RESEARCH    TRIANGLE
N  S  T I  T  U  T  E
                                                      December 17, 1976
                                    WORK PLAN
           EPIDEMIOLOGIC STUDY CONDUUfED IN POPULATIONS LIVING AROIM)
             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
                         Environmental Protection Agency
                      Research Triangle Park, N. C,  27711
   !l A  R C H  TRIANGLE  PARK,   NORTH  CAROLINA  27709

-------
                           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	      1-9
     1.5  Sample Selection Techniques 	      1-11

          1.5.1  Survey Participants	      1-11
          1.5.2  Air Sampling	      1-12
          1.5.3  Sampling for Soil Contamination	      1-13
          1.5.4  Sampling Tap Water	      1-13
          1.5.5  Quality Control	      1-14

     1.6  Sample Sizes and Sampling Error	      1-14

          1.6.1  Allocation of the Sample of Individuals. .  .  .      1-15
          1.6.2  High-Volume Air Samples	      1-17

     Appendix 1.1:  Population Characteristics of Survey Sites.      1-19
     Appendix 1.2:  Sample Sizes for Air Sampling 	      1-21
     Appendix 1.-3:  Wind Roses for Smelter Sites	    ,  1-24
     Appendix 1.4:  Resumes of RTI Project Staff	      1-30
     Appendix 1.5:  References	      1-36

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                                12-17-76

-------
                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 	       2-78
Appendix 2.3:  Survey Instruments	       2-86
                              iii                               12-17-76

-------
                     TABLE OF CONTENTS (Continued)
     Appendix 2.4:  Pretest Considerations	       2-100
     Appendix 2.5:  Relevant Correspondence 	     .  2-106
     Appendix 2.6:  Sample Collection Methodology 	       2-109
     Appendix 2.7:  References	       2-129

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	  .       3-3
          3.1.2  Household Samples	  .       3-3
                 3.1.2.1  Tap Water	       3-3
                 3.1.2.2  Dust. .....  	       3-3
          3.1.3  Environmental Samples	       3-4
                 3.1.3.1  Air Particulates	       3-4
                 3.1.3.2  Soil	       3-4

     3.2  Spark Source Mass Spectrometric  Analysis	       3-4
     3.3  Free Erythrocyte Protoporphyrin  (FEP)  Analysis.  .  .  .       3-5
     3.4  Urinary Creatinine Analysis 	       3-5
     3.5  Quality Control and Analytical Protocol 	       3-6

          3.5.1  Instrument Calibration 	       3-6
          3.5.2  Limits of Detection	       3-6
          3.5.3  Routine Analytical Protocol	       3-7
          3.5.4  Analytical Priorities	       3-7
          3.5.5  Quality Control Procedures ....  	       3-7
                 3.5.5.1  Instrument Performance	       3-7
                 3.5.5.2  "Accuracy and Precision	       3-8
                 3.5.5.3  Interlaboratory  Comparison	       3-9
          3.5.6  Calibration of High Volume Air  Samplers.  .  .  .       3-9

     3.6  Determination of Total .Particulate Solids  in Air.  .  .       3-11
     3.7  Personnel	       3-11
     3.8  References	,	       3-11

     Appendix 3.1:  Resumes of RTI Project Staff	       3-13

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                                12-17-76

-------
                TABLE OF CONTENTS (Continued)
                                                                Page

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
                                                                12-17-76

-------
                            LIST OF TABLES

Table                                                                Page

1.1.      Tentative sample allocation for individuals at the
          study sites	     1-16

1.2.      Tentative sample allocation for air samples	     1-18

1.1.1.    Selected population characteristics of survey sites. .     1-20

1.2.1     Lead content of air, yg/cu m	     1-22

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

A-2.6.2.  Exemplary format for presenting survey and
          laboratory results for study element ... 	     2-116
                                   vi                                12-17-76

-------
                            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	     1-7

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

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, Pennsylvania, performance
          site	     2-23

2.8.      Field operations time table	     2-44

2.9.      Field operations cost and labor-hour 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	     2-103
                                   vii                               12-17-76

-------
                      LIST OF FIGURES (Continued)

Figure                                                               Page

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	     2-104

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. . .   3-10
                                   viii                              12-17-76

-------
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 Stephen R.  Williams,
                                 •
senior statistician in SRDC.  Mr. Williams, assisted by Mr.  Lanny

Piper, statistician in SRDC, will be responsible for on-site delineation

of the target population, its stratification,  and the accumulation of

pertinent extant information about the study communities.   Additional

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 other Research Triangle Institute (RTI) centers that are involved in

this study and the Chemistry and Life Sciences Group at RTI.  Resumes

of the professional sampling personnel that will be substantively involved

in the study are presented in appendix 1.4.
                                1-1                              12-17-76

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




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




is to be used to collect samples of tap water, house dust, and soil




because probability sampling for these data was deemed impractical.




