March  10,  1977
                                     WORK PLAN
            EPIDEMIOLOGIC STUDY CONDUCTED IN POPULATIONS LIVING AROUND
              NONFERROUS SMELTERS TO DETERMINE BODY TISSUE BURDENS OF
                            SELECTED NONFERROUS METALS
                            EPA Contract No. 68-02-2442

                             RTI Project No. 31U-1372
                         Chemistry and Life Sciences Group
                                        and
                            Statistical Sciences Group
                            Research Triangle Institute
                               Post Office Box 12194
                       Research Triangle Park, N. C,  27709
                                   Prepared for
                          Enviroamemtai Protection Agency
                       Resaarc.lt Triangle Park, M, C.  27711
RESEARCH  T  R t  A H © L e  PARK,  NORTH-  CAROLINA  27709

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                           TABLE OF CONTENTS
LIST OF TABLES	       vi

LIST OF FIGURES	       vii

1.0  Survey Design	       1-1

     1.1  Sampling Personnel	       1-1
     1.2  Overview	       1-2
     1.3  Target Population 	       1-5
     1.4  The Sampling Frame	       1-10
     1.5  Sample Selection Techniques 	       1-13

          1.5.1  Survey Participants	       1-13
          1.5.2  Air Sampling	       1-14
          1.5.3  Sampling for Soil Contamination	       1-14
          1.5.4  Sampling Tap Water	       1-15
          1.5.5  Quality Control	       1-16

     1.6  Sample Sizes and Sampling Error 	       1-17

          1.6.1  Allocation of the Sample of Individuals.  .  .  .       1-17
          1.6.2  High-Volume Air Samples	       1-18

     Appendix 1.1:  Characteristics of Survey Sites 	       1-23
     Appendix 1.2:  Sample Sizes and Allocation For Air Sampling     1-42
     Appendix 1.3:  Wind Roses for Smelter Sites	       1-46
     Appendix 1.4:  Resumes of RTI Project Staff	       1-53
     Appendix 1.5:  References	       1-59

2.0  Field Operations 	       2-1

     2.1  On-Site Project Operations (At RTI)	       2-1

          2.1.1  Project Staff	       2-1
                 2.1.1.1  Overall Supervision 	       2-1
                 2.1.1.2  Survey Director 	       2-1
                 2.1.1.3  Site Administrator(s) 	       2-4
                 2.1.1.4  Data Receipt Control, Scan-Edit,
                          and Direct Entry	       2-4
                 2.1.1.5  Training Manual 	       2-5
                 2.1.1.6  Training Session(s) 	       2-5
          2.1.2  Data Receipt Control and Entry	       2-7
                 2.1.2.1  Receipt Control 	       2-7
                 2.1.2.2  Visual Scan-Edit	       2-7
                 2.1.2.3  Direct Data Entry 	       2-8
                 2.1.2.4  Quality Control 	       2-8
                                   ii                            3-10-77

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               - TABLE OF CONTENTS (Continued)
     2.1.3  Confidentiality of Project Data	
     2.1.4  Protection of Human Subjects Certification .  .

2.2  Off-Site Project Operations (At Smelter Locations).  .       2-14

  •   2.2.1  Performance Sites	       2-14
            2.2.1.1  Selection 	       2-14
            2.2.1.2  Public Relations	       2-14
            2.2.1.3  News Releases	       2-16
     2.2.2  Independent Subcontractors 	       2-17
            2.2.2.1  Recruitment 	       2-17
            2.2.2.2  Training	       2-24
            2.2.2.3  On-Site Consultants 	       2-25
     2.2.3  Household Data Collection	       2-26
            2.2.3.1  Screening 	       2-26
            2.2.3.2  Participant Consent Form	       2-27
            2.2.3.3  Study Questionnaire 	       2-29
            2.2.3.4  Sample Collection 	       2-30
            2.2.3.5  Quality Control 	       2-32
     2.2.4  Central Data Collection	       2-33
     2.2.5  Site Administrator's Responsibilities	       2-34
            2.2.5.1  Coordination of Field Operations;
                     Data Management	       2-34
            2.2.5.2  Sample Collection 	       2-35
            2.2.5.3  Data Storage, Packaging and Shipment.       2-35
     2.2.6  Quality Control	       2-37
            2.2.6.1  Training	       2-37
            2.2.6.2  Supervision 	       2-37
            2.2.6.3  Sample Collection 	       2-38
            2.2.6.4  Duplicate Sample Collection 	       2-39
            2.2.6.5  Reinterview	       2-39
     2.2.7  Respondent/Participant Burden	       2-40

2.3  Anticipated Problems	       2-41

     2.3.1  Smelter Resistance 	       2-41
     2.3.2  Recruiting Independent Subcontractors	       2-41
     2.3.3  Nonparticipants	       2-41
     2.3.4  Incomplete Data Sets	       2-42
     2.3.5  Missing Data	       2-42

2.4  Schedules for Field Operations	       2-43

     2.4.1  Time Schedule	       2-43
     2.4.2  Cost Schedule	       2-46

Appendix 2.1:  Resumes of RTI Project Staff and
               Consultants	       2-48
Appendix 2.2:  Tentative Training Manual Outline 	       2-76
Appendix 2.3:  Survey Instruments	       2-84
                              iii                             3-10-77

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                   TABLE OF CONTENTS (Continued)
     Appendix 2.4:  Pretest Considerations	       2-99
     Appendix 2.5:  Relevant Correspondence 	       2-105
     Appendix 2.6:  Sample Collection Methodology 	       2-109
     Appendix 2.7:  References	       2-132

3.0  Physical Methods of Analysis 	       3-1

     3.1  Atomic Absorption Analysis  	       3-1

          3.1.1  Biological Samples	       3-2
                 3.1.1.1  Blood 	       3-2
                 3.1.1.2  Urine 	       3-2
                 3.1.1.3  Scalp Hair	       3-2
          3.1.2  Environmental Samples	       3-3
                 3.1.2.1  Tap Water	       3-3
                 3.1.2.2  Dust	       3-3
                 3.1.2.3  Air Particulates	       3-3
                 3.1.2.4  Soil	       3-4
          3.1.3  Arsenic Analysis 	       3-4
          3.1.4  Market Basket Samples  	       3-5

     3.2  Spark Source Mass Spectrometric Analysis  	       3-5
     3.3  Free Erythrocyte Protoporphyrin (FEP)  Analysis   .  .  .       3-5
     3.4  Quality Control and Analytical Protocol 	       3-6

          3.4.1  Instrumentation	       3-6
          3.4.2  Limits of Detection	       3-7
          3.4.3  Routine Analytical Protocol	       3-7
          3.4.4  Analytical Priorities  	       3-8
          3.4.5  Quality Control Procedures 	       3-8
                 3.4.5.1  Instrument Performance	       3-8
                 3.4.5.2  Accuracy and Precision	       3-9
                 3.4.5.3  Inter laboratory Comparison	       3-10
          3.4.6  Calibration of High Volume Air  Samplers.  .  .  .       3-10

     3.5  Determination of Total Particulate Solids in Air.  .  .       3-10
     3.6  Personnel	       3-12
     3.7  References	       3-12

     Appendix 3.1:  Analytical Data Sheets	       3-13
     Appendix 3.2:  Resumes of RTI Project Staff	       3-27

4.0  Statistical Methods of Analysis	       4-1

     4.1  Confidentiality of Data Files	       4-1
     4.2  Data Analysis	       4-2

          4.2.1  Analysis of Environmental Levels 	       4-2
          4.2.2  Analysis of Tissue Levels	       4-3
                                iv                               3-10-77

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                TABLE OF CONTENTS (Continued)
                                                                Page
                                    i

4.3  Potential Problems	      4-5

     4.3.1  Missing Observations 	      4-5
     4.3.2  Trace Metal Intake Due to Diet	      4-8

4.4  Personnel	      4-9

Appendix 4.1:  Resumes of RTI Project Staff	      4-10
Appendix 4.2:  References	      4-17

5.0  Cost and Labor Projection	      5-1
                                                             3-10-77

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                          LIST OF TABLES

Table                                                            Page

1.1.      Tentative sample allocation for individuals at
          the study sites	     1-19

1.2.      Tentative sample allocation for air samples. . . .     1-21

1.1.1.    Selected population characteristics of survey sites    1-24

1.1.2.    Population residing in the tentative study area
          near Ajo, Arizona	     1-27

1.1.3.    Population residing in the tentative study area
          near Anaconda, Montana 	     1-29

1.1.4.    Population residing in the tentative study area
          near Bartlesville, Oklahoma	     1-31

1.1.5.    Population residing in the tentative study area
          near Bixby, Missouri	     1-33

1.1.6.    Population by stratum residing in the study area
          near Corpus Christi, Texas	     1-35

1.1.7.    Population residing in the tentative study area
          near Herculaneum, Missouri 	     1-37

1.1.8.    Population residing in the tentative study area
          near Palmerton, Pennsylvania 	     1-39

A-l.2.1.  Lead content of air, yg/cu m	     1-43

A-l.2.2.  Random assignment of days for high volume air
          samples:  an example	     1-45

A-2.6.1.  Tentative sample allocation for air samples. . . .     2-114

A-2.6.2.  Exemplary format for presenting survey and labora-
          tory results for study element:  lead	     2-116
                                vi                               3-10-77

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                          LIST OF FIGURES

Figure                                                           Page

1.1.      Preliminary distance-stratification for a target
          population based upon Zn and Cd content of topsoil
          according to Miesch and Huffman in East Helena,
          Montana	   1-9

1.1.1.    Geographic location of study smelter and tentative
          delineation of the study population, Ajo 	   1-28

1.1.2.    Geographic location of study smelter and tentative
          delineation of the study population, Anaconda. .  . .   1-30

1.1.3.    Geographic location of study smelter and tentative
          delineation of the study population, Bartlesville. .   1-32

1.1.4.    Geographic location of study smelter and tentative
          delineation of the study population, Bixby 	   1-34

1.1.5.    Geographic location of study smelter and tentative
          delineation of the study population, Corpus Christi.   1-36

1.1.6.    Geographic location of study smelter and tentative
          delineation of the study population, Herculaneum . .   1-38

1.1.7.    Geographic location of study smelter and tentative
          delineation of the study population, Palmerton .  . .   1-41

2.1.      Research Triangle Institute administrative structure   2-2

2.2.      Project administrative structure 	   2-3

2.3.      Location and number of interviewers from the current
          RTI listing living in counties within a reasonable
          distance of the Ajo, Arizona, performance site .  . .   2-19

2.4.      Location and number of interviewers from the current
          RTI listing living in counties within a reasonable
          distance of the Bixby and Herculaneum, Missouri,
          performance sites.	    2-20

2.5.      Location and number of interviewers from the current
          RTI listing living in counties within a reasonable
          distance of the Anaconda, Montana,  performance site.   2-21
                                vii                              3-10-77

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                    LIST OF FIGURES (Continued)

Figure                                                           Page

2.6.      Location and number of interviewers from the
          current RTI listing living in counties within a
          reasonable distance of the Bartlesville, Oklahoma,
          performance site	    2-22

2.7.      Location and number of interviewers from the
          current RTI listing living in counties within a
          reasonable distance of the Palmerton, Pennsyl-
          vania, performance site	    2-23

2.8.      Field operations time table 	    2-44

2.9.      Field operations cost and labor projections ....    2-47

A-2.4.1.  Location and number of interviewers from the
          current RTI listing living in counties within
          a reasonable distance of the Corpus Christi, Texas
          potential Pretest site	    2-102

A-2.4.2   Location and number of interviewers from the
          current RTI listing living in counties within
          a reasonable distance of the Hayden, Arizona,
          potential Pretest site	    2-103

A-2.6.1.  Geographic and temporal placement of high-volume
          air samples:  a partial hypothetical example
          depicting only the first two days of the survey .  .    2-115

3.1.      Calibration of Sierra Instrument Orifice, Model 330    3-11

5.1.      Sampling design cost and labor-hour projections .  .    5-2

5.2.      Field operations cost and labor-hour projections.  .    5-3

5.3.      Field supervision and shipping costs and labor-hour
          projections	    5-4

5.4.      Chemical analysis cost and labor-hour projections  .    5-5

5.5.      Statistical analysis cost and labor-hour projections   5-6

5.6.      Projected monthly costs by activity 	    5-7
                               viii                              3-10-77

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1.0  Survey Design




1.1  Sampling Personnel




     Professional staff in the Sampling Research and Design Center




(SRDC) have a broad range of experience in sampling theory and statistical




applications, including unequal probability sampling methods and theory,




response error modeling, optimization procedures, controlled selection




procedures, variance estimation for complex surveys, data analysis, ran-




domized response techniques, and other areas.  Dr. James R. Chromy is




Center Director and will have general supervision of sampling in this




study, especially for those tasks involving probability sampling tech-




niques.




     The selection of the study participants and the survey design for




air sampling will be under the direct supervision of Mr. Stephen R.




Williams, Senior Statistician in SRDC.  Mr. Williams, assisted by Mr.




Lanny Piper, Statistician in SRDC, will be responsible for on-site de-




lineation of the target population, its stratification, and the accumula-




tion of pertinent extant information about the study communities.  Addi-




tional support will be provided by SRDC research assistants and other




support staff, who have extensive experience in the preparation of sampling




materials and in the selection of probability samples.  These and other




related tasks will be completed by SRDC staff in close coordination with




the Chemistry and Life Sciences Group and the other Research Triangle




Institute (RTI) centers that are involved in this study.  Resumes of




the professional sampling personnel that will be substantively involved




in the study are presented in appendix 1.4.
                              1-1                                3-10-77

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1.2  Overview




     Sampling methodology to be used for obtaining a sample of the




household population is a stratified area sample in which a sequential




sample of persons is to be selected for participation in the study




survey.  An area sample is commonly used in population surveys that




must result in a high degree of accuracy.  This is because no complete,




current listing is readily available from which to sample the target




population; the area frame comprises a complete "listing" of this




population.  Also, a probability sample of sites and days is to be




selected for the purpose of obtaining high-volume air samples.  Selective




sampling may necessarily be used to collect samples of tap water, house




dust, and soil if probability sampling for these data is deemed




impractical; several random-sample methodologies are being investigated




at the Pretest site.




     Note that the specific methods proposed for measuring environment-




related factors differ somewhat among the various types of data being




sought.  These differences reflect several considerations, such as the




extent to which surrogate variables reflect the factors of interest,




the quality control of data collection, and the suitability and cost of




data collecting techniques under actual survey conditions.  However, the




planned methodology stresses probability sampling techniques wherever




possible in order to facilitate valid statistical analyses and to




increase the degree of control over data collection.  Field enumerators




will follow explicit, nonjudgmental procedures throughout.  These




procedures will range, as outlined in the following sections, from




obtaining small, possibly selective samples of relatively homogeneous




factors, such as tap water at a particular residence or school, to




obtaining large stratified random samples from a highly variable item,




                               1-2                                  3-10-77

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such as air quality in a smelter community.




     Specifically, the survey will result in the selection of a




stratified probability sample of persons who reside at various distances




downwind from nonferrous smelters in selected communities.  Approximately




240 persons, aged 35 and under, will be selected at varying distances




from the emission source in each of six smelter communities (a selective




sample of study sites was identified by the Project Officer on the




basis of prior investigation).  Additionally, 80 residents aged 60 and




older will be selected in each of three of these communities.  Blood,




urine, and scalp hair samples will be obtained and analyzed for these




persons and will comprise the basis for estimating community uptake




coefficients of lead, zinc, arsenic, copper, manganese, and cadmium.




To estimate the exposure levels of the "downwind" residents and an




"upwind" control group to these six elements, residence data and samples




of soil, household dust, and tap water will be obtained at each of the




six communities selected for study.  To estimate levels of atmospheric




exposure, high-volume air samples will be obtained at random locations




throughout the target area and at random points in time throughout




the survey period.  The number of dust and tap water samples will be




equivalent to the number of households that have individuals in the




sample—that is, less than or equal to 1,680, the total number of




individuals to be selected.  Additionally, RTI anticipates that a minimum




of 90 high-volume air samples will be taken at each smelter site, a




total of approximately 540 (90 x 6) air samples for the study.  Two soil




samples at each pre-schooler play area, and one composite soil sample




at each school playground and high-volume air sampling site will be




collected.






                              1-3                                3-10-77

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     Prior to the studies in the six sample communities, a Pretest or




pilot study will be conducted at Corpus Christi, Texas.  The method-




ology will be identical to that planned for the survey sites except that




a smaller sample of persons will be selected to participate and the




survey period will be shorter.  Approximately seven persons per age/sex




cohort will be selected from each of the two geographic strata repre-




senting the extremes of potential exposure and one person per cohort




will be selected from each of the remaining six strata.  This allocation




will result in a total of approximately 120 individuals in the Pretest




study and is such that the hypothesis of no significant difference in




uptake can be tested with reasonable power.  The survey design for air




sampling will also be equivalent to that planned for the main study




sites except that the period of time sampled will be reduced from 20




to 10 days—that is, approximately 45 high-volume air samples will be




collected during the Pretest.




     Each study site (community) will be visited prior to the survey in




order to ascertain the appropriate delineation of target (high-risk)




population and to develop sampling materials.  The actual sampling plans




will be conceptually equivalent but will necessarily be developed




individually to suit the particular circumstances of the community,




such as availability of mapping materials, prevailing atmospheric




patterns, geographic topography, type and location of the smelter and




other major emission sources, and population densities.  Tentatively, RTI




expects to obtain a balanced sample of five individuals from each cohort




from each of approximately eight distance strata (40 persons in each




cohort).  These strata will generally increase in size (land area) as




the distance from the stack emission increases, in order to optimize the






                              1-4                                3-10-77

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sample design according to the usual pattern of particulate fallout.




     Although the actual number of high-volume air samples will ultimately




depend upon the site circumstances, the number of air samples per stratum




will range from approximately two obtained on each of 3 days to three obtained




on each of 7 days.  The number of observations, both locations and days,




will increase as the distance from the emission source increases.  The




number of electric connections needed to accommodate the air samplers at




each of the study sites is expected to range from 8 to 18 depending




upon the number of strata used for sampling at the particular site.




     Often, studies of environmental quality present emphasis and




analyses that are based on purposefully selected samples of population




and environmental factors.  Such findings are highly susceptible to




biases and often are not valid.  In contrast, the methodology presented




in the present study stresses random probability sampling techniques




which will facilitate valid statistical analysis.




     The following sections address specific components of the survey




design including target population, construction of the sampling frame,




sample selection techniques, sample size, and the estimation precision.




     1.3  Target Population




     The primary target population consists of the relatively high-risk




human population that resides "downwind" of lead, zinc, and copper




smelters in selected U.S. smelter communities.  Specifically, American




Smelting and Refining Company (zinc), Corpus Christi, Texas, will be




used as a pilot test; the six study smelters consist of:




          St. John Mineral Corporation (lead), Herculaneum, Missouri;




          Missouri Lead Operating Company, Bixby, Missouri;
                              1-5                                3-10-77

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          Anaconda Company (copper), Anaconda, Montana;




          Phelps Dodge Corporation (copper), Ajo, Arizona;




          National Zinc Company, Bartlesville, Oklahoma; and




          New Jersey Zinc Company, Palmerton, Pennsylvania.




     In appendix 1.1, the sites are characterized according to population,




migration, and age characteristics.  Other neighboring communities, some




of which are listed in appendix 1.1, may also be included in the




target populations.  Also, figures in appendix 1.1 depict the population




and its stratification for Corpus Christi, Texas and the tentative




population delineations for the study sites.  Characterization of the




target population presented there is indicative of the technique that




will be used on the study sites.




     Delineation of the target population will be based largely on pre-




vailing wind patterns.  Tentatively, the high-risk population is




defined as all persons residing within 30 km of the emission source




(this limit may differ according to prevailing fallout patterns) and in




sectors that experience winds from the direction of the emission source




more than 3 percent of the time.  The 3 percent cutoff generally excludes




areas receiving 10 percent or less of the total fallout from the study




source.  It is planned that the target population will comprise all




persons in this high-risk population that are members of the categories being




studied.  Additionally, an "upwind" area segment will be sampled as a




control group to facilitate the isolation of effects from the particular




emission source under study. The target population is thus restricted so




that the available resources can best be utilized to answer questions




about the potentially high-risk population, although this restriction




precludes valid inferences about the entire population in some of the
                              1-6
                                                                 3-10-77

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study communities (in other communities, such as Ajo, Arizona, the wind




patterns and the population distribution are such that the entire community




comprises the high-risk population.)  Wind roses (see appendix 1.3) have




been developed for all test sites.  These diagrams depict the relative




frequency of wind velocity and direction.  At Anaconda, for example,




westerly winds prevail 85 percent of the time, largely at 7 to 21 miles




per hour. The target population for Anaconda, therefore, would ideally




comprise all persons (with exceptions noted below) residing in a fan-




shaped area to the east of the smelter.




     The population in these communities is additionally restricted to




the relatively young (preschool, school age, and age 20 to 35), and to




the relatively old (age 60 and older) that have not had occupational




exposure at the community smelter within the preceding 12 months.  The




exact delineation of this population will differ by site depending on




local circumstances such as those alluded to in the previous section.




Presurvey site visits are planned for the purpose of gaining the pertinent




local information needed to supplement extant materials in the construc-




tion of a sample frame (see section 1.3).




     Several aspects of the study present somewhat unique sampling




problems.  For example, most smelter communities are relatively small




(population 1,000 to 5,000) and show net outmigration during the past




decade.  In this stereotype community, relatively few of the 20 to 35




age group will remain in the community.  The minimum size for each




stratum will be imposed by the expected number in the population of the




most scarce cohort, usually the pre-school group.  The approximate
                              1-7                                3-10-77

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stratification guidelines presented in figure 1.1, therefore, will




necessarily differ by site.  Obviously, sampling from such populations




can guarantee adequate cohort representation over the range of distances




and potential exposures only to the extent that these cohorts are con-




tained in that population.  In other words, RTI anticipates, depending




on the community, that virtually all of the families residing near the




emission source will need to be screened in order to obtain adequate




information about uptake of some of the cohort groups in that area.




Figure 1.1 reveals that the area near the smelter represented by the




steep portion of the curve contains a highly variable particulate content.




     The curve presented in figure 1.1 was developed on the basis of




results from several prior studies [Refs. 1.1, 1.2, 1.3].   These works




reveal that the particulate dropout rates for varying distances from the




smelter follow a somewhat similar pattern for several of the elements to




be investigated in the study.  Distance-fallout data were compared for




zinc, cadmium, lead, and arsenic on the basis of air, surface soil,




and blood samples.  Surface soil samples reflect the fallout rates and




the atmospheric mobility of lead [Ref. 1.4].  The general shape of this




curve is useful in describing relatively homogeneous strata, which




contain approximately equal variances for element accumulation.  Equally




spaced readings on the vertical axis, therefore, identify distance




strata for which equal-size samples of persons will yield approximately




equal reliability for each stratum estimate.  Actually, the stratum




boundaries are being based on potential exposure according to methodology




in appendix 1.1; this refinement is expected to be a more effective




stratification and will still serve as a quasi-stratification of distance




from the smelter.







                              1-8                                3-10-77

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ro
I
           0  0.3 0.7  1.1   1.6
2.2
3.0                     5.0


 km from emission source
          Fig. 1.1.  Preliminary distance-stratification for a target population based upon Zn and Cd content of

                     topsoil according to Miesch and Huffman [Ref. 1.1] in East Helena, Montana.

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     It is noteworthy that stratum 8 in figure 1.1 Cf^om 5 to 8 kilo-




meters downwind of the smelter) is generally considered to be beyond




the range of atmospheric transport and, therefore, will serve to some




extent as a control group with minimal exposure.  More accurately,




however, the mobility of individuals in the area can be expected to




result in some exposure for most individuals living in the community,




thus precluding selection of a true control group from a smelter community.




In fact, the exposure levels at Corpus Christi, according to the standard




dispersion models, are substantial even beyond 30 km, hence, the decision




to sample upwind for the control group.




1.4  The Sampling Frame




     The first requirement for a probability sampling of any nature is




the establishment of a frame.  A frame is a collection of sampling units




that may be unambiguously defined and identified.  A list of persons,




families, or houses might be a sufficient frame for certain types of




samples.  For the planned survey, one must assume that a complete list




of the target population will not be available and will be costly to




develop.  Therefore, an area sampling frame will be developed.  Such




a frame will result in a probability sample—that is, all persons in tar-




get populations as tentatively defined in appendix 1.1 will have a known,




nonzero probability of being selected for the study.  The method and




materials used to obtain a stratified area sample may vary somewhat by




site but will follow the same basic methodology.  As shown in appendix 1.1,




the sites to be studied are generally characterized by such small pop-




ulations that Census of Population data are not sufficiently detailed to




use as a sampling frame.










                              1-10                               3-10-77

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     Corpus Christi, the one exception to this characterization, is a

tracted area for which the Census material constitutes a suitable base

for constructing an area frame.  The frame construction for Corpus

Christi will involve the following tasks:

     1.   Obtain the pertinent Census materials; these are already
          available at RTI and include 16 sheets of enumeration district
          (ED)/block maps and block and ED statistics;

     2.   Obtain county highway maps showing roads and other boundaries
          useful for constructing area segments and showing locations
          of dwelling units outside the urban area;

     3.   Obtain pertinent stratification information from local sources,
          such as health departments and weather services;

     4.   Delineate target area and strata boundaries;

     5.   Select for each stratum an ED or block with probability
          proportional to the 1970 population for the ED in which the
          first sample segment will be located.(a sample segment will
          comprise a cluster of from 6 to 14 households);

     6.   Continue task 5 using with-replacement sampling until a
          sufficient number of segments have been assigned to yield
          the requisite cohort samples; the procedure of tasks 5 and 6
          will be repeated within each sample ED and block to identify
          specific sample segments and their survey sequence.

     The process of developing the sampling frame for less populated

areas encompasses the same tasks except that aerial photography,

geological survey maps, and street maps will be used to delineate the

primary sampling units (PSUs).  To facilitate the selection of sample

segments, the sample PSUs will be cruised and subsegmented and households

will be listed according to methodology developed at RTI [Ref. 1.5].

     The information that is expected to be pertinent for stratifying

the target population may include several factors as noted earlier in

section 1.1.  Basically, the target population will be stratified,

first according to exposure potential from the  emission source  (essentially

                              1-11                               3-10-77

-------
a distance-from-source stratification) and second, according to age




and sex within the exposure Cor distance) strata.  Other factors,




which undoubtedly influence exposure and uptake of elements, such as




cigarette smoking and proximity to automobile traffic, will be




addressed through statistical analysis.  Care will also be taken




during the statistical analysis to account for the fact that the data




result from a stratified cluster sample and not from a simple random




sample.  Additionally, each stratum should be sufficiently large to




yield the requisite sample.  The minimum size stratum for each site can




be anticipated by viewing the smallest cohort proportion and making




allowances for possible nonresponse and occupational exposure.  Using




Ajo, Arizona as an example, approximately 7 percent of the population




is male and 60 or older.  According to the 1970 Census, 71 (i.e., 5/.07)




persons will be needed to produce the requisite sample of five in this




cohort if all participate, if none have had occupational exposure within




the preceding 12 months, and if all have lived in Ajo for at least a




year.  Therefore, the 71 persons plus additional to account for possible




nonresponse and occupational exposure suggests that the minimum stratum




size may be approximately 125.  What actually constitutes a reasonable




allowance for these sample losses, however, will be ascertained from




local sources and site experience. This minimum stratum size, the re-




latively small site populations, and the increasing stratum areas as the




distance from the source increases suggests that fewer than 8 strata




will be feasible for some sites.  The actual number of strata used will




depend on several factors including what constitutes the downwind population.
                              1-12                               3-10-77

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1.5  Sample Selection Techniques

     1.5.1  Survey Participants

     The major considerations outlined in this section involve the need

to obtain randomized samples from an adequate representation over a wide

range of distances from smelters for 6 to 8 cohort groups.  To accomplish

this objective, the downwind population in each "distance stratum" will

be partitioned, as described in section 1.3, into small segments such as

city blocks.  Instructions to data collection field staff will contain

the following information:

          A list of segments to be surveyed and the order of visiting
          these segments and households in the sample segments;

          Maps showing segment locations and specific boundaries;

          A form on which a tally will be maintained for each cohort
          group for each stratum;

          A form for recording a count of all eligible persons in those
          segments visited, which of them were asked to participate, and
          which did participate.

     The field enumerator will continue to visit segments in the pre-

designed order in each stratum until either the cohort samples (5 in

each cohort group) are obtained or until all households in the stratum

have been either contacted or verified as not containing any of the

eligible individuals still needed.  Except for eligible individuals that

do not cooperate, this technique will result in a probability sample of

the target populations that will facilitate valid inferences and analyses

of the data.  The use of cash incentives is expected to hold the nonresponse

and hence the departure from a probability sample to a minimum level.

In a similar study, the voluntary response rate without the use of

incentives was 80 percent  [Ref. 1.6].
                              1-13                               3-10-77

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     1.5.2  Air Sampling

     The placement of the air sample locations will coincide with the

first segments selected in each stratum for the sample of individuals.

Also, for each air sample location, a list of days during which the 24-

hour samples are to be obtained will be provided to the Site Administra-

tor.  This list of days comprises a probability sample of time periods

throughout the survey period.  From 4 to 6 air samplers will be operating

virtually throughout the survey period, and the requisite number of

electric connections is expected to range from 8 to 18 for each smelter

site depending on the number of strata.  Constraints on the allocation

require that no more than 2 strata are designated for monitoring on a

particular day, and that no stratum will be assigned more than 3 monitors

on any single day.  The procedure is as follows (see also table 1.2.2):

     1.   Randomly select 3 days from the first 19 days of the survey
          period without replacement and assign these to stratum 1—two
          locations proximate to the first two segments (household
          sampling units) will be monitored on each of these 3 days;

     2.   Repeat the procedure of number 1 for stratum 2;

     3.   Repeat the procedure for the remaining strata except that
          days already assigned twice are ineligible, and the number of
          days to be assigned to each stratum increases for strata that
          are more distant from the smelter.

     1.5.3  Sampling for Soil Contamination

     Samples of surface soil are to be collected in play areas of all

study children.  Two soil samples will be obtained from residential play

areas for pre-school age study participants at each smelter site, and one

composite sample will be taken from each school yard where study children

attend (and each air sampling location).
                              1-14                               3-10-77

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     Variation in the soil content of study elements throughout the play




areas, both for different locations and times, is expected to be small,




relative to variation in the air samples for example, but will undoubtedly




be sufficiently large to consider random sampling.  For this reason,




a methodology is being investigated in the Pretest which would result




in a reasonably unbiased sample of the surface soil in play areas of the




sample children.  This method involves a random point sampling which




would essentially ensure that all locations in the play area would have




a nonzero (and equal) probability of being selected.  Two points will




be selected in each play area in the Pretest and will be analyzed before




aggregation so that variance components and requisite sample size can




be ascertained.  If the Pretest reveals that random sampling is impractical,




a selective composite sample will be relied upon at the study sites to




measure element exposure from soil in the play area.  In either case,




the enumerators will first establish the boundaries of the most commonly




used play area and will then select surface soil samples from scattered




points in the play area.  These samples, which will be obtained con-




currently with the interview, will comprise the soil sample(s) for that




play area.




     1.5.4  Sampling Tap Water




     A sample of tap water will be obtained during the interview at the




residence of each study participant.  The tap water sample will be




obtained from the kitchen tap or other source commonly used for drinking




and/or cooking.  It is anticipated that two tap water samples will be




obtained, one sample taken from the first drawn water and another
                              1-15                               3-10-77

-------
sample taken after the water has been allowed to run for three minutes.
     •
The underlying assumption is that the element content of most ingested


water is between these two extremes.  The feasibility of this methodology

will be investigated at the Pretest site by analyzing the "before and


after" samples seperately for a subsample of the households.  Random


sampling at different locations and times (except the before and after

flush sampling) was not proposed for this measure of exposure, because

it should be relatively homogeneous within a household, and because what

little improvement in data that might result from a suitable randomization

of this measure does not appear to justify the accompanying increase in

respondent and interviewer burden.

     1.5.5  Quality Control

     Analytical errors—that is, errors in the laboratory analyses—can

constitute a serious problem [Ref. 1.4].  Several methods for controlling

these errors are described more fully in the data collection and laboratory

analysis sections of this Work Plan, but one aspect of the quality

control is described briefly here because it relates to sample random-

ization.  To the extent possible, the sample data will be stored in the

laboratory and analyzed in random groups rather than in batch groups as

they are sent in from the field in order that analysis error can be

identified as error rather than as factor effect.  Also, the forms used

for tallying eligibles in the sample segments will identify some 10

percent of certain eligibles as quality control individuals; duplicate

samples of blood and hair will be obtained for selected adult participants

and duplicate samples of tap water and dust will be taken at selected
                              1-16                               3-10-77

-------
dwellings.  Also, duplicate soil samples will be taken for 10 percent of




the school yards and air sampling locations.  The purpose of these




quality control observations is to measure the possible influence of




sample acquisition, packaging, shipping, and laboratory analysis.




Additionally, 10 percent of the sample individuals will be reinterviewed




at a later date to verify the information obtained on the survey ques-




tionnaire; the identity of these persons will be unknown to the initial




interviewer.




1.6  Sample Sizes and Sampling Error




     The sampling errors and sample sizes are presented here in two




sections, for individuals and for high-volume air samples.  An apparent




inconsistency exists between the proposed sample allocation of persons




and that for air samples.  This apparent inconsistency reflects the




anticipated small within-stratum variation of long-range, average




conditions, such as element absorption in soil  [Ref. 1.1], and the




relatively greater within-stratum variation anticipated for certain




unstable conditions, such as atmospheric composition at a specific




location on a particular day [Ref. 1.2].  This results in a slightly




larger sample of high-volume air samples being taken in the strata more




distant from the smelter, while, for persons (and soil samples), equal




sample sizes are to be taken from each stratum.




     1.6.1  Allocation of the Sample of Individuals




     If estimates of population totals or averages are sought, the optimum




sample allocation in stratified sampling is a function of stratum vari-




ances, costs, and stratum sizes, according to the following equation:
                              1-17                               3-10-77

-------
              "h= n(W /ch}/* NhV /cn)




where ru  = the optimum sample size for stratum h for an overall sample



of size n, N,  = the number of elements in stratum h of the population,



S,  = the standard deviation of stratum h, and C,  = the cost of sampling
 h                                             h


from stratum h.



     To meet the objectives of this study, however, accurate estimates



are needed of mean exposure at various distances from the emission source.



The N, , therefore, are dropped from equation 1.  Also, C,  in the
     n                                                  h


proposed study will be approximately constant for -all strata.  The



optimum n,  can then be obtained by using equation 1 and the fact that



the S,  are also approximately equal (see figure 1.1):



                         L


              ^ = n V E sh



                 - n/L



                 = 40/8



                 = 5



where L is the number of strata (8 or less), n is the number of



individuals per cohort (40), and other notation is as defined for equation



1.  The desired sample allocation of the 1,680 sample persons is described



in table 1.1, although, as noted earlier, the actual stratum sizes may



differ among smelter sites.  Based on prior studies  [Ref. 1.7, 1.8,



1.9 and 1.10, for example], this sample size should result in a reasonable



capability (Type I and Type II error both at 0.05) for detecting a lead



difference, for example, of 5yg/100 ml blood; 40 is commonly accepted



as the concentration above which health problems are likely to exist.



     1.6.2  High-Volume Air Samples



     The high-volume air samples are needed to estimate exposure levels



                              1-18                               3-10-77

-------
        Table 1.1.  Tentative sample allocation for individuals*
                            at the study sites .
Number of
Geographic
Site
Lead (1)
Lead (2)
Zinc (1)
Zinc (2)
Copper (1)
Copper (2)
Preschool
Male Female
5
5
5
5
5
5
5
5
5
5
5
5
Individuals by Cohort Group in Each Stratum
School Age
Male Female
5
5
5
5
5
5
5
5
5
5
5
5
20-35 Years
Male Female
5
5
5
5
5
5
5
5
5
5
5
5
60 Yrs
Male
5
0
5
0
5
0
& Older
Female
5
0
5
0
5
0
     *Assuming, tentatively, eight strata as depicted in figure 1.1:  0.0 - 0.29 km,
0.3 - 0.69 km, 0.7 - 1.09 km, 1.1 - 1.59 km, 1.6 - 2.19 km, 2.2 - 2.99 km,
3.0 - 4.99 km, and 5.0 - 7.99 km.
                                     1-19
12-17-76

-------
at varying distances from the emission source, at varying distances from




the transit line of the downwind pattern (corresponds to primary wind




direction), and at varying wind velocity and direction.




     All air samples will be collected by the Chemistry and Life Sciences




Group of RTI.  Each of these high-volume samples will be collected




over 24 hours on fiberglass filters.




     Two sampling questions need to be answered about the high-volume




air survey:




     1.   How many sampling points are needed in each stratum?




     2.   How many locations should be observed during a sample day?




Several 24-hour readings are needed in each stratum in order to measure




the variation over time [Ref. 1.2] as well as the need to measure the




influence on exposure of different wind velocities and directions.  The




basic sample size and allocation are presented in table 1.2, but they




necessarily will be tailored to suit the individual site circumstances.




