed in separate white sample bags. Garden samples will be placed in red sample bags. All sample bags will be labeled with the Dwelling ID Number using waterproof, permanent ink. E EQUIPMENT CHECKLIST FOR INTERIOR RESIDENTIAL VISITS PERMANENJ EQUIPMENT: Sample pump with tubing Stainless steel nozzle with tubing connector Plastic template Pens and pencils Clipboard Graph paper Flashlight Steel file Watch with second hand or digital readout PER VISIT HE Environmental sampling forms Dust cassettes Water sample bottles EQUIPMENT CHECKLIST FOR EXTERIOR RESIDENTIAL VISITS Clipboard Graph paper Pens and pencils Carpenter's crayon Template : b" x 24" Vacuum, hose, and nozzle Collection cassette and filters Scoop, paint brush, and brush Battery pack Rubber gloves Dust masks Wet wipes and paper towels Trash bag Soil probe Stainless steel spatula PER VISIT Ds Environmental sampling forms Bags for exterior dust and soil INTRODUCTION TO ENVIRONMENTAL VISIT 1. Hello Ms., Mrs., Mr. l I am and this is (etc.) 2. Thank you for agreeing to participate- in our Health Study. We are here to collect some environmental samples. and will collect some soil and dust samples from around the outside of your house. The soil samples will be small plugs about 1 " x 2". Is there anyplace we cannot collect soil or gardens where we should be especially careful? 3. and we would like to collect some dust samples and water samples from inside the house. In order to collect the water samples, we would like to first run the water for three minutes and then collect a sample. Thank you. 4. will begin the water test and then make a simple sketch of the house so that we can locate our samples. Is there anyplace we cannot go? 5. While is doing that, I would like to ask you some questions, would you mind? 6. Where does (do) 7. In what room does (do) sleep? spend the most time? 8. Which entrance to the house is used most often? 9. Administer the Environmental Questionnaire. 10. Explain urine sample collection and analysis for arsenic. f', APPENDIX F Influence of Altitude on Hematocrit, Blood Lead and Body Lead Burden Hematocrits, the percentage of red blood cells per deciliter of whole blood, can vary among individuals as a function of iron status (iron deficiency results in low hematocrits), age (younger children have 15-20% lower hematocrits than adults), physiological status (pregnant women have lower hematocrits than other adults) and elevation (hematocrits in children at high elevations, such as Aspen, Co., are about 15%-20% higher than children living at sea level). Since blood lead is usually reported in units of micrograms of lead per deciliter of whole blood and over ninety eight percent of the lead in whole blood is found in red blood cells, these changes in hematocrit can influence reported whole blood lead concentrations and distort comparisons with various reference groups. In order to facilitate comparisons between populations living at different elevations or different age groups, some adjustment should be made. One approach is to normalize all results to a common hematocrit e.g. 35% for children and 42% for adults. The effects of such an adjustment on blood lead concentrations can be seen in Table 1. An alternative approach involves including hematocrit as a covariate in any regression analysis involving blood lead. The latter approach has the advantage of providing a quantitative estimate of the effect size attributable to hematocrit, while at the same time providing improved precision in the parameter estimates relating environmental lead to blood lead. Of equal interest and cause for concern is the impact of variation in hematocrits on the validity of whole blood lead as a marker of lead burden. EPA's "health protective level" of 10 pg/dl is based on studies of child development which relate whole blood lead levels to developmental processes. The major longitudinal and cross-sectional studies, which