     Note that the specific methods proposed for measuring environmental




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 measurability of factors, the variability of factor measurements,




the quality control of data collection, and the suitability 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 selective samples of relatively homogenous factors, such




as tap water at a particular residence or school, to obtaining large




stratified random samples from a highly variable item, 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









                                1-2                              12-17-76

-------
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 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.  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, we anticipate 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.   One soil




sample will be collected at each pre-schooler play area, school playground,




and high-volume air sampling site.




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




pilot survey, 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.  Approximately




two persons per age/sex cohort will be selected from each geographic stratum




                                1-3                              12-17-76

-------
resulting in a total of approximately 128 (2x8x8) individuals.  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, aooroximately 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 plan




will 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, we expect 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 sample design according to the usual pattern of particular




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 2 obtained on each of 3 days to 3 obtained




on each of 7 days.  The number of observations will increase as the




distance from the stack increases.  The number of electric hookups




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.
                                 1-4
                                                                 12-17-76

-------
     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 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:




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




     (2)  Missouri Lead Operating Company, Bixby, Missouri;




     (3)  Anaconda Company (copper), Anaconda,  Montana;




     (4)  Phelps Dodge Corporation (copper), Ajo, Arizona;




     (5)  National Zinc Company, Bartlesville,  Oklahoma; and




     (6)  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.
                                                                 12-17-76

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




vailing wind patterns.  Wind roses (see appendix 1.2) 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.  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




being anticipated for the purpose of gaining the pertinent local infor-




mation needed to construct 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 older male




residents will not have had occupational exposure, and 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 popula-




tion of the most scarce cohort, usually the preschool group.  The approximate




stratification guidelines presented in figure 1.1, therefore, will necessarily
                                1-6                              12-17-76

-------
to
I
        o
        &
           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.

-------
differ by site.  Obviously, sampling from such populations can guarantee




adequate cohort representation over the range of distances only to the




extent that these cohorts are contained in that population.  In other




words, we anticipate, depending on the community, that virtually all of




the families residing near the stack 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 stack,




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 stack 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 samples,




surface soil samples, 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 in each exposure




level.  Equally spaced distance 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.




     It is noteworthy that stratum 8 in figure 1.1 (from 5 to 8 kilometers




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










                                 1-8                              12-17-76

-------
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.

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 a yet

unspecified target population will have a known, nonzero probability of

being selected for the study.  The method and materials used to obtain a

stratified area sample will vary by site.  As shown in appendix 1.1, the

sites to be' studied are generally characterized by such small populations

that Census of Population data are not sufficiently detailed to use as a

sampling frame.

     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/
          block maps and block statistics (on magnetic tape);

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



                                1-9                              12-17-76

-------
     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 enumeration district (ED) 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 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 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.  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 in 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 (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, 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


                               1-10                             12-17-76

-------
actually constitutes a reasonable allowance for these sample losses,

however, will be ascertained from local sources and site experience.

This minimum stratum size, the relatively 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.

1.5  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;

     -    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 filled or until all households in the stratum

have been either contacted or verified as not containing any of the
                              1-11                              12-17-76

-------
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].

     1.5.2  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 field enumerators.

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

hook-ups 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:

     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.



                               1-12                              12-17-76

-------
     1.5.3  Sampling for Soil Contamination




     Composite samples of surface soil are to be collected in play areas




of all study children.  Appproximately 80 (or less to the extent that




some families may have more than one child in the study)  of these soil




samples will be obtained from residential play areas for  each smelter




site, and one composite sample will be taken from each school yard where




study children attend.




     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 this reason, and because




random sampling appears impractical, a selective composite sample will




be relied upon to measure element exposure from soil in the play area.