Methodology for estimation of sample size and allocation is described




in appendix 1.2.  The per-site sample size totals 87 location-days.




This size sample is expected to produce a coefficient of variation for




element content of atmosphere of 0.20 or less at the stratum level.




     As mentioned above, the stratification and sample allocation will




vary somewhat among sites so that the examples presented for




clarification—namely, the fall-out curve in figure 1.1, the sample




allocation in table 1.2, and the random assignment scheme for air samples




presented in table 1.2.2—should be considered flexible.  Another




noteworthy point on the air sampling is that it is primarily to be




used to assess the past average exposure of the target population.










                              1-20                               3-10-77

-------
      Table 1.2.  Tentative sample allocation for air samples*.
Type of Observation
Locations (A)
Days (B)
24-hour samples (A x B)
Ratio, days/locations

Sl
2
3
6
1.5
Number
S2
2
3
6
1.5
of Observations,
S3
2
4
8
2.0
S4
2
4
8
2.0
S5
2
5
10
2.5
Si, in
S6
2
5
10
2.5
Each
S7
3
6
18
2.0
Stratum
Y
3
7
21
2.3

Total
18
-
87
-
*Based on data presented in appendix 1.2 [Ref. 1.2].
                                1-21
12-17-76

-------
Because it samples such a short time period (20 days), little measure of




seasonal effect will result.  Resource constraints have imposed this




relatively short sample period; admittedly a longer time period and




even a one-to-one matching between high-volume air samples and sample




persons might be desirable.  Basically, therefore, what is expected from




the proposed design is a measure for each distance stratum of the atmospheric




condition during the survey period and of how well the standard dispersion




models perform [Ref. 1.11].  This information can be used to adjust these




models so that historical climatic data can be used more effectively




to estimate average past exposure.  The same type of seasonal




adjustments will be used" on other "seasonal" factors in the analysis




to the extent seasonal effects are revealed over the course of the study.




     Another characteristic of the air sampling methodology is the




continuous sampling of predesignated points on specified days.  While




one might be tempted to shift the samplers away from "unusual" atmospheric




conditions, such variations would result in biased estimates.
                              1-22                               3-10-77

-------
         APPENDIX 1.1




CHARACTERISTICS OF SURVEY SITES
              1-23                       3-10-77

-------
                    Table 1.1.1.  Selected population characteristics of survey sites.*
I
NJ
„ Smelter
State
town
Arizona Ajo
Missouri Bixby


Herculaneum

Montana Anaconda
Oklahoma Bartlesville
Pennsylvania Palmerton
Texas Corpus Christ i
(Pretest site)
Neighboring
towns
Rowood
Bass
Buick
Viburnum
Festus
Crystal City
Horine
Povely
Gregson
Warmsprings
Dewey
Tuxedo Park


Population
number
5,881
<1,000
-
520
1,885
7,530
3,898
517
9,771
29,683
3,958
5,620
204,525
Net migration .
j inm Age groups, percent
since lyou,
percent 1-5 6-17 20-35 60+
-16.6 12 25 19 14





-18.9 10 22 18 19
6.4 10 20 20 17
-5.4 9 17 20 22
22.0 11 26 19 12
           *Based on the 1970 Census of Population.
  o
  i

-------
                METHODOLOGY FOR CHARACTERIZING THE

             STUDY POPULATION IN CORPUS CHRISTI, TEXAS
     Estimates of particulate concentration surrounding the ASARCO, Inc.


smelter at Corpus Christi, Texas were made using the Climatological


Dispersion Model (COM) of the EPA UNAMAP Library.  The COM is described


in detail by Calder [Ref. 1.12] and in less detail by Busse and Zimmer-


man [Ref. 1.13].  A brief description of the model and its application


follows.


     The average annual concentration (ground level) was estimated for


Pb, Mn, Cu, As, and Zn resulting from- the nine sources at ASARCO that


emit these elements.  The models used to estimate these concentrations


rely on such information as:


          Relative frequency of wind speed (6 categories) and direction

          (16) for each of six atmospheric stabilities,


          Mixing height of atmosphere [Ref. 1.14],


          Temperature (outside and stack gas),


          Emission height,


          Stack diameter, and


          Emission rate and velocity.


     These concentrations were calculated for a 60 km square area around


ASARCO.  Concentrations were calculated each 0.8 km up to 8 km from

                                                            2
ASARCO and each 1.6 km for the remaining area in the 3600 km  area.


Gradients of these concentrations were plotted on maps depicting pop-


ulation location and Census defined areas (Blocks, Enumeration Districts


[EDs], and Tracts).  These gradients revealed several pertinent con-


siderations:




                              1-25                              3-10-77

-------
          Most of Corpus Christ!'s population resides "upwind" of the
          ASARCO plant.

          Individuals residing downwind (largely to the northeast) are
          apparently exposed to substantial concentrations (from ASARCO)
          even beyond 30 km from the source; 75 yg/m^ was estimated at
          30 km.

     -    The gradients also revealed useful strata boundaries for use
          in the sampling components of the investigation.

     Based on the concentration estimates, it was concluded that the

study population should be taken within 30 km even though this distance

will not result in an adequate control group.  The control sample will

be selected from Corpus Christi residents to the southeast where con-
                           3
centrations of only 10 yg/m  were estimated.  Additionally, to obtain

the maximum possible information about individuals throughout the full

range of exposure potential, the upwind (wind from the direction of the

smelter less than 3 percent of the time) population—except for the control—

was excluded.  Also, to hold the public relations activities to a reasonable

level, the study area was restricted to Nueces county; approximately 3,800

persons reside within the 30 km limit in San Patricio county but this

constitutes only 4 percent of the total downwind population.

     The tentative study populations delineated for the other study

sites will probably have similar exclusions—that is, counties with a

small proportion of the population will be excluded and the distance

limit (30 km) may be reduced or increased depending on particulate

dispersion and population location.
                              1-26                              3-10-77

-------
      Table 1.1.2.  Population residing in the tentative study
                       area near Ajo,  Arizona*
County

 Pima



 Total
Census Division
      Ajo
Town or Area

     Ajo

    Other
Population

   5,881

     412

   6,293
  Based on 1970 Census of Population
                               1-27
                                               3-10-77

-------
'' • •,-.  BOUNDARY 	 |	;'p	 	'	 	^ '_ill_ 	 	"' 	 '' ' :	 	!  _   '



 •~—y '••   '• •  •   -A  .'.    . '•' /••   •      :   i     •>', \   '«  I
                                                                        Oen
^«-:'.-4i-
 ~ * . •'<-•. \
                                33
..      34
 >     r-f*v-'~- =
      V:.- :ii-  ;
i

35
                             •A/'
                              i
                                                             a: <•
                                                                               ,,
                                                                               31
  VX32
1. ^\ ".:
                     Figure  1.1.1.  Geographic location  of  study smelter and
                       tentative delineation of the study population, Ajo
                 •.r.v:,	,M—-*--—r/i  •
           .   ..   ^   .  •   .,.-,
 ''• s|     • ^ •'-„ C |.V""'> ' v Cardiaan-"' '•'-•'-• .  f-V-i « :4CamelbackM'
•/.. Jtf-i8^;-\.,  e^re-SET".' v *.  -S^ A.^-''-'--"^!-""-:•-'v_ mn^'si
  ;5M_^r '  *»  r :^w M.:   ,«• «jj 11979'
 ''^^;2^iX^::rSiT'' ;>•
 ;jVT3-"'•.-:«' ••/• ''V^>--j-.>x'  /* r.p* '  fe».-l(1r':;'   ^"y-5    '.!>•'   n  '  ''!"'.\': Ki / -8V .;-'-/K./slv' •• .N
 "? ™« S  •' IS ; * '

 '"^   ••-•
                                   »

                                   --' i
   • '/**  1    .  /7*O i  *,s   '  -**          ' '   '
   i    -    •
          \    '  /  l
          i      '.  /
       "  "1-28- """
                                                                          3-10-77

-------
      Table  1.1.3.   Population  residing  in  the  tentative  study  area
                         near Anaconda,  Montana*
  County

Deer Lodge


Silver Bow
  Powell

   Total
  Census Division

     Anaconda
 Deer Lodge Valley

       Butte
   Ro eke r-Rams ey
Walkerville-Browns
    Cottonwood
Town or Area
  Anaconda
    Butte

 Walkerville
    Other
Population

   9,771
   3,255

  23,368
     980
   1,097
     285

     816
                                                 39,572
    Based on 1970 Census of Population
                                 1-29
                                                 3-10-77

-------
                                                 Sl.ilt Hd'u
       '••  • • -'-   ;,.   _—  "•          i\

\-  •-/*i  •."'•         .:. : f)ppoi-tunity   ^


  \
                          _
                        KKIt I.OliCK rVEw LQDGC    I-
                            ccr    >Tv*Li-tT /• *   ||

                        i             uJ::

-------
      Table 1.1.4.   Population residing in the tentative study area
                      near Bartlesville,  Oklahoma*
  County

Washington
   Osage
  Rogers

  Nowata


   Total
    Census Division

         Cop an

         Dewey

     Bartlesville
Bartlesville Southeast
    Ochelato-Ramona
       Pawhuska
       Barnsdall
    Oolagah-Talalo

South Coffeyville-Wann
Town or Area

    Copan
    Other
    Dewey
    Other
Bartlesville

  Ochelato
   Ramona
    Other
                                                 Avant
                                               Barnsdall
                                                 Other
    Wann
    Other
Population

     558
     845
   3,958
   1,240
  29,672
   1,026
     330
     600
   1,897

     909
     439
   1,579
     485

     513

     135
     525

  44,771
    Based on 1970 Census of Population
                                1-31
                                                  3-10-77

-------
                        \,
                       2>
/•C^jj;(
  Figure  1.1.3.   Geographic  location of  study smelter  and
tentative delineation of  the study population, Bartlesville
                              __ j. orvix i
                              »:•;•.>..,35  •;;
                          F.ili.H"   «'\.i
                           •'•  >,.;%:-^,x
                                                            »**"  TWASMINOTON fe"" t-"n-» • NOWAI
                                                           S   '   CO   pim.WfrtT.iiit.1
                                                          /•     •_ c.». |J  i-J-^^

                                                                      '
                                                          ^     I OCMtVAT*. I KOGEH^CO.
                                                          --       "•«"     /
                                                          <»-     -,   I   /.,«» I
                                                                             ^
                            1-32
                                   3-10-77

-------
     Table 1.1.5.   Population residing in the tentative study area
                         near Bixby,  Missouri*
 County

  Iron
Reynolds
 Madison
  Wayne


Crawford

  Total
   Census Division
  Arcadia township
                    Iron township
                   Kaolin township
                  Liberty township
                   Union township
       Carroll
Lesterville township
    Webb township

    Polk township
St. Francois township
  Liberty township
  Central township
 Twelvemile township

   Logan township
Cedar Creek township

        Osage
Town or Area

   Arcadia
   Ironton
 Pilot Knob
    Other
  Annapolis
   Des Arc
    Other

 Centerville
   Dillard
Population

     627
   1,452
     582
   2,046
   1,116
     245
     478
     330
     222
   1,049

     209
     762
     205

     398
     268
     279
     210
     129

     325
     144

      36
                                                  11,112
   Based on 1970 Census of Population.
                               1-33
                                                  3-10-77

-------
      location of  study smelter and

  of  the  study  population,  Bixby


                                      /       | l-,u< K»*O   I MADISON CO. I M'"
                                    . lf  . —— .—1     O"<*"'«1      \ 1 "'

                                    /     I    |   .,J   I  -•—,&
K-) )-v.'•• "'^ w m--   (r^,, --.•
I  '"•'-(~—^      l \. \\°  v -: ^?-(
KI V .Ku^Cenji.; : .  \\ \\*^*T'v'''/'!  '—
hf^^5>=i====;-j(i V^: i ;IMO°~
V'••-'-,\V\. „, ,  .^=J\l.oM-'t.<
-------
Table 1.1.6.  Population by stratum residing in the study area

                  near Corpus Christi, Texas
Stratum
Potential exposure
         3**
     yg/m
Population   Sample size
1 (Control) <25
2 25 - 150
3 150 - 300
4 300 - 450
V
5 450 - 600
6 600 - 800
7 800 - 1,600
8 >1,600
Total
54,265
76,747
14,296
872
302
356
591
741
148,170
42
6
6
6
6
6
6
_42
120
      Based on 1970 Census of Population.
     **
       Based on atmospheric dispersion model described in appendix 1.1.
                            1-35
                                         3-10-77

-------

-------
        Table  1.1.7.
Population residing in the tentative study area

   near Herculaneum, Missouri*
     County


    St. Louis
 Census Division
Town or Area
Population
    Jefferson
 Ste. Genevieve
Monroe (Illinois)**
Total (in Missouri)
Lemay


Concord



Meramec

Rock

Joachim




Central

Big River
Valle

Jackson

Bella Villa
Lemay (part)
Other
Concord
Lemay (part)
Sunset Hills
Other
Parkdale
Other
Kimmswick
Other
Crystal City
Festus
Herculaneum
Pevely
Other
Hillsboro
Other
-
De Soto
Other
Bloomsdale
Other
1,419
36,759
22,381
21,217
3,356
92
12,979
836
7,640
268
44,403
3,898
7,530
1,885
517
8,108
432
4,995
1,316
5,984
1,995
411
647
   all  except
 Prairie DuLong
                                                                      17,491
                                               189,068
       Based on 1970 Census of Population.

      **
        Tentatively excluded from the study area.
                                   1-37
                                               3-10-77

-------
^/^^'^S^-^^^^.-^.^\4 .-V•-•{- (-.<"--Sxr'':-

^^i^^SM^^:, .,..uv. ,',_„• A. V-
, \
\ \
1
i'i

?/ l\
y i^
^
/!
1
! / c
V ~
ft «
/
Si h \'!
                    Figure  1.1.6.  Geographic, location of study  smelter and
                  tentative delineation of the study population, Herculaneum
^^;r...^fy^so--p
"—«*•<- •/- /si-w-N£<-_ ••••••(;
  ^Kl   '  ..-*c  ^x ^vC:j^  y *"



                                                            -
                                                      t      )

-------
      Table 1.1.8.
     Population  residing  in  the  tentative  study  area
       near  Palmerton,  Pennsylvania*
  County

  Carbon
  Monroe
Northampton
     Census Division

     Kidder township
  Penn Forest township
  Towamensing township
    Lower Towamensing
    Palmerton borough
    Franklin township

        East Penn

  Tunkhannock. township
  Chestnuthill township
         Jackson
          Polk
        Hamilton
          Ross
         Eldred

     Lehigh township
     Walnut borough
     Moore township
     Chapman borough
        Bushkill
    Wind Gap borough
       Plainfield
   Slockerton borough
     Upper Nazareth

     Lower Nazareth
       East Allen
      Bath borough
   Bethlehem township
     Bethlehem city
         Hanover
          Allen
       Northampton
North Catasaugua borough
Town or Area
                                              Other than
                                            Weissport East
                                            Eastlawn Garden
                                                 Other
Population

     298
     423
   1,096
   2,360
   5,620
     514

     659

     159
   2,021
     404
   1,284
     995
     998
     990

   6,086
   1,942
   3,791
     191
   3,387
   2,270
   2,144
     753
   1,613
   1,992
   2,091
   2,737
   1,829
   4,536
  52,065
   5,434
   1,856
   8,389
   2,941
                                 1-39
                                                    3-10-77

-------
                         Table 1.1.8.* (Continued)
  County            Census Division          Town or Area        Population

  Lehigh •         Catasaugua borough               -                5,702
                        Hanover                    -                1,217
                       Whitehall             Fullerton(U)           7,908
                                                 Other             10,415
                    North Whitehall                -                6,819
                    South Whitehall                -               14,210
                    Allentown city                 -              109,527
                    Upper Macungie                 -                4,390
                      Weisenberg                   -                1,737
                         Lynn                      -                2,047
                      Heidelberg                   -                1,532
                        Lowhill                    -                1,002
                      Washington                   -                3,732
                  Slatington borough               -                4,687
                    Coplay borough                 -                3,642

   Berks                Albany                     -                  555

Schuylkill             West Penn                   -                2,636

   Total                                                          305,626
     Based on 1970 Census of Population.
                                1-40                               3-10-77

-------
 _^^^V^A'quash!(^la^
^^v^'^^f^V^?^^



*^^^^S*+ ' '«&
^f
   Sub      /Vj
   s*a-.--;v!'ftr

-------
                APPENDIX 1.2




SAMPLE SIZES AND ALLOCATION FOR AIR SAMPLING
                    1-42
                                                3-10-77

-------
     The requisite sample sizes and allocations are based tentatively



on data presented in table 1.2.1  [Ref.  1.2].   These  allocations will



ultimately reflect also the specific smelter-site characteristics,



which will be obtained from site visits.



     The variances (based on table 1.2.1 data) equal 891 and 305 for



strata 6 and 8, respectively.  Sample sizes of 10 and 23 for these



two strata will yield estimates with less than a 20 percent coefficient



of variation (CV).  If a regression estimator proves effective, say with



a correlation coefficient (R .123...p) of 0.8, then the CV would be



approximately 12 percent.








            Table 1.2.1.  Lead fcontent of air, yg/cu m.*
Day
1
2
3
4
Stratum
(2.2
13.0
84.0
18.0
-
6; 2 locations
- 3.0 km)
30.0
68.0
66.0
-
Stratum
(5.0
1.3
15.0
9.6
24.0
8; 3
- 8.0
7.6
36.0
3.2
60.0
locations
km)
4.2
25.0
4.2
29.0
     *Based on reference 1.2.
                                                   2             - 2
     The variances were calculated according to:  S  = |. (X.. - x) /(nm-1)
where
     X   = Pb readings for day i and location j with i ranging from

           1 to n and j ranging from 1 to m.
                                1-43
3-10-77

-------
     The coefficients of variation are calculated according to:



     C  =  S / x /nm
            e
where
    Se  =  S /1-R .12...p and the other terms are as defined above.
                 y


     Also, the following ratio of standard deviations for each stratum



suggests that the sample ratio for day/locations should be approximately



2.2:



  mn/m  =  SQ/SL



where



     S  and S  are the standard deviations for days and locations,
      D      Li


respectively.



     An example of the assignment of the air samplers by location



and day within each stratum is presented in table 1.2.2.
                                1-44                             3-10-77

-------
                 Table 1.2.2.  Random assignment of days for high volume air samples:  an example*



                                                 —2-                                                 Electric drops.
Stratum	1   2   3   4   5   6   7   8   9   10   11   12   13   14   15   16   17   18   19     required number







1
JS
Ln

U)
1
O
•vj
1 XX
2 x
3 xx
4 x
5 x xx
6 x xx
7 xx
8 x x
Each x represents 2 or 3 sampling locations
drops.


x 2
xx 2
x x 2
xx x 2
xx 2
xx 2
xxx x 3
xxx x x 3
for each stratum-day as indicated by the requisite number of electric




-------
        APPENDIX 1.3




WIND ROSES FOR SMELTER SITES
              1-46                              3-10-77

-------
KJO -
             7.1
            6-1,
               6.0
                                             7.7
                                                                         •—r—
                                                                          n  i r
                                           1-47
                                                                            3-10-77

-------
3-5
  '-.I
      / V'y  /"->'
      \V c^-  •)
       \/-  ^^-J
                                      ,       c'-vr->      c1 -^

                                  pERl'ctNT  CCCURRENC
                                         ,3. r.   l|T2l   Z*S5
  1-48
                                      3-10-77

-------
'M-icLL. .  OK.    ,;;U;jr-i
    .=,
 •j.
     O\
      ^
                                           D   ',.;


                                          ^   ^
                                           !  A>»  'I - I

                                                
-------
    Bl 11. K-fJLUVrK-Hl'RCULfr-i: I.'M .  H'J
                  7.3
                   •  <*x   "^   [L
               0.7
                                            I	
                                           CL.CC;
'"* .1      f [ [ • C     ^  1 •"»

-Cr.Nl  OCCURKENCL
0 .1
                                            ,"  ~ 1	Lll   j
t
                                          1-50
                  3-10-77

-------
CORPUS CHRISTI, TEXAS
                                 9.9
0.00
0.05      0.10     0.15

  Per-cent Occurence
 I
0.20
                                                17.0

1 1
1 1
1--* A-fi
7-1 n




                             11-16  17-21 Over 21
                                  1-51
                                                                  3-10-77

-------
 r KLi'ii.K i 1.1 N '  ' M .
     M .'j
      "•'  fi^      \\  \\
          #$^    \\\\
                        :M\
                                 /^
                                       ,-. r*,-\    r- f* .<     *"» f-o     O  t **
                                       J-OU    *J • O ' *     »J • y J     -J-lt.


                                             PE:R.-CLNT OCCURRENCE.

f

 I
                                   1-52
                                                                 3-10-77
  -=«-5>%'>rrr-.:..'j..-.-'-.^--.--:: -^•/-v':^'y-r';-'.V:«-:''y .*'.'-::s-v—•:•;-.• •••:.•• "..>-; ^.t ^--/wvv-Trw1^:

a^^;^\>^^--^V^^-^^>^^^

-------
        APPENDIX 1.4




RESUMES OF RTI PROJECT STAFF
             1-53                          3-10-77

-------
JAMES R. CHROMY, Senior Statistician and Director,
                 Sampling Research and Design Center


Professional Experience

     1966 to date.  Research Triangle Institute, Research Triangle Park,
     North Carolina 27709.

          1976 - date:  Director, Sampling Research and Design Center.
          Responsible for coordinating research program in sampling statistics
          and for coordinating sampling and other statistical support for a
          wide variety of projects being conducted throughout the Institute.

          1972 - 1975:  Manager, Sampling Department and Senior Statistician,
          Statistics Research Division.  Responsible for the development of survey
          designs and sampling techniques for a wide variety of projects in which
          data are collected by means of sample surveys.  Supervised a permanent
          staff of thirteen professional statisticians, nine support personnel
          and many additional temporary support staff at peak periods.

          1968 - 1971:  Head, Sampling Section and Senior Statistician,
          Statistics Research Division.  Developed sample designs for the
          National Assessment of Educational Progress in 1969 and 1970.  This
          task included both the selection of 9-year-olds, 13-year-olds, and
          17-year-old students in-school by means of a school frame and 17-year-
          olds and young adults (ages 26-35), out-of-school through an area frame.
      ,    Was responsible for the design of samples selected for other studies.

          1966 - 1968:  Statistician, Statistics Research Division.  Develop-
          ment of optimal sample designs in terms of minimum cost and maximum
          precision.  Assisted in the development of computer micro-simulation
          population models.

     1962 - 1965.  Statistical Reporting Service, USDA, Lincoln, Nebraska.
     Agricultural Statistician.  Assisted in field office operations of agricul-
     tural area surveys and objective yield estimates.  Conducted monthly
     cattle-on-feed mail surveys and nonresponse interview surveys.

Education

     B.S., Technical Agricultural Economics, University of Nebraska, Lincoln,
          Nebraska, 1964.
     M.E.S., Experimental Statistics, North Carolina State University, Raleigh,
          North Carolina, 1966.

     Ph.D., Statistics, North Carolina State University, 1974.

Professional Activities

     Alpha Zeta
     American Association for Public Opinion Research
     American Statistical Association
     Biometric Society
     Gamma Sigma Delta
     International Association of Survey Statisticians
     Phi Kappa Phi
                                   1-54                               3-10-77

-------
JAMES R. CHROMY (Continued)
Selected Publications

     Chromy, J. R. and Hendricks, W. A. [1967].  Further Investigations of
     Sampling Plans for Estimating NASO Budget Requirements.  Project SU-284
     Final Report, Research Triangle Institute.

     Chromy, J. R. [1967],  Matrices of Transitional Probabilities for a
     Demographic Simulation Model.  Working Paper No. 7 developed for the
     Demographic Micro-Simulation Model Project.  Research Triangle Institute.

     Chromy, J. R. [1968].  A Generalization of the' Matrix of Probabilities
     Approach for Population Micro-Simulation.  Working Paper No. 19 developed
     for the Demographic Micro-Simulation Project.  Research Triangle Institute.

     Chromy, J. R. [1968].  Methods for Assigning Ages in the Initial Population.
     Working Paper No. 25 developed for the Demographic Micro-Simulation Project.
     Research Triangle Institute.

     Chromy, J. R. and Horvitz, D. G.  [1970].  "Appendix C:  Structure of
     Sampling and Weighting;" Report 1, 1969-1970 Science;  National Results
     and Illustration of Group Comparisons.  Washington, D.C.:  Government
     Printing Office.

     Chromy, J. R., Moore, R. P., and Clemmer, Anne [1972].  "Design Effects
     in the National Assessment of Educational Progress Survey,"  Proceedings,
     Social Statistics Section, American Statistical Association, pp. 48-52.

     Chromy, J. R. (Editor) [1973].  A Study of the SES and STOC Stratification
     for NAEP Samples.  Project 25U-796-6 Final Report, Research Triangle
     Institute.

     Moore, R. P., Chromy, J. R., and Rogers, W. T. [1974].  National Assess-
     ment's Approach to Sampling - Year 02.  National Assessment of Educa-
     tional Progress, Denver, Colorado.

     Chromy, J. R. [1974].  Pairwise Probabilities in Probability Non-replacement
     Sampling.  Ph.D. dissertation, North Carolina State University, Raleigh, N.C.

     Chromy, J. R. and Horvitz, D. G.  [1974].  "The Use of Monetary Incentives
     in National Assessment Household Surveys."  Proceedings, Social Statistics
     Section, American Statistical Association, pp. 171-179.

     Piper, Lanny L. and Chromy, J. R. [1975].  "Design Effects for Alphabetic
     Cluster Samples."  Proceedings, Social Statistics Section, American
     Statistical Association.
March 1976
                                  1-55                             3-10-77

-------
LANNY L. PIPER, Statistician


Professional Experience

     1972 to date.  Research Triangle Institute, Research Triangle Park,
     North Carolina  27709.  Statistician, Sampling Research and Design
     Center.  Design and analyze survey samples.

Education

     B.S., Mathematics, Miami University, Oxford, Ohio, 1970.

     M.S., Statistics, North Carolina State University, Raleigh, North
          Carolina, 1972 (National Science Foundation Fellowship)

Professional Activities

     American Statistical Association, member.

Selected Publications

     Chromy, J. R. and Piper, L. L. [1973].  A Survey of High School Seniors
     to Determine Responses to the Job Skills Sampling Questionnaire.
     Project 25U-814 Final Report, Research Triangle Institute.

     Mason, R. E. and Piper, L. [1973].  Technical Report Children's
     Television Workshop Surveys 1972-1973.  Project 25U-683, Research
     Triangle Institute.

     Piper, Lanny L. and Chromy, James R. [1975].  Design Effects for
     Alphabetic Cluster Samples.  Presented at the 1975 Annual Meetings
     of the American Statistical Association.
April 1976
                                                                     3-10-77

-------
STEPHEN R. WILLIAMS, Senior Statistician
Professional Experience

     1975 to date.  Research Triangle Institute, Research Triangle Park,
     North Carolina  27709.  Senior Statistician, Sampling Research and
     Design Center.  Involvement in the sample design and analysis for a
     variety of studies.  Project or sampling leader in several large-
     scale dental  surveys.

     1970 - 1975.  Southern Research Institute, Birmingham, Alabama  35205.
     Senior statistician, Economic Research and Planning Section.  Project
     leader on a study to design and assist in the implementation of a
     statewide information system for health planning.  Project leader on
     numerous health studies in the areas of epidemiology, ambulatory-
     health care, health-facilities planning, information systems, and the
     characterization of hospital inpatients and their care.  Statistics
     instructor at the University of Alabama.  Econometrician and bio-
     statistician support on numerous and varied studies in the social
     sciences field.

     1960 - 1970.  United States Department of Agriculture.  Survey
     statistician and mathematical statistician in the Research and Develop-
     ment Branch.  Primary responsibilities in nationwide surveys involving
     area- and multiple-frame and other types of probability sampling.
     Mathematics instructor at Rollins College, Winter Park, Florida.

Education

     B.S., Economics, University of Wyoming, Laramie, Wyoming, 1958.
     M.S., Economics, University of Wyoming, Laramie, Wyoming, 1959.

     M.S. coursework requirements in Statistics, Iowa State University,
          Ames, Iowa, 1963.

     Completed additional courses in Statistics at George Washington
          University and University of Florida, 1963-1967.

     Presently pursuing Ph.D., Biostatistics, University of Alabama,
          Birmingham, Alabama.

Selected Publications

     Williams, S. R. [1971].  "Forecasting Florida Citrus Production,
     Methodology and Development."  U.S. Department of Agriculture .
     Bulletin.

     Williams, S. R. and Schaffer, S. [1971].  Selected Population, and
     Housing Characteristics From a Sample Survey of Households in Greene
     County, Alabama.  Project Final Report, Southern Research Institute.
                                   1-57                              3-10-77

-------
STEPHEN R. WILLIAMS (Continued)
     Williams, S. R., Tropper, P., and Schaffer, S.  [1972].- A Local-Area
     Information Generation System for Transportation, Housing, and
     General Urban Development.  Project Final Report, Southern Research
     Institute.

     Williams, S. R. [1974].  Ambulatory Health Care;  Survey and Fore-
     casting Methodology.  Project Final Report, Southern Research Institute.

     Williams, S. R. and Nash, E. [1974].  Factors Associated with the
     Incidence of Congenital Anomolies;  A Localized Investigation.
     Project Report, Southern Research Institute.

     Williams, S. R. and Schaffer, S. [1975].  "Health Information Systems,"
     Southern Research Institute Bulletin, pp. 12-17.

     Williams, S. R. and Folsom, R. E. [1976].  Bias Resulting From School
     Nonresponse;  Methodology and Findings.  Project Report, Research
     Triangle Institute.
April 1976
                                     1-58                               3-10-77

-------
APPENDIX 1.5




 REFERENCES
     1-59                              3-10-77

-------
                            REFERENCES
1.1       Miesch and Huffman, "Abundance and distribution of lead,  zinc,
          cadmium, and arsenic in soils in Helena Valley, Montana."  Area
          Environmental Pollution Study (EPA Office of Air Programs
          Publication No. AP-91), p. 65.

1.2       Djurie, D., et al., "Environmental contamination by lead  from
          a mine and smelter."  Archives of Environmental Health, Vol.  23,
          pp. 275-279, October 1971.

1.3       Oyanguren, H., and E. Perez, Archives of Environmental Health,
          Vol. 13, p. 185, 1966.

1.4       Seeley, J. L., et al., "Determination of lead in soil."   Applied
          Spectroscopy, Vol. 26, No. 4, pp. 456-460, 1972.

1.5       Research Triangle Institute, Field Sampling Manual.  Research
          Triangle Park, North Carolina:  Research Triangle Institute,
          1976.

1.6       Hammer, D. I., et al., American Journal of Epidemiology,  Vol. 93,
          p. 84, 1971.

1.7       Barltrop, D., et al., "Significance of high soil lead concentrates
          for childhood lead burdens."  Environmental Health Perspectives,
          Washington, D.C.: Government Printing Office, Vol. 7, pp. 78-81,
          1974.

1.8       Chisolm, J. J., et al., "Variations in hematological responses
          to increased lead absorption in young children."  Environmental
          Health Perspectives, Washington, B.C.: Government Printing Office,
          Vol. 7, pp. 7-12, 1974.

1.9       David, 0., "Association between lower level lead concentrates
          and hyperactivity in children."  Environmental Health Perspectives,
          Washington, D.C.: Government Printing Office, Vol. 7, pp. 17-25,
          1974.

1.10      Anderson, D., and J. Clark, "Neighborhood screening in the
          communities throughout the nation for children with elevated blood
          lead levels."  Environmental Health Perspectives, Washington, D.C.:
          Government Printing Office, Vol. 7, pp. 3-6, 1974.

1.11      Turner, D. B., Environmental Protection Agency.  Workbook of
          Atmospheric Dispersion Estimates.  Washington, D.C.: Government
          Printing Office, 1970.

1.12      Calder, K. L., "A climatological model for multiple source air
          pollution."  Proceedings Second Meeting of the Expert Panel on
          Air Pollution Modeling, NA 70 Committee on the Challenge of Modern
          Society, Paris, France, p. 33, July 1971.
                                  1-60                          3-10-77

-------
                      REFERENCES (Continued)


1.13      Busse, A.  D., and J. R. Zimmerman,  Users Guide for the Climatological
          Dispersion Model, EPA-R4-73-024.  Research Triangle Park,  North
          Carolina,  p. 133, 1973.

1.14      Holzworth, G. C., Mixing Height,  Wind Speed,  and Potential for
          Air Pollution Throughout the Contiguous United States.   Research
          Triangle Park, North Carolina:  Environmental  Protection Agency,
          Office of  Air Programs (AP-101),  p.  118, 1972.
                               1-61                             3-10-77

-------
2.0  Field Operations




2.1  On-Site Project Operations (At RTI)




     2.1.1  Project Staff




     2.1.1.1  Overall Supervision




     Field operations will be under the general supervision of James D.




Bates, Director of the Survey Operations Center (SOC) in the Statistical




Sciences Group (SSG) of the Research Triangle Institute (RTI).  All SSG




activities for this research effort will be coordinated under the general




supervision of Dr. W. Kenneth Poole, Director of the Statistical Methodology




and Analysis Center (SMAC).  The RTI and project administrative structures




are presented graphically in figures 2.1 and 2.2,  respectively, with




RTI units likely to be involved in this research effort shaded in figure




2.1.




     2.1.1.2  Survey Director




     Benjamin S.  H. Harris, III, Health Survey Specialist within SOC




will serve as Survey Director, assisted by survey assistant Martha L.




Smith and other survey specialists and survey assistants as required.




Working in close coordination with representatives of SMAC, the Sampling




Research and Design Center (SRDC - see section 1.0), and the Chemistry




and Life Sciences Group (CLSG - see section 3.0),  the Survey Director




will be responsible for supervising the Field Operations, including the




following tasks:




     .  Training RTI project staff in study objectives and data collection




        procedures;




        Public relations at the performance sites;
                                   2-1                          3-10-77

-------
                                                                Treasurer
                                                             W. II. Perkins, Jr.
                                                            Office of Accounting
                                                              R. S. McLean
 Corporate V. P.
  S. C. Asbton
Office of Research
   Contracts
  J.  C. Ragan
ro
I
to



Center for
Population
and Urban-Rural
Services
Acting
Director
Q. W. Lindsey
'////////////
/Chemistry and Life Sciences /
/ / Vice President '///
/// M. E. Wall ////


Center for
Educational
Research and
Evaluation
Director
J. A. Davis



Social Sciences
Vice President
W. C. Eckerman



Center for
the Study of
Social Behavior
Director
A. M. Cruze




Center for
Health
Studies
Director
J. T. Wakelcy

Statistical Sciences
Vice President
D. G. Horvitz


Chief Scientist
B. V. Shah


r
Center for
Development
and Resource
Planning
Director
J. A. Street





Senior Statist!
Paul G. Home
Energy, Engineering, and
Environmental Sciences
Vice President
J. J. B. Worth

:ian
yer


'//////
//Computer /
S Applications >
/. Center //
/ Director /
R. 11. Thornton'

/ Statistical '/
f Methodology and /
, Analysis Center ,
s Director /
O'W. K. Poole •'/





National Assessment
Administration Center
Director
W. K. Grogan, Jr.



X/Survey //
/ Operations '/
'/ Center //
/ Director //
'/I. D. BatesV/
1
'// ita/xy
/Research and /
s Design Center /
/ Director //
J. R. Chromy >
    Fig. 2.1.   Research  Triangle Institute administrative  structure.

-------
N>
I
U)
         UNC
         C.  M.  Shy
         Epidemiologist
         Program Advisor
         Research Assistant
                                                       M. E. Wall
                                                    Program Director
                                                    CLSG  '
R. W. Handy
Chemist
Program Advisor
                                           SSG
W. K. Poole
Senior Biostatistician
Program Advisor
1
J . Kearney
1
Laboratory
Assistants



SRDC

J . Chromy
S. Williams
L. Piper
L. Bressler


SOC

D. Bates
B. Harris
M. Smith


SMAC-CAC

T. Hartwell
L. Bressler

                                                                                   Field Operations Personnel
                                                                                   Survey Specialists
                                                                                   Survey Assistants
                                                                                   Survey Clerks
                                                                                   Independent  Subcontractors
         Fig. 2.2.  Project administrative structure,

-------
        Recruitment and briefing of independent subcontractors;




        Pretest of data collection instruments and procedures;




      .  Receipt control, verification, and entry of data; and




        Quality control procedures relevant to the foregoing tasks.




      2.1.1.3  Site Administrator(s)




      Data collection, coordination and validation at the performance




sites will be conducted by a CLSG professional acting as Site Administrator




(SA)  and independent subcontractors, with overall supervision by the




RTI Survey Director and backup administrative assistance available from




RTI's national staff of Field Supervisors (see below).  The SA will be




responsible for overall coordination and quality control of data collection




at each performance site; for the collection of all air samples, general




soil  and water samples, and market basket samples (see below); and for




coordination and shipment of data from the performance site to RTI.




An SA will remain at the site for the duration of data collection; the




same  SA(s) at the very least will oversee such activities at sites representing




the same type smelter.  At the present time, RTI anticipates that J.




Kearney will be one SA, with backup from Project Leader Handy and Survey




Director Harris (see figure 2.2).