form the basis for EPA and CDC health guidances, were all conducted on cohorts of children living near sea level with average hematocrits of 35%. The question arises as to whether 10 µgldl whole blood has the same meaning with respect to tissue lead concentrations and developmental outcomes at both sea level and at higher elevations. In an effort to gain some insight into this questions, a physiologically based pharmacokinetic model (O'Flaherty, 1993) was used to estimate the impact of a change in hematocrit and the overall size of the red blood cell pool and on the lead content of the major lead pools in the body. The model was run under two conditions, 35% and 42% hematocrits, with identical lead exposure inputs, i.e., these model runs were simulating two children with identical exposure histories but different size red blood cell pools. The results are shown in Table 2 (baseline exposure) and Table 3 (elevated exposure). The results of the modelling exercise support the hypothesis that hematocrit (altitude) can influence blood lead concentrations in the absence of a real difference in tissue lead concentrations or total body lead burden. For example, comparing two year olds with hematocrits of 35% versus 42%, the child with the higher hematocrit is predicted to have a blood lead level which is 20 percent higher while total body lead burdens, and more importantly soft tissue lead burdens are identical. Note that a two year old child exposed to elevated levels of lead in soil and dust sufficient to produce a blood lead of 8.2 µg/dl at sea level (hematocrit = 350/6) would have a blood lead of 9.9 µg/dl in Aspen (hematocrit = 42%). These results from a model simulation suggest that EPA's "health protective level" of 10 µg/dl is more conservative for populations living at altitudes significantly above sea level. Soil clean-up levels designed to prevent exceedences of the 10 pg/dl "health protection level" may be overly conservative. This issue needs further study. O O N M 000 tn v� q m en 00 to o i M o N to w �--� O n o 0 0 0 000 cn ,N-, r - op CZ C7 N N N N ^s q to to W [� O z to N M z N N to .,., 0 o 0 00 kn M 00 M G0 Table 2 PBPK Model Inputs Year 1 Year 2 Year 3 Food 15 µg/day 30 ,cg/day 15 ug/day Water 5 ppb 5 ppb 5 ppb Dust 40 ppm 40 ppm 40ppm Soil 40 ppm 40 ppm 40 ppm Air .5 µg/m' .5 Izg/m3 .5,u Total Intake (µg/day) (mg/yr) 20 7.26 26 9.53 26 9.49 PBPK Model Outputs Hematocrit (%) 35 42 Age (yrs.) 1 2 3 1 2 3 Blood (µg/dl) 3.2 2.8 2.5 3.8 3.4 3.0 Plasma (µg/dl) .026 .023 .020 .026 .023 .020 Soft Tissue (µg/dl) .026 .023 .020 .026 .023 .020 Bone (ppm) 2.5 2.0 1.8 2.5 2.0 1.8 Total Body Burden (mg) 1.2 1.4 1.5 1.2 1.4 1.5 Ref: E. O"Flaherty PBPK Model (See T.A.P.) Table 3 PBPK Model Estimates of the Impact of Change in Hematocrit, Brought About by Differing Altitudes, on Blood Lead Concentration, Tissue Lead Concentration and Total Body Lead Burden PBPK Model Inputs Vaar t Year 2 Year 3 Food 15 ug/day 30 ug/day 15 ug/day Water 5 ppb 5 ppb 5 ppb Dust 500 ppm 500 ppm 500 ppm Soil 500 ppm 500 ppm 500 ppm Air .5 ug/m' .5 ug/m' .5 ug/m' Total Intake (ug/day) (mg/yr.) 58 21.16 85 31.03 62 22.49 PBPK Model Outputs Hematocrit (%) 35 42 Age (yrs.) 1 2 3 1 2 3 Blood (ug/dl) 7.6 8.2 6.0 9.0 9.9 7.1 Plasma (ug/dl) .065 .071 .050 .065 .071 .050 Liver (ppm) .065 .071 .050 .065 .071 .050 Bone (ppm) 4.8 5.9 4.9 4.8 59 4.9 Total Body Burden (mg) 2.3 4.1 4.1 2.3 4.1 1 4.1 Ref: E. O"Flaherty PBPK Model (See T.A.P.) Children's (< 72 mo.) Hematocrit in Rocky Mountain Communities Altitude N Arithmetic S.D. Min. Max. Mean Leadville 10,300 317 40.8 2.61 32 49 Aspen 8,900 14 41.8 2.51 37 46 Telluride 7,800 94 40.1 2.22 35 45 Butte 203 38.5 2.52 30 51 Midvale 128 37.7 1.79 32 43 APPENDIX G Individual Data Listing for 1996 and 1997 N OO vO•s � oN U_ kf) a,wl r r U o a O n en oo 4n 00 00 — fel �o vi en UN 00 00 N • N O N N r V 00 N N m N e�+1 oro � V r en O «+ N 00 kll v _ Ur ~ M _ .r-1 b N M .M-� iF W) � h 00 H'I h �O M O G M 00 ON00 N 67 pp W11 N t+7 r 0000 VW1 N OMO O +► O cn 471 cil N oo + oo C4 en Cd C U_ O O r 00 N en r4 Q+ O vl N N v�'1 N en �p h C C Q u U o p M o+ M eo °.