The enumerators will first establish the boundaries of the most commonly




used play area and will then select from 3 to 5 surface soil samples




from scattered points in the play area.  These samples, which will be




obtained concurrently with the interview, will comprise the composite




sample 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 cooking (a single pass after the water has been allowed to run for a




few seconds).   Random sampling at different locations and times was not




proposed for this measure of exposure, because it should  be relatively




homogeneous within a household, and because what little improvement in
                               1-13                              12-17-76

-------
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 lab analyses—can constitute




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




errors are described more fully in the data collection and lab analysis




section of this work plan, but one aspect of the quality control is




described briefly here because it relates to sample randomization.  To




the extent possible, the sample data will be stored in the lab 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 10 percent of the eligibles




as quality-control individuals.  Two samples of blood and hair will be




obtained for each of these individuals and two samples of tap water and




dust will be taken at their dwelling.  Also, two soil samples will be




taken for 10 percent of the sample preschool children that are designated




for quality control.  The purpose of these quality control observations




is to measure the possible influence of sample acquisition, packaging,




shipping, and lab analysis.  Additionally, 10 percent of the sample




individuals will be reinterviewed at a later date to verify the infor-




mation obtained on the survey questionnaire; 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.




                               1-U                               12-17-76

-------
     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:
         =  n(NhV /ch )7 1 \V /ch
where IL  = 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



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 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):
     n   =  n S, / E S,
      s        h     h
         =  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.

                               1-15                              12-17-76

-------
        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.
                                     1-16
12-17-76

-------
     1.6.2  High-Volume Air Samples




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




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




Division of RTI.  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




sample size and allocation is presented in table 1.2,  but it will be




altered to suit the individual site circumstances.  Methodology for




estimates 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 variation for element content of




atmosphere of 0.20 or less at the stratum level.
                               1-17                              12-17-76

-------
      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
S±, in
S6
2
5
10
2.5
Each
S7
3
6
18
2.0
Stratum
S8
3
7
21
2.3

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

-------
               APPENDIX 1.1




POPULATION CHARACTERISTICS OF SURVEY SITES
                   1-19                              12-17-76

-------
                   Table  1.1.1.   Selected population  characteristics of survey sites.*
Smelter Neighboring
D 1 3.L&
town towns
Arizona Ajo
Rowood
Missouri Bixby
Bass
Buick
Viburnum
Herculaneum
Festus
Crystal City
Horine
i Povely
o
Montana Anaconda
Gregson
Warmsprings
Oklahoma Bartlesville
Dewey
Tuxedo Park
Pennsylvania Palmerton
Texas Corpus Christi
(pretest site)
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 .
i Q^n ge 8rouPs> percent
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
IsJ
I
M
•-J
I
          *Based  on  the  1970  Census  of Population.

-------
        APPENDIX 1.-2




SAMPLE SIZES FOR AIR SAMPLING
            1-21                               12-17-76

-------
     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 content 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.
                               1-22
12-17-76

-------
     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  =  S /S



where



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


respectively.
                               1-23                              12-17-76

-------
        APPENDIX 1.3




WIND ROSES FOR SMELTER SITES
            1-24                              12-17-76

-------
7.1
5.^
  5.0
               i Z^  ^
                 '. A«ta /   X v •.
                     /:/»
                 K//^r
       ^T  ^'
      , v ^


                                 •:• '.;°.   ci ' c    o. i fs
                   1-25
 12-17-76
c."\L:;-or>NiA oof/.PUTsa rn

-------
      3-5
1 j - '3
                                    PEK-C1NT  OCCURRENC
                               i,.
7 - M
      • M-i   »•:-
         1-26
  12-17-76

-------
                                                                                 OCCURRENCE
                                                1-27
12-17-76
;>••"ij;*--' V-'VV' •^•"~v« ^u'-''*"•••- •
r;^=*^V;. r>r-V.-l": :  v*•"'•  v

-------
PI !i:K--!jLL'vri-:-nrK-ujLfiM! I:M.  HU .
               7.-3
          7.1
                                                  _^ -"• ,1     f j f -C     ^ 1 ^
                                                 \E:K-c;r.Ni  OCCURRENCE
0.15
                                        1-28
                                                                       12-17-76




-------
/\
                                     3.CJ
                            S
                                            *•• ^ i      '"• r • O      O  1 °
                                            u • u '*      U • y J      J • I *.


                                          'E;R.-Cf:NT  OCCURRENCE.