      2.1.1.4  Data Receipt Control, Scan-Edit, and Direct Entry




     Data receipt control, scan-edit,  and entry at RTI will be under




the general supervision of Mildred C.  Pennington.   Throughout planning




for and conduct of receipt control, scan-edit and entry, one experienced




Survey Assistant will be assigned to the project to provide overall supervision




of these tasks.  Experienced survey clerks will check in survey instruments,




perform the scan-editing, maintain manual logs, and refer problem cases to




the Survey Assistant or Survey Director for resolution.  Direct data entry
                                   2-4                        3-10-77

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will also be conducted under the supervision of Survey Assistant Smith,




with overall guidance from the Survey Director as needed.




     Resumes of individuals named in the preceding paragraphs will be




found in appendices 2.1 and 3.1.




     2.1.1.5  Training Manual




     A training manual will be developed by RTI for use in training RTI




project staff and briefing independent subcontractors.  This manual will




address study objectives; data collection instruments; detailed rationale




and procedures for collecting environmental and biological samples;




coding and editing instructions for all survey instruments; instructions




for administration, coordination, and quality control of all field operations;




and discussions of anticipated problems.  A tentative outline for this




training manual appears in appendix 2.2.




     2.1.1.6  Training Session(s) .




     Before data collection begins at the first performance site, RTI




will conduct an intensive one week training session for RTI project staff,




in particular the prospective SA(s)  who will be responsible for coordination




of data collection activities at the performance sites, and staff who will




be responsible for data receipt control and entry at RTI.  The training




session agenda will in general resemble the training manual outline in




appendix 2.2 and will address study objectives; data collection instruments;




rationale and detailed procedures for collecting environmental and biological




samples; instructions for administration, coordination, and quality control




of all field operations; coding and editing instructions for all survey




instruments; and discussions of anticipated problems.  Since data collection
                                  2-5                      12-17-76

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at the performance sites will be carried out consecutively and will therefore




cover several months, and since some activities will begin immediately




while others will follow in sequence, additional briefing sessions may be




required as refreshers or as special problems arise.




     These training sessions will be conducted by the Survey Director,




Project Leader, and other appropriate personnel assisted by RTI project




consultant experts in epidemiology, biochemistry, and community health




sciences:  Dr. Stephen H. Gehlbach, Assistant Professor of Community Health




Sciences at Duke University, Adjunct Assistant Professor of Epidemiology




in the University of North Carolina (UNC) School of Public Health, and




Director of Research for the Family Medicine Program at Duke University




[Ref. 2.1]; Dr. Carl M. Shy, Director, UNC Institute of Environmental




Studies; and Dr. Boyd R. Switzer, Assistant Professor of Nutrition, UNC




School of Public Health.  Resumes of these consultants will be found in




appendix 2.1.
                                    2-6                      12-17-76

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     2.1.2  Data Receipt Control and Entry




     2.1.2.1  Receipt Control




     Data will be received at RTI/SOC from three sources:  the independent




subcontractors at the performance site, the SA at the performance site, and




RTI/CLSG.  From the independent subcontractors, RTI/SOC will receive




copies of each day's Household Screening Questionnaires (HSQ's) and Logs




(HSL's) and each week's Production, Time and Expense Reports.  From the




SA, RTI/SOC will receive Participant Consent Forms (PCF's) and Study




Questionnaires'(SQ's). From RTI/CLSG, RTI/SOC will receive results of




chemical analyses.  Examples of survey instruments appear in appendix




2.3.




     Each completed survey instrument will be checked in by identification




(ID) number by project personnel on the day received; at the same time,




the document will be assigned to a batch for control purposes.  Completed




survey instruments will be maintained in batches while they are in RTI's




custody.




   .  2.1.2.2  Visual Scan-Edit




     Following check-in and receipt acknowledgement, each document will




be scan-edited on an item-for-item basis to detect omissions, incon-




sistencies, and/or illogical or incompatible entries.  Specifically, this




review is designed to verify:




        That the executor understood and followed the question sequences




        and intent correctly and that entries seem reasonable and




        consistent;




        That any sampling or skip sequences were correctly followed




        and that no applicable items were omitted; and
                                   2-7                      3-10-77

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        That each instrument is properly identified and that all items

        required for verification of the individual's work were

        completed.

     2.1.2.3  Direct Data Entry

     Following scan-edit and error resolution by telephone or other action

(see below), complete survey instruments will be coded by use of communications

terminals permitting direct data entry operations.  Direct data entry means

simply that programmable terminals with keyboards and cathode ray tube

display screens are used instead of manual coding and keypunch.  A programmed

format specifically designed for the survey instrument appears on the display

screen.  As the terminal operator looks at the hard-copy documents, he or she

keys the responses into the terminal.  The keyed data then appear instantaneously

on the display screen.  The data are recorded on magnetic tape cassettes for

transmission to a computer facility.  Hence, the direct data entry process

accomplishes in one step what previously has taken two steps.  In addition,

time savings are substantial because of quality control opportunities

cited below.

     2.1.2.4  Quality Control

     RTI will use three types of quality control in processing the survey

data:  a check of the survey data at the source; at the data entry point,

since the data will be entered through programmable terminals; and the
                                                                                \
traditional concept of verification through re-keying.

     .  Reinterview:  As a quality check of the interview process, RTI plans

to reinterview by telephone, personal visit, or mail, in that order of

preference, approximately ten percent of the population for whom completed
                                2-8                           3-10-77

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questionnaires are obtained.  The actual method of reinterview (mail,




telephone, or personal visit) will be determined according to which is




more convenient, cost-effective, and/or appropriate; telephone would




be the preferred method.  RTI does not anticipate that the reinterview




process would involve the entire SQ.  This procedure will actually permit




a two-fold verification:  that the interview was conducted, and that




responses are consistent.  In the event that inconsistent responses are




detected, an attempt will be made to determine if the inconsistencies




are due to variations in participant response or interviewer error or




misinterpretation; in the latter case, .the interviewer will be contacted




in an effort to resolve the problem.




     .  Visual Scan-Edit;  Should a completed survey instrument fail




the visual edit check, two procedures will be implemented.  First, an




attempt will be made to resolve the problem by telephone from RTI/SOC




to the site of instrument completion.  Second, should the problem be




critical enough to necessitate further action, the document will be trans-




mitted to the appropriate person with specific instructions for resolution.




     .  Direct Data Entry;  Programmable terminals, referred to in numerous




articles as -intelligent terminals,  have proven to be very effective devices




for converting data to machine-readable form.  These devices allow editing




at the point of data entry in a manner that was previously unavailable.




Error rates drop because operators can easily correct keystroke errors




which are normally left for the verifier when keypunches are used.  Even




if the operator must go back to a previous field to make a correction,




no already keyed data are lost.  As the data are entered, the terminal




checks the data for proper range or invalid punches, and if an error is
                                   2-9                     3-10-77

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detected, locks the keyboard.  If necessary, the editing supervisor or




survey assistant can aid the data entry clerk in resolving the error.




     The basic philosophy associated with direct data entry is to provide




a device that allows the operator to make easy corrections of keystroke




errors and to detect at data entry time any errors that may be corrected




by review of the hard copy instrument.   Beyond these checks, it is desirable




to have a minimum of ten percent verification by re-keying to insure that



the data are converted to machine-readable form with a very low error




rate.  Should an error rate of more than one percent per operator be discovered



through re-keying, 100 percent verification of that operator's work will



be carried out.  The Survey Director will be provided regular reports




of the results of direct data entry quality control procedures.
                                   2-10                        3-10-77

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     2.1.3  Confidentiality of Project Data




     There are two basic areas where there should be concern about maintaining




data confidentiality:  source documents (survey instruments/questionnaires)




and data tape files.  RTI recognizes the need to maintain these project




documents under strict controls to insure confidentiality and record integrity.




     Storage for hard-copy source documents (HSQ, PCF, and SQ) shall be in




a secure, well-ventilated, vault-like room in the basement of the Ragland




building on the RTI central campus at Research Triangle Park, North Carolina.




The room has about 600 square feet of floor space and has both wall and




free-standing shelving.  Access is by one locked door, with controlled,




i.e., signed for, entry only on authority of one of the project staff




in charge of receipt control and coding operations.  Materials will be




stored here, with such working amounts as are necessary being removed,




signed for by record identification, and worked on in a secure space under




supervision.  Materials will be received in the mail on a daily flow basis




and, insofar as possible, be dealt with on a flow basis, with real-time receipt




control records being maintained for all processing steps.  Overnight




storage of processing batches will be in a locked and secure work space.




When processing has been completed, all source documents will be filed       *




in an ordered, accessible manner.  During all stages of processing and




storage, project personnel will control access to and removal and replacement




of survey instruments from specified working and storage areas.
                                  2-11                          3-10-77

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     Data tape files will be maintained on a strict need-to-know basis




throughout the extent of the project; at no time will these files be




readily accessible except under specific authority of a senior professional




working on the project.  However, only the PCF will provide a link between




the various ID numbers and a specific participant's name, and the PCF




will never be converted to machine-readable form - that is, the data tape




files will never contain participant's names or addresses.
                                   2-12                         3-10-77

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     2.1.4  Protection of Human Subjects Certification



     The Department of Health, Education and Welfare has determined




that RTI should operate under the special assurance provisions of the




Protection of Human Rights regulations.  Upon notification, the




Institute's Committee on Human Rights is prepared to review the data




collection forms and protocol for this study.  The membership of the




Institute's Committee on Human Rights consists of:






                         Dr. J. N. Brown




                         Dr. W. C. Eckerman




                        • Dr. D. G. Horvitz




                         Dr. M. E. Wall




                         Mr. S. C. Ashton




                         Mr. R. L. Welborn
                                   2-13                          3-10-77

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2.2  Off-Site Project Operations  (At Smelter Locations)


     2.2.1  Performance Sites


     2.2.1.1  Selection


     The Project Officer has specified the following smelter locations


as performance sites for this research effort:


        Anaconda, Montana;


     .  Palmerton, Pennsylvania;


        Herculaneum, Missouri;


        Bartlesville, Oklahoma;


        Bixby, Missouri; and


        Ajo, Arizona,

                                                                            2
most likely in that order  (see section 2.4 - Schedules for Field Operations)-?-


     2.2.1.2  Public Relations


     RTI plans to establish communication with certain agencies/organizations


at/regarding each performance site.  These agencies/organizations will


include but not necessarily be limited to the following:


     .  Various federal agency representatives, including regional EPA


representatives, EPA1s Industrial Environmental Research Laboratory, and


the Center for Disease Control (CDC):  These agencies have had various


interests and contacts in/with environmental studies of smelter communities,


including a recent CDC study [Ref. 2.2]; such contacts/experience may


prove useful to this research effort.


        State and local health agency representatives;  These agencies


may also have had various levels of interest and experience regarding
2 i/
—— In addition, RTI will perform a Pretest at one additional smelter
    location, probably Corpus Christi, Texas - see appendix 2.4.
                                   2-14                          3-10-77

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environmental/health studies of smelter communities; such interest/




experience is expressed in correspondence such as that reproduced as




appendix 2.5 and may prove useful to this research effort.  RTI will




contact appropriate representatives of these agencies in an attempt to




secure their cooperation, assistance, endorsement and participation.




In particular, RTI hopes that the assistance of these agencies might be




enlisted in securing qualified field staff and sites for training field




staff and central data collection (see below).  During initial contact




with appropriate agencies, RTI hopes to make arrangements for the follow-




up of participants for whom study data collected indicate medical attention,




and participants will be informed of such arrangements (see below).




     .  Local education authorities;  RTI will contact appropriate representa-




tives of these agencies in an attempt to secure their cooperation, assistance,




participation, and endorsement.  The cooperation of appropriate education




authorities is considered essential since it will be necessary to collect




soil and water samples at each school where study children participants




attend.  In addition, schools are potential sites for training field staff




and central data collection.




     .  Smelter representatives;  RTI anticipates meeting with represen-




tatives of the smelter industry and individual smelter firms in an attempt




to secure their cooperation and inform them of study activities.  The




role chosen by the smelters may have a significant impact on the cooperation




of potential participants in the smelter communities.
                                   2-15                         3-10-77

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     .  Other;  In addition to the agencies listed in the preceding




paragraphs, RTI plans early meetings/discussions/investigations regarding




other elements in the smelter communities related to the logistics of




this research effort, including local electric utilities regarding power




drops for air sampling devices; transportation alternatives for independent




subcontractors, participants, and in particular the shipment of study




materials to and from RTI; hotels/motels for training and accommodation




of field staff; and municipal agencies such as the police department to




inform them of study activities.




     2.2.1.3  News Releases




     Once the various levels of public relations have been completed,




and the positions and levels of participation of the various agencies




have been determined, RTI plans a series of news releases, approved by




the Project Officer, through the appropriate federal, State, or local




agency to inform the public of the study's objectives and activities in




an attempt to improve cooperation by potential study participants.  RTI




anticipates that all involved agencies, including the smelter(s), will




have an opportunity to review these news releases before they are released.




RTI anticipates involvement of local and area newspapers, radio, and tele-




vision in this publicity campaign utilizing news releases and public service




announcements which would explain succinctly the reasons for and potential




benefits of the study.  This publicity campaign will probably start at




each performance site approximately two weeks before data collection is




to begin.
                                  2-16                          3-10-77

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     2.2.2  Independent Subcontractors




     2.2.2.1  Recruitment




     While at the smelter location to contact appropriate federal, State




and/or local agencies related to the study, RTI will initiate recruitment




of field staff/independent subcontractors to participate in the actual




study data collection.  RTI plans to retain two types of staff who will




work as independent subcontractors to perform data collection in the field,




coordinated by the SA:




     .  Field Interviewers  (FI's) who would be responsible for contacting




and screening households, completing questionnaires, measuring paint lead




levels, and collecting dust and water samples and some soil samples; and




     .  Medical personnel  such as Registered Nurses or medical technicians




to obtain the blood and hair samples, collect the urine samples, and perform




the hematocrit and urine protein and specific gravity determinations.




     With regard to recruiting the field staff at each location, RTI




anticipates three potential sources:




     .  RTI listings:  RTI has been conducting national surveys for




over 16 years and has conducted other studies involving surveys in various




parts of the nation.  As a result, a current list is available of some




2,500 persons who have served RTI on one or more projects or have indicated




their availability.  This list will serve as the starting point in securing




qualified individuals.  Many of the persons on this list have at least




some health-related training and/or experience.  For example, figures
                                   2-17                      3-10-77

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2.3 through 2.7 present graphically the number of interviewers from the




current RTI listing living in counties within a reasonable distance of the




performance sites in Arizona, Missouri, Montana, Oklahoma, and Pennsylvania,




respectively.  That is not to say that all of these individuals would be




available or suitable for this research effort (see below).




     .  State and local agency contacts;  RTI hopes that some qualified




field personnel might be retained through the assistance of State and local




agencies, particularly health agencies (see appendix 2.5).  RTI may offer




such agencies an active role in the collection of biological samples from




household survey participants by subcontracting that aspect of the data/




sample collection to such agencies, by engaging agency personnel to work




for RTI during their off time, or by assisting RTI in retaining qualified




individuals to serve as independent subcontractors.




     .  Newspaper advertisements;  Appropriate advertisements will be




placed in local or area newspapers.




     .  Interviews;  Once potential field staff have been located, they




will be screened and interviewed by RTI staff, most likely the Survey




Director, in order to determine their qualifications and availability




for this research effort. At each site, RTI anticipates retaining at




a minimum three FI's and two medical staff members; an additional FI




will most likely be retained at each of the three sites where individuals




over 60 years of age will be surveyed, so that data collection can be




completed at each site in approximately one month (see below).
                                   2-18                          3-10-77

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          LEGEND
®   Places ol 100.000 01 more inhabitants
•   Places of 50.000 to 100.000 inhabitants
O   Places of 25,000 to 50.000 inhabitants outside SMSA's
         Standard Metropolitan
          Statistical Areas (SMSA's)
  Fig  2.3.   Location and number of  interviewers from the  current RTI  listing
              living in  counties within a  reasonable distance of  the Ajo, Arizona,
              performance site  [Source:  Ref. 2.3, p.  972].
                                           2-19
12-17-76

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 I
t-0
O
                                                                                                             LEGEND

                                                                                                     ®  Places ol 100.000 or mo'e inhabitants
                                                                                                     •  Places ol 50.000 lo 100.000 inhabitants
                                                                                                     O  Places ol 25.000 lo 50.000 inhabitants outside SMSA's
                                                                                                          •:TT~) Standard Metropolitan
                                                                                                             Statistical Areas iSMSA'sl
               Fig.  2.4.   Location  and number of interviewers from the current RTI listing  living in  counties
                            within a  reasonable distance of  the Bixby and Herculaneum, Missouri, performance  sites
                            [Source:   Ref.  2.3, p. 995].

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10
to
ISJ
I
                                                       BILLINGS
                                                    YELLOWSTONE
                                                       •
                                                     BIKINGS
    SCALE
O IO 2O 3O 4O SO MILC5
                                                                                                   LEGEND
                                                                                         •   Places of 50,000 to 100.000 inhabitants
                                                                                         O   Places of 25.000 to 50.000 inhabitants outside SMSA's
                                                                                                  Standard Metropolitan
                                                                                                   Statistical Areas (SMSA's)
                Fig.  2.5.  Location  and number of interviewers from the  current RTI  listing  living in
                            counties  within a reasonable distance of the  Anaconda, Montana, performance  site
                            [Source:   Ref.  2.3, p. 996].

-------
to
to
to
                                                                                            BARTLESVILLE**
                                                                              OKLAHOMA CITY -
                                                                              CANADIAN  ^ OKLAHOMA .

                                                                             OKIAHOMA cirr
                      LEGEND


            ®  Places ot 100.000 or more inhabitants

            •  Places of 50.000 to 100.000 inhabitants

            O  Places ol 25.000 to 50.000 inhabitants outside SMSA's
                   ,*—i Standard Metropolitan

                      Statistical Areas (SMSA's)
10

I-1
^J
                                                                                       SCALE

                                                                                    IO  »O 3O  4O 9O MILC9
                Fig.  2.6.   Location  and number  of interviewers  from  the  current RTI  listing living  in counties

                             within a  reasonable  distance of the  Bartlesville, Oklahoma, performance  site

                             [Source:   Ref.  2.3,  p. 1006].

-------
                                                                                                        BINGHAMTON
 NJ

 NJ
 CO
N)
-»4
ON
                                                                                              I ( f ^ . /^^^l^T^    Al I CMTrMAIM
                                                                                                                     IWN r'BETHLE H EM • E ASTON
                               LEGEND
                      (•)  Places ol 100.000 or more inhabitants
                      •  Places ol 50.000 to 100,000 inhabitants
                      D  Central cities ol SMSA's with (ewer than 50.000 inhabitants
                      O  Places ol 25.000 to 50.000 inhabitants outside SMSA's
                               Standard Metropolitan
                                Statistical Areas (SMSA's)
     SCALC
_IO  JO    JO
               Fig.  2.7.   Location and number  of interviewers from  the current RTI listing  living  in counties
                            within  a reasonable  distance  of the Palmerton,  Pennsylvania,  performance  site
                            [Source:  Ref.  2.3,  p. 1008].

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     .  Qualifications;  Potential FI's should ideally be known to and/or




recommended by RTI, various State or local agencies, and/or similar organiza-




tions; present evidence of relevant survey, environmental, and/or health-




related experience; live within a reasonable distance of the performance




site; have an automobile available; be available to work irregular hours




and/or weekends; and be physically capable of carrying the survey equipment




and materials.  The medical independent subcontractors should ideally



meet the above criteria, and be awcrently employed in some area requiring




acquisition of blood samples, preferably from children.  In certain areas,




such as Arizona, RTI will attempt to retain experienced independent sub-




contractors who are bilingual - that is, speak English and Spanish, although




a recent RTI study demonstrated no significant difference in performance



between monolingual and bilingual interviewers working with elementary




school children and adults with limited English-speaking ability in four




areas of the United States, including parts of Texas and Arizona [Ref. 2.4].




     2.2.2.2  Training




     After the independent subcontractors have been recruited and before




data collection activities begin, RTI will conduct two-day briefing sessions



at each performance site to acquaint the independent subcontractors with



study objectives; survey instruments; rationale and detailed procedures




for collecting environmental and biological samples; administrative and




quality control considerations; and anticipated problems, in order to
                                   2-24                         3-10-77

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increase the relevance and quality of the data collected.  The training




session agenda will follow closely the outline and content of the training




manual, a tentative outline of which is presented in appendix 2.2.




     The training sessions will be conducted by the Survey Director,




RTI Senior Chemists, and consultants, and will be attended by the RTI




professional SA and the independent subcontractors.  During the training




sessions, the independent subcontractors will be carefully instructed in




all aspects of the field work.  Considerable emphasis will be placed on




the objectives and significance of the study and the nature of the data




collection.  Practice interviews will be conducted to insure that each




FI becomes thoroughly familiar with household screening and interviewing




techniques and use of the survey instruments.  During the first day of




household contact, which will hopefully follow immediately the training




session, the Survey Director and SA will accompany the FI's to assist




them with their first household contacts.  If it becomes apparent that




any independent subcontractor needs additional training, such instruction




will be provided before the field work assignment is given.




     2.2.2.3  On-Site Consultants




     As a contingency, RTI plans to enlist the services of physician con-




sultants on-site to serve as points of contact for the field staff in




the event that any problems or questions are encountered in the data




collection process, particularly in regard to the acquisition of biological




samples.  For example, the existence of certain disease entities such as




bleeding tendencies may preclude the acquisition of a blood sample from




a given participant.
                                    2-25                          3-10-77

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     2.2.3  Household Data Collection




     2.2.3.1  Screening




     Once RTI/SRDC has designated the data collection areas/grids within




each performance site related to distance downwind from the smelter; data




collection instruments and forms have been approved by the Office of Manage-




ment and Budget (OMB); and the field staff have been retained and trained,




household data collection will begin.




     FI's will be primarily assigned to specific areas or grids within




the smelter community; this procedure should facilitate the FI's familiarity




with and recognition within that area or grid.  Data will be collected




by door-to-door interview.  Each residence unit encountered in each data




collection grid will be visited in sequence.  Within each residence unit




so encountered, households will be screened to determine those containing




eligible individuals - that is, those (1) with no direct occupational




exposure to the smelter within the preceding 12 months, (2) who have lived




within the smelter study area for at least the preceding 12 months, and




(3) who fall within one of the four study age groups:  pre-school 1-5 years




or 12-72 months of age, school age 6-18 years of age, and adults 20-35




years of age (with an option to age 40), and in three sites 60 years of




age or greater.  Such eligibility will be determined by the FI as part




of the household data collection process.  A residence unit within the




data collection grid may contain more than one household containing an




eligible study participant.  Similarly, such a household may contain more




than one eligible study participant.  Each eligible person in those residence




units will be invited to participate in the study until the required number




and distribution of participants is obtained.










                                  2-26                          3-10-77

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     At the time of first household contact, the FI will introduce himself




as a representative of RTI and EPA; present study identification and




(hopefully) copies of letters from appropriate federal, State and local




agencies; and explain the nature and purpose of the study.  The FI will




maintain a log record of residence units and households visited and screened




on a Household Screening Log (HSL - see appendix 2.3).  Screening of the




household to determine whether or not it contains eligible individuals




will be determined by administration of the HSQ (see appendix 2.3).  RTI




anticipates a certain number of nonrespondents, or households which cannot




be screened; nonparticvpants or refusals; and -ineligibles, . or households




which contain no eligible respondents.  If an eligible person refuses to




participate in the study, the refusal and the reason(s) therefore will




be noted on the HSL.  Visits to screen potential households or to enlist




participants will be limited to three.




     2.2.3.2  Participant Consent Form




     When an eligible person within a household agrees to participate,




the precise location of the residence unit will be noted on a map at




the time of the enlistment, so that the distance of the residence unit




from the smelter can be accurately calculated.  In addition, the




individual will be required to sign a Participant Consent Form (PCF - see




appendix 2.3) in order to participate in the study.
                                   2-27                        3-10-77

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     The PCF will introduce the study; explain its objectives,




sponsorship (the relationship and roles of RTI and EPA), and re-




quirements of and risks, burdens, and benefits to participants; and




stress that participation is completely voluntary and that all data




collected will be kept confidential.  The PCF will hopefully contain




an indication of the support and/or involvement of appropriate State and




local agencies; the names and telephone numbers of appropriate authorities




so that participants may obtain additional information if desired; and




inform the participants of arrangements with these agencies for appropriate




follow-up of any study participants for whom study data collected indicate




a need for medical attention.  The PCF will be signed by the participant




or, in the case of persons under age 18, the parent or other responsible




guardian, and will contain an agreement to provide the necessary information




and samples, including a specific release and arrangements (appointed




time and place) to draw blood.  Participants may freely withdraw from




the study at any time; however, in order to encourage participation RTI




will offer an incentive of ten dollars to each participant to be paid




after the blood sample is obtained.  Again, confidentiality of data will




be stressed, including steps taken to disassociate the name of the par-




ticipant from the data once collected; for example, the PCF is the only




data collection instrument which will bear the name of the participant




and allow its association to study identification numbers, but will be
                                   2-28                         3-10-77

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maintained in hard copy only and stored in a restricted area, as indicated




in a previous section.  To further emphasize this disassociation, the




incentive will be paid in cash rather than by check or money order, although




the participant or his/her guardian will sign a receipt indicating that




the incentive was received.  The PCF will make two copies, one for the




head of the household and one for the participant or his/her guardian;




the original will be attached to the questionnaire until it is received




at RTI and verified.  Where required, the PCF will be available in more




than one language - for example, English and Spanish for Arizona.




     2.2.3.3  Study Questionnaire




     The Study Questionnaire (SQ - see appendix 2.3) is divided into four




parts, Part A related to the household and which will be completed only




once for each household containing at least one participant; Part B related




to the individual participant;  Part C providing information on the interviewer




and respondent; and Part D recording paint lead levels and the results




of hematocrit and urine protein and specific gravity determinations,




and indicating whether or not corresponding and duplicate environmental




and biological samples were obtained, and the date, time, and place of




acquisition of such samples.  Participants will be identified by a unique




study number used to correlate and cross-identify the questionnaires




and samples (see below) by way of pre-printed self-adhesive labels.




     Household information includes questions related to family socioeconomic




status (occupations, educational levels), and questions related to food
                                   2-29                          3-10-77

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sources and preparation.  Information on individual participants includes




demographic characteristics such as age, sex, race, marital status,




occupation, and education level; residence information; health informa-




tion such as current health status and history of exposure to heavy




metals, including questions related to symptoms of clinical and sub-




clinical toxicity; personal characteristics such as exposure to cigarettes




and various drugs and sundries, and average number of hours spent outside




each day; and dietary information such as exposure from foods high




in heavy metal content [Ref. 2.5] and history of pica, the ingestion of




non-food substances such as paint, clay, and plaster.  In addition, for




children participants, information will be collected on location of play




area(s) and school(s) attended.




     2.2.3.4  Sample Collection




     The specific methods proposed by RTI for measuring environment-




related factors differ somewhat among the various types of exposure.




These differences reflect several considerations such as the extent to




which surrogate variables reflect the factors of interest, the measur-




ability of factors, the variability of factor measurements, the quality




control of data collection, and the suitability of data collection techniques




under actual survey conditions.  The proposed methodology stresses random




sampling techniques wherever possible to facilitate valid statistical




analyses and to increase the degree of control over data collection;




FI's will follow explicit, nonjudgmental procedures throughout.  These
                                  2-30                           3-10-77

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procedures will range, as described in appendix 2.6, from obtaining small




selective samples of relatively homogeneous items, such as tap water




at a particular residence, to obtaining large stratified random samples




for a highly variable item, such as air quality in a smelter community.




     As indicated in preceding sections, data collection will be divided




among the various field staff.  The collection of environmental samples




will be divided between the SA and the FI.  The SA will be responsible




for collecting air, market basket, and general soil and water samples




such as soil and water samples from each school where study children




participants attend; RTI anticipates that more than one school age child




participant may attend the same school.  The FI will be responsible for




the selection and screening of residence units, households, and eligible




participants; acquisition of the PCF and administration of the SQ; collection




of dust and tap water samples for each participating household, and soil




samples from the appropriate play area for each pre-school child participant;




measurement of paint lead levels; explanation of the procedure for collecting




the urine sample; and arrangements for the participant to go to a central




location for acquisition of the biological samples and disbursement of




the incentive.  At that central location, the urine, blood and hair samples




will be collected by the medical independent subcontractor, who will




also perform the hematocrit and urine protein and specific gravity deter-




minations.




     For each household containing a study participant, paint lead levels




will be measured, samples of housedust and tap water will be collected,




and the precise location of the residence noted on a map so that the distance




of the residence unit from the smelter can be accurately calculated.  For











                                   2-31                          3-10-77

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each study participant, RTI shall endeavor to obtain a completed PCF and




SQ, and samples of blood, urine, and scalp hair; in addition, soil samples




will be collected from the appropriate play area for each pre-school child




participant and from each school yard where study children participants




attend.




     2.2.3.5  Quality Control



     Two aspects of quality control will directly involve the participating




households and individuals - duplicate samples and reintewLew.   For




households/participants for whom duplicate samples are to be collected,




the purpose and procedures for collecting the duplicate samples (see below)




will be explained.  Each person completing an HSQ or an SQ will be informed




that they may be selected for reinterview.
                                   2-32                         3-10-77

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     2.2.4  Central Data Collection




     As indicated in preceding sections and paragraphs, RTI plans to arrange




for the collection of biological samples at a central location which would




be manned by at least one medical staff member and probably an FI for




four hours in the evening Monday through Friday and eight hours during




the day on Saturdays.  Participants would come to this location to deposit




their urine samples and permit the collection of blood and scalp hair




samples.  In addition, hematocrits and urine protein and specific gravity




determinations will be performed at this location.  In the event that




a participant does not have transportation to the location, RTI will be




prepared to provide transportation.  In the event that the participant's




physical condition makes travel impractical, such as an elderly, disabled,




or otherwise infirm person, the medical staff member may have to go to




the home in order to obtain the necessary samples.  Ideally, the biological




samples will be collected the day after the participant is enlisted or




during the day on the next Saturday.
                                   2-33
                                                                3-10-77

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     2.2.5  Site Administrator's Responsibilities


     At each performance site, the SA will have three areas of responsibility:


(1) general supervision and coordination of field operations; (2) collection


of certain general samples; and (3) data management, handling, and shipment.


     2.2.5.1  Coordination of Field Operations; Data Management
                «

     As indicated in preceding sections, an RTI professional will serve


as SA and as such be responsible for the coordination and quality control


of data collection; these individuals will remain at each site for the


duration of data collection at that site, and at the very least the same


individual(s) will oversee such activities at sites representing the same


type smelter.  The SA will work in close communication with the Survey


Director and other professionals at the RTI central facility at Research


Triangle Park, North Carolina, in order to coordinate and supervise immediate


field operations at each performance site.  The SA will have to coordinate


his own project activities with those of the independent subcontractors


to ensure that various project activities proceed as effectively and efficiently


as possible with regard to both time and cost.  The SA will also serve as


a trouble-shooter.


     Among the field operations which the SA will have to coordinate


are:


        Obtaining household mapping information, copies of HSLs, HSQs,


and administrative forms, and soil, tap water, and housedust samples from


the FI's;
                                   2-34                         3-10-77

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        Scheduling and transportation of participants to the central




data collection facility for collection of biological samples, including




delivery of the completed PCF and SQ to the central data collection facility;




and




        Retrieval of the completed PCFs, SQs and biological samples




from the central data collection facility.




     2.2.5.2  Sample Collection




     As intimated and discussed in preceding sections and appendix 2.6,




the SA will be responsible for collecting random air samples in the




smelter community, composite soil samples from the smelter community at




large as well as from each school yard where study children participants




attend, water samples from each school where study children participants




attend, and market basket samples.




     2.2.5.3  Data Storage, Packaging and Shipment




     With regard to survey instruments, the SA will only be responsible




for shipping the completed PCFs and SQ's to RTI/SOC, although he will




receive copies of HSLs, HSQs, and various administrative forms from the




appropriate independent subcontractors for review and reference as needed.




     All samples will be chilled to 0°-5°C (not frozen) after collection




and will be shipped in this condition via Federal Express.   Shipment by




Federal Express eliminates the possibility of sample contamination due




to pressure gradients in transit.  High density polyethylene containers




will be used for tap water, urine and soil samples; Poly-Seal caps will




be used to provide a leak-proof seal without contamination.  Plastic containers




will be shipped in styrofoam blocks in which depressions are cut to exactly




hold each container.  RTI experience with such shippers has resulted in no




container damage and a minimum of sample temperature change during transit.







                                   2-35                         3-10-77

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     Zip-Loc plastic containers will be used for air, scalp hair and dust




samples.  RTI experience with Zip-Loc plastic containers indicates that




the Zip-Loc seal insures containment protection eliminating sample loss




and contamination.  The plastic bags will be shipped in a styrofoam-lined




box.




     Blood samples will be shipped to RTI in specially designed 8-tube




Vacutainer shippers.  As with other samples, blood samples will be chilled




(not frozen) in order to reduce losses due to hemolysis and volatilization.
                                   2-36                         3-10-77

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     2.2.6  Quality Control




     2.2.6.1  Training




     In order to standardize the quality of data collection techniques




and procedures from the outset, a training manual will be developed by




RTI for use in training RTI project staff and briefing field interviewers.




This manual will address study objectives; data collection instruments;




detailed rationale and procedures for collecting environmental and




biological samples; instructions for administration, coordination, and




quality control of all field operations; instructions for data receipt




control, scan-edit, and entry; and discussions of anticipated problems




(see appendix 2.2).  In addition, RTI will conduct training sessions for




RTI project staff and independent subcontractors which will address study




objectives and procedures in order to increase the quality and relevance




of data collected.  One major objective of the training activities will be




to provide explicit, nonjudgmental procedures for the field staff to follow.




     2.2.6.2  Supervision




     The RTI Survey Director will supervise and coordinate the field




operations, providing flexibility of coverage should additional pro-




fessional level effort be required at any time during the data




collection period.  An SA will remain at the performance site until




data collection is completed, and the same SA(s) will be used at least




for sites of the same smelter type.  RTI plans to enlist the services




of physician consultants on-site to serve as points of contact for the




field staff in the event that any medical problems or questions are
                                   2-37                          3-10-77

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encountered in the data collection process, particularly in regard to




the acquisition of blood samples.




     The Institute has a field operations staff of Field Supervisors (FSs)




located at key points across the country who have coordinated the work




of field data collection staffs for a variety of projects and will be




available to assist with supervision and/or coordination of data collec-




tion for this project if required.  These area supervisors are currently




based in or near the following major metropolitan areas:  Boston, New




York, Washington, Atlanta, Pittsburgh, Detroit, Chicago, St. Louis,




Houston, Los Angeles, and San Francisco.  At the very least, the appropriate




FSs will be made aware of project activities and provided a copy of the




training manual; depending upon time and cost considerations, the appropriate




FS may be invited to attend the training session at the performance site.




     In order to facilitate supervision, both RTI/SOC and the SA will re-




ceive copies of the HSLs, HSQs and various administrative forms completed




by independent subcontractors which will provide an opportunity to monitor




the production and activity of the field staff.




     As indicated in preceding sections, the Survey Director and SA will




accompany the independent subcontractors during the first day of data




collection at each performance site.  The SA will be encouraged to meet




frequently with independent subcontractors to review study progress and




problems, and independent subcontractors will be observed occasionally in




the performance of their duties.  Survey instruments will be edited upon




receipt at RTI/SOC.




     2.2.6.3  Sample Collection




     Each sample will be properly labeled as it is collected.  Each individual




sample will be treated the same as all other samples of that particular type.








                                   2-38                         3-10-77

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     2.2.6.4  Duplicate Sample Collection




     As a check on the quality or precision of collecting certain




of the biological and environmental samples, RTI plans to collect




duplicate soil, housedust, tap water, blood, and scalp hair samples (the




last two from adult participants only) from ten percent of the sample




sources, using the same technique and as nearly as possible the same sites




as the original sample (see appendix 2.6).  In the event that problems




are detected, an attempt will be made immediately to determine the cause




and appropriate resolution of the problem.




     2.2.6.5  Reinterview




     As a quality check of the interview process, RTI plans to reinter-




view by telephone, personal visit, or mail, in that order of preference,




approximately ten percent of the population for whom completed questionnaires




are obtained.  The actual method of reinterview (mail, telephone, or




personal visit) will be determined according to which is more convenient,




cost-effective, and/or appropriate; telephone would be the preferred




method.  RTI does not anticipate that the reinterview process would .involve




the entire SQ.




     This procedure will permit a two-fold verification - that the interview




indeed took place and that responses are consistent.  In the event that




inconsistent responses are detected, an attempt will be made to determine




if the inconsistencies are due to variations in participant response or




FI error or misinterpretation; in the latter case, the FI will be contacted




in an effort to resolve the problem.
                                  2-39                         3-10-77

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     2.2.7  Respondent/Participant Burden




     The only anticipated risk to participants will involve the acquisition




of the blood sample, and the burden will consist of the time to respond




to the questionnaire(s), the time and inconvenience of allowing the FI




into the household to collect the household environmental samples; and




the time, inconvenience and perhaps minor discomfort of providing the biological




samples  (see below).  In order to complete household data collection,




approximately two hours of time may be required of each participant, including




travel and the collection of all relevant samples.  More specifically,




RTI anticipates that 45 minutes will be required to complete the question-




naire (s) for each participant, 30 minutes will be required to collect




the household environmental samples, and 20 minutes will be required to




obtain the biological samples, leaving 25 minutes for travel time to the




central data collection facility.