•! r V m C u oro 4. C N CC U V r b T `-' as W- ey r rn 06 N N G U. C Un � It p o m �, O N h to N�^� a v p cNri irl- kn O oo u rn Ok +rn It h N %0 Vt M v1 W1 N N •-• N 'd C c i EC6 E E E 00 CL ao d CA c IL u a U v tka zn w w u. w w x ca Q w x m Mj Q u°. rA APPENDIX H Project Investigators and Key Personnel Project Investigators and Key Personnel Dr. Bob Bornschein University of Cincinnati Dr. Paul Succop University of Cincinnati Ms. Sandy Roda Mr. Tom Dunlop Pitkin Co. Environmental Health Dept. Dr. Jerry Henningsen Region VIII Toxicologist, U.S. EPA Principal Investigator, responsible for overall scientific leadership and attainment of study goals. Co -Investigator responsible for data management, analysis and collaboration in data evaluation Site Manager responsible for recruitment, clinic operations and community relations and on site staff supervision. Also Director of Hematology and Environmental Analysis Laboratory, responsible for the analysis of all biological and environmental samples and analytical quality control Responsible for the overall liaison between the various entities involved in the study, and assistance in developing study plan and its final review, and development of any necessary post -study follow-up. EPA Project Toxicologist responsible for assisting in work plan development and review of final report. APPENDIX I Field and Laboratory Quality Control Results BLOOD LEAD SURVEILLANCE AND EXPOSURE OF YOUNG CHILDREN TO ELEVATED SOIL LEAD AT THE SMUGGLER SUPERFUND SITE; ASPEN, COLORADO (1997) FIELD AND LABORATORY QUALITY CONTROL RESULTS PREPARED BY: The University of Cincinnati PREPARED FOR: Pitkin County Environmental Health Department U.S. Environmental Protection Agency, Region VM ASPEN, COLORADO FIELD AND LABORATORY QUALITY CONTROL RESULTS The quality of sample collection and analysis can be monitored by evaluating specific quality control procedures implemented as .part of a project's sampling and analytical plans. In the Aspen, CO Surveillance and Exposure study various types of quality control measures were utilized to assess overall quality including the accuracy and precision of sampling and daily laboratory activities. The following report summarizes the results of the quality control data generated for the study samples. Specific protocols were followed for the collection of blood and employed techniques to ensure quality and avoid contamination of the sample. Blood collection equipment and supplies were stored and set up in a manner to keep them free from dust and contaminants. A thorough cleansing of the puncture site was employed to prepare the patient for sampling. Samples were Kept refrigerated until shipped at the end of the week of sampling to the University of Cincinnati Hematology & Environmental (H&E) Laboratory. The samples were immediately prepared for analysis upon arrival at the laboratory. Blood samples were analyzed for lead by Anodic Stripping Voltammetry (ASV). All samples were analyzed in triplicate. The Method Detection Limit for ASV in this laboratory is 1.0 ug/dl. A. BLOOD LEAD FIELD QUALITY CONTROL RESULTS Aliquots of 11 samples were analyzed by the Centers for Disease Control (CDC) after analysis by the University of Cincinnati H&E Laboratory. Individual results, the summary statistics, and regression analysis for these samples are listed in Table 1. One of the samples was actually a field control and the result was not included in the statistics for the study samples. Blood samples supplied by CDC were disguised as study samples, intermixed with the children's samples before shipment, and analyzed by the laboratory blinded as to their true identity. The CDC target lead concentration of these samples was 4.3 ug/dI. The analyzed