                              1-29
12-17-76


-------
        APPENDIX 1.4




RESUMES OF RTI PROJECT STAFF
             1-30                         12-17-76

-------
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
                                   1-31                               12-17-76

-------
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
                                 1-32                               12-17-76

-------
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
                                   1-33                              12-17-76

-------
STEPHEN R. WILLIAiMS, 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.
                                    1-34                             12-17-76

-------
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
                                    1-35                              12-17-76

-------
APPENDIX 1.5




 REFERENCES
     1-36                             12-17-76

-------
                              REFERENCES
1.1.      Miesch and Huffman, Abundance and distribution of lead, zinc3
          cadmiwn, and arsenic in soils in Helena Valley3 Montana.  Area
          Environmental Pollution Study (EPA Office of Air Programs
          Publication No. AP-91), p. 65.

1.2.      Dusan Djurie1, 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.      J. L. Seeley 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.
                                   1-37                          12-17-76

-------
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), and




Thomas G. Virag, Senior Survey Specialist within SOC.  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.




     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                      12-17-76

-------
                                                                             Treasurer
                                                                         W. H.  Perkins, Jr.
                                                                        Office of Accounting
                                                                           R. S. McLean
                                   Corporate V. P.
                                    S. C. Ashton
                                  Office of Research
                                      Contracts
                                     J. C. Ragan
N>
 I
                             Chemistry and Life Sciences
                                  Vice President
                                   M. E. Wall
 Social Sciences
 Vice President
W. C. Eckerman
Statistical Sciences
  Vice President
  D. G. Horvitz
Energy, Engineering, and
 Environmental Sciences
    Vice President
    J. J. B. Worth
                                             Center for
                                            the Study of
                                           Social Behavior
                                              ...   .
                                             A D'"*tor
                                             A- M- Uuze
     Fig.   2.1.    Research  Triangle  Institute administrative  structure.

-------
                                                       M. E. Wall
                                                    Program Director
         UNC
         C.  M.  Shy
         Epidemiologist
         Porgram Advisor
         Research Assistant
CLSG
R. W. Handy
Chemist
Program Advisor
J. Kearney
                                                                                               SSG
            W. K. Poole
            Senior Biostatistician
            Program Advisor
i
CO
                                                    Laboratory
                                                    Assistants
                                                                      SRDC
  SOC
                                                                                                               SMAC-CAC
               J. Chromy
               S. Williams
               L. Piper
               L. Bressler
        D. Bates           T-
        T. Virag           L.
        B. Harris
        M. Smith
Field Operations Personnel
Survey Specialists
Survey Assistants
Survey Clerks
Independent Subcontractors
Hartwell
Bressler
to
         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 and general soil samples (see below);




and for coordination and shipment of data from the performance site to




RTI.  The SA will remain at the site' for the duration of data, collection;




the same SA at the very least will oversee such activities at sites represent-




ing 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, Survey Assistant




Smith 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                   .   12-17-76

-------
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 arid 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

-------
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

-------
     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 questionnaires 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                      12-17-76

-------
        That each instrument is properly identified and that all items




        required for verification of the individual's work x^ere




        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, 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 mail, telephone, or personal visit, approximately ten




percent of the population for whom completed questionnaires are obtained.
                                2-8                      12-17-76

-------
This procedure will actually permit a two-fold verification:  that the




interview was conducted, and that responses are consistent.




     .  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 transmitted 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 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.
                                  2-9                      12-17-76

-------
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                     12-17-76

-------
     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, Survey Director




Harris or Survey Assistant Smith.  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                     12-17-76

-------
     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, and the PCF




will be destroyed when the study is concluded.
                                      2-12                     12-17-76

-------
     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. Weborn
                                   2-13      .               12-17-76

-------
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:



        Ajo, Arizona;



        Anaconda, Montana;



        Bartlesville, Oklahoma;



     .  Bixby, Missouri;



        Herculaneum, Missouri; and



        Palmerton, Pennsylvania,


                                                                                2 I/
not necessarily in that order  (see section 2.4 - Schedules for Field Operations)vi—



     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 and tne 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
2.1/
—i— A decision has been made that Bartlesville, Oklahoma, will not be the

    first performance site; in addition, RTI will perform a pretest at one

    additional smelter location, probably Corpus Christi, Texas - see

    appendix  2.4.
                                   2-14                     12-17-76