     To offset this burden, RTI will offer the incentive of ten dollars




per participant and an opportunity to obtain some health measurements, such




as the hematocrit, urine protein, and the various analyses for metal burden.




Potential participants will be informed of arrangements with appropriate




area agencies for the followup of study participants for whom study data




indicate medical attention.
                                   2-40                         3-10-77

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2.3  Anticipated Problems




       RTI has identified the following potential problem areas which may have




a significant impact on project time, cost or validity.




          2.3.1  Smelter Resistance




     RTI has assumed that the smelter industry will provide at the very




least a promise of verbal cooperation or passive resistance.  In the event




that the smelter takes.a position of active resistance, project performance




at a given site might be seriously jeopardized, since most of the performance




sites are relatively small communities whose economy is significantly influenced




by the smelter.




     2.3.2  Recruiting Independent Subcontractors




     Since the six performance sites were not specified prior to the




signing of the contract, RTI predicated field operations costs on the




assumption that qualified independent subcontractors could be retained




at, or within a reasonable distance of, the smelter community performance




site.  Should RTI be unable to find qualified independent subcontractors




at, or within a reasonable distance of, the performance site, they will




have to be brought into the performance site from more distant points




at an additional expense for travel and subsistence.




     2.3.3  Nonparticipants




     As indicated in preceding sections, RTI anticipates a certain number of




nonrespondents, nonparticipants, and ineligibles.  However, in some of these




small smelter communities, these various categories of nonparticipants may




significantly reduce the number of data sets available for analysis.   Through




callbacks and the incentive, RTI hopes to keep nonrespondents and non-
                                   2-41
                                                              3-10-77

-------
participants at a minimum, but eligibility is determined by established criteria.




In some of these small smelter communities, for example, the number of




adult men without direct occupational exposure may be small.




     2.3.4  Incomplete Data Sets




     Even though an individual may agree to participate in the study and




sign a PCF, a complete set of questionnaires and samples for that individual




may not be obtained for a variety of reasons such as baldness, inability




or refusal to provide a scalp hair or urine sample, or refusal to provide




a blood sample.  RTI has anticipated some of the potential problems in




obtaining complete data sets and made appropriate provisions, such as




offering an incentive to be paid only after collection of the blood sample;




transportation to and from the central data collection facility; and




arranging for the medical independent subcontractors to visit the participant




at home to collect the biological samples if necessary.  Nonetheless,




participation in this survey is voluntary and the small size of most




of these smelter communities limits the number of eligible volunteers.




Therefore, RTI will accept as a minimum data set a blood sample and completed




HSQ, PCF, and SQ.




     2.3.5  Missing Data




     Since various data elements must be shipped to RTI from the performance




site via Federal Express and/or mail, the possibility exists for those data




elements to be lost or damaged so as to not be useable.  In the past, RTI




has had little problem with regular first class mail.
                                   2-42                         3-10-77

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2.4  Schedules for Field Operations




     2.4.1  Time Schedule




     Figure 2.8 presents graphically a time schedule for the field




operations, including preparations, data collection in the field, and




data processing.  In figure 2.8, tasks at RTI are as follow:




     Task 1 - Preparation of work plan and data collection instruments;




     Task 2 - Review and revision(s) of work plan and data collection




              instruments;




     Task 3 - Preparation of training manual;




     Task 4 - Training session;




     Task 5 - Data receipt control, edit and direct entry;




     Task 6 - Reinterview; and




     Task 7 - Preparation of final report.




For each performance site, Phase I refers to public relations,




recruitment of independent subcontractors, and publicity; Phase II




refers to training; and Phase III refers to data collection.  This




time table is predicated on approval of study protocol and data




collection instruments by EPA and OMB early in 1977.  In order to




minimize interviewer and participant burden, RTI anticipates that




field operations at each site would be conducted during temperate




weather; some studies have indicated that weather plays a significant




role in project efficiency and participation. [Ref. 2.6]




     At this point in time, RTI anticipates that the performance




sites would be studied in the following order:




     Pretest - Corpus Christi, Texas;




     Performance site 1 - Anaconda, Montana;




                      2 - Palmerton, Pennsylvania;




                      3 - Herculanuem, Missouri;





                                2-43                           3-10-77

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to
I
I
M
O




RTI




PRETEST
PERFORMANCE
SITE 1

2

3

4

5

6

TIME
FRAME

TASKI
P^ '"k *,
l*.'...*..~f 	 '




















0 N D
1976


iisK'i' '„ '^V/'.j
...'....{ 	 "^''.Sl5. ,./Jm.j
TASK 3i:;:i;:^|TASK 4
>99<>?$^>6<5<>^^

TASK| 11 | | | 1

ii
i 	 i,*;i
ii
i | i !
ii
r i «.i
ii
• i » i
ii
1 \ 1 »« 1
II
i | m i
n
1 • 1 *-

J F M A M J J A S 0 1 N D
1977 1977




S56I

TASK 7
















J F M
1978
      Fig. 2.8. Field operations time  table.

-------
                      4 - Bartlesville, Oklahoma;




                      5 - Bixby, Missouri; and




                      6 - Ajo, Arizona.




It is further anticipated that the elderly age group will be studied




at Herculanuem, Bartlesville, and Ajo.
                                2-45                       12-17-76

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     2.4.2  Cost Schedule




     Figure 2.9 presents graphically cumulative estimated cost (exclusive




of fee) and labor (man-months) projections by month for the field operations.




These cost and labor projections are based on figure 2.8 and predicated




on the same assumptions.
                                   2-46                         3-10-77

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I
M

?
                                    •      •   MAN-MONTHS

                                           •   COST
            Fig. 29     Field operations cost and labor  projections.

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                APPENDIX 2.1
RESUMES OF RTI PROJECT STAFF AND CONSULTANTS
                     2-48                         12-17-76

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JAMES D. BATES, Director, Survey Operations Center
Professional Experience

     1963 to date.  Research Triangle Institute, Research Triangle Park, North
     Carolina 27709.

          1976 to date:  Director, Survey Operations Center.

          1972-1976:  Manager, Survey Methodology and Operations Department.

          1971-1972:  Senior Economist', Center for the Study of Social Behavior.

          1968-1971:  Head, Economics Section in Social Statistics Group.

          1965-1968:  Economist in Sampling Group of Statistics Research Division.

          1963-1965:  Statistics Research Division contract with U.S. Agency for
          International Development on project as Survey Statistician.  Rural
          Economic Surveys, Federal Office of Statistics, Nigeria, West Africa.

     1961-1963.  Florida Citrus Commission, Department of Agricultural Economics,
     University of Florida, Gainesville, Florida.  Assistant Marketing Research
     Economist.

Education

     B.S., Agricultural Economics, University of Florida, 1958.

     M.S., Agricultural Economics, University of Florida, 1963.

     Completed course work toward Ph.D. in Economics at North Carolina State
     University.

Professional Activities

     American Economic Association, member.
     American Farm Economic Association, member.
     Phi Kappa Phi.
     Gamma Sigma Delta.
     Alpha Zeta.

Publications and Reports

     "Behaviorial Characteristics of Customers Shopping for Fresh Oranges,"
     (with S.W. Williams and M.R. Godwin) Florida Citrus Commission, in
     cooperation with the University of Florida Department of Agricultural
     Economics, Agricultural Experiment Station and the Marketing Economic
     Division of ERS, USDA, Pub. S.C.C.-E.R.D. 65-8, May 1965.

     A Study of Job Vacancies and Manpower in Durham County, James D. Bates,
     Statistics Research Division, Research Triangle Institute, July 1966.

     A Study of Financial Assistance to Child Care Institutions by the State
     of North Carolina, James D. Bates and James A. Street, Statistics Research
     Division, Research Triangle Institute, March 1967.
                                2-49                          12-17-76

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     Operating Costs in Homes for the Aged and Nursing Homes in North Carolina.
     D.A. King and J.D. Bates, Statistics Research Division, Research Triangle
     Institute, March 1967.

     An Intensive Investigation of the Problems Associated with Young Men who
     are Mentally Unqualified for Military Service, A.M. Huq, T.H. Jerdee,
     J.D. Bates and Don Jackson, Research Triangle Institute, May 1967.

     An Index of Economic Status of Individual Rural Families, J.D. Bates,
     J.V. Rachal and L. Gould, Research Triangle Institute, January 1971.

     Alcohol Safety Action Program, Annual Report, J.R. Miller, B.A. Moser,
     S. Trustman and J.D. Bates, March 1972.

     Drug Usage and Arrest Charges, William C. Eckerman, James D. Bates, J. Valley
     Rachal, and W. Kenneth Poole, December 30, 1971.

     North Carolina Survey on Aging, J.D. Bates and D.W. Jackson, March 9, 1972.

     An Operational Consumption Measure of Economic Status; With Applicability
     to United States Rural Families, J.D. Bates, J.V. Rachal, W.K. Poole and
     R.P. Moore, October 1972.

     A Description of Field Procedures and Data Processing for the Household
     Survey for New Towns, J.D. Bates, and D.W. Jackson, November 30, 1973.

     A Review of USAID Projects in Four Major Livestock Producing States in
     Nigeria; An Assessment of Range Management, J.D. Bates, G. Howze, F.A.
     Abercrombie, and H. Van Blake, May 1975.
3/76
                                 2-50                          12-17-76

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                                CURRICULUM VITAE

  V           .         ,      STEPHEN HUNTER CEHL3ACH



Born;   January 14, 1942, in Moline, Illinois

Education;   Academic;   Received A.B. degree, Harvard College 1964.

                         Graduated from Case Western Reserve School of
                         Medicine (1963)


             Internship and Residency;   Mixed medical-pediatric internship
                                         at the Royal Victoria Hospital in
                     .  *                  Montreal, Quebec
                              •                               *
                                         One year residency in pediatrics
                                 •        at Childrens1  Hospital Medical Center
                                         in Boston

              1 v<
              /.:'./'                       One year residency in pediatrics at
              >:; •       .          .      ..Duke Medical Center

Military Service:   Served tvo years in U. S. Public Health Service assigned to
                    the North Carolina State Board of Health as Field Epidemiologist
                    working primarily in the field of general-communicable disease j-_
                    control

Llcensure;   North Carolina, December, 1971         ••     .    •    '

Publications;   (coauthor):  "Haernolytic Anaemia in Infectious Mononucleosis Due
                       Inapparent Congenital Spherocytosis,"  Scand. J. Haemat.,
           '  •'  .     '7:  141-144, 1970.
                (coauthor):  '"Clinical Reactions Following Rubella Vaccination,"
                       JAMA, 220:  1569-1572, 1972.
                (coauthor):  "Coccidioidomycosis," Arch.  Int. Med., 131:  254-255,
                       1973.'
                (coauthor):  "Spread of Disease by Fecal-Oral Route in Day
                       Nurseries,"  HSMHA Health Reports, 83:  320-322, 1973.
                                         2-51
                                                                   12-17-76

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PUBLICATIONS:  Gehlbach,  S.,  Cooper,  B.,  "Haemolytic Anaemia in Infectious
                  Mononucleosis  Due  Inapparent  Congenital Spherocytosis,"
                  Scand.  J. Haemat.,  7:   141-144,  1970.

             1  Grand, M., Wyll,  S.,  Gehlbach, S.,  "Clinical Reactions Following
                  Rubella Vaccination," JAMA, 220:   1569-1572, 1972.

               Gehlbach,  S.,  Hamilton, J.,  Conant,  N.,  "Coccidioidomycosis,"'
                  Arch.  Int.  Med.,  131:   254-255,  1973.

               Gehlbach,  S.,  MacCormack,  J., Drake,  B.,  Thompson,  W., "Spread of
                  Disease by  Fecal-Oral Route in Day Nurseries," HSMHA Health Reports,
                  88:   320-322,  1973.                          .     ;   '	

               Gehlbach,  S.,  Williams, W.,  Woodall,  J.,  Freeman, J., "Pesticides
                  and Human Health  -  An Epidemiologic Approach," Health Service
                  Reports, 89:   274-277,  1974.                         '.

               Gehlbach,  S.,  Williams, W.,  Perry,  L., Woodall, J., "Green Tobacco
                  Sickness -  Ann Illness  of Tobacco Harvesters," JAMA, 229:  1880-
                  1883,  1974.          •              .

               Roe,  C.,  Schonberger, L.,  Gehlbach, S., et. al.:  "Enzymatic
                  Alterations in Separate Outbreaks of Reye's  Syndrome:
                  Prognostic Implications", presented to the Reye's Syndrome
                -^Conference, Columbus, Ohio,  October, 1974.

               Gehlbach, S.,  Williams, W.: "Pesticide Containers.:  Their
                  Contribution to Poisoning," Arch. Env. Health, 30:  49-50, 1975.

               Landrigan, P.J.,  Gehlbach,  S.H.,  Rosenblum,  B.F.,  etc."Epidemic
                  lead absorption near an  ore smelter, N.E.J.M. 292: 123-219,
                  1975.

               Roe,  C.  R., Schonberger, L.B., Gehlbach, S.H., Wies, L.A. and
                  Sidbury, J.B.,  "Enzymatic  alterations in  Reye's syndrome:
                  Prognostic  implications",  Pediat.  55: 119-126,  1975.

               Gehlbach, S.H., Gutman,  L.T., Wilfert,  C.M.,  Brumley, G.W.,
                  and Katz, S.L.  "Recurrence of  skin  disease  in a nursery:
                  Ineffectually of  hexachlorophene  bathing", Pediat.  55:
                  422-424, 1975.

               Gehlbach, S.H., Williams, W.A., et.al.: "Nicotine  absorption
                  by workers  harvesting green tobacco", Lancet  1: 478-480, 1975.

               Gehlbach, S.H., and Williams, W.A.:  "Epidemiology  of pesticide
                  poisonings  in North Carolina",  (Abstract)  Pediat. Res.,  4:
                  297,  1975.
                                     2-52                       12-17-76

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BENJAMIN S. H. HARRIS, III, Health Survey Specialist
Professional Experience

     1964 to Date.  Research Triangle Institute, Research Triangle Park,
     North Carolina 27709.

          1974 - date:  Health Survey Specialist, Survey Operations
          Center, Statistical Sciences Group.   Currently Project
          Leader of a follow-back study of children who received
          diagnostic doses of radioactive iodine over the period
          1946-1967; Survey Director of a study of heavy metal
          absorption by persons living near non-ferrous smelters;
          Task Leader of tasks related to establishment and coordina-
          tion of an Advisory Committee, training and quality con-
          trol of record'abstractors, and hospital nonresponse in
          a national survey of the incidence,  prevalence, and costs
          of traumatic injury to the central nervous system; Task
          Leader of off-site and data collection activities related-
          to the evaluation of, and exploration of alternatives to,
          the Hospital Discharge Survey; also  involved in a study
          of the outcomes of alternative modes of treating prostatic
          carcinoma.  Major contributor to the evaluation of the
          Mecklenburg County, North Carolina,  Alcohol Safety Action
          Project and the establishment and maintenance of a national
          registry of chronic intermittent dialysis patients; and
          monitored grant review committees for the National Institute
          on Alcohol Abuse and Alcoholism (NIAAA).

          1971 - 1974:  Medical Science Analyst, Center for Health
          Studies.  Project Leader of a study  of diagnosis and deter-
          mination of disability in alcoholism; the preparation of a
          directory of State and local alcoholism services; and a  pilot
          follow-back study of patients treated for tuberculosis in the
          North Carolina Sanitorium system during the period 1930-1950
          by pneumothorax and pneumoperitoneum with fluoroscopy.  Super-
          vised survey of Medicare procedures  used by physicians in
          selected metropolitan areas; major contributor to a study
          involving the collection and analysis of data relating to civ-
          ilian techniques in international development assistance, and a
          survey of attitudes and capabilities of major hospitals  in
          North Carolina regarding the handling of patients involved  in
          radioactive accidents.   Coordinated  site visits to alcoholism
          treatment centers sponsored by NIAAA and prepared a summary and
          evaluation of the site visit process, assisted with the  Third
          Annual Alcoholism Conference of NIAAA, and involved in the
          medical evaluation of the supplemental food program for  Women,
          Infants, and Children.   Assisted in  the preparation of new  con-
          tract proposals related to health services, and served as a
          consultant to the Craven County (N.C.) Health Department in the
          preparation of a proposal to the North Carolina Regional Medical
          Program.
                                       2-53                     12-17-76

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                                        -2-
          1966 - 1971:  Health Services Analyst, Operations Research
          and Economics Division.  Principal Investigator on studies of
          hospital utilization in the last year of life and the economic
          costs of kidney disease; major contributor to study of the post
          nuclear attack prevention and control of communicable respi-
          ratory diseases; supervised survey of drug usage among arrestees
          for serious crimes in selected metropolitan areas; research on
          the economic costs of alcoholism and excessive fertility.

          1964 - 1966:  Biologist, Natural Products Laboratory.  Respon-
          sible for biological assays and pharmacologic evaluation of
          synthetic and naturally-occurring toxic agents, the Immediate
          operation of the Institute's animal colony, coordinating the
          Laboratory's bio-assay program, and assisting in the preparation
          of new contract proposals in bio-medical areas.

     1961 to 1964.  Duke University Medical Center, Durham, North Carolina 27710.
     Research Assistant, Department of Psychiatry, Division of Electroencephalo-
     graphy (EEC).  Research activities included portable EEC, the EEC in various
     types of epilepsy, guides for teaching EEC, neurophysiologic changes in
     the brain of the cat after administration of hallucinogens, and changes
     in electrical activity resulting from drowsiness and psychopharmacologic
     agents; preparation of Keysort data cards for classification and conden-
     sation of EEC's; and recording EEC's in operating rooms during neurosurgical
     procedures. • During this time also served as junior staff psychiatrist,
     John Umstead (State mental) Hospital, Butner, North Carolina.
Education
     B.A., Zoology, Duke University, Durham, North Carolina, 1960.
     Graduate work in medicine, Duke University School of Medicine,  1960-1965.
     Course in Operations Research, Georgia Institute of Technology, Atlanta,
        Georgia, 1968.
     San Diego Summer School of Alcohol Studies, University of California,
        San Diego, 1972.
Honors
     President, Pre-med scholastic honorary society, Duke University,  1959-60.
     NIMH student research stipends,  summers of 1961 and 1963.
     Who's Who in North Carolina, 1973.
                                   2-54                      12-17-76

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                                        -3-
Selected Publications

     "Experience with Portable Electroencephalography in a General  Hospital."
        Electroencephalography and Clinical Neurophysiology.  1963,  15:1047
        (Abstract of paper presented to  Southern EEC Society, Durham,  N.C.,
        November 17, 1962).
     "Psychiatric Problems in Children with Frontal, Central  and  Temporal Lobe
        Epilepsy." Southern Medical Journal,  1966,  59:49-53,  coauthor.
     "Murine Toxicity of Cochliobolus carbonum." Applied Microbiology.  1968,
        16(11):1710-1722, coauthor.
     "Interictal Focal or Lateralized Discharges Occurring in the Electroencepha-
        lograms  of Patients Suffering From Centrencephalic Epilepsy."  Confinia
        Neurologica. 1968, 30:368-374, coauthor.
     The Economic Cost of Kidney Disease and Related Diseases of  the Urinary
        System  (PHS Pub.' No.  1940).   Washington, D.C.:  U.S.  Government  Printing
        Office,  1970.
     "Estimation of a Potential Hemodialysis Population."  Medical  Care. 1970,
        8(3):209-220,  coauthor.
     "The Number and Cost of Medicines Prescribed for the Treatment of Patients
        with Selected Diseases."  Inquiry.  1970,  7(3):38-50.
     Postattack  Communicable Respiratory Diseases.   Research  Triangle  Park,  N.C.:
        Research Triangle Institute,  1970,  coauthor.
     Care in Hospitals and Institutions  During  the  Last  Year  of Life by  Cause of
        Death;   United States,  1962-1965 Deaths.  Washington, D.C.:  U.S. Depart-
        ment of  Commerce, National Technical Information Service, '1972 (NTIS
        Accession No.  PB-208-639).
     Military Civic Action Final Report, Volume I:   Evaluation of Civilian Tech-
        niques in International Development Assistance.   Research Triangle Park,
        N.C.:  Research Triangle Institute, 1972.
     Medical Facilities - Control  of  Radioactive Materials in North Carolina
        Transportation Accidents (RM-24U-754).   Research Triangle Park,  N.C.:
        Research Triangle Institute,  1973.
     "Alcohol Abuse:  An Overview."   Adit;   Approaches to Drug Abuse and Youth,
        1973,  2(1):1-2, 11-15.
     Mecklenburg Alcohol Safety Action Project;   An Analysis  of Ultimate
        Performance Measures to Determine Total Project  Impact.   Research
        Triangle Park,  N.C.:  Research Triangle Institute, 1974.
     "Edgar  Allan Poe on Sullivan's  Island."  South Carolina  Magazine, 1975,
        39(2):8-15.
     Evaluation  Reports I and IV;  Hospital  Discharge Survey Evaluation Study.
        Research Triangle Park,  N.C.: Research Triangle Institute, 1976, coauthor.
                                     2-55                       12-17-76

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MILDRED C. PENNINGTON, Research Assistant II
Professional Experience

     1973 to date.  Research Triangle Institute, Statistics Research Division,
     Research Triangle Park, North Carolina 27709.  Research Assistant to the
     manager and supervisor of the clerical staff of the Survey Methodology and
     Operations Department.

     1942-1973.  United States Department of Agriculture

          1961-1973:   United States Department of Agriculture, Statistical
          Reporting Service and the North Carolina Department of Agriculture,
          Division of Agricultural Statistics, Raleigh, North Carolina.  Sta-
          tistical Assistant to the statistician and supervisor to the clerical
          staff of the Input and Collection unit.
             r

          1942-1961:   United States Department of Agriculture, Standards and
          Research Division, Statistical Research Laboratory, Institute of
          Statistics, North Carolina State University, Raleigh, North £arolina.
          Act as assistant to the statistician and supervisor to the clerical
          staff of the Survey Operation Group.

Education

     Needham Broughton High School, Raleigh, North Carolina 1935

     Attend one week course on Supervision and Group Performance, Atlanta,
     Regional Training Center, Atlanta, Georgia, 1971

Professional Activities

     Association for Coordination Interagency Statistics, North Carolina State
     Departments, 1971-1972; member.
February 1973
                                2-56                         12-17-76

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                                CURRICULUM VITAE
                                   Carl  M. Shy

  I.  Born:  October 23, 1931  - Milwaukee, Wisconsin
      Married:   June 6, 1959
      Wife:  Eve Carol  (nee Ruciich)                           •   '
      Children:   Leslie (3/26/60)                    •
                 Rosalie (4/2/62)
                 Ann (6/4/65)                    '             ;  .

 II.  Pre-Medical Education:  1. A.B.  St.  Louis  University,.1956
                                 Major in  Philosophy and Economics

                              2. St.  Louis and Marquette Universities,  1956-57
                                 Graduate  Studies  in Philosophy and  Economics
III.   Medical  Education:
        Year
  1.'  1958-1962
     Location

Marquette University.
School of Medicine
  2.   1960 (Summer)       Marquette University
                         School  of Medicine
  3.   1962-1963

  4.   1963-1964


 "5.   1964-1965



  6.   1965-1967
University of Michigan

University of Michigan
Medical  Center

University of Michigan
School of Public Health
University of Michigan
School of Public Health
Appointment and D?gres

Medical Student, M.D.
 received June 1952

Student Fellowship
 (2 months) in Physiology

Intern (Straight Medicine)

Resident I in Internal
 Medicine

Student in Department of
 Epidemiology:  M.P.H.
 Received May 1965

Student in Department of
 Epidemiology:  Dr.P.H.
 Received April 1957
 IV.   Post-Doctoral  Public Health,  Medical  and  Academic  Experience:

        Year                  Location                        Appointment
  1.-  1967-1971
U.S. Public Health Service
National Air Pollution
 Control Administration
(Mow the Environmental
 Protection Acjr.vicy)
 Durham, North Caroline. •
 Epidemiologist and Chief,
  Epidemiology Branch,
  Division of Health Effect
  Research
                                 2-57
                                  12-17-76

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                                    -2-
2.  1971-1972
3.  9/72-12/73
4.  1968-1973



5.  1969-Present



6.  1970-Present

7.  1971-Present
8.  1968-Present
    1971-Present

9.  1/74-Present
Environmental Protection
 Agency, Office of Research
 and Monitoring, Division
 of Health Effects Research,
 Research Triangle Park,
 North Carolina

Environmental Protection
 Agency, Office of Research
 and Monitoring, National
 Environmental Research
 Center, Research Triangle
 Park, North Carolina

University of North
 Carolina
 Department of Epidemiology

Duke University
Deputy Director
 Division of Health
 Effects Research
Director, Human Studies
 Laboratory (Final Civil
 Service Grade was GS-16)
Adjunct Assistant Professor
Assistant Clinical Professo;
 of Epidemiology (Part-tinse-
 Appointment)
Journal of Chronic Diseases    Editorial  Consultant
Wake County Hospital
State of Ohio
State of North Carolina

University of North Carolina
Staff Member, Medical Night
 Clinic (General Pediatric
 and Internal Medicine
 Practice)

Medical Li censure
Medical Li censure

Director, Institute of
 Environmental Studies
Lecturer, Department of
 Epidemiology, School of
 Public Health
                                2-58
                                   12-17-76

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                                     -3-
V.  Membership in Scientific Organizations:

    1.  Alpha Omega Alpha National  Honorary Medical  Fraternity

    2.  Delta Omega National Honorary Public Health  Society

    3.  American Association for the Advancement of  Science

    4.  Society for Epidemiologic Research

    5.  American Public Health Association

    6.  North Carolina Lung Association,  Advisory Committee on Air
        Pollution
                             2~59                      12-17-76

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                                       -4-
VI.  Publications:
     1.  Shy, C.M.  and Meade,  R.C.:   The hippuric  acid  radioisotope  ranograrn,
     Harquotte Msd.  Rov.   26:139-147, 1951.

     2.  Shy, C.M.:   Diagnostic procedures  for determining  hypertension  of  renal
     origin.   Marquette Msd.  Rev.   26:194-199, 1961.

     3.  Meade, R.C.  and  Shy,  C.M.:   The evaluation of  individual  kidney function
     using radioiodohippurate  sodium.  J. Urol.  86:163-170,  1961.

     4.  Shy, C.M.:   A comparison  of psychoanalytic and  philosophical  thought.
     Harquette Ned.  Rev.  27:61-67,  1962.

     5.  Shy, C.M.:   Of Man and Machines  (Student  Editorial).  Marquette Mad. Rev
             *
     6.  Associate  editor of  Vol.  27, No. 3  (March 1962)  issue of  Marquette Mad.
     Rev.

     7.  Shy, C.M.:   The  pituitary-thyroid  relationship  in  Graves' disease.
     Marquette Med.  Rev.  27:162-166,  1962.          •

     8.  Shy, C.M.:   The  determinants of the one-second  forced expiratory volume,
     as a measure of  chronic obstructive  lung  disease,  in a.total  population stud;
     Doctoral dissertation submitted  and  accepted  in partial fulfillment of the
     requirements for the degree of  Doctor of  Public Health, April 1957.  Dissert?
     is available in  microfilm form  from  University Microfilms, Ann Arbor, Michig;

     9.  Shy, C.M., Creason, J.P., Pearlman, M.E., McClain,  K.E.,  Benson, F.B. anc
     Young, M.M.  The Chattanooga  School  Children  Study:  Effects  of Community
     Exposure to Nitrogen Dioxide.   1.  Methods, Description of Pollutant Exposure
     and Results of Ventilatory Function  Testing.  J. Air Pollution Control Assoc.
     20:539-545, August 1970.

     10.  Shy, C.M., Creason, J.P., Pearlman, M.E., McClain,  K.E.,  Benson, F.B. and
     Young, M.M.  The Chattanooga  School  Children  Study:  Effects  of Community
     Exposure to Nitrogen Dioxide.   2.   Incidence  of Acute  Respiratory Illness.
     J. Air Pollution Control  Assoc.  20:582-588, September  1970.

     11.  Shy, C.M.:   Health Effects.   Chapter  in National Emissions Standards
     Study, A Report  to Congress,  1970.

     12.  Cohen, A.A., Shy, C.M.,'Benson,  F.B.,  Riggan, V.'.R.  and Hcv/ill,  V.A.:  Air
     Pollution Episodes:  Guides  for  Health Departments and  Physicians.   HSMHA Heal
     Reports, June 1971.

     13.  Hammer, D.I.,  Finklea,  J.F.,  Hendricks, R.H., Shy,  C.M. and Hoi-ton, R.J.M
     Hair Trace Metal  Levels and Environmental  Exposure.  Amor. J. Epic!.  93:B4-92,
     February 1971.


                                2-60                      12-17-76

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                                   -5-

 14. Pearlman,  M.E.,  Finklea,  J.F.,  Shy,  C.M.,  VanBruggen, J.B. and Newill,
 V.A.:   Chronic Oxidant Exposure  and Epidemic  Influenza.  Environmental
 Research,  June 1971.

 15. Pearlman,  M.E.,  Finklea,  J.F.,  Creason, J.P., Shy, C.M., Young, M.O.
 and Horton,  R.J.M.:  Nitrogen  Dioxide and Lower Respiratory  Illness, Pediatri;
 47(2),  February 1971.

 16. Shy,  C.M.:  Environmental  Epidemiology.   Chapter in Environmental Hancibor
 for .International  Students.   University  of North Carolina,  (In Press),  1972.

 17. Hammer,  D.I.,  Finklea, J.F., Hendricks, R.H., Hinners, T.A., Riggan, W.B.
 and Shy,  C.M.:  Trace  Metals  in  Human Hair as  a Simple Epidemiologic Monitor
 of Environmental  Exposure.  Trace  Substance.in Environmental Health, Vol. 5,
 1972.
         f
 18. Cohan, A.A.,  Dromberg, S., Buechley,  R.'.-/., Heiderscheit, L.T. and Shy,
 C.M.:   Asthma  and  Air  Pollution  from a Coal-Fueled Power Plant.  Arnsr.  J.
 Public  Health  62:1181-1188, September 1972.

 19. Mauser,  T.R.  and Shy, C.M.   Position  Paper: NO  Measurement.  Environ. Sc
 and Techno!. 6:890-894, October  1972.             X

 20. Shy,  C.M., Hasselblad, V., Heiderscheit,  L.T. and Cohen, A.A.:  Environmc
 Factors in Bronchial Asthma.   Published  in Environmental Factors in Respiratc
 Disease,  1972.

.21. Love,  G.J.,  Shy, C.M., Calafiore, D.C., Benson, F.B. and Finklea, J.F.:
 The Strategy for Determining  the Effects  of Environmental Pollution on  Human
 Health.   Environ.  Letters 3(1):13-20, 1972.

 22. Pinkerton, C., Creason, J.P., Shy, C.M., Hammer, D.I., Bueckleys R.W. anc
 Murthy, G.K.:   Cadmium Content of Milk and Cardiovascular Disease Mortality.
 Trace Substances in Environ.  Health, Vol. 5,  1972.

 23. Riggan,  W.B.,  Hammer, D.I.,  Finklea,  J.F., Hasselblad, V., Sharp, C.R.,
 Burton, R.M. and Shy,  C.M.:   CHESS  - A Community Health and Environmental
 Surveillance System.   Published  in  Proceedings of Sixth Berkeley Symposium or
 Mathematical Statistics and Probability,  Vol.  VI, Effects of Pollution  on
 Health, University of  California Press,  1972.

 24. Finklea, J'.F., Cranmer, M.F., Hammer, D.I., McCabe, L.F., fiewill, V.A.
 and Shy, C.M.:  Health Intelligence  for  Environmental Protection:  A Demandir
 Challenge.   Published  in Procacdings of  the Sixth Berkeley Symposium on Mith;:
 tical Statistics and Probability, Vol. VI, Effects of Pollution on Health,
 University of  California Press,  1972.
                           2-61                      12-17-76

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                                   -6-


 25.  Pearlman,  M.E..,  Finklea, J.F., Creason, J.P., Shy, C.M., Young, M.M.
 and  Morton,  R.J.M.:   Nitrogen Dioxide and Lov/er Respiratory Illness.
 Published in October 18,  1971 issue of Modern Medicine.  (Abstract)

 26.  Shy,  C.M.:   Referee  for Article "Air Pollution:  A Major Public Health
 Problem"  by  Ayres, Evans  and Bue'nler.  Published as CRC Critical Review in
 Clinical  Laboratory  Sciences, January 1972.

 27.  Shy,  C.M., Hasselblad, V., Burton, R.M., Nelson, C.J. and Cohen, A.A.:
 Effects of Air Pollution  on Ventilatory Function of U.S. School Children:
 Results of Studies in Cincinnati, Chattanooga and Mew York.  Arch. Environ.
 Health 27:124-128, September 1973.

 28.  Nelson,  C.J., Shy, C.M., English, T., Sharp, C.R., Andleman, R., Truppi,
 L. and VanBruggen, 0.:   Family Surveys of Irritation Symptoms During Acute Air
 Pollution Exposures:  1970 Summer and 1971 Spring Studies.  J. Air Poll. Ccntr.
 Assoc. 23:81-86, February 1973.

 29.   Shy,  C.M. and J.F.  Finklea.  Air Pollution Affects Coraiunity Health.
 Environ.  Sc. and Techn.  7:204-208, March 1973.

 30.   Shy,  C.M., J.F.  Finklea, D.C. Calafiore, F.B. Benson, W.C. Nelson and
 V.A.  Newill.  A Program  of Community Health Surveillance Studies (CHESS).
.Published in Determination of Air Quality - Proceedings of the ACS
 Symposium on Determination of Air Quality, p. 41-48, Plenum Press,
 New  York-London, 1972.

 31.   Shy,  C.M., C.J. Nelson, F.B. Benson, R.S. Chapman, W.B. Riggan and V.A.
 Newill.   Ventilatory Function in School Children:  1967-1958 Testing in
 Cincinnati Neighborhoods.  Published in Health Consequences of Sulfur Oxides:
 A Report  from CHESS  1970-1971.  In press.

 32.   Shy,  C.M., V. Hasselblad, J.F. Finklea, R.M. Burton, M. Pravda, R.S.
 Chapman,  and A.A. Cohen.  Ventilatory Function in School Children 1970-1971
 Testing.in New York  Communities.  Published in Health Consequences of Sulfur
 Oxides:   A Report from CHESS 1970-1971.  In Press.

 33.   Shy,  C.M., W.B. Riggan, W.C. Nelson, R.C. Dickerson, F.B. Benson, J.F.
 Finklea,  A. Colucci, D.I. Hammer, and V.A. Newill.  An Overview of CHESS.
 Published in Health  Consequences of Sulfur Oxides:  A Report from CHESS
 1970-1971.   In press.                              .              .

 34.   Finklea, J.F.,  C.M.  Shy, G.J. Love, C.G. Hayes, W.C. Nelson, R.S. Chapman
 and  D.E.  House:  Health Consequences of Sulfur Oxides:  Summary and
 Conclusions Based Upon CHESS Studies of 1970-1971.  Published in Health
 Consequences of Sulfur Oxides:  A Report from CHESS 1970-1971.  In press.

 35.   Shy,  C.M.:  Transportation and Health.  In Proceedings of the Coni^cticut
 Conference on Transportation, Connecticut Lung Association, 1973, I.", prc-ss.

                            2-62                      12-17-76

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                                      -7-
VII.  In-House Technical  Reports  and  Inter-Agency  Experience  in  Federal
      Government:

      1.  Shy, C.M.,  Hammer,  D.I.,  Goldberg, H.E., Newill, V.A.  and
          Nelson,  W.C.  Health  Hazards  of  Environmental Lead.  (To be
          submitted for publication.)   Revised March,  1972.

      2.  Love, G.J., Shy,  C.M.,  Calafiore, D.C.,  Benson, F.B. and
          Finklea, J.F.   The  Strategy for  Determining  the Effects of
          Environmental Pollution on Human Health.

      3.  Member of combined  EPA-DHEW Environmental Health Task  Force to
          prepare  a report  to Congress  entitled  "Human Health and Environ-
          mental Pollution."  April-May, 1971, published in 118  Congressional
      .  .  Record S.  4169, March 17, 1972.

      4.  Staff member  in preparation of Air Quality Criteria documents for
          nitrogen oxides,  carbon monoxide and photochemicel oxidants.
          March-September,  1970.

      5.  Member of EPA Health Planning Task Force to identify EPA health
        •  research needs  in relation to legislative mandates and agency
          directives, and to  plan a consolidated EPA health research pro-
          gram:  July - November, 1971.

      6.   Member of EPA Task  Force to revise existing air quality criteria
          for  sulfur  oxides:  May-July, 1972.

      7.   Assistant to Dr. Vaun Newill, Chief, Health Effects Branch, EPA
          Headquarters in developing submission to the President's New
      ...-;:...  Technology  Initiatives  Program,  Washington, D.  C.,  November -
          December 1971.  Submission was accepted and funded  for  FY
      .    1973-1977.