concentrations were 3.6, 4.1, 5.6, 4.9, and 5.1 ug/dl. Table 2 presents the summary statitics for these results. A second vacutainer of blood was collected from 8 study participants and sent to the H&E Laboratory as a blind duplicate. The individual results and descriptive statistics for the differences between the duplicate sample analysis are shown in Table 3. B. BLOOD LEAD LABORATORY QUALITY CONTROL RESULTS _ In the laboratory, different blood samples whose lead values were previously determined by IDMS, were incorporated into the sample stream of study samples. The purpose of these samples is to determine the accuracy of the analytical method, ASV, relative to IDMS and to assess the precision of the method. The presence of the samples in the analytical run was known to the technician. Results were entered onto control charts which demonstrated that acceptable performance was achieved. The participant blood samples were analyzed over a six day period (1018196 - 10114196) and in three ..� different analytical runs. ■:\#_WW' Handwipe samples were obtained at two different time points from all children in the survey and shipped back to Cincinnati for analysis. Three wipes are taken from each hand of the child and combined as one sample. The samples are digested and analyzed by flame -atomic absorption spectroscopy (FAAS). Field blanks are collected at each of the residences and serve to demonstrate the possibility of contamination on field sample collection. Due to the number of wipes per sample, laboratory blanks determine the amount of lead actually present in wipe material and thus are subtracted from the total lead found in each sample following analysis. a� There were 21 field blanks collected and analyzed. The average of the blanks was 1.31 ug of lead + 0.5991. One field control fell outside of the three standard deviation limits of acceptability indicating possible contamination of field samples in that residence at this time (T -0121 -0000 -1 -H1 -C1 & B 1). All laboratory reagent blanks were <1 ug and for four analytical sets method blanks were 4.3, 3.2, 3.2, & 3.2 ug. Field controls were also inserted into samples prior to their shipment to Cincinnati (Table 4). Soil, Exterior dust, Interior dust, and Street dust samples were collected and then ' shipped to the University of Cincinnati Hematology & Environmental Labs for analysis. Soil, Exterior and Street dust samples were dried and served to a particle size of 250 .. TABLE DUPLICATE SAMPLES ANALYZED BY UC AND CDC UC CDC (ug/dl) (ug/dl) 1) 2.8 3.4 2) 2.8 2.4 3) 2.3 2.9 4) 3.9 3.4 5) <1.0 2.2 6) 1.9 1.7 7) 3.2 2.4 8) 4.8 5.0 9) 5.6 4.6 10) 5.1 4.9 (QC=9.5) 8.7 N 10 10 Mean 3.34 ug/dl 3.29 ug/dl S.D. 1.49 1.19 Median 3.0 3.2 Minimum <1.0 1.7 Maximum 5.6 5.0 Mean Difference 0.57 ug/dl Slope 1.113 y -intercept -0.322 Correlation 0.8897 TABLE 2 UC PERFORMANCE ON BLOOD LEAD AUDIT FIELD CONTROLS CDC Assigned Concentration 4.3 u gld 1 N 5 Mean 4.66 ug/dl S.D. 0.80 % C.V. 17% Median 4.9 Minimum 3.6 Maximum 5.6 TABLE 3 BLOOD LEAD FIELD DUPLICATES TABLE 4 UC PERFORMANCE ON ENVIRONMENTAL FIELD CONTROLS SOIL and EXTERIOR INTERIOR DUST HANDWIPE DUST % Recovery % Recovery % Recovery 104 93 122 98 92 117 103 89 117 102 91 114 106 86 106 101 83 106 105 112 98 114 106 119 109 96 101 N 13 6 8 Mean 104% 89% 114% S.D. 6 4 6 TABLE 5 LABORATORY INTERNAL QUALITY CONTROL RESULTS SOIL and EXTERIOR INTERIOR DUST HANDWIPE DUST NIST % Recovery NIST % Recovery 20 ug % Recovery 2710 90 2710 91 98 90 90 100 94 91 98 91 94 98 93 2711 94 97 92 96 96 2711 95 96 99 91 97 97 97 2704 87 91 91 92 1648 97 93 98 N 12 12 8 Mean 92% 94% 98% S.D. 2 3 1 TABLE 6 CO -LOCATED ENVIRONMENTAL SAMPLE RESULTS SAMPLE -i SAMPLE -Z SOIL (ppm) 819 1040 42 41 105 78 EXTERIOR ENTRY 131 144 DUST (ppm) 245 270 110 101 1591 1921 1853 1538 187 162 EXTERIOR STREET 556 660 DUST (ppm) 250 80 88 9 813 1059 715 696 INTERIOR DUST 479 476 (ppm) 21 53 342 314 491 271 630 669 292 256