-------
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




representatives of these agencies in an attempt to secure their cooperation,




assistance, participation, and endorsement.  The cooperation of appro-




priate education authorities is considered essential since it will be




necessary to collect soil samples in each school-yard 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.  The role chosen by the smelters




may have a significant impact on the cooperation of potential partic-




ipants in the smelter communities.
                                  2-15                     12-17-76

-------
     .  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 involvement of local and area newspapers, radio, and




television in this publicity campaign utilizing news releases and public




service announcements which would explain succinctly the reasons for




and potential benefits of the study, such as the dangers of heavy metal




absorption. This publicity campaign will probably start at each performance




site approximately two weeks before data collection is to begin.
                                   2-16                     12-17-76

-------
     2.2.2  Independent Subcontractors




     2.2.2.1  Recruitment




     While at the smelter location to contact appropriate federal, state




and/or lopal agencies related to the study, RTI will initiate recruit-




ment of field staff/independent, subcontractors to participate in the




actual study data collection.  RTI plans to retain two or three 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, and collecting dust




and water samples and some soil samples.




     .  Medical personnel such as Registered Nurses or medical technicians




to obtain the blood samples and collect the urine samples; and perhaps




     .  Barbers to collect the scalp hair samples with a minimum of




burden to the participant (see below).




     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                     12-17-76

-------
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;  In areas where the RTI listings




and/or State and local agency contacts are inadequate, 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 and/or the SA or a Field Supervisor (FS-see below), 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
                                   2-18                     12-17-76
                                                                •\

-------
                                           9    -C.V          -   -
                                          '*" ,'' V'> O* '.', C      N      -'    v
                                          /v"','.'':;:{'';-,   »y^.^.'^^ayy.?
          LEGEND
®   Places ol 100.000 or more inhabitants
•   Places ol 50.000 to 100.000 inhabitants
O   Places of 25,000 to 50.000 inhabitants outside SMSA's
         Standard Metropolitan
          Statistical Areas (SMSA's)
SANH CRUJ
  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

-------
NJ
 I
NJ
                                                                                                             LEGEND

                                                                                                       Places of 100.000 at more inhabitants
                                                                                                       Places ol 50.000 lo 100.SoO .nhaoitants
                                                                                                       Places ol 25.000 to 50.000 inhabitants outside SMSA's
                                                                                                          t-| Standard Metropolitan
                                                                                                             Statistical Areas iSMSA's)
               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].

-------
10


M
-vj
                            ,, MISSOUL*  -  I P°WELL

                          '" '•/ OMttSOUl"
    SCALE

O IO 2O 3O 4O SO MILES
                                                                                                   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].

-------
10
I
to
NJ
                                                                               OKLAHOMA CITY
                                                                               CANADIAN  ^ OKLAHOMA
                                                                               OKIAHOM.A ciry
                       LEGEND

             ®  Places of 100.000 or more inhabitants

             •  Places of 50,000 to 100,000 inhabitants

             O  Places of 25,000 (o 50,000 inhabitants outside SMSA's
                      Standard Metropolitan
                       Statistical Areas (SMSA's)
to
I
I-1
-j

»-j
0\
                                                                                        SCALC

                                                                                   0  10 2O  3O  «O SO MILES
                Fig.  2.6.   Location and number  of interviewers  from the  current RTI listing living in counties
                              within a reasonable  distance of the  Ba'rtlesville,  Oklahoma,  performance site
                              [Source:   Ref.  2.3,  p. 1006].

-------
                                                                                                        BINGHAMTON
NJ
U>
ro
I
                                                                                                       ,o.,«  < .SCRAN TON
                                                                                      \2
                                                                           DfADiNC  / PHILADELPHIA V"
                                                                                                                        •BETHLEHEM EASTON
                               LEGEND

                     (•)   Places ot 100.000 or more inhabitants
                     •   Places ol 50.000 to 100.000 inhabitants

                     D   CenKal cities ol SMSA's with fewer than bO.OOO inhabitants

                     O   Places ol 25.000 to 50.000 inhabitants outside SMSA's
I Standard Metropolitan
 Statistical Areas (SMSA's)
                                                                                                         O _ 	IO 	iO  30   «   SO MILCS
              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].