      8.   Member of Federal Inter-Agency Ad Hoc Committee on  Classification
          of Toxic Substances:  November 1972  - present (December 1972).

      9.   Co-Chairman with Dr. David Rail  for Project "Biological and Genetic
          Effects  of  Pollution" as part of the US/USSR Environmental
          Agreement,  November 1972 - Present.

     10.  Submission  of contract  proposal  "Environmental and Familial Determinants
          of Respiratory  Disease  in Adolescents" for National Heart and Lung
          Institute,  March  7-April  7, 1972; Shy, Chapman, House,  and DeSantis.

     11.  Finklea, J.F.,  M. J.  Cranmer, D. I. Hammer, L. J. McCabe, and C. M.
          Shy.- Health  Intelligence for Environmental  Protection:  A Demanding
          Challenge.

     12.  Love, G. J.,  C. R.  Sharp, J.  F.  Finklea, C. M. Shy  and J. Knelson.
          Atmospheric Levels  of Air Pollution Producing Significant Ham;,
          June 13, 1972.

                              2-63                      12-17-76 •

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                                  -8-
13.  Shy,  C.  M.   Health Effects  of  Various Ambient Air Concentrations
     of Lead.  EPA Position  Paper Developed at Request of Director,
     National Environmental  Research Center, RTF, N.C., October 12,
     1971.

14.  Shy,  C.  M.   Health Research and Air Quality Criteria.  Chapter
     VIritten  for Revision  of Air Quality Criteria for Sulfur Oxides,
     June  1972 (Unpublished).
                          2-64                     .  12-17-76

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                                     -9-
VIII.  Papers Presented at Scientific and Other Public Hastings

       1,   The Cincinnati  School  Children  Study.  The  effects of air pollution
           on ventilatory  performance of elementary  school children.  Presented
           at the annual meeting  of the  Society  for  Epidemiologic Research,
           Washington,  D.C.,  May, 1968.

       2.   The determinants of the one second  forced expiratory volume in an
           epidemic logic study 'of a total  community  (Tecumseh, Michigan).
           Presented -at the annual  meeting of  the American Public Health As-
           sociation,  Detroit, Michigan, November, 1968.

       3.   The Cincinnati  and Chattanooga  School Children Air Pollution Studies.
    •  .     Presented at the meeting of the U.S. -Japan  Cooperative Science
           Group, Boston,  Massachusetts, February, 1969.

       4.   An epidemic! ogic study of the effects of  nitrogen dioxide exposure
           on a population.  Presented at  the  annual meeting of the Tennessee
           Public Health Association,  Nashville, Tennessee, October, 1959.
       5.   Ca]   A national  Health Effects  Surveillance Natv/ork.

           Cb'l   Air Pollution  and Asthma.

           (c)   Air Pollution  and Acute  Respiratory Disease.

           (dj   Cigarette  Smoking and  Epidemic  Influenza.  Papers presented
                at the  Arizona Chest Disease Symposium, Tucson, Arizona,
                March,  20-22,  1970.

       6.   Monitoring the  Health  Effects of Air Pollution Control.  Presented
           at the Southeastern Industrial  Health Conference, Gatlinburg,
         .  Tennessee, October  1,  1970.

       7.   Health Hazards  of Automobile  Emissions.  Presented at the Mid-
           Atlantic sectional  meeting  of the Air Pollution Control Association,
           Harrisburg,  Pennsylvania, October 8, 1970.

       8.   The  Chattanooga  Schoolchildren Study.  Effect of Atmospheric Nitro-
           ge'n  Dioxide  Exposure on the Incidence of Acute Respiratory Disease.
           Presented at the 98th  annual  meeting of the American Public Health
           Association, Houston,  Texas,  October 26, 1970.

       9.   Air  Pollution and Acute Respiratory  Disease.  Presented at the Third
           Annual  New York  State  Conference on  Air Pollution, Albany, New York,
           October 29,  1970.

      10.   Shy,  C.M.  Health Hazards of  Proposed Fossil Fueled Powar Plant in
           Astoria, Queens, New York.  Citizens for Clean Air, New York, New
           York,  October,  1970.
                                  2-65                      12-17-76

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 11.  "Shy,  C.M.   Repeat of above.  New York City Common Council Hearings.
      New York,  New York,  December,  1970.

 12.   Shy,  C.M.   Health Hazards of Carbon Monoxide.  West Virginia
      State Medical  Society Annual Meeting, Charleston, West Virginia,
      January 30,  1971.

 13.   Shy,  C.M.   Asthma and Air Pollution.  West Virginia State Medical
      Society Annual  Meeting,  Charleston, West Virginia, January 31, 1971.

 14.   Shy,  C.M.   Community Health and Environmental Surveillance Studies.
      Colloquim  for Foreign Scientist-Visitors, Duke University, January
      16,  1971.

 15.   Shy,  C.M.   Briefing  on Mercury, Cadmium .and Lead as Hazardous
      Substances.   Presented to National Air Quality Criteria Advisory
      Committee,  Rockville, Maryland, March 18, 1971.

 16.   Shy,  C.M.   A  Program of  Co-tunity Health and Environmental
      Surveillance  Studies  (CHESS).  Presented at the annual meeting
     .of  the American Chemical Society, Los Angeles, April, 1971.

 17.   Shy,  C.M.,  Hammer, D.I., Hendricks, R.H., Hinners, T. and
      Finklea, J.F.   Hair  as an Epidemiologic Tool  to Quantitate
     Trace Element Body Burdens.  Presented at the Fifth Annual
      Conference  on Trace  Substances and Health, Columbia, Missouri,
     June,  1971.
»
 18.   FinJOea, J.F.,  Cranmer,  M.F., Hammer, D.I., McCabe, L.J., Nev/ill,
     V.A,  and Shy,  C.M.   Health Intelligence for Environmental Protection:
     A Demanding Challenge.   Presented at the Sixth Berkeley Symposium
     on Mathematical  Statistics and Probability, Berkeley, California,
     July  19, 1971.

 19.   Burton,  R., Morris,  C.,  Shy, C.M., Benson, F.B. and Heiderscheit, L.
     A Community Survey of Cigarette Smoking and Alveolar Carbon Monoxide.
     Presented at  the 99th annual American Public Health Association,
     Minneapolis,  Minnesota,  October 11-15, 1971.

 20.  Shy,  C.M.,  Hasselblad, V., Burton, R.H., Cohen, A.A., Pravda, M.
     and Deutscher,  S.  Is Air Pollution in New York City Associated
     With  Decreased  Ventilatory Function in Children.  Presented at the
     99th  annual American  Public Health Association, Minneapolis,
     Minnesota, October 11-15, 1971.

 21.   Shy,  C.M.   Chairman,  Symposium on Epidemioloqic Methods  to Measure
      BioloGic Response to Environmental Pollution.  Annual Meeting of
      Society for Epidemiologic Research, Atlanta, Georgia, Hay,  1971.

 22.   Shy,  C.fl.   Asthir.a and Air Pollution.  Presented at annual necjti'ng
      of  Southeastern Allergy  Association, Asiieville, fl.C., October, 1071.
                           2-66                      12-17-76

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23.  Shy, C.M. and associates.   Effect of Atmospheric  Participate
     Matter and Sulfur Dioxide  on Ventilatory Performance of
     Children.  Presented at annual  treating  of American  College
     of Chest Physicians, Philadelphia, Fa.,  October,  1971.

24.  Shy, C.M.  Health Effects  of Motor Vehicle Emissions.  Presented
     at annual Southeastern Industrial  Health Conference, Gatlinburg,
     Tennessee, November, 1971.

25.  Shy, C.M.  Evaluation of Health Hazards  of Fuels  and Fuel Additives.
     Presented at Annual  Public Hearing on Long Range  Medical Aspects of
     Air Pollution, Rutgers Medical  School,  Piscatav/ay,  Mew Jersey,  _
     March, 1972.             .

26.  Report on Health Consequences of Sulfur Oxides:   A Report  from
     CHESS 1970-71 to the iiational Air Quality Criteria Advisory
     Committee, Washington, D.  C., November 16, 1972.

27.  Presentation at the EPA Research Seminar for Federal Agencies,
     Washington, D. C., ••oveinber 20, 1972.

28.  Chairman, Workshop on Multiple Factors  in Disease at the New York
     Academy of Sciences International Symposium on Pulmonary Reactions  . •
     to Organic Dusts,  New York, November 8, 1972.

29.  Shy, C. M., et al.  Effects of Air Pollution on  Ventilatory Function
   '' of U. S. School Children:   Results of Studies in  Cincinnati,  Chattanc
     and New York.  Presented at the American Medical  Association, Air
     Pollution Medical Research Conference,  Chicago,  Illinois,  October
     2-3, 1972.

30.  Shy, C. M.  Health Consequences of Environmental  Deterioration.
     Presented at the Conference on the Environment,  Chapel Hill,  North
     Carolina, December 1, 1972.

31.  Shy, C. M.  Testimony at Court Hearing, Tampa, Florida,  April 26,
     1972, Regarding Health Effects of S0_ and Participate  Emissions.
  S                                      Cf
32.  Shy, C.M.  Air Pollution and Its Relation to Respiratory Disease
     (CHESS)..  Presented at the Scientific Session, Association of
     Pediatric Pulmonary Centers, American Academy of Pediatrics,  New
     York, M. Y., October  14, 1972.

33.  Shy, C.M.   Reported Results of the CHESS Program at Regional  Meeting
     of  the Council on Environmental Quality, Public and Occupational
     Health.of the American Medical Association, Washington,  D.C.,
     December  1,  1972; and v/ith Dr. Finklea summarized EPA's  health
     research  program to the same AMA Council, December 9,  1972.
                        2-67                      12-17-76

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34.  Shy, C.M.  Adverse Health Effects of Transformed Products  of SCL
     Emissions - Resulted from CHESS Program.   Presented at Weather and
     Air Pollution Committee Session, American Academy of Allergy,
     Washington, D. C., February 9, 1973.

35.  Shy, C.M.  Additional  Analysis of 7-City  Lead  Study.   Presented to
     EPA's Hazardous Materials Advisory Committee,  Washington,  D. C.,
     February 26, 1973.

36.  Shy, C.M.  Air Pollution Epidemiology.  Presented to Sophomore Medica
     Students, Duke University Medical Center, .Durham, N.  C.,  February 27.
     1973.

37.  Shy, C.M.  Briefing on CHESS Program for  Science Nev/sv/riters, Washing
     D. C., March 2, 1973.
      >
38.  Shy, C.M.  Effects of Low Levels of Oxi.dants and N0? Upon  Humans.
     Presented at CRC Automotive Air Pollution Symposium,  Washington,  D.  C
     March 8, 1973.

39.  Shy, C.M.  Health Intelligence for Air  Quality Standards.   Presented
     Meeting of the President's Air Quality  Advisory Board, St.  Louis, Mar
     27, 1973.                                     .

40.  Shy, C.M.  Assessing Environmental  Health Effects in Populations.
     Presented at Annual Meeting of N. C. Tuberculosis and Respiratory
     Disease Association, Wrightsville Beach,  N: C., April  13,  1973.

41.  Shy, C.M.  Health Effects of Environmental Contaminants.   Presented
     at Annual Meeting of the American Industrial Health Conference, Denva
     Colorado, April 17, 1973.

42.  Shy, C.M.  Transportation and Health, Presented at the Connecticut
     Conference on Transportation, Hartford, Connecticut,  May 16, 1973.
 -'i
43.  Shy, C.M.  Human Health Effects of Nitrogen  Dioxide Exposure:  A
     Review.  Presented at the National Academy of Science, National
     Research Council Conference on Health Effects  of Air Pollutants,
     October 4, 1973.
                      2-68                      12-17-76

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                                     -13-
IX.   Awards and Honors
     Superior Service Medal,  U.S.  Public  Health  Service, June  1971
     Quality Increase (GS  14/2 to  14/3} February,  1970
     Delta Omega National  Honorary Public Health Society, May  1955
     Scientific Writing  Award, Marquette  Medical Review, June  1962
     Alpha. Omega Alpha  National  Honorary  Medical Fraternity, June 1961
     Second Place,  Gram!ing Memorial  Student  Medical Essay, September 1960
                             2-69 '.                    12-17-76

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MARTHA LILLIAN SMITH, Survey Assistant
Professional Experience:
     1973 to Date.
     1972 to 1973.
     1965  to 1972.
     1964 to 1965.
     Summer.
     1962 to 1963.
Research Triangle Institute, Statistics Research Division
Research Triangle Park, North Carolina.
Survey Assistant on New Towns Study, National Longitudinal
Study of High School Class of 1972, Supervisor of
Microfilming Department, Survey Assistant on a Thyroid
Neoplasm Study and Study of Head and Spinal Cord Injury.

Resident Counselor, Smith College, Northampton, Mass.
Assisted Dr. Betty Spear, Chairman, University of Mass.,
Department of Women's P. E. in Developing a historical
research project for a national convention of the
American Association of Health P. E. and Recreation.
President, graduate class.

Western Guilford High School, Greensboro, North Carolina,
Teacher of health, P. E., and mathematics.  Coached varsity
track and field, basketball and golf.  Chairman of boys
and girls P. E. Department.  Chaired department's self study
for Southern Assoc. of Accredtion.  Supervisor of student
teachers.  Advisory Committee on Girls Athletics of the
N. C. High School Athletic Association.

Union Pines High School, Cameron, North Carolina.  Teacher
of health, P. E., and government.  Coached varsity and
junior varsity basketball.
General counselor, Camp Lakeside, Hendersonville, North
Carolina.

Director of the girls camp, Camp Lakeside, Hendersonville,
North Carolina.

Head tennis counselor, Camp Ton-A-Wanda, Hendersonville,
North Carolina.

Director of programming and counseling, Camp Mountain Lake,
Hendersonville, North Carolina.

Trip director, Tripp Lake Camp, Poland Maine.
                                        2-70
                                               12-17-76

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Education
     1957 to 1960.  Diploma - Central Davidson High School,  Lexington,
                    North Carolina.

     1960 to 1964.  B. S. May, 1964 - Appalachian State University, Boone,
                    North Carolina
                    Major:  Health and Physical Education
                    Minor:  History

     1958 to 1969.  Graduate.Work - University of North Carolina, Greensboro,
                    North Carolina.
                    Major:  Physical Education

     1972 to 1973.  M. S. May, 1973 - Smith College, Northampton,
                    Massachusetts
                    Major:  Physical Education
                    Thesis Topic:  Survey on Women's Athletics in
                    Massachusetts
Contributing Work

     Risk of Thyroid Neoplasms after Receiving Diagnostic Doses of
     Radioactive Iodine During Childhood.  Monthly Technical Progress
     Reports, Research Triangle Park, N. C.:  Research Triangle Institute,
     September, 1974 to November, 1976.  (co-author)

     Followup of Patients Receiving Diagnostic Doses of 131 Iodine
     During Childhood-Summary Report:  Pilot Study.  Research Triangle
     Park, N. C.:  Research Triangle Institute, February, 1975.
     (co-author)
Publications

     A Study of Interscholastic Athletics in the Springfield, Massachusetts
     Educational Region.  Martha L. Smith, Masters Thesis, Smith College,
     Northampton, Massachusetts, May, 1973.
 11/76
                                         2-71                       12-17-76

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 Name;   Boyd  Ray  Switzer,  Ph.D.      Sex;  Male      Birth Date;  October 3, 1943

 Title;   Assistant  Professor  in Department of Nutrition, School of Public Health
         and  Assistant  Professor in Department of Biochemistry and Nutrition,
         School of  Medicine.

 Social  Security  No;  229-60-0083        Place of Birth;  Harrisonburg, Virginia

 Martial Status;  Janie J.  Switzer, wife.     No. of Children;  2

 Education
                                                           Degree and
     Institution               Discipline                 Year Conferred
 Bridgewater  College             Chemistry                  B.A. (cum laude)
 Bridgewater, Virginia                                      1965

 University of North Carolina   Biochemistry               Ph.D. 1971
 Chapel  Hill, North Carolina

 Professional Experience

 June to September  1964 National Science Foundation Undergraduate Research
                        Participant, University of Tennessee, Knoxville,
                        Tennessee.  This work resulted in a publication in
                        J. Am. Chem. Soc. 87:4477, 1965.

 Sept. 1965-Sept. 1968   National Institutes of Health (NIH) Research Trainee.
                        University of North Carolina at Chapel Hill.

 Sept. 1968-Aug.  1970    NIH  Predoctoral Fellow.  University of North Carolina
                        at Chapel Hill.

 Aug. 1970-April  1971    Postdoctoral Research Assistant.  University of North
                        Carolina at Chapel Hill.

 April 1971-Sept. 1971   NIH  Postdoctoral Fellow.  University of North Carolina
                        at Chapel Hill.

 Sept. 1971-July, 1972   NIH  Postdoctoral Fellow.  University of Southern Cali-
                        fornia, Los Angeles, California.

 July 1972-Present       Assistant Professor, Department of Nutrition.

 Dec., 1972-Present      Assistant Professor, Joint Appointee in the Department
                        of Biochemistry and Nutrition.

Membership   in Organizations
 American Chemical Society
American Association for the Advancement of Science
The Lambda Society at Bridgewater College
                                      2-72                       12-17-76

-------
 Major  Research Activities

 Study  of Collagen  Biosynthesis  in Human Skin Fibroblasts in Tissue Culture.
 June 1966  to August  1970.

 Ornithine  Transcarbamylase:  Mode of Fluoride Inhibition.  Aug. 1970 to July
 1972.

 Nutritional Evaluation  of  the Focus on Optimal Development (F.O.O.D.) Project
 in Durham  Public Schools (biochemical component).  May to June 1973.

 Diet-Hormone Interaction with Emphasis on the Role of Insulin and Glucagon
 (collaborative study with  Dr. J.C. Edozien).  July 1972 to present.

 Medical Evaluation of the  Special Supplemental Food Program for Women, Infants
 and Children (WIG).  Director of Biochemistry Laboratory.  July 1973 to present.

 Presentations

 Annual Meeting of  the American  Society of Biological Chemists, San Francisco,
 California, June 16, 1971.

 Annual Meeting of  the Tissue Culture Association, Lake Placid, New York, June 7,
 1971.

 Annual Meeting of  the North Carolina Academy of Sciences, Wilmington, North
 Carolina, May 3, 1969.

 Annual Meeting of  the Federation of American Societies for Experimental Biology,
 Atlantic City, April 9, 1974.

 Teaching Experience

 The University of North Carolina 1972-present.

    1.   NUTR 200, Cell Biology  (lecture)  and NUTR 201 Cell Biology Laboratory
        taught jointly with Dr. John J.B.  Anderson.

    2.   NUTR 202, Nutritional Biochemistry taught jointly with Dr. J.C. Edozien
        and Dr.  John J.B. Anderson.

    3.   Faculty member of 1973 Summer Program in Health Sciences sponsored by
        North Carolina Health Manpower Development Program.

    4.   BIOC 8,  Biochemistry for Dental Hygiene Students, taught jointly by
        several faculty members.

    5.   BIOC 226, Biochemical Regulations, taught jointly by  several faculty
        members.

Research advisor for 1 or 2 students and  have not directed any masters or
doctoral dissertation research previously.
                                        2-73

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Special Assignments

Self-study Report of the Department of Nutrition, 1972.

Self-study Report of the School of Public Health, 1972.

Task Force Report for the Research and Development Board of the North Carolina
Public Health Association, March to August 1973.

Member of the Vitamin A Panel of the Institute of Nutrition, Jan. 1973 to
present.

Chairman of Doctoral Advisory Committee in the Department of Nutrition, 1974
to present.

Chairman of M.P.H. Comprehensive Examination Committee in the Department of
Nutrition, October 1974 to present.

Chairman of the Fellowship and Traineeship Committee, School of Public Health,
1974-75.

Member of the Safety Committee, School of Public Health, 1974-75.

Member of the Board of Scientific Directors, Institute of Nutrition,  Feb. 1975
to present.
                                         2-74                       12-17-76

-------
 Boyd Ray Switzer, Ph.D.


                                   BIBLIOGRAPHY
 1.  Bowman, N.S., Rice, D.E., and Switzer, B.R.  Magnetic Nonequivalence in
     Derivative of a-Hydroxy Acids.  J. Am. Chem. Soc. 89:4477, 1965.

 2.  Switzer, B.R., Waters, M.D., and Summer, G.K.  Studies on Regulation of
     Alkaline Phosphatase Activity and Collagen Biosynthesis in Human Skin
     Fibroblasts  (abstract).  Fed. Proc. 28:901, 1969.

 3.  Switzer, B.R., Summer, G.K., and Waters, M.D.  Protein Biosynthesis in
     Mammaliam Cell Cultures  (abstract).  J. Elisha Mitchell Society 85:115,
     1969.

 4.  Switzer, B.R. and Summer, G.K.  Improved Method for Hydroxyproline Analysis
     in Tissue Hydrolysates.  Anal. Biochem. 39:487, 1971.

 5.  Switzer, B.R. and Summer, G.K.  A Modified Fluorometric Micromethods for
     DNA.  Clin. Chim. Acta. 32:203, 1971.

 6.  Switzer, B.R.  Studies on Collagen Biosynthesis in Human Skin Fibroblasts.
     Dissertation, 1971.

 7.  Switzer, B.R. and Summer, G.K.  Effect of Ascorbate and Medium Change on
     Human Fibroblasts in Culture (abstract).  In Vitro 6:383, 1971.

 8.  Switzer, B.R. and Summer, G.K.  Studies on Collagen Biosynthesis in Human
     Skin Fibroblasts (abstract).  Fed. Proc. 30:1195, 1971.

 9.  Switzer, B.R. and Summer, G.K.  Collagen Synthesis in Human Skin Fibro-
     -blasts.  Effect of Ascorbate, a-Ketoglutarate and Ferrous Ion on Proline
     Hydroxylation.  J. Nutrition 102:721, 1972.

10. "Switzer, B.R. and Summer, G.K.  Inhibition of Collagen Synthesis by a,a'-
     Dipyridyl in Human Skin Fibroblasts in Culture.  In Vitro 9:160, 1973.

11.  Waters, M.D., Summer, G.K., Switzer, B.R., Moore, R.D. and Heitkamp, D.H.
     Alkaline Phosphatase Activation and Collagen Synthesis in Human Skin
     Fibroblasts in Culture.  Exptl. Cell Res. 80:170, 1973.

12.  Switzer, B.R., Zand, T., Niehaus, N.J., and Edozien, J.C.  Effect of Diet
     on Fasting Plasma Immunoreactive Insulin (abstract).  Fed. Proc. 33:669,
     1974.

13.  Edozien, J.C., Niehaus, N.J. and Switzer, B.R.  Effect of Diet on Fasting
     Plasma Catecholamines in Rat (abstract).  Fed. Proc. 34:881,  1975.
                                         2-75                       12-17-76

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          APPENDIX 2.2
TENTATIVE TRAINING MANUAL OUTLINE
                2-76                        3-10-77

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1.0  Introduction




     1.1  Research Triangle Institute (RTI)




     1.2  Environmental Protection Agency




     1.3  Background:  Related and Previous Studies




     1.4  Study Objectives




     1.5  RTI Project Staff and Structure




     1.6  Project Timetable




2.0  Preparations for Field Operations




     2.1  Involvement of Other Agencies




     2.2  News Releases




3.0  Overview of Field Operations




     3.1  Introduction and Purpose




     3.2  Sampling Considerations




     3.3  Survey Instruments




     3.4  Household Data Collection




     3.5  Confidentiality




     3.6  Quality Control




     3.7  Supplies Required for Conduct of Field Work




     3.8  Disposition of Supplies




4.0  Household Contact and Data Collection




     4.1  Preparation




     4.2  Screening




          4.2.1  Assignment of Field Staff




          4.2.2  Sampling Considerations




          4.2.3  Explaining the Study ..
                     2-77                             3-10-77

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     4.2.4  Household Screening Questionnaire




     4.2.5  Household Eligibility




     4.2.6  Household Screening Log




     4.2.7  Problems




            4.2.7.1  Nonrespondents




            4.2.7.2  Nonparticipants




            4.2.7.3  Ineligibles




4.3  Household Data Collection




     4.3.1  Participant Consent Form




     4.3.2  Study Questionnaire




     4.3.3  Sample Collection




            4.3.3.1  Household




                        Soil (Pre-school age only)




                     .   Tap Water




                        House Dust




                     .   Paint Lead




            4.3.3.2  Individual




                     .   Urine




                        Scalp Hair




                     .   Blood




     4.3.4  Incentive




     4.3.5  Liaison with Central Data Collection Facility




     4.3.6  Quality Control




            4.3.6.1  Labels




            4.3.6.2  Duplicate Samples




            4.3.6.3  Reinterview









                2-78                            3-10-77

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     4.3.7  Problems

            4.3.7.1  Refusals

            4.3.7.2  Incomplete Data Sets

            4.3.7.3  Transportation for Participants to Central
                     Data Collection Facility

4.4  Survey Instruments:  Administration

     4.4.1  Household Screening Questionnaire

     4.4.2  Participant Consent Form

     4.4.3  Study Questionnaire

            4.4.3.1  Household Information

            4.4.3.2  Individual Information

            4.4.3.3  Interviewer/Respondent Information

            4.4.3.4  Sample Information

4.5  Sample Collection Methodology

     4.5.1  Soil

     4.5.2  Tap Water

     4.5.3  House Dust

     4.5.4  Paint Lead

     4.5.5  Urine

     4.5.6  Scalp Hair

     4.5.7  Blood

     4.5.8  Quality Control:  Duplicate Samples

4.6  Central Data Collection

     4.6.1  Overview

     4.6.2  Scalp Hair Sample
               2-79                         3-10-77

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          4.6.3  Blood Sample

          4.6.4  Hematocrit

          4.6.5  Urine Sample

                 4.6.5.1  Urine Protein

                 4.6.5.2  Specific Gravity

          4.6.6  Quality Control:   Duplicate Samples

          4.6.7  Problems

                 4.6.7.1  Incomplete Data Sets

                 4.6.7.2  Adverse  Participant Reaction

     4.7  Work Schedule

5.0  Administrative Procedures

     5.1  Reporting

          5.1.1  Household Screening Log

          5.1.2  Production, Time  and Expense Reporting

     5.2  Contacts

          5.2.1  RTI Staff

          5.2.2  Site Administrator

          5.2.3  Central Data Collection Facility

          5.2.4  Local Consultants and Agencies

     5.3  Special Problems

6.0  Data Receipt Control and Entry (RTI Staff and Site
     Administrator(s) Only)

     6.1  Survey Instruments

          6.1.1  Household Screening Log

                 6.1.1.1  Receipt

                 6.1.1.2  Batching

                 6.1.1.3  Scan-Edit

                 6.1.1.4  Direct Data Entry



                     2-80                         3-10-77

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     6.1.2  Household Screening Questionnaire

            6.1.2.1  Receipt

            6.1.2.2  Batching

            6.1.2.3  Scan-Edit

            6.1.2.4  Direct Data Entry

     6.1.3  Participant Consent Form

            6.1.3.1  Receipt

            6.1.3.2  Batching

            6.1.3.3  Scan-Edit

     6.1.4  Study Questionnaire

            6.1.4.1  Receipt

            6.1.4.2  Batching

            6.1.4.3  Scan-Edit

            6.1.4.4  Direct Data Entry

6.2  Results of Chemical Analysis
     (Chemical Analysis Report Form)

     6.2.1  Receipt

     6.2.2  Batching

     6.2.3  Scan-Edit

     6.2.4  Direct Data Entry

6.3  Quality Control

     6.3.1  Scan-Edit

            6.3.1.1  Visual

            6.3.1.2  Direct Data Entry

     6.3.2  Re-keying

     6.3.3  Reinterview

            6.3.3.1  Household Screening Questionnaire

            6.3.3.2  Study Questionnaire



                2-81                         3-10-77

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7.0  Site Administrator Responsibilities (RTI Staff and
     Site Administrator(s) Only)

     7.1  Coordination of Field Operations

          7.1.1  Training Sessions

          7.1.2  Local Agencies

          7.1.3  Independent Subcontractors

          7.1.4  On-Site Consultants

          7.1.5  Field Supervisors

          7.1.6  Central Data Collection Facility

     7.2  Sample Collection

          7.2.1  Air

          7.2.2  Soil

          7.2.3  Water

          7.2.4  Market Basket

     7.3  Data Management and Shipment

          7.3.1  Survey Instruments

                 7.3.1.1  Household Screening Questionnaires

                 7.3.1.2  Household Screening Logs

                 7.3.1.3  Participant Consent Forms

                 7.3.1.4  Study Questionnaires

                 7.3.1.5  Independent Subcontractors'  Production,
                          Time and Expense Reports

          7.3.2  Environmental Samples

                 7.3.2.1  Air

                 7.3.2.2  Soil

                 7.3.2.3  Water

                 7.3.2.4  House Dust
                     2-82                         3-10-77

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                        7.3.3  Biological Samples




                               7.3.3.1  Urine




                               7.3.3.2  Scalp Hair




                               7.3.3.3  Blood




                   7.4  Special Problems




APPENDIX:  Glossary of Terms
                                      2-83                     3-10-77

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   APPENDIX 2.3
SURVEY INSTRUMENTS
         2-84                          3-10-77

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                              RESEARCH TRIANGLE INSTITUTE
                                                                         OMB No.
                                                                         Approval Expires
                     STUDY OF HUMAN TISSUE HEAVY METAL BURDEN IN
                           NON-FERROUS SMELTER COMMUNITIES

                             HOUSEHOLD SCREENING LOG
Site Number
                                Segment Number
                                     Interviewer Number
                   Date
                                                         Day of Week
                       (Month)
(Day)   (Year)
tsehold
mber

•







































Street Address
















i
















Eligible
Household
Member(s)
Yes

























No

























Member(s)
Agree(s) to
Participate
Yes

























No























Number
of
Participants



















































Reason (s) for Nonparticipation. Nonresponse, or
Ineligibility



















•





                                           2-85
                                         3-10-77

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                                                                                           OMB No.
                                                                                           AD pro vf I ExpirM
                                       RESEARCH TRIANGLE INSTITUTE

                               STUDY OF HUMAN TISSUE HEAVY METAL BURDEN IN
                                       NON-FERROUS SMELTER COMMUNITIES
      NOTICE: The information recorded on this questionnaire wilt b« held in strict confidence, and will b« usad >olaly for medical
      rasaarch into tha effect! of  environmental factors  on  public haalth. All result! will be summarized for groups of people; no
      information about individual parsons will ba ralaasad without tha consant of tha individual. This questionnaire is authorized by law
      (43 U.S.C. 1857 as amended). While you are not required to respond, your cooperation is needed to make the results of tha survey
      comprehensive, accurate, and timely.
                                  HOUSEHOLD SCREENING QUESTIONNAIRE

  1.  Site number:       [    |                        2.   Segment number: |   [   |        3.   Interviewer number  |   |   |   |

  4.  Household number:  |    |   |   |                       5.  Date:  |   |   |  - |   |   | - |   |   |
                                                                  (Monthl
                                                                                         lYearl
 8. What is the exact address of this residence?
           (Street Number and Nemel
                                                                                (Apartment Humbert
           (Citrl                                     (Sate)

 7. a.   Do you have a telephone?    |  1  | Yes /Go to Question 761


    b.   If yes. what is the number?
                                                                                                        (Zip Codel
              I  2 I No (Go to Question 7cl
                                                       (Am Codel
         If no, what is the number of the nearest telephone?     I   j   I    ! - I   I   I   I  —
                                                       (Ant Codel
                                           I   |  Co to Question SI
 3.  How many persons reside in this household?
      |  ' I Do not know
      CD
 9.  For each person in your household, including yourself, please indicate the age, birthdate, sex, length of residence at this address and in
     this community, occupation, and relationship to you, beginning with the oldest and proceeding to the youngest:
Household
Member
Number
01
02
03
04
05
06
07
08
09
10
Age
(Years)




















Btrthdate
Month




















O.y




















Veer




















Sex
(M or F)










Length of Res
At this
Address
Units




















MO.
orY










dence
In tli
Commu
Units




















is
nitv
M.O,
orY










Occupation^)
During Pan
12 Months










Relationship
to
Respondent










Participant
Number




















10. a.   Has anyone in your household worked at the smelter at any time during the past 12 months?
                   [jj Yes (Go to Question 10b>
jTJNo
I 3  | Do not know
    b.  If yes, indicate relationship to respondent
        and household member number(s) from question 9
      If it is apparent that tha household contains no persons eligible to participate in this study, thank tha respondent and proceed to the
      next household. However, if parsons in the household appear to be eligible to participate in this study, continue to question 11.
11.  Would you participate in a health study as a paid volunteer?      |  1 I  Yes         j  2 | No
12.  In your opinion, would other members of your household participate in a health survey as a paid volunteer?

              [jj Yes. all        [z] Yes, some       [jjj NO          (JJJ Do not know
                                                    2-86
                                                      3-10-77

-------
                                                                                           OMB No.
                                                                                           Approval Expires

                                         RESEARCH TRIANGLE INSTITUTE

                             STUDY OF HUMAN TISSUE HEAVY METAL BURDEN IN
                                     NON-FERROUS SMELTER COMMUNITIES

                                        PARTICIPANT CONSENT FORM

      I understand that the Research Triangle Institute is engaged in a study of heavy metal  (arsenic, cadmium, copper, lead,
 manganese, and zinc) exposure and absorption by persons living in communities near non-ferrous smelters. I understand that this
 survey is being conducted because increased amounts of heavy metal absorption have recently been discovered among persons living
 near smelters in the United States, particularly young children. I  understand that the survey is being conducted in order to help
 measure the levels of heavy metal exposure and absorption by persons living in communities near non-ferrous smelters, and is limited
 to the purpose stated. I further understand that the survey is being conducted under the auspices of the United States Environmental
 Protection Agency in cooperation with the Center for Disease Control of the United States Public Health Service and the

 (State and local health departments)	.


      I do hereby  freely consent to participate in this study  of heavy metal absorption and understand that my participation will
 consist of providing answers to a questionnaire related to heavy metal exposure  and  the  following  environmental and biological
 samples:  (1) two  four  ounce  samples of cold tap water from a source commonly used for drinking  and cooking, (2) a sample of
 housedust from a small area (0.25m2) from the surface of the floor of a room commonly used for family activities using a small
 vacuum  device, (3) a small (approximately four  ounces)  early morning urine sample, (4) a small sample of scalp hair, (5) a small
 (approximately 10 cc) blood sample to be taken from an arm vein, and (6) measurement of paint lead levels using a special portable
 apparatus. I understand that two four ounce samples of surface soil  will  be taken from the play area(s) of  each pre-school child
 participant and that in some small children the blood sample may be obtained from a finger or heel. I understand that an agent of the
 Research Triangle Institute will administer the questionnaire in my home and at the same  time collect  the tap water, housedust, and
 soil  samples, and measure the paint lead levels. I  further understand that I am to deliver my  urine specimen to

 (Address of designated central data collection facility)	
 on (Day  of week)
                (Data)
                        .at (Time)
.a.m./p.m. where an agent of the Research
 Triangle Institute will obtain the scalp hair  and blood samples and where I will receive an incentive of ten dollars for my full
 participation in this study. I understand  that a small  number of households and individuals will be selected for the collection of
 duplicate tap water, housedust, scalp hair, and blood samples and reinterview, but that such selection would not entitle me to further
 compensation.

     I understand that a report of my test results will be sent to the State and  local health  authorities. In addition, t would/would
 not like a copy  of this report sent to my family physician. Dr.
 Address:  	;	
 I understand that my name will not otherwise be voluntarily disclosed, that all  information collectad in this study will be compiled
 into a general summary which will be strictly confidential, and that my name will not be referred to in any way when compiling and
 evaluating the results of the study.

     I understand that participation in this study may result in no direct benefits to me, other than those described herein, and that I
 am free to  withdraw from this  study at any time.  It has been explained to me  that there are no significant risks to me  from
 participation in this study. I  further understand that  while participating in the study I will be free to ask any questions concerning
 the study; if I have any further questions about the project, I know that I am free to contact
(Local health department representative)
(State health department representative)
                                                        telephone number
                                                        telephone number
                                                                                                                    or
or Mr. Benjamin S. H. Harris, III, Survey  Operations Center, Research Triangle Institute, Research Triangle Park, North Carolina
27709, telephone number 919-549-8311, extension 2700.
Date:
                                Participant's Name;
          (Month)
(Day)
(Year)
Site Number:
     Segment Number:
                                                          Participant Number:
                                                                                        Household Number:
Signatures:
                                                            Witness:.
|    I Participant
   Parent, guardian, or other legal representative of participant*
                                                                 Interviewer Number:
 • If the participant is a minor (under 18 years of age), this consent form must be signed by the parent or legal guardian.
                                                         2-87
                                                                            3-10-77

-------
                                                                        OMB No.
                                                                        Approval Expires
                    STUDY OF HUMAN TISSUE HEAVY METAL BURDEN IN
                           NON-FERROUS SMELTER COMMUNITIES
  Sponsored by:
     Health Effects Research Laboratory
     Environmental Protection Agency
     Research Triangle Park. North Carolina 27711
                                      Conducted by:
                                        Research Triangle Institute
                                        P.O. Box 12194
                                        Research Triangle Park, North Carolina 27709
       THE RESEARCH TRIANGLE INSTITUTE OF RESEARCH TRIANGLE PARK, NORTH CAROLINA, IS
       UNDERTAKING A RESEARCH STUDY FOR THE U.S. ENVIRONMENTAL PROTECTION AGENCY
       OF LEVELS OF HEAVY METAL ABSORPTION BY PERSONS LIVING IN COMMUNITIES NEAR
       NON-FERROUS SMELTERS. THE INFORMATION RECORDED IN THIS QUESTIONNAIRE WILL BE
       HELD IN STRICT CONFIDENCE AND WILL BE USED  SOLELY FOR  MEDICAL RESEARCH INTO
       THE EFFECTS OF ENVIRONMENTAL FACTORS ON PUBLIC HEALTH. ALL RESULTS WILL BE
       SUMMARIZED  FOR GROUPS OF PEOPLE; NO INFORMATION ABOUT INDIVIDUAL PERSONS
       WILL BE RELEASED WITHOUT THE CONSENT OF THE INDIVIDUAL. THIS QUESTIONNAIRE IS
       AUTHORIZED BY LAW (42 U.S.C.  1857 AS AMENDED). WHILE YOU ARE NOT REQUIRED TO
       RESPOND, YOUR COOPERATION IS NEEDED TO MAKE THE RESULTS OF THIS SURVEY COM-
       PREHENSIVE, ACCURATE, AND TIMELY.
                            Study number:
Site number:
Segment number:
Household number:
Participant number:
                                            2-88
                                                     3-10-77

-------
                                                         -2-
 1.
                                   A.  HOUSEHOLD INFORMATION


For each person in your household, including yourself, please indicate age, beginning with the oldest and proceeding to the
youngest (Enter responses in matrixbelaw ):
Household
Member
Number
01
02
03
04
05
06
07
08
09
10
Age
(Years)




















Educa-
tional
Level










Currently
Employed at
Smelter
1 = Yes 2 = No










Normally
Spend Day
at Horns
1 = Yes 2 = No










Excess Metal Absorption
Screened










Diagnosed










Partici-
pant
Number




















 2.   For each person in your household, including yourself, please indicate educational level, again beginning with the oldest and
     proceeding to the youngest (Enterresponses in matrix above using codes listed below for highest educational level completed):
              8th grade or less
              High school - incomplete
              High school graduate
                                    [  4 [ College - incomplete


                                      5  College graduate
                        Technical school beyond high school
                                                                            Do not know
                                           6
                                         Graduate school
                     9  {Other
3.   Does anyone in your household currently work at the smelter? (Enter responses in matrix above.)

4.   Which members of your household normally spend their day at home? (Enter responses in matrix above.)

5.   Has anyone in your household ever been screened for excess heavy metal absorption?
              Yes
                             No
Do not know
                                                                       (Enter response in matrix above.)
6.   Has any member of your household ever been diagnosed as having excess heavy metal absorption?


                                  No
        Yes
Do not know
                                                                       (Enter response in matrix above.)
7.   For male head of household, indicate:

     a.   Household member number:

8.   For female head of household, indicate:

     a.   Household member number:


9.   What is the approximate age of your house?
                                                            b.   Current occupation:
                                                            b.   Current occupation:
                                                           Years
                                                                         Do not know
                                                        2-89
                                                                                           3-10-77

-------
                                                          -3-
  10.  What type of structure is your house? (51 percent or more of exterior surface.)
            Solid brick, concrete, or rock
            Brick or rock veneer
            Stucco
                                               Asbestos
                                               Aluminum siding
                                               Composition siding
                               Wood frame
                                                                             Do not know
                               Other (Specify)
                                                                              No
11.  Is there evidence of flaking paint present in the home?        1  Yes


12.  Are paint chips present in the soil surrounding the home?     1  Yes

13.  Do you cool your home with any of the following appliances? (Check  all that apply.)
                                                                                       Interviewer observation
                                                                              No
          Central air conditioning


      I 2  I Window air conditioner(s)
            Evaporative cooler(s)
        3
                                                Window fan(s)
 Ceiling exhaust fan(s)


 Circulating fan(s)
                               None of these
                                                                              Do not know
                                                                             Other (Specify)
 14. Are any of the following articles used in storing, preparing, and/or serving food in your household? (Check all that apply.)
Articles
1 . Unglazed pottery
(homemade or craft)
.2. Glazed pottery
(homemade or craft)
3. Hand-painted flatware
Uses
Storing food(s)
No
1
1
1
Yes
2
2
2
Specify food(s)



Preparing food(s)
No
1
1
1
Yes
2
2
2
Specify food(s)



Serving food(s)
No
1
1
1
Yes
2
2
2
Specify food(s)



[  * | None of these
                         Do not know
15.  Does your household grow any of its own food in a home garden?

     If yes, specify food(s) 	
                                                                          Yes
                                                                                          No
                                                                                                        Do not know
16.  Where does your household ordinarily shop for groceries? (Specify)
17.  Where does your household obtain fresh fruit and/or vegetables? (Specify)
18.  What is the primary source of your water for drinking?
      m
          Bottled water
           Tap - municipal supply
Tap - community well
                                              Tap - private well
Tap - cistern
                                                                             Do not know
                                                                        [ 7 [ Other (Specify)

19.  Is that the same primary source of water for drink mixes such as coffee, tea, Kool-Aid, etc.?
           Yes
                             No
                                      If no, how does it differ? (Specify) .
20. What is the primary source of your water for cooking?

           Bottled water
          Tap - municipal supply
                                              Tap • community well
                                              Tap - private well
                           5 I Tap - cistern
                                                                          6  Do not know
                                                                             Other (Specify)
                                                         2-90
                                                                                                 3-10-77

-------
                                                      -4-
  21.  Has anyone in your family ever been under medical care for:

                                 No      Yes     Relationship to respondent and/or household member number:
a. Seizures?

b. Hyperactivity?

c. Mental retardation?

d. Skin conditions other
than acne?
e. Kidney stones?

f. Broken bones?

'

1

1

1

•

1













2

2

2

2

2

2

(Specify)

(Specify!

(Specify)

(Specify)

(Specify)

(Specify)





































                                       B. PARTICIPANT INFORMATION
   IF THE PARTICIPANT IS UNDER 18 YEARS OF ACE, THIS SECTION OF THE QUESTIONNAIRE MAY HA VE TO
   BE ADMINISTERED IN WHOLE OR IN PART TO  THE PARENT OR GUARDIAN. AND MUST BE ADMINISTERED
   IN THAT PERSON'S PRESENCE. IF THE PARTICIPANT SUFFERS FROM A SPEECH OR HEARING DEFICIT, THIS
   SECTION OF  THE QUESTIONNAIRE MAY HAVE TO  BE ADMINISTERED  TO THE SPOUSE OR ANOTHER
   SPOKESMAN-SEE SECTION C
  First, I would like to ask some general questions about you/the participant.

                               Male        2  Female

                               White
1.   Sex (by observation):
2.   Race (by observation):
           American Indian
           Unknown
                             Asiatic
                             Other
                             (Specify)
5.   What is your/the participant's birthdate?
           (Month)      (Day)       (Year)
Black

Spanish
surname
6.   What is your/the participant's approximate weight in pounds?
 3.   Household member number (from A-1):
 4.  What was your/the participant's age in years at last birthday?

                            Years
                                                           7.   What is your/the participant's marital status?

                                                                    Married     2  Never married
                                                                                                    Widowed
                                                                    Divorced    5 | Separated
                                                                 I    i
                                                                 [_6j Other (Specify).
 Next, I would like to ask some questions about your/the participant's education.
 8.  Are you/is the participant in school now?
                                              1   Yes (Continue)      | 2 | MO (Go to Question 11)
 9.   What type of school do you/does the  |  1  | Kindergarten, nursery, play, or day care school (Continue)
     participant attend?
                                      2  I Elementary school

                                      3   Junior high school
                                         Senior high school
                                                             (Continue)   6
                                                                            Junior college
                  College
                                                                              Graduate school
                                                                                                 (Go to question 11)
                                                                         \  8 i Technical school
                                                                         
-------
                                                             •5-
 Next, I would like to ask some questions about your/the participant's occupation and residence.
 11. Are you/is the participant presently employed in any capacity?    1  Yes (Go to question 13)
 12.' If not presently employed, which of the following best describes your/the participant's status?


                                     (Co to question 18)
                                                                           No (Continue)
Housewife   J

Student    )
Unemployed
                                                                    Retired
                    Child (Go to question 21)
 13. What is/was your/the participant's usual occupation? (Specify).
                                             6  Disabled
                                                                                        (Continue)
 14. Are you/is the participant presently employed in this occupation?
                                                      Yes
                     2  No
 15.  If yes to above question, how many years have you/has the participant been employed in that occupation?

     If no to above question, how many years were you/was the participant employed in that occupation?

 16.  If you are/the participant is presently employed, what is the nature of the company for which you/the participant work(s)?
     (Specify)
 17.  How long have you/has the participant been employed by your/the participant's present employer?
 18.  How many times have you/has the participant changed occupations during the past 5 years?
                                                                                                  Units
                                                                                             Months
                                                                                             Years
 19.  Does your/the participant's occupation usually take you/the participant away from home?
 20.  Have you/has the participant worked at a smelter at any time during the past 12 months?
                                                                          1   Yes
                                         2   No
                                                                        Yes (STOP!)   2   No (Continue)
 21.  Have you/has the participant ever worked at or lived for as long as 12 months within 2 miles of:
                                            Worked at            Lived near
                                          >
     a.   Paper/wood industry

     b.   Smelting industries

     c.   Glass manufacturing plant

     d.   Pesticide manufacturing plant

     e.   Mining area

 22.  How many hours of the day, on the average, do you/does the participant normally spend more than 2 miles from home?
Yes
1

1

n
i

1

No
2
2
2

2
2

Yes
1
1

1
1
1

No
2
2

2

2

2
23.  How many years have you/has the participant lived in this city or town?
                                                                                                                   Hours
                                                            Years (If less than 1 year. STOP!;
24.  How long have you/has the participant lived at this address?
                                                   Units
              1   Days    2   Months     3   Years
25.  How many times have you/has the participant changed living quarters during the last 5 years?
                                                           2-92
                                                                               3-10-77

-------
                                                             -6-
 IMext, I would tike to ask some questions regarding your/the participant's personal habits.

 26. What is the natural color of your/the participant's scalp hair?
              Brown
                          Black
Red
Blonde
Gray
Bald
Other (Specify)
 27.  How many times per week, on the average, do you/does the participant shampoo your/the participant's hair?
 28.  Which of the following hair care products do you/does the participant use? (Check all that apply and specify the most frequently
     used brand.)
                                               Brand                      '                         Brand
        1
           Washing (Shampoo or soap)
        2  Setting lotion
           Hair spray
                              Artificial coloring
                           5  Permanent
                              Last application date
                                                                                     (Month)      (Day)       (Year)
29.  Have you/has the participant ever smoked as many as 5 packs of cigarettes-that is, as many as 100 cigarettes during your/the
     participant's entire life?
                                 | 1 [Yes (Continue)


30.  Do you/does the participant now smoke cigarettes?
                                 No (Go to Question 34)
                        Yes
                                       No
37.  How old were you/was the participant when you/the participant first started smoking?
                                                          Years
32.  If you/the participant no longer smoke(s), how old were you/was the participant when you/the participant last gave up smoking?


                       Years
33.  On the average, how many cigarettes do (did) you/does (did) the participant smoke per day?

            [  1 [ Less than V4 pack (1-4 cigarettes)
                                 About I'/j packs (25-34 cigarettes)
                 About Vt pack (5-14 cigarettes)
                 About 1 pack (15-24 cigarettes)
                             5   About 2 packs (35-49 cigarettes)
                                 More than 2 packs (50 or more cigarettes)
34. What is the average number of hours that you/the participant spend(s) out of doors each day?


35.. Do you/does the participant ever eat non-food substances such as paint, clay, dirt, or plaster?


36- (For children participants only) Where does the participant play most frequently? (Check one.)


            |  1 [ At home indoors


              2  At home outdoors
                                                                Hours
                                                            Yes
                                                             No
               On the same block indoors
           4   On the same block outdoors
                                           On a different block indoors


                                        6  On a different block outdoors
                 Other (Specify)
                                                            2-93
                                                               3-10-77

-------
                                                            -7-
 Next, I would like to ask some questions regarding your/the participant's health.
 37.  What do you consider the current status of your/the participant's health?
1
38. Are you/
0

1

2
Excellent 2 C
s the participant curre
None
Tranquilizer
Sedative
>ood 3 Fair 4 Poor
ntly taking any prescription medication(s) on a regular daily basis? (Check all that apply.)
3
4
5
Analgesic 6 Antibiotics (Specify) .._
Hormone 7 Othe' (Specify) . _ 	


Oral contraceptive
39. Do you/does the participant currently have any 'of the following symptoms?
If yes, specify
how long
Yes No Yes
a. Loss
b. Weig
c. Fatic
d. Naus
vom
e. Diar
of appetite 1
2
h. Cough 1

ht loss 1
,ue []]
ea and/or 1
ting
hea 1
f. Abdominal pain 1

2
2
i. Changes in skin pigmentation 1
j. White lines across fingernails 1

2
2
2
k. Pins and needles, numbness or 1
	 pain of the limbs
Weakness or withering of the 1
muscles of the limbs
m. Pain or soreness of the mouth, 1
nose, or eyes
g. Sore throat 1

2
n. Skin irritation 1




If yes. specify
how long
No
2

2
2
R

2

2

2

Next, I would like to ask some questions regarding your/the participant's diet.
40. Which meal(s) do you/does the participant usually eat at home? (Check all that apply.)
                          Breakfast
Lunch
                                                                      Dinner
41. When you do not/the participant does not eat at home, where do you/does the participant eat? (Check all that apply.)
                          Meal prepared at home but eaten elsewhere      2  School    [  3 [ Work
                                                  Restaurant
                          Other (Specify)
42. Are you/is the participant presently following any of the following dietary regimens? (Check all that apply.)

            I 1 I Formula/prepared baby foods    | * [ Reducing diet
                 Bland food ulcer diet
                 Diabetic diet
   Organic foods
   Vegetarian
                          None of these
Other (Specify) .
                                                           2-94
                                                  3-10-77

-------
                                                              -8-
     43.  On the average, how often do you/does the participant eat the following foods? (Check the appropriate box.)






Foodstuff



a. Shellfish
b. Fish
c. Beef liver
d. Roast beef
e. Hamburger
f. Chicken
g. Frankfurters
h. Bacon
i. Eggs
j. Whole milk
k. Breakfast cereal
1. White bread
m. White rice
o

c
o


r
£8
o 5

1















a
o
u
c
o
n-*
O Qi
JJ 0
< 5
2













o


o
u
c
O i»
3 O
n °
a 3

-------
     -9-
COMMENTS
    2-96                         3-10-77

-------
                              D. SAMPLE INFORMATION

               For each sample collected for a given household or individual,
               attach  the  appropriate  label  to the  appropriate  container
               before collecting the sample. Complete section  D below when
               appropriate.
1. Study number:


2. Site number:
         3.  Segment number:
                                                                                                                            LABELS
                                                                                                                                            to
                                                                                                                                ^^^^3
4. Household number:
5.  Participant number:
6. Paint lead measurements:    I   Exterior toward smelter      II  Exterior away from smelter     III   Interior dust -1     IV   Interior dust - 2        V  Interior dust - 3     VI   Interior kitchen



1
VO
8.


9.
10.
11.
CO
1
012.

Type of
Sample


Soil
Tap Water
Sou/re:
House Dust
Surfacu:
-- Scalp Hair
Blood


Urine
Original Sample
Collected
Yes

1
1


1
1
1


1
No

2
2


2
2
2


2
If Collected, Date
Month






















Day






















Year






















If Not Collected,
Reason












I nterviewer
Number


































Duplicate Sample
Selected
Yes

1
1


1
1
1
NX NX
/\/\
y\x
No

2
2


2
2.
2
NX NX
X\/\
y\x
Collected
Yes

1
1


1
1
1


1
No

2
2


2
2
2


2
If Collected, Date
Month






















Day






















Year






















If Not Collected,
Reason











13.  Hcmatocrit:
15.  Specific gravity:
                                                                            (Month)      (Day)      (Year)
                                                                               COMMENTS:
14.  Urine protein:
                                                                 16.  Date:
                                                                 17.  Interviewer number:

-------
        RESEARCH TR.LANC3LE INSTITUTE

STUDY OF HUMAN TISSUE HEAVY METAL BURDEN
     NON-FERROUS SMELTER COMMUNITIES

         Chemical Analysis Report Form
Sample Number










-
















ro
1
vo
00





-r
i-1
_ o
-4
^4





































































































































Motal
Symbol


















































Units
Determination No. 1


















































i
,
















































Completed by (RTI ID iwinbor):




















































Determination No. 2























































i


,

,






























































































ode

























Sample

























Dato completed:





















































Number










































































































^ ^
Metal
Symbol





















































Units
Determination No. 1


















































(


>
i
i

,
i












•





















i
























































Determination No. 2

























i
























,
,
4



































,





























































Cc












-


-








                           (Montli)
(Day)

-------
      APPENDIX 2.4
PRETEST CONSIDERATIONS
         2-99                       3-10-77

-------
                        PRETEST CONSIDERATIONS






     In order to test and standardize the data collection instruments




and procedures, RTI will conduct a Pretest of this Work Plan in a limited




number of households at a non-ferrous smelter site not selected for the




main study effort, most likely Corpus Christi, Texas, with the approval




of the Project Officer.  The Pretest will be conducted by the RTI project




staff and consultants with on-site assistance by independent subcontractors.




The Pretest will simulate the main study as closely as possible and will




therefore follow the Work Plan as closely as possible, including sampling,




field operations, and chemical analysis.  If no major problems are encountered




with the Work Plan such that modifications are minimal or unnecessary,




then the data from the Pretest would provide at least some limited data




on a seventh non-ferrous smelter community.  If problems are encountered




which require modifications of the data collection instruments or procedures




before proceeding with the main data collection effort, some of the data




collected in the Pretest may still be useful (other than as a justification




for the modification), depending upon the nature of the problem and/or




the required modification.  The decision in favor of Corpus Christi (over




Hayden, Arizona) has been based on a number of considerations related




to the logistics of executing the study protocol at a site for the first




time, in particular the availability and costs of, and problems and staff




burden associated with, various ancillary and support services including:




     1.  Attitude of the smelter;  Both of the smelter firms with




operations at Hayden are involved in various litigations, although




only the Asarco plant at Hayden is specifically involved in such




litigation.  In addition, there is information that the smelter
                                  2-100                      3-10-77

-------
industry may undertake an epidemiological study at Hayden.




     2.  Attitude of federal, State, and local agencies;  RTI would




prefer a Pretest site where the appropriate federal, State and local




agencies would be interested, perhaps experienced, and hopefully could




be actively involved, in such a study.  At a meeting at Phoenix,




Arizona, on November 23, 1976, RTI was encouraged by support expressed




by the Arizona Department of Health Services and the University of




Arizona College of Medicine; however, the primary focus of that meet-




ing was Ajo.




     3.  Availability of independent subcontractors;  The Pretest




will attempt to simulate the main study as closely as possible, except




on a smaller scale, and will therefore follow the Work Plan as closely




as possible, including involvement of independent subcontractors.  Fig-




ures A-2.4.1 and A-2.4.2 present graphically the number of inter-




viewers from the current RTI listings living in counties within a




reasonable distance of the sites in Texas and Arizona respectively,




which were under consideration for the Pretest.  That is not to say,




however, that all of those individuals would be available or suitable




for this research effort.  For example, RTI has two other major survey




research efforts planned for the Phoenix area in early 1977 which




would deplete the number of available interviewers in Maricopa county




during that time.  More important, however, is the distance which the




interviewers must travel to reach the site and the cost and burden




associated with that travel.
                                 2-101                      3-10-77

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O
10
CO
O
                                                                                                                            TEXARKANA

                                                                                                                                HXAtKANA
                                                                                                               ,Mlcnw
                                                                                                       SHERMAN DENISJON
                                                                            •v.N*H"v
                                                                            -,.—
                                                               -S — t-    \  - --   •
                                                                  j     i   >»"<»  i   ••"«' "" r     i   	,
                                                                                 -r - -
                                                                                       — ~
        ....     A\
      I       X/io-
                                                                                                  jy*  /i
                                                                                       	 T    1 "jQyQORPUS/CHRIST!
                               LEGEND

                      <•)  Places ot 100000 or mo>e inhabitants
                      •  Places ol 50.000 to 100000 inhabitants
                      O  Central cities ot SMSA's *ith lewer than Ml.OOO inhabitants
                      O  Places ot 25.000 to 50.000 inhabitants outside SMSA's
                             . Standard Metropolitan
                               Statistical Areas iSMSA'sl
            	 fOlNSUftG £)
MC ALLEN PHARR^^/  .„,»•! OH"UiN<^f<  BROWNSVILLE HARLINGEN SAN BENITO
   EOINBURG   —' nn  '
                  Fig. A-2.4.1.   Location  and  number  of  interviewers  from the current RTI  listing  living in  counties
                                     within a  reasonable  distance  of the  Corpus  Christi,  Texas,  potential Pretest site
                                     [Source:   Ref.  2.3,  p.  1013].

-------
                             '-r  --• ;• TUCSON/;••- - :;„;
                                                           ®JUCSON
          LEGEND

®   Places of 100.000 Of more inhabitants
•   Places of 50.000 to IOO.OOO mhaBilants
O   Places of 25.000 to 50.000 inhabitants outside SMSA's
         Standard Metropolitan
          Statistical Areas (SMSA's)
                                                               « «=*«
                                                                     •0     to    IOO
  Fig.  A-2.4.2.
Location  and number  of interviewers from the current RTI
listing living  in counties  within a reasonable distance of
the  Hayden, Arizona,  potential  Pretest site [Source:   Ref.
2.3, p. 972].
                                         2-103
                                                     3-10-77

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     4.  Nature of the Site;  RTI would prefer a community large




enough to permit some flexibility in the event of a large number of




nonparticipants, and so that the logistics of implementing the field




operations for the first time would not be too involved.  Both of the




Pretest sites under consideration would present a bilingual popula-




tion.  However, Hayden and Winkelman, Arizona, which together make up




the Hayden smelter community, have a combined population of less than




2,000, have extremely limited transportation and medical facilities,




and are approximately two hours driving one way from the nearest




transportation facilities and sources of supplies and support services.




     5.  Cost;  Since the performance sites for the main study




were not known when the proposal was written, one of the smelter




communities in the St. Louis area was considered as a Pretest site for




the purpose of estimating Pretest cost.  Several of the considerations




cited in preceding paragraphs will have some impact on cost, particularly




the availability of qualified independent subcontractors within a reasonable




distance of the site, the magnitude of the Pretest, and the site itself.




For example, round trip tourist air fare Raleigh to Corpus Christi is




$230, and Raleigh to Tucson is $308 (plus ground transportation to Hayden).




The outcome of the Pretest may have some impact on RTI's time and cost




projections.




     Some of these same considerations entered into the choice of the




three performance sites where elderly persons will be studied, in that




RTI will need a larger population base and additional independent sub-




contractors.
                                 2-104                      3-10-77

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     APPENDIX 2.5
RELEVANT CORRESPONDENCE
         2-105                      3-10-77

-------
 OTHOR. WMITEMECK. D.D S-. MM-DCNT

I ROBERT 0. McCULLOUGH. O.O.. vice .HCSIOCNT

 THOMAS DONICA. M.O.. stc«£T«.»

 GLEN L. BERKENBIIE. M.O.

IWALLACE BVRO. M.O.

IAANOLO HELVEY

 EUGENE A. OWENS. MO.

|».A,-TAT6-TAYLOR

|H«ROLOA.TOAZ
                                                       R. LEROY CARPENTER, M.D.. M.P.H.
                          Northeast 10th Street I* Stonewall
                             Post Office Box 53551
                          Oklahoma City, Oklahoma 73105
                         September  17,  1976
Carl Hayes,  Ph.D.
Air Pollution Control Division
Research  Triangle Park,
North  Carolina  27711

Dear Dr.  Hayes:

I very much  appreciate talking with you about the studies  on the
Heavy  Metal  Absorption conducted  in Bartlesville in the Spring of
1975.  I  had previously discussed the findings with Dr. Phillip
Landrigan at the Center for Disease Control.

I feel much  more comfortable with your assurance that the  final
report when  released to the public will be modified.  I expressed
to you our anxiety about some of  the language in the preliminary
report and I am  pleased that you  are planning to modify this
language  to  indicate that the levels obtained in the children in
the Bartlesville survey are not of sufficient magnitude to warrant
immediate and concentrated reappraisal.

I am pleased that the EPA plans to conduct follow-up studies in
some of the  towns to further delineate the epidemiological
significance of  the levels found  in the children.  I would
strongly  urge that Bartlesville,  Oklahoma be selected as one of
the towns for further study.  As  we discussed on the telephone
Bartlesville was the first town to be studied and you and  I  both
realize that some of the technical aspects of the study were some-
what less than satisfactory especially in the areas of specimen
collection and in the methodology of sampling.  I would like to
suggest that this is one very good reason for going back to
Bartlesville with a follow-up study.   In addition I would  like
to emphasize that some of the highest levels of cadmium and  lead
were found in children in Bartlesville and feel that this  finding
would  be  an  important factor in selecting Bartlesville as  one of
the towns for further study.
                                 2-106
                                                               3-10-77

-------
Carl Hayes, Ph.D.                2                September 17, 1976


Although I am unable at this time to commit the resources of the
State Health Department's Epidemiology Program to assist in further
follow-up studies I can assure you of our interest and we would be
happy to evaluate the extent of the follow-up studies and the
degree to which we could participate.  Bartlesville is located in
a county that does not have a local health department and for this
reason the Epidemiology Program at the State Department of Health
would assist in any further investigation of this problem.

At the present time we are not taking any action on the preliminary
report which you forwarded some three weeks ago.  I indicated to
you that we felt that it would be important before the final report
is released to the public that a meeting be arranged between the
management of the National Zinc Company in Bartlesville and the
local physicians in Bartlesville and representatives of the State
Department of Health.  We do not plan to ask for this meeting until
such time as we receive the final draft copy of the report.
           *
                                     Sincerely yours,
                                     Armond H. Start, M.D.
                                     Director, Division of
                                     Communicable Disease
AHS/mls
                              2-107                   3-10-77

-------
OTMOfl. VWITENFCK. 0 0 S.. •or«ioc«T

^OfiERTD McCULLOUCH. 00. vet ».r«-nt«.

•HOMAS OONICA. M 0 . irt.tT*«v

GIENL. BEnxtrjaiiE.wo

WALLACE 8VHQ. MO

   bo MELVEY

   E A. OWENS. M.D.

W. * -TATE- TAYlOfl

IABOLO A. TO«
                               WALTER D. ATKINS. O.O.S., M.P.H.
Northeast 10th Street 4 Stonewall
   Post Office Box 53551
Oklahoma City, Oklahoma 73105


 January  24,  1977
           Warren  Galke
           Health  Scientist
           Population Studies Division
           U.S. Environmental Protection Agency
           Health  Effects Research  Laboratory
           Research  Triangle Park,
           North Carolina  27711
                                            EPA Contract No. 68-02-2442
                                            RTI Project No. 31U-1372
           Dear Mr .  Galke :

           I appreciate the opportunity to review  the draft work
           plan.   I  am very impressed by the quality and the detailed
           methodology found in the plan.   I have  discussed the plan
           with members of the Epidemiology Program  staff and we  have
           no comment or suggestions for incorporation into the final
           product.   We consider appropriate communication to be  an
           essential  element in working with a project involving
           people of  a community.   We commit ourselves to assist  this
           project within the limits of our resources.

                                            Sincerely  yours,
                                            Armond H.  Start, M.D.
                                            Director,  Division of
                                            Communicable Disease Control

           AHS/mls
                                          2-108
                                3-10-77

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        APPENDIX 2.6
SAMPLE COLLECTION METHODOLOGY
            2-109                           12-17-76

-------
                     SAMPLE COLLECTION METHODOLOGY

A.   General Considerations

     The specific methods proposed by RTI for measuring environment-related

factors differ somewhat among the various types of exposure.  These differences

reflect several considerations such as the extent to which surrogate

variables reflect the factors of interest, the measurability of factors,

the variability of factor measurements, the quality control of data collec-

tion, and the suitability of data collection techniques under actual

survey conditions.  The proposed methodology stresses random sampling

techniques wherever possible to facilitate valid statistical analyses

and to increase the degree of control over data collection; Field Interviewers
                                                                      o
(FI's) will follow explicit, nonjudgmental procedures throughout.  These

procedures will range, as described in subsequent sections, from obtaining

small selective samples of relatively homogeneous items, such as tap

water at a particular residence, to obtaining large stratified random

samples for a highly variable item, such as air quality in a smelter

community.

     Sample collection will be divided among the various field staff.

The collection of environmental samples will be divided between the Site

Administrator (SA) and the FI.  The SA will be responsible for collecting

air, market basket, and general soil and water samples such as soil and

water samples from each school where study children participants attend;

the FI will be responsible for the collection of dust and tap water samples

for each participating household and soil samples from the appropriate

residential play area for each pre-school child participant, and the

measurement of household paint lead levels.  Responsibility for the collection
                                 2-HO                      3-10-77

-------
of biological samples will be shared by the independent subcontractors.




The FI will be responsible for the explanation of the procedure for collect-




ing the urine sample, and arrangements for the participant to go to a




central location for collection of the biological samples; at that central




location, the urine and blood samples will be collected by the medical




independent subcontractor, the hematocrit and urine protein and specific




gravity will be determined by the medical independent subcontractor,




and the scalp hair sample will be obtained, either by the medical independent




subcontractor or an FI.




     For each household containing a study participant, samples of housedust




and tap water will be collected, and paint lead levels will be measured.




For each study participant, RTI shall endeavor to obtain samples of blood,




urine, and scalp hair; soil samples will be collected from the appropriate




play area for each pre-school child participant and from each school




yard where study children participants attend.  In addition, air, soil,




and market basket samples will be collected for the overall smelter community,




and drinking water samples will be obtained from each school where study




children participants attend.
                                  2-111                       3-10-77

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B»  Environmental Samples




    1.  Air



    Twenty four hour air particulate samples will be collected by the SA




using high-volume sampling units (Fisher Scientific, Cat. No. 1-037-40) on




pre-washed Tape A 8" x 10" glass fiber filters (Fisher Scientific, Cat. No.




9-730-68).




      The highr-volume air samples will be obtained at random points, which




are coincidental with a subsample of the random blocks (segments) containing




sample individuals.  This matching is not intended to provide matched




observations between individuals and air samples, but rather1 to expedite the




selection of a random point sample that is dispersed throughout the target




population and that is representative of the area over time.  These samples




will be taken at random points in time concurrently with the other data




collection activities at each performance site.  At any point in time during




the survey period, approximately five high-volume units will be operating




at the site being investigated.




      The SA will be provided with a list of sample days numbering from




approximately 1 to 19.  The randomization process will involve assigning,




for example, three numbers from 1-19, selected at random and without replace-




ment, and subject to the constraint that each day is assigned at most to




three strata at each site.  The constraint will facilitate maximum utilization




of the high-volume air sampling equipment.  The following partial table




represents a hypothetical example of such a randomized list:
                                      2-H2                       12-17-76

-------
     Stratum                       Days on which a high-volume air sample is to be
                                     taken (day 1 - first day of survey at site)


       S                                               8, 12, 17


       S2                                              2, 8, 15
       Sg                                      2, 3, 9, 10, 12, 14, 19


According to this schedule, two and three air samples  (see table A-2.6.1)


would be taken in strata S_ and SQ, respectively, on the second day of the
                          /      o

survey, and so on until approximately 87 operation sets are taken at that


site (see figure A-2.6.1).  Table A-2.6.2 presents the type of format which


might be used to describe the survey and lab results for one of the study


elements, such as lead.


     The sampling units will be placed at locations prescribed by the


stratum-day sampling scheme shown in figure A-2.6.1.  Power drops will be used


as required.

                                              3
     The initial air flow, approximately 1.7 m /min. , and the final flow


will be accurately read from the pressure gauge and related to total sample


volume by the following expression [Ref.2.7]:
                                                       3
                              V = air volume samples (m )


                              Q± = initial air flow (m3/min)


                              Q  = final air flow (m /min)


                              T = sampling time (min.)
                                    2-113                       3-10-77

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  Table A-2.6.1.  Tentative sample allocation for  air  samples.*




                                  Number  of  Observations  in Each Stratum,  Si

Type of Observation          S1      S2      ^3     54      85     Sg     Sy     SQ




Locations per day              22222233



Days                          "33445567



Ratio, days/locations        1.5     1.5     2.0     2.0    2.5    2.5    2.0    2.3





 Based on the following data from Djuric [Ref.  1.2].:
Day                Stratum  6;  2  locations            Stratum 8;  3 locations

                   (2.2 - 3.0  km)                    (5.0 - 8.0'ktn)
1
2
3
4
13.0
84.0
18.0
«_..«
30.0
68.0
66.0
« — ««•
1.3
15.0
9.6
24.0
7.6
36.0
3.2
60.0
4.2
25.0
4.2
29.0
                                          21           2             2
with approximate estimates of variance:  s.,  = 	r-  (xij-'x)   = 891;  and s0 ~ 697
                                          o   nm~1                       o


suggesting a total sample size, nir>, needed  for  a  20  percent c.v.:   ™r>,= (_— ) = 9

                                                                      °   '2 x
a ratio;
           2            '                                                * 2°
          s,. days
suggests that sample size ratio days/locations should be
          s, locat.
           o
          approximately 2.2


                 2    1  n  _  =  2
          where s, = —r- T.  (x.-x)   and  (nm).  is  total  sample size in stratum h.
                 b   n-1 ^   i               n
                                 2-H4                      3-10-77

-------
        Smelter
NJ
        Fig. A-2.6.1.
Geographic and temporal placement of high-volume air samples:
depicting only the first two days of the survey.
a partial hypothetical example

-------
  Table A-2.6.2.  Exemplary format for presenting survey and laboratory results  for study element:   lead.


Pb reading,
Observation mg. per
number cubic meter
1 4.2
2 36.0
3 60.0


Distance
from source,
km
2.5
1.2
1.3


Direction from
source, degrees
from transect
0.4
-5.2
-10.1


Wind
velocity,
km/hr
35.1
20.4
2.4

Wind
direction,
degrees from
transect
-10.5
-10.4
-5.3

Ground
level
temp . ,
°C
32.1
34.5
35.1
Upper
atmosphere
temp . ,
°C
30.0
33.1
40.0
87
7.8
5.0
35.6
2.4
-2.1
38.1
34.0

-------
    Wind direction, wind speed and extent of precipitation will be noted




for each sampling day.




    Although each sampler will be calibrated at RTI,  the air flow calibration




data will be validated at the site with an EPA audit  device.




    After the collection period, the filter will be removed from the sampler,




folded so that only surfaces with collected particulates are in contact and




placed in a tightly secured plastic Zip-Loc bag for shipment to RTI.
                                   2-117                      12-17-76

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     2.  Soil




     The basic sampling protocol will call for the collection of samples




of surface soil at air sampling sites, from the residential play areas




of pre-school age study children participants, and from the school yard(s)




where study children participants attend.  Two soil samples will be obtained




from the primary residential play area of each pre-school age child partic-




ipant; if a given household contains more than one pre-school age study




participant, these soil samples may represent more than one child.  One




soil sample will come from each air sampling location and one from each




school yard where study children participants attend.




     Variation in the soil content of study elements throughout the sample




collection areas, both for different locations and time, is expected




to be small relative to variation in the air samples.  Nonetheless, two




samples will be taken from each residential play area of pre-school age




study participants in order to obtain some measure of variation in element




exposure from soil in play areas.  The boundaries of the most commonly




used play area will be established and the two surface soil samples collected




from random points in the play area using a random number table.  Samples




will be collected in appropriately labeled four ounce plastic bottles




for shipment to RTI.
                                                            3-10-77

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     3.  House Dust


     A sample of settled dust will be collected for each household by


the FI using a vacuuming technique after that of Solomon and Hartford


[Ref. 2.8],  A single sample will be taken from the floor in the central


area of the room which is the most frequent site of common family activity,


away from the walls.  The sampling area will be delineated and standardized


using a 0.5 x 0.5 m template placed on the surface.  In taking each dust

                                           2
sample, one pass will be made of the 0.25 m  area utilizing a portable


vacuum source.  The vacuumed dust will be trapped in a special chamber;


the dust gathered will then be placed in appropriately labeled, tightly


secured Zip-Loc bags for shipment to RTI.  In the event that part of the


floor of the selected room is carpeted and part bare, a section of carpeted


floor will be selected for acquisition of the dust sample.