-------
surveyed, so that data collection can be completed at each site in




approximately one month (see below).  In addition, RTI is considering




retaining the services of a barber at each site to assist with the




collection of the scalp hair sample (see below).




     .  Qualifications:  Potential FI's should ideally be known to




and/or recommended by RTI, various State or local agencies, and/or




similar organizations; 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 currently employed in some area




requiring acquisition of blood samples.  The barber(s) should ideally




present evidence of training, experience, and quality performance; live




within a reasonable distance of the performance site; have an automobile




available; and be available to work irregular hours and/or weekends.




In certain areas, such as Arizona, RTI anticipates that independent sub-




contractors will most likely have to be bilingual - that is, speak English




and Spanish.




     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                     12-17-76

-------
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.  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




consultants 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                      12-17-76

-------
     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 Management 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.  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.




     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-schopl 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
                                  2-26                     12-17-76

-------
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.




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




as a representative of RTI and EPA; present his 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 nonrespondentsj or households which cannot




be screened; nonpartioipants 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.  Where required, the HSQ will be




available in more than one language - for example, English and Spanish




for Arizona.




     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
                                2-27                       12-17-76

-------
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.


     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 the smelter firm


and 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 in-


formation 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 participant from the data once collected;
                                    2-28                       12-17-76

-------
for example, the PCF is the only data collection instrument which will




bear the name of the participant and allow its association to study identi-




fication numbers, but will be maintained in hard copy only and stored




in a restricted area, as indicated in a previous section.  To emphasize




this disassociation, for example, the incentive will be paid in cash




rather than by check or money order, although the participant or his/her




guardian will initial 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 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.  Where required, the SQ will be




available in more than one language - for example, English and Spanish




for Arizona.




     Household information includes questions related to family socioeconomic










                                2-29                       12-17-76

-------
 status  (occupations,  educational levels),  and questions related to  food




 sources and  preparation.   Information  on individual participants includes




 demographic  characteristics  such as age, sex,  race, marital  status,




 occupation,  and  educational  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 to food stuffs high




 in heavy metal content [Ref.  2.4] 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  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                       12-17-76

-------
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 and general soil samples such as soil samples from each




school yard 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; 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 and




blood samples will be collected by the medical independent subcontractor;




the hematocrit will be determined by the medical independent subcontractor;




and the scalp hair sample will be obtained, perhaps by a barber.




     For each household containing a study participant, 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
                                   2-31                       12-17-76

-------
can be accurately calculated.  For 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

                                         2 2/
where study children participants attend.—1—

     2.2.3.5  Quality Control

     Two aspects of quality control will directly involve the participating

households and individuals - duplicate samples and reintervieu.  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 2/
—i— In addition to the environmental and biological samples specified in
    Exhibit A:  Scope of Work for this contract, the Project Officer has asked
    RTI to consider two additional measurements, paint and dietary lead, which
    might increase the significance of data collected in this research effort.
    Since these measurements are not part of the Scope of Work, procedural and
    cost considerations are presented in a separate document.
                                    2-32                        12-17-76

-------
     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 perhaps




a barber for four hours in. the evening Monday through Friday and 9 a.m.




to 5 p.m. 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 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 Saturday.
                                    2-33                        12-17-76

-------
      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 air and  soil  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  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                       12-17-76

-------
        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, and composite soil samples from the smelter community


at large as well as from each school yard where study children participants


attend.


     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.


     High density polyethylene containers (120 ml) will be used for tap


water, urine and soil samples.  Different types of caps are being investi-

                                                                       *
gated to provide a leak-proof seal, without contamination.  Shipment by


Federal Express eliminates the possibility of sample contamination due


to pressure gradients in transit.  Plastic containers will be shipped in


styrofoam blocks in which depressions are cut to exactly hold each container.
                                 2-35                       12-17-76

-------
RTI experience with such shippers has resulted in no container damage




and a minimum of sample temperature change during transit.




     Zip-Loc plastic containers will be used for air, scalp hair




and dust samples.  Provisions will be made to insure a tight seal




to prevent 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                       12-17-76

-------
     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.  The SA will remain at the performance site until '




data collection is completed, and the same SA 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
                                   2-37                       12-17-76

-------
field staff in the event that any medical problems or questions are




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 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                       12-17-76

-------
     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).