     Random sampling at different locations and time is not proposed for


this measure of exposure, because the sample should be relatively homogeneous


within a household, and because what little improvement in data that might


result from a suitable randomization does not seem to justify the accompanying


increase in participant and interviewer burden.
                                   2-119                         3-10-77

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     4.  Tap Water




     At each household, the FI will collect two samples of cold tap water




in four ounce plastic bottles, from the kitchen tap or other source commonly




used for drinking and/or cooking.  The first sample will be £aken immediately




upon turning on the water, without flushing; the second sample will be




taken after the water has been allowed to run for three minutes.  Time




will be measured using a stop watch.  Random sampling at different locations



and time is not proposed for this measure of exposure, because the samples




should be relatively homogeneous within a household, and because what




little improvement in data that might result from a suitable randomization




does not seem to justify the accompanying increase in participant and




interviewer burden.
                                2-120                       3-10-77

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     5.  Paint Lead Measurement




     At the time of household data collection, the FI will measure paint




lead levels using a Princeton Gamma-Tejch Portable Paint Lead Analyzer




such as that shown in figure 2.10.  Six paint lead measurements will




be taken, one on an exterior wall considered to be closest to the smelter




(I), one on an exterior wall considered to be farthest from the smelter




(III), three at different points on one interior wall in the same room




where the house dust sample is obtained (III-V), and one in the approximate




center of an interior kitchen wall (VI).  The readings will be recorded




in Part D of the SQ (see appendix 2.3).  Paint lead measurement is not




part of the Scope of Work of this contract; impact on project cost projections




will be assessed after the Pretest.
                                2-121                      3-10-77

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         Portable Lead Paint Analyzer


                                            -
                           Model XK-3
            Sensitivity - 0.5 mg/cm2    Full Scale - 99.9 mg/cm2
            Penetration - 85% through   Weight - 51/2 pounds
                    25 paint layers  Dimensions - 9.5" x 3.75" x 7"
         PRINCETON GAMMA-TECH
Box 641 • Princeton, N.J. O854O • Tel: 60S 984-7310 • Cable PRINGAMTEC • Telex: 843488

                       Fig. 2.10.
                            2-122
3-10-77

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C.   Biological Samples




     1.  Urine




     At the time that the participant is enlisted, arrangements will




be made for the collection of a urine sample in a four ounce plastic




bottle.  A twenty-four hour urine sample would be considered ideal, but




is considered impractical to collect from children, and adults who work




away from home.  The interviewer will leave the appropriately labeled




specimen bottle with the participant, explaining that the participant




is to collect a urine specimen from the first micturation on the morning




that the participant is to have the blood sample drawn; the urine specimen




will then have to be refrigerated by the participant until it is delivered




to the central data collection facility.  In the event that a participant




arrives at the central data collection facility without a urine specimen,




an attempt will be made to obtain one at that time, with appropriate




labeling and notation; if the morning urine sample was collected but




left at home, arrangements will be attempted to send an FI to the partic-




ipant's home to retrieve the urine sample.   Where RTI provides participant




transportation to the central data collection facility, this last step




may be avoided.  In some instances, RTI may ultimately have two urine




samples for some participants.  The central data collection facility




must have toilet facilities.




     If children participants are not toilet-trained, special procedures




may have to be implemented in order to obtain a urine specimen.  RTI




is considering testing commercial disposable absorbent diapers for this




purpose in the Pretest.   The mother would be provided two such commercial




disposable absorbent diapers and an appropriately labeled Zip-Loc bag,











                                 2-123                      3-10-77

-------
with instructions to place the disposable diaper next soiled by urine




only in the Zip-Loc bag for delivery to the central data collection facility




with interim refrigeration as required.  In the event that the disposable




absorbent diapers are not workable, adhesive plastic bags will be considered.




     At the central data collection facility, the medical independent




subcontractor will determine urinary protein using reagent strips and




specific gravity using a urinometer.  Results will be entered in Part D




of the SQ (see appendix 2.3).  Measurement of urine protein and specific




gravity are not part of the Scope of Work of this contract; impact on




project cost projections will be assessed after the Pretest.
                                2-124                       3-10-77

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     2.  Scalp Hair




     From each study participant from whom the collection of such a sample




is feasible, a full-length sample of scalp hair of sufficient quantity




for chemical analysis will be obtained using thinning shears.  Although




the amount of scalp hair available from the participant will ultimately




determine the size of the scalp hair sample, a concerted effort will




be made to collect as large a sample as possible from each participant




up to the minimum amount needed for chemical analysis.




     Scalp hair samples will be collected at the central data collection




facility and placed in appropriately and individually labeled Zip-Loc




plastic bags; the scalp hair sample will be completely enclosed within




the plastic bag which will be locked carefully and returned to RTI for




analysis.
                                  2-125                       3-10-77

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     3.  Blood




     An attempt will be made to collect a blood sample from each participant




from a brachial vein by venipuncture using a heavy metal-free 10 ml.




Vacutainer tube containing liquid EDTA as an anticoagulant.  Prior to




venipuncture, blood flow in the selected arm will be restricted using




a tourniquet; the venipuncture site will be prepared by cleansing with




an individually wrapped sterile alcohol swab.  Venipuncture will be accom-




plished by a disposable 20 G x 1 1/2 inch Vacutainer needle contained




in a reusable Vacutainer holder.  After collection of the blood sample,




the Vacutainer tube will be appropriately labeled and then inverted several




times to insure mixture with the anticoagulant; the venipuncture site




will again be cleansed with an individually wrapped sterile alcohol swab,




pressure applied to retard hematoma formation, and a sterile adhesive




bandage applied.




     Where venipuncture by Vacutainer presents problems, as in the very




young, obese, or elderly, alternatives may have to be employed at the




discretion of the individual collecting the sample.  In most instances,




venipuncture may still be accomplished using a disposable needle and




syringe with Immediate transfer of the blood sample to a heavy metal-




free 10 ml. Vacutainer tube containing liquid EDTA as an anticoagulant.




The syringe would permit gradual and variable withdrawal of blood and




be therefore less likely to collapse the vein.  The preparation of the




venipuncture site and the handling of the sample would be identical to




that described in the preceding paragraph.




     In the case of children participants, blood samples (0.5 ml.) may




have to be drawn via finger (children over two years of age) or heel




(children less than two years of age) stick using long point microlances








                                  2-126                      3-10-77

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and heparinized capillary tubes.  The method of drawing blood samples




by finger or heel involves several steps.  After the child is secure




or even before, his hand or foot must be cleansed of all noticeable dirt,




grime and anything else, such as food stains, with a cotton swab.  After




that, the finger tip  (usually the index finger) or heel to be stuck is




selected, held, and wiped with an individually wrapped sterile alcohol




swab.  After this, the finger or heel is massaged by applying gentle




pressure towards the  puncture site, thereby pushing the blood up toward




the puncture site.  When the puncture site appears somewhat red and engorged




with blood, the site  is punctured with an individually packaged long




point microlance.  The first drop of blood thus elicited is wiped away




with an individually  wrapped dry sterile gauze pad.  The free-flowing




blood is then collected with a gentle milk-ing motion into two or preferably




three heparinized capillary blood collection tubes of approximately 280




microliters in volume to within one inch of their top end.  During the




blood collection procedure, care should be taken to see that the tip




of the capillary tube is held right on the point of puncture and the




blood collected there so that the blood does not run down the finger




or heel and then into the tube, thereby opening possibilities of contamina-




tion.  The tube fills itself through capillary action; when each tube




is full, the blood collector places each tube on a clean level surface.




When blood sample collection is completed for a particular child (see




hematocrit section immediately following), the puncture site is wiped




with a dry sterile gauze pad pressed to the puncture to stop the bleeding,




and a sterile adhesive bandage is applied.  The blood samples in the




capillary tubes will then be transferred to an appropriately labeled




vial for refrigeration and shipment to RTI for analysis.








                                  2-127                       3-10-77

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     4.   Hematocrit Determination




     Hematocrit will be determined at the performance site by the




microhematocrit method using a microhematocrit centrifuge.  Hematocrit




values will be read with a reader and recorded in Part D of the SQ (see




appendix 2.3).




     In the case of Vacutainer blood samples, two microhematocrit




tubes will be filled three-fourths full from the blood in the Vacutainer




tube and one end of each hematocrit tube will be sealed with putty.  The




microhematocrit tubes will then be centrifuged, the percentage of packed




red cells read on a hematocrit reader, and the value recorded on the SQ.




The stopper will be replaced in the Vacutainer tube which will then be




refrigerated for shipment to RTI for analysis.




     In the case of the finger or heel stick, the procedure will




be the same as that in the preceding paragraph except that only one micro-




hematocrit tube will be filled per participant, directly from the puncture




site.
                                  2-128                       3-10-77

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D.   Considerations of Dietary Heavy Metal Exposure




     Diet is an important contributor of trace metal to an individual.




Moreover, the amount of trace metal in various diets may vary by several




orders of magnitude.  Accordingly, it may be quite important to the success




of the present study to obtain some measure of the amount of trace metals




in the diets of the sample individuals.  Procedures which have been suggested




for obtaining diet trace metal levels include:




     1.   Feces samples,




     2.   Analyzing duplicate diets or meals from sample individuals,




     3.   Questions regarding diet in the Study Questionnaire, and




     4.   Analyzing area grocery store food samples (Market Basket




          procedure).




     After review of the literature, discussions with consultants and




other experts, and careful deliberation, RTI decided to employ questions




regarding diet and the market basket approach together in order to obtain




some measure of the amount of trace metals in the diets of the sample




individuals.  Those two procedures, while less precise than chemical




analysis of feces samples and duplicate meals, are considerably less




expensive, more suitable and practical under actual survey conditions,




and less of a burden to the participant and interviewer.




     1.   Dietary History




     RTI has included  several questions regarding eating habits and diet




in the SQ which will be completed for every participant by the FI during




household data collection, including the frequency with which the partici-




pant eats certain foodstuffs known to contribute to trace metal exposure




[Ref. 2.5].  RTI has planned that these questions would be part of the
                                 2-129                      3-10-77

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data collection process from the beginning; therefore, this method of




collecting information on dietary trace metal exposure results in no




additional significant cost.



     2.  Market Basket




     In this approach, which is also relatively inexpensive, the RTI




Site Administrator would purchase exemplary market baskets of food from



grocery stores at the smelter sites.  The food would then be returned to




RTI for analysis for trace metal content.  RTI is in communication with




the Food and Drug Administration regarding the details of this procedure,




including the specific foods which comprise the market basket sample.




     The market basket procedure is not part of the Scope of Work of




this contract; impact on project cost projections will be assessed after



the Pretest.
                                2-130                      3-10-77

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E.   Quality Control




     Each sample will be properly labeled as it is collected.   Each indi-




vidual sample will be treated the same as all other samples of that particular




type.




     As a check on the quality or precision of the procedures and techniques




for collecting certain of the biological and environmental samples, RTI




plans to collect duplicate housedust, tap water, blood, and scalp hair




samples (the last two from adult participants only) from ten percent




of the sample sources, using the same technique and as nearly as possible




the same site(s) as the original sample.




     The duplicate housedust sample will be taken from a floor area immediately




adjacent to the site of the original sample using the same collection




procedures.  The duplicate tap water sample will be taken from the same




water source as the original after flushing sample using the same collection




procedure.  The duplicate scalp hair sample will be taken using the same




collection procedure in an amount equal to the original sample (where




possible).  The duplicate blood sample will be taken from the same venipuncture




using the same collection procedure as the original sample by changing




Vacutainer tubes.  The duplicate samples will be taken by the same person




as the original sample and at the same approximate time.
                                2-131                       3-10-77

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APPENDIX 2.7




 REFERENCES
  2-132                       3-10-77

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                                REFERENCES







2.1. Landrigan, P. J., et al., Epidemio lead absorption near an ore smelter:




     the role of particulate lead.  New England Journal of Medicine,




     Vol. 292, No. 3, pp. 123-129, January 1975.




2.2. Center for Disease Control, Protocol:  nationwide survey of children




     living near primary non-ferrous metal smelters.




2.3. U. S. Department of Commerce, Social and Economic Statistics Admin-




     istration, Bureau of the Census.  County and City Data Book, 1972;




     Statistical Abstract Supplement.  Washington, D. C.:  U. S. Government




     Printing Office, 1973.



2.4. Hartwell, T. D., et al.  Design, Data Collection and Analysis of a




     Field Test of Instruments and Procedures to Measure English Language




     Proficiency.  Research Triangle Park, N.C.:  Research Triangle Institute,




     April 1976.




2.5. Bureau of Foods, Compliance Program Evaluation, FY 1974 Heavy Metals




     in Foods Survey (7320.130, Chemical Contaminants Project), June 19, 1975.




2.6. Hall, W. G., and L.'T. Slovic, U. S. Department of Commerce, National




     Bureau of Standards.  Survey Manual for Estimating the Incidence of




     Lead Paint in Housing (NBS Technical Note 921).  Washington, D.C.:




     U. S. Government Printing Office, 1976.




2.7. Federal Register, Vol. 36, p. 8192, 1971.




2.8. Solomon, R. L.,  and J. W.  Hartford, Lead and cadmium in dust and soils




     in a small urban community.   Environmental Science and Technology.




     Vol. 10, No. 8,  pp. 773-777, August 1976.
                                2-133                      3-10-77

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3.0  Physical Methods of Analysis




     This section describes the sample preparation procedures which will




be carried out on the blood, urine, scalp hair, tap water, dust, air




particulate, soil, and market basket samples collected at the smelter




sites.  These materials will be analyzed for As, Cd, Cu, Mn, Pb and Zn




by atomic absorption spectrophotometry.




     A spark source semiquantitative scan will be obtained on two biological




samples from each age-sex group by Commercial Testing and Engineering Company,




Golden, Colorado.  This corresponds to a total of 252 samples from the




six smelter sites which will be analyzed in this manner.




     Free erythrocyte protoporphyrin (FEP) content will be determined in




each blood sample to establish the extent of chronic exposure to lead.




A microspectrofluorometric procedure will be employed.




     Quality control will play a prominent role in all routine analytical




operations.   Both internal and external reference materials will be used




to insure continuing analytical accuracy.




3.1  Atomic Absorption Analysis




     All atomic absorption analysis will be carried out on a Perkin-




Elmer Model 403 Atomic Absorption Spectrophotometer using an HGA-2000




Graphite Furnace with deuterium arc background correction.  Absorption




peaks will be recorded with a Perkin-Elmer Recorder Model 056.  Homogeneity




of the final sample will be insured by treatment in an ultrasonic bath




prior to analysis.  Sample injection will be accomplished with an Eppendorf




pipet.




     All glassware used in sample preparation will be soaked overnight




in 1% HNO,,  rinsed well with deionized water and dried.  Precleaned




volumetric pipets will be used for reagent and sample deliveries.  All




                                 3-1                              3-10-77

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HNCL solutions will be prepared from analytical reagent grade material




and deionized water.




     Sample preparation procedures are described below for each matrix.




Special workup conditions will be used for sample solutions slated for




arsenic analysis (see Section 3.1.4).




     3.1.1  Biological Samples




     Samples in this category include blood, urine and scalp hair speci-




mens collected from the study participants.




     3.1.1.1  Blood




     Blood samples will be diluted with 0.5% (v/v) HNO. and analyzed




directly for the metals of interest.  Results will be reported as weight




of metal/100 ml blood.




     3.1.1.2  Urine




     Urine samples will be diluted with 1.0% (v/v) HNCL and analyzed




directly for the metals of interest.  Results will be reported as weight




of metal/100 ml urine.




     3.1.1.3  Scalp Hair




     Scalp hair samples will be cut into approximately 1 cm sections




with stainless steel scissors and rinsed with a 1:1 methanol:ether




mixture.  The hair material will be washed twice with a 10% Prell (liquid)




solution, rinsed well with deionized water and dried at 105°C.  A 250 mg




(approximately) portion of the washed hair collection will be weighed




and digested at 85°C with a 1:1 HNO_ mixture.  The concentrate will be




diluted with deionized water and analyzed directly for the metals of




interest.  Results will be reported as weight of metal/gm hair.
                                3-2                               3-10-77

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     3.1.2  Environmental Samples




     Samples in this category include dust collected at the homes of the




study participants, air particulate samples collected according to the




sample design described in section 1.6.2; tap water samples taken from




the homes of study participants and schools of school-age subjects; and




soil samples taken at the air sampling locations, from the play area of




pre-schoolers, and the school yard of school-age subjects.




     3.1.2.1  Tap Water




     Each tap water sample, already acidified with HNO_ at the collection




site, will be analyzed directly for the metals of interest.  Results




will be reported as weight of metal/liter tap water.




     3.1.2.2  Dust [Ref. 3.1]




     Dust samples will be weighed and digested at 85°C with 1:1 HNO~.




Deionized water will be added to a reference volume, the suspension will




be filtered, and the filtrate analyzed directly for the metals of interest.




Results will be reported as weight of metal/gm dust.




     3.1.2.3  Air Particulates




     Air particulate samples will be eluted from a 2.0 x 20.3 cm strip




of the glass fiber filtering media with 1% (v/v) HNO- in a 50° - 60°C




water bath.  The filter strip will be quartered, placed in a covered




beaker and warmed with dilute HNO_ for 30 minutes.  The supernatant will




be drawn off and the filter sections treated for an additional 30 minutes




with a fresh portion of 1% (v/v) HNO~.  The solution will be decanted,




combined with the original supernatant, diluted to a reference volume




with deionized water, filtered and analyzed directly for the metals of




interest.  Results will be reported as weight of metal/m  air (see appendix




2.6, B.I for calculation of air sample volume).




                                 3-3                               3-10-77

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     3.1.2.4  Soil  [Ref. 3.2]




     The soil sample will be screened on a 20 mesh ASTM sieve and dried




at 105°C.  A weighed soil sample will be slurried in a minimum volume of




deionized water and digested with concentrated HNO_ at approximately




100°C.  To the cooled mixture will be added 30% H202 and the heating




continued with intermittent swirling.  The cooled digestate will be




filtered, diluted to a reference volume with deionized water, and analyzed




directly for the metals of interest.




     3.1.3  Arsenic Analysis




     The analysis of arsenic by a graphite furnace procedure presents




certain problems unique to this relatively volatile and interference-




prone element.  To overcome losses of arsenic from the furnace prior to




atomization, tap water, hair, dust, and air particulate sample solutions




will be "stabilized" with 1000 ppm nickel and will contain 1% (v/v) HN03




to. minimize the effect of small differences in acid strength on signal




intensity.




     Blood, urine, and soil extracts will be subjected to an extraction




workup to remove matrix interferences.  This procedure is based on




literature methods  [Ref. 3.3, 3.4] and is outlined below:




     •  Overnight treatment with cone. HC1 at room temperature.




     •  Reduction of arsenic species with SnCl_/KI and extraction of these




        products into benzene.




     •  Back-extraction of total arsenic into dilute dichromate containing




        1% (v/v) HN03.




     •  Addition of 1/10 volume of 10,000 ppm nickel.
                                 3-4                              3-10-77

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     3.1.4  Market Basket Samples




     The food items collected at site grocery stores will be analyzed




for all six elements.  Each sample will be subjected to acid hydrolysis




conditions and metal concentrations determined by standard additions.




     Since this work area is not part of the originally proposed study,




an estimate of additional cost will be made after the Pretest.




3.2  Spark Source Mass Spectrometric Analysis




     Two samples of each biological type from every age-sex group and




smelter site (total 252) will be submitted for spark source mass spec-




trometric analysis.  A semiquantitative scan will be obtained by the




Instrumental Analysis Division of Commercial Testing and Engineering




Company, Golden, Colorado.  The analysis will be run on an Associated




Electrical Industries (AEI) Model MS7 instrument.




3.3  Free Erythrocyte Protoporphyrin (FEP) Analysis




     A fluorometric method based on the procedure reported by S. Piomelli




[Ref. 3.5] will be used to determine FEP.  The method requires only 20




microliters of whole blood.  The ethyl acetate-acetic acid extraction




and the free porphyrin separation with aqueous HC1 will be carried out




and the fluorescence of the lower porphyrin layer measured directly.




The excitation monochromator will be set at 400 nm and a scan obtained




with the emission monochromator at 500-700 nm (fluorescence emission




maxima occur at 608 and 658 nm with a relative intensity ratio of 2.08).




Standard solutions of coporphyrin will be used for calibration purposes.




     This assay will detect FEP levels as low as 4.5 yg/100 ml whole




blood.




     A Hitachi Perkin-Elmer Model MPF-2A Fluorescence Spectrophotometer




will be used for the FEP analysis.




                                 3-5                              3-10-77

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3.4  Quality Control and Analytical Protocol




     3.4.1  Instrumentation




     At the start of each analytical run, the atomic absorption spectro-




photometer will be calibrated for the element to be analyzed for, using




standard solutions containing known quantities of metal in the appropriate




control matrix material.  Pooled collections of blood, urine, scalp




hair, tap water, dust and soil, shown to have minimal or nonelevated




metal concentrations, will serve as baseline matrix material.  In each




case the actual metal concentration will be determined by the method of




standard additions.  Potential control soil samples will be obtained at




a distant upwind location from the smelter in an attempt to simulate




soil type.




     Air particulate calibration solutions will be prepared by spiking




glass fiber filter sections with known amounts of the metals of interest.




     In the case of scalp hair, dust, soil and air particulate calibrations,




the standard additions will be done prior to sample workup.




     These calibration solutions will serve as internal reference materials




as described below.




     The calibration data will be fitted to the exponential equation, y =




ae   + k, where




                       x = peak response, mV,




                       y - weight of metal, ng, and




                   a,b,k = constants.




The values assigned to the constants will be determined by a linear regression




program on a Monroe Model 1800 programmable calculator.  Sample metal concen-




trations will be calculated from this exponential expression on a Texas Instru-




ments Model 51-11 calculator.




                                 3-6                              3-10-77

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     3.4.2  Limits of Detection
     Detection limit (DL) will be defined as that amount of metal which
will give a net signal two standard deviation units greater than the
mean matrix signal.  This corresponds to that amount measurable at a
precision level of 50% Regular Standard Deviation (RSD).  An analysis
giving a net signal less than two blank standard deviation units will be
reported as not detected (ND).
     3.4.3  Routine Analytical Protocol
     After the instrument has been calibrated for a specific metal in a
particular collection matrix, an analytical run (60-80 samples) will be
initiated by a team of two analysts.  Duplicate sample injections will
be made on all samples, provided the intensity of the two signals satisfies
the following criterion:
First Signal,         Maximum Permissible          Permissible Range of
% of Full Scale           Variation	      Second Signal. % of Full Scale
     90                      +10%                          81-99
     80                      +10%                          72-88
     70                      +10%                          63-77
     60                      +10%                          54-66
     50                      +10%                          45-55
     40                      +15%                          34-46
     30                      +17%                          25-35
     20                      +20%                          16-24
     10                      +25%                           6-14
      5                      +40%                           3-7
      2                      +50%                           1-3
     Depending on the total furnace program time, 20 to 30 samples will be
processed per hour.  The analysts will alternate between sample injection
and data calculation; the metal concentration of each sample will be determined


                                 3-7                              3-10-77

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immediately after analysis.  Matrices which vary widely in metal levels




(air particulates, soil, dust) may exhibit concentrations outside of the




linear working range.  These samples will be set aside, suitably diluted




and analyzed as a group against appropriate calibration standards.




     Sample weights/volume, dilution factors, calibration and raw analytical




data will be recorded on the Analytical Data Sheets, examples of which




are shown in appendix 3.1.




     3.4.4  Analytical' Priorities




     First priority will be given to the biological samples (urine,




blood and scalp hair).   Included in this category is the blood FEP




assay.  Tap water samples will be analyzed next.  Dust, soil and air




particulate analysis will be performed as soon as the others have been




completed.




     3.4.5  Quality Control Procedures




     The quality control measures incorporated in the routine analytical




protocol will serve two major functions:  to maintain constant instrument




performance and determine analytical precision and accuracy.




     3.4.5.1  Instrument Performance




     Instrument performance will be monitored by determining the signal




response of a reference material after every 10-15 samples.  These




evaluations will be carried out with an original calibration solution




(internal reference) or, when available, an external reference material




with a metal concentration known to the analyst.  These procedures are




not intended to assess precision or absolute accuracy but to establish




the validity of the original calibration data.  If the reference sample




signal has changed by more than +10-15% or +2 standard deviation units,







                                3-8                              3-10-77

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appropriate measures will be taken before continuing the analytical run


(e.g., changing the graphite tube, balancing the D~ arc-light source


intensities, recalibrating).


     3.4.5.2  Accuracy and Precision


     Accuracy will be assessed by analysis of external reference materials


approximately every 20 samples.  This procedure will be carried out


blind.  The reference materials will be coded and processed in the same


manner as field samples.  External reference materials available for


this purpose are listed below:


          • Blood (CDC) - Pb and FEP;


          • Tap water (EPA/Cincinnati) - all metals;


          • Air particulates (EPA/RTP) - As and Pb, others as they become
                                                           /

            available.


     Precision will be assessed by analysis of duplicate samples (see


Section 2.2.6.4).  These materials will be coded at the smelter site; their


identity as a duplicate will be unknown to the analyst.  Samples which


will be evaluated in this manner are listed below:


          • Blood (10%) adult participants only,


          • Scalp hair (10%) adult participants only,


          • Tap water (10%) second sample after flushing,


          • Dust (10%), and


          • Soil (10%) from air sampling sites and school  yards.


     Evaluation of the tap water duplicates will serve two functions.


The two consecutively drawn samples will be analyzed and the results


used to estimate variability in water quality with time.  Equal aliquots


from the duplicates will be combined, the blend split in two portions


and each analyzed to determine analytical reproducibility.


                                 3-9                              3-10-77

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     3.4.5.3  Interlaboratory Comparison




     An interlaboratory comparison study will be initiated.  Samples to




be identified by the EPA Project Officer will be split for independent




analysis.




     3.4.6  Calibration of High Volume Air Samplers




     All high volume air samplers will be calibrated against a top




loading Orifice Calibration Unit Model 330 (Sierra Instruments, Inc.,




St. Paul, Minnesota).  This device has been standardized against a




primary standard, positive displacement Rwots Meter by the Environmental




Protection Agency, Research Triangle Park, North Carolina (EPA/RTP).




The calibration data are presented in figure 3.1.




     Each high volume sampler will be equipped with a pressure gauge for




monitoring air flow across the 20.3 cm x 25.4 cm glass fiber filter.  To




calibrate the pressure gauge readout in terms of air flow, one, two, and




three, etc., glass fiber filters will be placed on the sampler to simulate




resistance to air flow.  As the resistance to air flow changes, measurements




of the pressure drop across the orifice will be made with a water manometer




and related to the corresponding pressure gauge reading.  With this




calibration data, the gauge on each sampler may be directly converted to




standard cubic meters air flow per minute across the filter medium.




     Sampler calibration will be checked at the site with an EPA audit




device.




     After use at a smelter site, brushes on the air samplers will be




changed and the unit recalibrated.




3.5  Determination of Total Particulate Solids in Air




     Subsequent to filter prewashing with 5% HNO-, each filter will be




tared, inspected for imperfections, and handled in a manner consistent




                                3-10                              3-10-77

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U)
 I
M
O
 I
,-J
                       Fig. 3.1.  Calibration ofMSierralnstrument Orifice,  Model 330.

-------
with the procedures described in the Federal Register [Ref. 3.5].  Each


filter will be stamped with an identification number and placed in a


Zip-Loc bag for transport to the site.  On return to RTI, the filters


will be weighed as described [Ref. 3.6] and the net weight reported as

                              3
weight of total particulates/m  air.


3.6  Personnel


     All chemical analysis will be carried out at RTI under the direction


of Dr. Robert W. Handy, Senior Chemist in the Chemistry and Life Sciences


Group (CLSG).  Dr. Monroe E. Wall, CLSG Director and RTI Vice President,


will provide overall coordination for all phases of this program.


     Assisting Dr. Handy will be chemical professionals Gail T. Hess,


David F. Natchske, Karen Robbins and technician Carolyn Foust.  Mrs.


Hess will direct and evaluate the routine quality control measures


during daily analytical runs.


     Resumes of these individuals will be found in appendix 3.1.


3.7  References


     3.1.  Solomon, R. L., and J. W. Hartford, Environmental Science and


           Technology, Vol. 10, p. 777, 1976.


     3.2.  Krishnamurty, K. V., E. Shpirt, and M. M. Reddy, Atomic Absorption


           Newsletter, Vol. 15, p. 68, 1976.


     3.3.  Fitchett, A. W., et al., Analytic Chimica Acta, Vol. 79, p. 93,


           1975.


     3.4   Forehand, T. J., et al., Analytical Chemistry, Vol. 48, p. 999,


           1976.


     3.5   Piomelli, S., Journal of Laboratory and Clinical Medicine, Vol. 81,


           No. 6, p. 932, 1973.


     3.6   Federal Register, Vol. 36, p. 8192, 1971.


                                3-12                              3-10-77

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     APPENDIX 3.1




ANALYTICAL DATA SHEETS
          3-13                              3-10-77

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               ANALYTICAL DATA SHEETS - AA ANALYSIS
                           INSTRUCTIONS
     There is a separate form for reporting the analytical results of each




matrix.  The individual forms have several features in common and some which




are unique for the matrix material being analyzed.  The- following information




will be supplied in the appropriate space:




     a)   The chemical symbol of the element being analyzed.




     b)   The bound notebook reference will be cited for each analytical




          run.  This notebook will be used to record all operating con-




          ditions and any observations or remarks concerning the analysis.




          The notebook reference will also be noted on the strip chart




          recording.




     c)   The date and the operator(s) initials will be shown.




     d)   All calibration standards will be injected in duplicate and the




          corresponding peak height recorded.




     e)   A least squares regression analysis will be carried out on four




          standard solutions run in duplicate and the equation representing




          the best fit will be noted.




     All samples analyzed during a run will be injected in duplicate.  The




following data will be recorded for each matrix type:




     a)   Column 1.




     Each sample will be identified by the same code numbers used to label the




sample container at the smelter site.
                                3-14                              3-10-77

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     b)   Column 2.
     Instrument response during atomization is measured as peak height,
expressed in units of millivolts (mv).
     c)   Column 3.
     The weight of metal injected- is calculated from a calibration equation
of the form y = ae   + k, where
     y = weight of metal injected
     x = peak height
 a,b,k = constants.
     d)   Column 4.
     F is a function of the volume of analytical solution injected into the
graphite furnace.
               Volume injected            I?
                    10 yl                100
                    25 pi                 40
                    50 ul                 20
     e)   Column 5.
     The weight of metal contained in each ml of the solution injected into
the furnace is calculated by multiplying the number in Column 3 by F.
     The remaining columns on the Data Sheet are treated differently for
each matrix.
     a)   Drinking Water -
     To convert weight of metal/ml water to weight of metal/liter water
simply change the units of weight as follows:
                    Units wt/ml         Equiv. units wt/1
                        Pg                   ng (ppt)
                        ng                   pg (ppb)
                        Pg                   mg (ppm)
                                 3-15                               3-10-77

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     b)   Urine -



     The constant D (Column 6) is defined as the volume (ml) to which one



ml of urine sample is diluted prior to injectipn in the graphite furnace.



For example, if a 1:1 dilution is performed, D = 2; if a 1:49 dilution



is necessary, D = 50.



     The weight of metal/100 ml urine  (Column  7) is determined  by mul-



tiplying the value in column 5 by 100D.



     c)   Blood -



     As with urine, the constant D (Column 6) is defined as the volume (ml)



to which one ml of urine sample is diluted prior to injection in the graphite



furnace.  For example, if a 1:9 dilution is carried out, D = 10.



     The weight of metal/100 ml blood  (Column 7) is determined by multiplying



the value in Column 5 by 100D.



     d)   Hair -


                        vf
     D (Column 6) = V± (^-).



     where, V. = volume (ml to which sample digest is diluted.



            Vf = final volume (ml) of diluted aliquot.



             A = volume (ml) of aliquot withdrawn from initial sample



                 volume (V.) for further dilution to V-.



     NOTE - If no aliquoting of V. is performed, the term V../A = 1.
     	                        i                         i


                                   D = V±




     The weight of metal/gm hair (Column 8) is found by multiplying Column 5



by D and dividing this product by the sample weight, W  (gm)(Column 7).



     Wt. metal/gm hair = Column 5 (—)



     Example;  A 250 mg hair sample was digested and diluted to 5 ml.  Two



ml of this solution was diluted to 10 ml prior to furnace injection.





                               3-16                               3-10-77

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          Vi = 5; Vf = 10; A = 2; W = *25

          D = 5 <|£) = 25; |= 100

          Wt. metal/gm hair = Column 5 (100).

     e)   Air Particulates

     In the case of air particulate analysis, D is defined as follows:
                      V   F
     D (Column 6) = V±(^) ^-.
                           a
     where, V. = volume (ml) to which the extract of the entire filter

                 strip is diluted.

            V  = final volume (ml) of diluted aliquot.

             A = volume (ml) of aliquot withdrawn from initial sample

                 volume (V.) for further dilution to V_.

            F  = total filter area.

            F  = area of filter used in analysis.
             cl

     NOTE - If no aliquoting of V. is performed, the term Vf/A = 1, and
                                       a
     The weight of metal on the entire filter (Column 7) is determined

by multiplying Column 5 by D.  Column 7 is divided by air volume (m )

(Column 8) to give weight of metal /m  air (Column 9) .  The calculation

of air volume is shown on the air collection log sheet.

          Wt. metal/m  air - Column 5 (D/air volume)
                        2
     Example ;  A 40.6 cm  section of a 20.3 x 25.4 cm filter was treated

with acid and diluted to 100 ml.  Two ml of this solution was diluted
                                                        3
to 5 ml prior to furnace injection.  Air volume = 2500 m .
          V
± = 100; Vf = 5; A - 2; F  - 515.6; F& = 40.6
          D = ioo(4)  rrr = 25° (12-7) - 3175
                  £.
                               3-17                               3-10-77

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          Wt metal/m3 air = Column 5 (3175)/2500

                          = Column 5 (1.27)

     f)   Housedust
                      vf
     D (Column 6) = V.^^).

     where, V. = volume (ml) to which sample digest is diluted.

            V  = final volume (ml) of diluted aliquot.

             A = volume (ml) of aliquot withdrawn from initial sample
     NOTE
       volume (V.) for further dilution to V-.

- If no aliquoting of V. is performed, the term V../A = 1, and
                              D = V±
     The weight of metal/gm dust  (Column 8) is found by multiplying

Column 5 by D and dividing this product by the sample weight, W(gm)

(Column 7).

          Wt. metal/gm dust = Column 5  (—).

     Example;  A 250 mg dust sample was digested and diluted to 25 ml.

Two ml of this solution was diluted to  25 ml prior to furnace injection.

          V± = 25; Vf = 25; A = 2; W =  .25

          D = 25 (|^) = 312.5; | = 1250

          Wt. metal/gm dust = Column 5  (1250).
                                          2
     The total weight of metal in a .25 cm  collection is found by either

multiplying Column 8 by the weight of sample collected over this area or

multiplying Column 5 by D.

     g)   Soil
                      Vf
     D (Column 6) = V.(-rL').
                    X A
                               3-18                              3-10-77

-------
     where, V. = volume (ml) to which sample digest is diluted.



            V  = final volume (ml) of digested aliquot.



             A = volume (ml) of aliquot withdrawn from initial sample



                 volume (V.) for further dilution to V...



     NOTE - If no aliquoting of V. is performed, the term Vf/A = 1, and



                                   D = V.



     The weight of metal/gm soil (Column 8) is founding by multiplying



Column 5 by D and dividing this product by the sample weight, W(gm)



(Column 7).



          Wt. metal/gm soil = Column 5 (—) .
                                        W


     Example;  A 1.0 gm soil sample was digested and diluted to 250 ml.



One ml of this solution was diluted to 100 ml prior to furnace injection.



          V± = 250; Vf = 100; A = 1; W = 1



          D = 250 0^) = 25,000; | = 25,000



          Wt. metal/gm soil = Column 5 (25,000).
                              3-19                               3-10-77

-------

Matrix
- Housedust
Standard (wt/vol.)
1
Staple
(ode




2.
Peak
height
(mv)




3.
Wt.
metal
injected
ANALYTICAL DATA SHEET
Peak Height (mv)




4. 5.
Wt. metal/
ml anal.
F soln.
- AA ANALYSIS
Element -
Notebook No.
Date
Operator(s)
Calibration Equ.
6. 7. 8. 9. 10.
Wt. metal
Sample Wt. metal/ .25 cm^
D weight gm dust area Comment
3-20                              3-10-77

-------
ANALYTICAL DATA SHEET

Matrix
- Air Particulates
Standard (wt/vol
1
Sample
•ode




2.
Peak
height
(mv)




3.
Wt.
metal
injected
.) Peak




4.
F
Height (mv)



,
5.
Wt. metal/
ml anal.
soln.
- AA ANALYSIS
Element -
Notebook No.
Date
Operator (s)
Calibration
6. 7.
Wt. metal
D on filter




Equ.
8. 9. 10.
Air Wt.
volume metal/
(m-*) m^ Comment
3-21
3-10-77

-------
ANALYTICAL DATA SHEET - AA ANALYSIS
I..
Sample
fode

Matrix -
Standard




2.
Peak
height
(mv)

Blood
(wt/vol.) Peak Height
9
9


3. 4.
Wt.
metal
injected F

Element -
(mv) Notebook No.
Date
Operator (s)
Calibration Equ.

5. 6. 7. 8.
Wt. metal/ Wt. metal/
ml anal. 100 ml
soln. D blood Comment

3-22
3-10-77

-------
ANALYTICAL DATA SHEET - AA ANALYSIS
1.
•ample
"code
Matrix -
Standard




2.
Peak
height
(mv)
Urine
(wt/vol.) Peak Height




3. 4.
Wt.
metal
injected F
Element -
(mv) Notebook No.
Date
Operator (s)
Calibration Equ.

5. 6. 7. 8.
Wt. metal/ Wt. metal/
ml anal. 100 ml
soln. D urine Comment
3-23
3-10-77

-------
ANALYTICAL DATA SHEET - AA ANALYSIS
1.
Sample
code
Matrix - Drinking Water
Standard (wt/vol.) Peak Height (mv)
»
»
>
»
2. 3. 4.
Peak Wt .
height metal
(mv) injected F
Element -
Notebook No.
Date
Operator (s)
Calibration Equ.
5. 6. 7.
Wt. metal/
ml anal. Wt. metal/
soln. 1. water Comment
                3-24
3-10-77

-------
ANALYTICAL DATA SHEET - M ANALYSIS
1
Sample
Mjde
Matrix -
Standard




2.
Peak
height
(mv)
Soil
(wt/vol.)




3.
Wt.
metal
injected
Peak Height (mv)
»
»
»
>
4. 5.
Wt. metal/
ml anal.
F soln
Element -
Notebook No.
Date
Operator (s)
Calibration Equ.
6. 7. 8. 9.
Sample Wt. metal/
D weight gm soil Comment
                3-25                              3-10-77

-------
                  ANALYTICAL DATA SHEET - AA ANALYSIS
Matrix - Hair                                Element -
Standard
(wt/vol.)
Peak Height (mv)
Notebook No.
, Date
, Operator (s)
, Calibration Equ.

1. 2.
Peak
Sample height
•code (mv)

3.
Wt.
metal
injected

4. 5.
Wt. metal/
ml anal.
F soln.
6. 7. 8. 9.
Sample Wt. metal/
D weight gm hair Comment
                                  3-26           .                   3-10-77

-------
        APPENDIX 3.2




RESUMES OF RTI PROJECT STAFF
              3-27                               3-10-77

-------
ROBERT W. HANDY, Senior Chemist

Professional Experience

     1975 to date.  Senior Chemist, Chemistry and Life Sciences Division,
     Research Triangle Institute, Research Triangle Park, North Carolina.
     Development of trace metal analysis techniques by atomic absorption
     spectrometry and general analytical methodology.  Monitoring gas and
     aerosol levels in environmental chamber studies using instrumental
     and wet chemical methods.  Analysis of environmental and biological
     materials for trace metals by atomic absorption spectrometry.  Isola-
     tion, identification and quantitatiori of drug metabolites from various
     biological fluids using radiochemical tracers, gas and liquid chro-
     matographic techniques.

     1965 to 1975.  Chemist, Chemistry and Life Sciences Division, Research
     Triangle Institute, Research Triangle Park, North Carolina.  Synthesis
     of substituted cinnamylidene malononitriles; research in modified
     steroid synthesis and drug metabolism.

     1954 to 1964.  Research Chemist, Kay-Fries Chemicals Co., Inc., West
     Haverstraw, New York.  Synthesis and bench-scale process development
     of fine organic intermediates; orthoesters, pyrimidines and miscel-
     laneous polyfunctional compounds.

Education

     B.S., Chemistry, Brown University, Providence, Rhode Island, 1954.
     M.S., Organic Chemistry, Stevens Institute of Technology, Hoboken,
       New Jersey, 1964.
     Ph.D., Medicinal Chemistry, University of North Carolina, Chapel Hill,
       North Carolina, 1971.

Professional Societies

     American Chemical Society

Selected Publications

     "Reactions of some 4-Piperidones with Olefin-forming Phosphorus
     Reagents," M.S. Thesis (1964).

     "The Synthesis of Some l-(B-Diethylaminoethyl)-2-(p-ethoxybenzyl)-
     5-substituted Benzimadazoles," F. I. Carroll, R. W. Handy, J. A.
     Kepler and Joan A. Gratz, J. Heterocyclic Chem., 4^ 262 (1967).

     "Metabolism of Antifertility Steroid IV - The Synthesis of 6-Chloro-
     17-hydroxypregna-4,6-diene-3,20-dione-4-^C-acetate (Chlormadinone
     Acetate)," K. H. Palmer, R. W. Handy and M. E. Wall, J. Labelled
     Compounds, 7_, 16 (1971).

     "The Total Synthesis of 7 (8 ->• lla) Aboestrogens.  Delination of the
     Role of Steric Effects in the Biochemistry of Steroids," C. G. Pitt
     and R. W. Handy, Tetrahedron, 27, 527 (1971).


                              3-28                              3-10-77

-------
R. W. HANDY
Page 2
     "An in vitro and Correlated in vivo Study of the Metabolism of
     Chlormadinone Acetate," Ph.D. Dissertation (1971).

     "Metabolism of Antifertility Steroid VII - Chlormadinone Acetate,"
     R. W. Handy, K. H. Palmer and M. E. Wall, The Pharmacologist, 13_
     (2) 221 (1971).

     "Comparative Metabolism of Chlormadinone Acetate," R. W. Handy, T.
     R. Hess and M. E. Wall, The Pharmacologist, 15_ (2) 228 (1973).

     "The Metabolism of Antifertility Steroids:  The In Vitro Metabolism
     of Chlormadinone Acetate," R. W. Handy, K. H. Palmer, M. E. Wall
     and C. Piantadosi, Drug Metabolism and Disposition, 2_ (3), 214
     (1974).

     "Metabolism of Norethynodrel in Thrombophlebitic - Thromboembolic
     Subjects," R. W. Handy, Dawn Dominquez, Marsha Poirer, M. E. Wall,
     C. E. Cook, C. D. Christian and R. Bressler, Experientia, 31, 446
     (1975).

     "Quantitative Determination of Codeine in Plasma by Gas Chromato-
     graphy," Ruth A. Zweidinger, F. M. Weinberg and R. W. Handy, J.
     Pharm. Sci., 65_, 427 (1976).

     "Estimation of Permissible Concentrations of Pollutants for Con-
     tinuous Exposure," Robert Handy and Anton Schindler, EPA-600/2-76-155
     (1976).

     "Analysis of Aluminum Chlorohydroxide by Selective Ion Electrode
     Potentiometry," paper accepted for presentation at 1977 Pittsburgh
     Conference.
Patents
     U.S. Patent 3,121,751, "Production of Purified Orthoformic Esters,"
       1964.

     U.S. Patent 3,223,713, "Cyclic Malonaldehyde Diacetals," 1965.

     U.S. Patent 3,258,496, "Purified Orthoformic Esters," 1966.

     U.S. Patent 3,323,925, "Wax Polishes," 1967.

     U.S. Patent 3,415,846, "2,6,7-Trioxabicyclo (2.2.2) octanes," 1968.
November 1976

                               3-29                             3-10-77

-------
TERESA ROBERTS HESS, Junior Chemist
Professional Experience

     1972 to date.  Junior Chemist, Chemistry and Life Sciences, Division,
     Research Triangle Institute, Research Triangle Park, North Carolina.
     Research on metabolites of chlormadinone acetate in rat liver, rhesus
     monkeys and humans.  Investigation into the deposition of estradiol
     benzoate, testosterone propionate, progesterone, and their metabo-
     lites, in bovine tissue.  Metabolic studies of trichlorocarbanilide
     in rats, rabbits, monkeys and humans.  Analysis of rat blood, brain
     and femur for lead.  Identification of components related to energy
     wastes and effluents.

     October 1970 to August 1971.  Lab Technician under Dr. Kenneth Vick,
     U.S. Department of Agriculture, Entomology Research Division,
     Gainesville, Florida.  Research centered around the determination
     of the structure of the sex pheromones of Black Carpet beetle,
     T. Inclusum and T. Galabrum, and the biological aspects of the phero-
     mones, for example, limits of detection of the insects for the phero-
     mones .

     June 1970 to September 1970.  Summer Lab Technician with St. Regis
     Paper Company, Jacksonville, Florida,

Education

     B.S., Chemistry, University of Florida, 1971.
June 1976

                              3-30                             3-10-77

-------
DAVID F. NATSCHKE, Junior Chemist


Professional Experience

     September 1976 to date.  Research Triangle Institute, Research
     Triangle Park, North Carolina 27709.  Junior Chemist, Chemistry and
     Life Sciences Division.  Analyze biological and environmental
     samples by atomic absorption.  Methods development.

     June 1974 - July 1975.  Phelps-Dodge Corp., Morenci, Arizona.
     Assistant Chemist.  Analysis of a variety of samples by classical
     methods.  Some programming.

     September 1972 - May 1973.  New Mexico Bureau of Mines, Socorro,
     New Mexico.  Student Analyst.  Analyzed samples by atomic absorption
     and classical methods.

Education

     Military Electronics School, 1966-1967.

     B.S., Chemistry, New Mexico Institute of Mining & Technology,
          Socorro, New Mexico, 1974.

     Graduate School in Chemistry, University of North Carolina,
          Chapel Hill, N.C., 1975-1976.

Professional Activities

     American Chemical Society, member.
     ACS Undergraduate Award in Analytical Chemistry, 1974.
October 1976

                                3-31                              3-10-77

-------
KAREN W. ROBBINS, Junior Chemist


Education

     B.A., Chemistry, University of North Carolina, Chapel Hill,
          North Carolina, 1974.
     Computer Science, Durham Technical Institute, 1975.

Experience

     1976 to present.  Research Triangle Institute, Research Triangle
     Park, N. C.  Junior Chemist.  Materials experience in preparation
     of piezoelectric films and optical coatings.   Analysis of basic oxide
     furnace materials and processes.

     1973 to 1974.  Pathology Laboratory, University of North Carolina at
     Chapel Hill.  Research assistant on various pathology problems.
March 1977
                                 3-32                              3-10-77

-------
 4.0   Statistical Methods  of Analysis




 4.1   Confidentiality of Data Files




      In  carrying out its  statistical analyses, RTI will utilize machine-




 readable data  files maintained at the Triangle Universities Computation




 Center (TUCC)  located in  the Research Triangle Park.  To maintain the




 confidentiality of these  data files, RTI will use an encrypting of data




 procedure.




      The encrypting procedure involves the use of a routine which scrambles




 data  passed to the routine so that they are meaningless to anyone unless




 they  are decrypted.  The  routine draws random numbers and adds a different




 number to each character  of the data.  The starter for the random number




 generator, referred to as the key, is passed to the routine in the




 calling  sequence.  Thus with the same starter to the random number




 generator, the data can be decrypted when required for processing.  An




 encrypting procedure has  the advantage of not splitting the primary data




 base  and not having to depend on computer center personnel (non-RTI




 personnel) to maintain the confidentiality of a link file.




      In  addition to the encrypting procedure, TUCC has developed an




 extensive security system which RTI programmers use to protect computer




 account  codes and data from other users.   This is accomplished through a




 password protection system for account codes, data sets,  and data storage




volumes.   These facilities are different  from and replace the similar




 features provided by IBM.   This system is described in TUCC publication




GI-066-0, TUCC Security Features [Ref.  4.1].   Copies of this publication




are available on request.
                                4-1                           3-10-77

-------
4.2  Data Analysis

     RTI will use the TUCC IBM 370/165 computer facility for its data

analysis.  The data will be stored on 9-track tapes written at 1000 bpi

with an OS standard label.

     In its analysis, RTI will examine the following relationships:

     (a)  the relationship between environmental levels of the trace

          metals of interest  (i.e., levels of metals in air, water, soil

          and dust samples),  the distance from the smelter, wind speed,

          and wind direction; and

     (b)  the relationship between tissue levels of the trace metals

          (i.e., levels in hair, blood and urine), environmental levels,

          and sociodemographic variables (e.g., age, sex).

     As is now envisioned, the principal statistical techniques that will

be used to examine these relationships are the analysis of variance,

multiple regression and stepwise regression.  In addition, it may also

be worthwhile to examine some multivariate techniques (i.e., techniques

which consider the above relationships for more than one trace metal at

a time).

     4.2.1  Analysis of Environmental Levels

     In particular,  for the relationships in (a)  above,  the following type of

model will be analyzed for each trace metal being studied:

     Y.jk(M)  - u + D.  + S. + Wk + e.jk                           (1)
where
     Y.., (M) = concentration of metal M in either air, water, soil, or dust
                   i   *    u  -th ^-        -th  •  ,
               samples for the i   distance, j    wind speed,
               and k   wind direction,

           u = mean metal M level,
                                4-2                            3-10-77

-------
          D. = i   distance effect
           i


          S. = j   wind speed effect,



          W,  = k   wind direction effect, and



        e. .,  = random error.
         ijk



     In the above model, the independent variables (distance from smelter,



wind speed, wind direction) have been categorized and indexed by i, j,



and k, respectively.  This allows for a general type of relationship



between the levels of the metals and the independent variables rather



than imposing a functional relationship as does regression.  With this



model, one may use the technique of analysis of variance to test for the



effects of different distances from the smelter, differences in wind



speed, and also differences in wind direction.  These correspond to



tests of equality of the D., the S., and the W, , respectively.
                          i       J           K


     As required by the subject Request for Proposal (RFP), the analyses of



the environmental levels,  whether they be air, water, dust, or soil,



will be done separately for each site.   If differences between sites are



also of interest, this may be investigated by including a site variable,



L, , in model (1)  to produce




     Yhijk(M) ' U + Lh + °i + Sj + \ + ehijk .                   (2)



Site differences  may then be tested by testing the equality of the L,



and the differences may be exhibited by displaying the adjusted site



means from model  (2).



     4.2.2  Analysis of Tissue Levels



     For the relationships in (b) above, the analysis will again be done by



site and in this  case will also be done by broad age categories, since



soil samples are  taken only for school and preschool children.   In







                                4-3                           3-10-77

-------
 particular,  the  following  type  of  model will be  analyzed  for  each  trace



 metal:



     Y..k(M)  - u + A. +  S . +  B^ +  B2X2k
             +  B,X,. + B.X.. +  BCXC. + e. ..                       (3)
                 3  3k     4 4k    5  5k    ijk                       v  '
where
         Y.., (M) = concentration of metal M in either blood, hair or
            J                               i                      i

                   urine samples for  the k   individual in  the i   age

                            ,  .th
                   group and  j   sex  group;



               u = mean metal M level;


                                        t*h
              A. = age effect for the i   age group;



              S. = sex effect for the j   sex group;



       B,,...,B. = regression coefficients to be estimated;



     X,,  , ...,X,.,  = corresponding concentration of metal M in the air,


                   water, soil, and dust samples, respectively,


                   for the k   individual; and



            e. .,  = random error.
             ijk


The above model will permit the examination of the effect of age and sex



as well as  environmental levels on metal M tissue levels.  A similar



model may also be used to examine the effects of distance and wind



direction on metal M tissue levels.   In model (3), testing for age and



sex effects corresponds to testing the equality of the A. and S. while



testing for the relationship  between  tissue levels and environmental



levels corresponds to testing the nullness of B,,...,Br.  When the



parameters  in model (3) have  been estimated,  the resulting fitted equation



may serve as a predictive model for the reference population.



     In order to help determine the form of model (3) for the various



metals, it may be worthwhile  to employ the technique of stepwise regression.






                                4-4                           3-10-77

-------
 This  technique  can be used  to give insight into the relative strengths
 of  the various  demographic, environmental and meteorological variables
 in  predicting tissue levels in humans.  In essence, this technique selects
 those variables  (in a stepwise manner) which best predict the dependent
 variable of interest (i.e., tissue levels).
     In addition to using the various statistical models given above,
 other techniques which will be employed to examine the relationships of
 interest include:  computing correlations between pairs of variables;
 examining scatter plots of  tissue levels versus the demographic, environ-
 mental, and meteorological variables; and computing means of the demo-
 graphic, environmental, and meteorological variables for various cate-
 gories of tissue levels and then plotting these means.
 4.3  Potential Problems
     4.3.1  Missing Observations
     Because of the nature of the data being collected for the present
 study, there undoubtedly will be a large number of missing observations.
 These missing observations may consist of all or only selected observations
 from a sample individual (e.g.,  the individual refuses to give any data
 at all or he gives all the data desired except a urine sample).   In
 order to carry out the analyses described in section 4.2, it will be
 necessary to determine how these missing observations are to be  handled,
 keeping in mind that the easiest solution of only analyzing individuals
 with complete observations is probably unsatisfactory because too many
 individuals with partial observations would have to be discarded.
     The specific techniques to be used for handling missing observations
will be determined during the analysis,  and will depend upon several
 considerations.   Some of the pertinent considerations include the
 following:
                                4-5                           3-10-77

-------
          The reason for  the missing observation,



          The type of measurement  (e.g., tissue level) for which the



          observation is  missing,



          The type of analysis or estimate for which the missing obser-



          vation is needed,



          The number of missing observations for that measurement,



          The minimum measurable level if the observation is missing



          because it is less than that level, and



          The information available from that and other individuals that



          may facilitate  the estimation of the missing observation.



The methodology decided upon will be made available for Project Officer



review and will be fully documented in the final report.   The following



methodologies will be among those considered.



     If relatively few observations are approximately "randomly" missing



for a particular measurement, cohort means will probably be substituted



for the value and the degrees of freedom will be appropriately modified.



     If relatively few observations are missing because they are below a

                                                            x'
                                                             i
measurable minimum, the range midpoint of this observation,  —j, may be



substituted for the missing value,  particularly if the range is small



(i.e., if [0,x!] is small where x!  is the smallest measurable value for



X.).  However, if the number or range of unmeasurable observations is



large, a more refined technique may be used.   Under this  condition,



methodology for the estimation of distributional location and scale



parameters under the situation of singly censored samples,  would be



appropriate for the initial analysis.  In Sarhan and Greenberg [Ref. 4.2],



order statistics are used to obtain unbiased best linear  estimates of







                                 4-6                           3-10-77

-------
location and scale parameters from samples of size 20 or smaller and



unbiased "nearly best" linear estimates from larger samples in which



single censoring occurs.  Once the distributional parameters are estimated,



it will then be possible to substitute values for the untneasurable



observations based upon the estimated distribution.



     In running the regression analyses described in section 4.2, one



may encounter either missing dependent (Y) or missing independent (X)



variables.  To handle this problem, one might use a model in which an



indicator variable reflects the missing independent variables and "two-



stage" estimation models [Ref. A.3] are used to predict missing dependent



variables.  The two-stage method is used in SAS [Ref. 4.4], one of the



software systems utilized by RTI.  The method uses a least squares



solution to obtain parameter estimates from the available observations,



and then uses estimates of missing values from this preliminary model in



place of the missing values—the analysis can then be conducted as if



the data were complete except for changes in degrees of freedom.  However,



if information is known about the range of the dependent variable, i.e.,



that 0 < y.. < y! where y!  is the minimum detectable level for Y., then
       —  ij —  i        i                                      i


the two-stage estimation alone would ignore this useful bit of informa-



tion.  Therefore, the two-stage estimation (estimating missing data on



the basis of complete observation vectors) would be used to set., values



when they fall below the minimum measurable level, but only if these



estimated values were within the known range [0,y!j.  Thus, the following



imputed value would be used for a missing y..:
       y*.
0,  if y. < 0.
               y!  otherwise
                                4-7                            3-10-77

-------
where

     y*.  is  the imputed value for the missing y.. value,
     A
     y..  is  the first-stage estimate of the missing y.., and
       J                                              J
     y! is the minimum detectable level of Y..

     The  indicator variable model suggested above for accommodating

missing X variables in regression analysis might be of the following
type:

     y.. = I..[B0 + 0^] +  (1-I.)62 + Ej                          (4)

where
     y. is an observed dependent variable for individual j,
     I. is an indicator variable (0,1) according to whether the X obser-

        vation is present or missing because it is below measurability,
     (3,  are parameters to be estimated, and
      1C
     e. is a stochastic error term.
      J
     4.3.2  Trace Metal Intake Due to Diet
     At the present time,  it is anticipated that environmental levels of

air, water, soil, and dust will be sampled to determine human exposure

to the trace metals of interest.  However, it is well known that diet is
also an important contributor of trace metal to an individual.  For
example,  EPA personnel have indicated that the proportion due to diet of
the total lead absorbed by individuals may be as high as .66.  In
addition, the amount of lead in various diets may vary by several

orders of magnitude.  Accordingly,  it may be quite important to the
success of the present study to obtain some measure of the amount of
trace metals in the diets  of the sample individuals.   Procedures which
have been suggested for obtaining diet trace metal levels include:


                                4-8                             3-10-77

-------
        Feces samples




     •  Analyzing duplicate diets from sample individuals,




     •  Adding questions about diet to the individual's question-




        naire, and




     •  Analyzing area grocery store food samples.




     EPA and RTI personnel have investigated these procedures to determine




if one or more of them should be incorporated into the present study.




At the present time, RTI plans to ask questions about diet in the study




questionnaire and to collect and analyze area grocery store food samples.




Hopefully, these two procedures will provide some estimates of the




relative levels of trace metal intake due to diet.




4.4  Personnel




     The analysis of the data for the current project will be under the




direction of Senior Statistician Dr. W. Kenneth Poole who is the Director




of RTI's Statistical Methodology and Analysis Center (SMAC).  Working




with Dr. Poole in analyzing the data will be Senior Statistician Dr.




Tyler Hartwell who is also a member of SMAC.  In addition, Programmer




Ms. Lois Bressler from the Computer Applications Center (CAC) will




assist Drs. Poole and Hartwell with the data processing.  Resumes of




these individuals will be found in appendix 4.1.
                                4-9                              3-10-77

-------
        APPENDIX 4.1




RESUMES OF RTI PROJECT STAFF
            4-10                             3-10-77

-------
W. KENNETH POOLE, Head, Statistical Methodology Department

Professional Experience

     1967 to date.  Research Triangle Institute, Research Triangle Park, North
     Carolina, 27709.  Statistician, Statistics Research Division.  Consults
     in matters relating to the theory and application of stochastic processes.
     Does applied research in reliability, regression analysis and estimation.

Education

     B.S., Mathematics, Austin Peay State University, Clarksville, Tennessee,
          1961.
     M.P.H., Biostatistics, University of North Carolina, Chapel Hill, North
          Carolina, 1963.
     Ph.D., Statistics, University of North Carolina, Chapel Hill, North
          Carolina, 1968.
     Held a one-year traineeship at Vanderbilt University during 1961-1962.
     Attended a six-week summer session on Biostatistics at Stanford University,
          1962.

Professional Activities

     American Statistical Association, member.
     Institute of Mathematical Statistics, member.

Selected Publications

     "Particle Size Distribution and Hopper Flow Rates," with E. D. Sumner,
     Journal of the Pharmaceutical Sciences, Vol. 55, No. 12, December 1966.

     "Water Absorptive Properties of Selected Solids in a Lipophilic Base I,"
     with E. D. Sumner, D.  N.  Entrekin, and A. F. Ike, Journal of the
     Pharmaceutical Sciences,  Vol. 58, No. 1, January 1969.

     "Some Aspects of Linear Prediction in Stationary Time Series," Institute
     of Statistics Mimeo Series, No. 566, University of North Carolina,
     Chapel Hill, North Carolina, 1968.

     "An Investigation of Certain Physical and Mechanical Properties of Wood-
     Plastic Combination," with Eric Ellwood, Robert Gilmore, and James A.
     Merrill.   ORO-638, Isotopes-Industrial Technology, Division of Technical
     Information, United States Atomic Energy Commission.

     "Fertility Measures Based on Birth Interval Data."  Theoretical Popula-
     tion Biology. Vol. 4,  No. 3, pp. 357-387, September 1973.

     "Some Methodological Issues in Cohort Analysis of Archival Data," with
     K. 0. Mason, H. H. Winsborough, and William M. Mason, American Socio-
     logical Review. Vol. 38,  pp. 242-258, April 1973.

     "Estimating the Effect of Unwanted Fertility of a Post-Parturn Re-
     cruitment Strategy," with J. R. Udry.  American Journal of Public Health,
     Vol. 64,  No. 7, pp. 696-699, July 1974.
                              4-11                            3-10-77

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"The Estimation of Examiner Error and the True Transition Probabilities
for Teeth or Surfaces in Dental Clinical Trials," with B. V. Shah and
A. C. Clayton.  Archives of Oral Biology, Vol. 18, pp. 1291-1302, 1973.

"Estimation of the Distribution Function of A Continuous Type Random
Variable Through Randomized Response," Journal of the American Sta-
tistical Association, Vol. 69, No. 348, December 1974.

"An Index of The Economic Welfare of Rural Families," Frances M.
Magrabi, Jean L. Pennock, W. Kenneth Poole and J. Valley Rachal.
Journal of Consumer Research. Vol. 2, #3, pp. 178-187, December 1975.

"Diphenylhydantoin and Phenobarbital Concentration In Saliva and Plasma
of Man Measured by Radioimmunoassay," C. E. Cook, EJ.len Amerson,
W. Kenneth Poole, Philip Lesserr and Lorcan O'Tauma.  Clinical Phar-
macology and Therapeutics, Vol. 18, //6, pp. 742-747, December 1975.

"A Computer Program for Multiple Decrement Life Table Analyses" with
P. C. Cooley, to appear in Computer Programs in Biomedicine.
 9/76
                          4-12                             3-10-77

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TYLER D. HARTWELL, Senior Statistician

Professional Experience

     1964 to date.  Research Triangle Institute, Research Triangle Park,
     North Carolina, 27709.   Statistician, Statistical Methodology and
     Analysis Center.  The work has involved the application of statistical
     methods to a wide variety of research areas.  Considerable experience
     in using statistical computer packages to analyze laboratory and sur-
     vey data.  Research areas have included:  analysis of the impact on
     environmental variables of nuclear power plants, estimation of the
     incidence and prevalence of head and spinal cord injuries, analysis
     of survey instruments and procedures designed to measure English
     language proficiency, use of ridge regression in copper smelter gas
     blending for control of sulfur dioxide, investigation of the role of
     leadership in preventing drug abuse in the army, evaluation of
     training methods designed to help army leaders reduce social problems
     in their units, investigation of the relationships between drugs and
     crime, projecting the supply of nursing manpower, evaluating sampling
     techniques as related to a national assessment of education, simulat-
     ing hospital utilization, projecting U. S. manpower requirements for
     short-term general hospitals, method comparison of NC-  air-monitoring

     instruments, investigation of the relationships between atmospheric
     oxidant and various pollutant and meteorological variables,- time
     series analysis of non-stationary rocket vibration data, design of
     chemical experiments, and estimating tolerance limits from censored
     samples.

     1962 to 1964.  North Carolina State University, Raleigh, North Carolina.
     Graduate work in the Department of Experimental Statistics.

     1961 to 1962.  Autonetics, a Division of North American Aviation,
     Downey, California, Mathematical Analysis Group.  The work included
     systems reliability, data analysis and developing computer programs.

Education

     B.S., Mathematics, University of Michigan, Ann Arbor, Michigan, 1961.
     M.E.S., Statistics, North Carolina State University, Raleigh, North
          Carolina, 1964.
     P.h.D., Statistics, North Carolina State Universtiy, Raleigh, North
          Caroina, 1971.

Professional Activities

     American Statistical Association, member.
     Biometric Society, member.
     Phi Eta Sigma
     Phi Kappa Phi

Selected Publications

     "Expected Mean Squares  for Nested Classifications," with D. W. Gaylor,
     Biometrics. Vol. 25, pp. 427-430, 1969.

                              4-13                             3-10-77

-------
"Simulation of Hospital Utilization," with D. G.  Horvitz and
J. R. Batts, Proceedings of the American Statistical Association,
Social Statistics Section, pp. 129-138, 1970.

"Estimating Variance Components for Two-Way Disproportionate Data
with Missing Cells by the Method of Unweighted Means," with
D. W. Gaylor, Journal of the American Statistical Association,
Vol. 68, pp. 379-383, 1973.

"Compariability of Nine Methods for Moitoring N0_ in Ambient Air,"

with C. A. Clayton, Environmental Monitoring Series, EPA-650/4-74-012,
1974.

"Head and Spinal Cord Injury:  A Pilot Study of Morbidity Survey
Procedures," with W. D. Kalsbeek, submitted to American Journal
of Public Health. 1976.

"Estimating Morbidity Trends by Means of a Source Panel Design," with
W. D. Kalsbeek.  Paper presented at 104th Annual  Meeting of the
American Public Health Association, Miami Beach,  Florida, October,
1976.

"Investigation of the Role of Multihearth Roaster Operations in
Copper Smelter Gas Blended Schemes for Control of S07," with

B. H. Carpenter and K. J. C. Smith, submitted to  Environmental  Science
and Technology, 1976.

"Preliminary Analysis of Nonradiological Environmental Data at  the
Zion Nuclear Power Plant," Research Triangle Institute, Research
Triangle Park, North Carolina, 1976.

"Design, Data Collection and Analysis of a Field  Test of Instru-
ments and Procedures to Measure English Language  Proficiency,"
Research Triangle Institute, Research Triangle Park, North Carolina,
1976.

"Examining the Properties of Qualified Observer Opacity Readings
Averaged Over Intervals of Less Than Six Minutes," Research Triangle
Institute, Research Triangle Park, North Carolina, 1976.

"An Experimental Evaluation of Three Training Methods Designed  to
Help Company Level Army Leaders Reduce the Incidence of Social
Problems in Their Units," Research Triangle Institute, Research
Triangle Park, North Carolina, 1975.

"The Role of Company Level Leadership in Preventing Drug Abuse  in
the Army," Research Triangle Institute, Research Triangle Park,
North Carolina, 1974.

"Review of Methods of Estimating Number of Narcotic Addicts,"
Research Triangle Institute, Research Triangle Park, North Carolina
1975.
                       4-14                             3-10-77

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"Trends in Registered Nurse Supply," Research Triangle Institute,
Research Triangle Park, North Carolina, 1975.

"Relationship of Criminal Behavior and Drug Abuse:  Phase I:  The
Identification, Evaluation, and Possible Utilization of Available
Data Sets," Research Triangle Institute, Research Triangle Park,
North Carolina, 1975.

"Examination of the Relationships Between Atmospheric Oxidant and
Various Pollutant and Meteorological Variables," Research Triangle
Institute, Research Triangle Park, North Carolina, 1975.

"Investigation of Motion Control and Fiber Lab Instrument Performance
in Determining the Characteristics of Cotton Samples," Research Triangle
Institute, Research Triangle Park, North Carolina, 1972.

"Evaluation of Sampling Plans which Determine the Characteristics of
a Bale of Cotton," Research Triangle Institute, Research Triangle
Park, North Carolina, 1972.

"Effects of Nitrogen Oxide Levels on Health Characterisitcs of Persons
in Chattanooga, Tennessee," Research Triangle Institute, Research
Triangle Park, North Carolina, 1973.

"Ten Year Projections of U.S. Manpower Requirements for Short-Term
General Hospitals in Five Personnel Categories, Research Triangle
Institute, Research Triangle Park, North Carolina, 1973.

"Estimation of Annual Ingestion of Strontium-90 from Two Diets in
Selected Segments of the U.S. Population," Research Triangle Institute,
Research Triangle Park, North Carolina, 1966.

"Advanced Studies of Stochastic Processes:  Power Spectral Analysis
in Non-Stationary Models," Research Triangle Institute, Research
Triangle Park, North Carolina, 1967.

"Methodology for Assessing the Harzards of Electromagnetic Radiation
to Ordinance:  Statistical Tolerance Limit Calculations With and
Without Censoring of the Data," Research Triangle Institute, Research
Triangle Park, North Carolina, 1968.
10/76

                         4-15                             3-10-77

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LOIS D. BRESSLER, Programmer


Professional Experience
     1969 to date.  Research Triangle Institute, Research Triangle Park, North
     Carolina 27709.  Programmer, Computer Applications Center.  IBM 370/165 OS,
     FORTRAN, and statistical package programs.

     1967-1969.  General Telephone Company of the Southeast, Durham North Carolina.
     Programmer and systems programmer.  IBM 360/30 and 40 DOS, PL/I and Assembler
     Language, billing applications and systems programming.

Education

     B.A., Mathematics, University of North Carolina, Asheville, North Carolina,
          1966.
     Graduate work in linguistics and computer science, University of North Carolina,
     Chapel Hill, North Carolina, 1970-1972.

Selected Publications

     Improved Exposure Measurements.  S. B. White, C. A. Clayton and L. D. Bressler.
     Prepared for U.S. Department of Transportation, National Highway Traffic
     Safety Administration, Washington, D.C., September 1975.
     North Carolina Educational Policy Plans for the 1970's.  Alvin M. Cruze,
     Stephen A. Johnston and Lois A. Bressler.  Prepared for North Carolina
     Department of Administration, Raleigh, N.C., April 1974.
January 1976
                                      4-16                               3-10-77

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APPENDIX 4.2




 REFERENCES
     4-17                          3-10-77

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                              REFERENCES
4.1.      Triangle Universities Computation Center (TUCC), Memorandum:
          TUCC Security Features (General Information Series Document
          No. GI-066-1).  Research Triangle Park, North Carolina:  TUCC,
          February 1976.

4.2.      Sarhan and Greenberg, Contributions to Order Statistics.  New
          York:  John Wiley & Sons, Inc., 1962.

4.3.      Cochran, W. G. and G. M.  Cox, Experimental Designs.  New York:
          John Wiley & Sons, Inc.,  1962.

4.4.      Service, J., A User's Guide to the Statistical Analysis System
          (SAS).  Raleigh:  North Carolina State University, 1972.
                                  4-18                            3-10-77

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5.0  Cost and Labor Projections




     Cumulative projected costs (exclusive of fee)  and monthly direct




labor charges for this study have been estimated and are shown graphi-




cally in Figures 5.1 through 5.6.




     Figure 5.1 shows cost and labor projections for the sampling design




phase of this work.  Figure 5.2 shows the same information for field




operations and is identical to Figure 2.9 on page 2-47.  Figure 5.3




gives cost and labor estimates for the field supervision activities




at the smelter sites.  Included in these projections are costs for




sample shipment to RTI.  These estimates assume the pretest study will




take place during March 1977 and that the final smelter will be sampled




during November 1977.  Figure 5.4 shows the projections for chemical




analysis.  An essentially constant monthly level of effort is projected




for this work area.  Figures 5.6 gives the monthly statistical analysis




projections and shows an increased effort during the data evaluation




phase of the study.  Figure 5.6 shows the comparative monthly costs  .




(exclusive of fee) for each of the 5 work areas.  The projected costs




are based on the same estimates used in constructing Figures 5.1




through Figures 5.5.
                              5-1                               3-10-77

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                                                                                                                                     -  24.00O
                      •       •    MAN - MONTHS
                                  COST
                         J       F       M      A      M      J
0       N      D
A       S      0       N      0
                                                             TIME  FRAME
Fig. 5.1.      Sampling design cost and labor-hour projections.

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Fig. 5. 2.    Field operations  cost  and  labor-hour  projections.

-------
                                                                                                                                       -  70,000
                                •   MAN-MONTHS
                            - -•    COST
                         JFMAMJJASOND
                                                              TIME  FRAME




Fig. 5.3   Field supervision and shipping costs and labor-hour projections

-------
    CO
        80
        70
        60
        50
V  I
    £  30
        20
        10
                                          -«   MAN-MONTHS
                                          ••   COST
           Fig. 5.4.    Chemical analysis cost  and labor-hour projections.

-------
                                                                                                                                                      35,000
Fig. 5-5.      Statistical  analysis cost and  labor-hour  projections.

-------
 I
^J
CO
 I

o
 I
                                                                                                 KEY:

                                                                                                 I-SAMPLE DESIGN

                                                                                                2-FIELD  OPERATIONS

                                                                                                3 FIELD SUPERVISION  AND SHIPPING
                          o

27POO
X
I6.OOO

15,000
14,000

I3j000
12,000

11.000

iqpoo
9,000
8,000

7,000

6DOO
5,000

4.000
3.000

2,000

1,000


/.
_x
-

-
-

-
-

-

-
-


-

-
_

-
-

-

-


4
A,

















2



r-

























3
**"



















































5



OCT-DEC 1976
4-CHEMICAL ANALYSIS

4












2












J_




























3




















































5_

JAN 1977

4















2




1



























3




























4

2





















5 '




































3


























































5_

MAR
5- STATISTICAL ANALYSIS


4


2
















1





^
































3



















































5








APR


J_







4














3



2
































































5

MAY



4






2











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5_

JUNE






2















1



























3
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4













































5
1
JULY
                                                                           Tl ME  FRAME


                                    Fig.5.6.    Projected  monthly  costs by activity.

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                                                          KEY:
                                                           I-SAMPLE  DESIGN
                                                           2-FIELD  OPERATIONS
                                                           3- FIELD  SUPERVISION  AND  SHIPPING
                                                           4-CHEMICAL  ANALYSIS
                                                           5-STATISTICAL  ANALYSIS

16.000
15,000

14,000
13,000

12,000
11,000
Ln




4








3






2






















































5
AUG 1977


4



•3















P
b



















3















































5



SEPT

4444

4




2












1






















3





























4


O










5





OCT





1
f.















2















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5





NOV





2
41.






































5





DEC




^
ft






































5





JAN 1978





2






































5





FEB





2
ins






































5





MAR

                                TIME   FRAME
Fig. 5-6.(Cont'd).     Projected  monthly  costs  by activity

-------