     2.2.6.5  Reinterview




     As a quality check of the interview process, RTI plans to re-




interview by mail, telephone, or personal visit approximately ten




percent of the population for whom completed questionnaires are obtained.




This procedure will permit a two-fold verification - that the interview




indeed took place and that responses are consistent.
                                2-39                       12-17-76

-------
     2.2.7  Respondent/Participant Burden




     The only anticipated risk to participants will involve the acquisition




of the blood sample, and the biwden 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.




     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 and the various analyses for metal burden.  Potential




participants will be informed of the potential dangers of heavy metal




absorption and benefits to be gained in the early discovery of heavy metal




absorption in the participants and their communities.  Participants will




be informed of arrangements with appropriate area agencies for the follow-




up of study participants for whom study data indicate medical attention.
                                   2-40                       12-17-76

-------
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

independent subcontractors could be retained at, or within a reasonable

distance of., the smelter community performance site.  Should RTI be unable

to find 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

nohrespondents,  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                       12-17-76

-------
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 sample or a 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.  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, but. is consider-




ing using registered mail in this study.
                                   2-42                       12-17-76

-------
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. 2.5]




     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                      12-17-76

-------
       SITE
       RTI
ACTIVITY
                    TASKI
                                 TASK
         o
                          TASK 4
                                             TASK
                                                                                   S551
                                                                                       TASK 7
    PRETEST
    PERFORMANCE

        SITE  I
to
I
                                                                     n..  i «•  i
                                                                              ^*W*
        TIME

       FRAME
     N
0



1976
  J



1977
M
M
S
ON
0



1977
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

-------
     2.4.2  Cost Schedule




     Figure 2.9 presents graphically cumulative estimated cost




(exclusive of fee) and labor hours by month for the field operations.




These cost and labor hour projections are based on Figure 2.8 and




predicated on the same assumptions.
                               2-46                       12-17-76

-------
                APPENDIX 2.1
RESUMES OF RTI PROJECT STAFF AND CONSULTANTS
                     2-48                         12-17-76

-------
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

-------
     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
                                 2-5,0                         12-17-76

-------
                                CURRICULUM VITAE

                             STEPHEN HUNTER GKHL3.ACH



Born;   January 14, 1942, in Mo line, 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
               • •.>,'                                  '        •   -                 :
               !,.-./'                       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              .
                          «         ..•:-.          ••  .        N
Licensure;   North Carolina, December, 1971         ••     .    :    '

Publications;   (coauthor);  "Haeraolytic Anaenia in Infectious Mononucleosis Due
                       Inapparent Congenital Spherocytosis,"  Scand. J. Haernat.,
   "*'••••.     '7:  141-L44, 1970.
         «      (coauthor);  '"Clinical Reactions Following Rubella Vaccination,"
                       JAMA. 220;  1569-1572, 1972.
      •-. .   .    (coauthor):  "Coccicioidomycosis," 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

-------
PUBLICATIONS:  Gehlbach, S.,  Cooper,  B.,  "Haemolytic Anaemia in Infectious
                  Mononucleosis  Due Inapparent  Congenital Spherocytosis,"
                  Scand. J. Kaemat.,  7:   141-144,  1970.

               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

-------
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 Methodology and
        Operations Department, Statistics Research Division.  Currently
        Project Leader of a follow-back study of children who received
        diagnostic doses of radioactive iodine over the period 1946-1960.
        Also involved in a national survey of the incidence, prevalence, and
        costs of traumatic injury to the central nervous system; a study of
        the outcomes of alternative modes of treating prostatic carcinoma;
        and a national registry of chronic intermittent dialysis patients.
        Major contributor to the evaluation of the Mecklenburg County, North
        Carolina, Alcohol Safety Action Project; 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 determination 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 by pneumothorax
        and pneumoperitoneum with fluoroscopy during the period 1930-1950.
        Supervised survey of Medicare procedures used by physicians in selected
        metropolitan areas; major contributor to a study involving the collec-
        tion and analysis of data relating to civilian techniques in inter-
        national 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 evalua-
        tion of the site visit process, assisted with the Third Annual Alcoholism
        Conference of NIAAA, and involved in medical evaluation of the supple-
        mental food program for Women, Infants, and Children.  Assisted in the
        preparation of new contract 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.

        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 pre-
        vention and control of communicable respiratory 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.  Responsible
        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.
                                       2-53                         12-17-76

-------
   1961 to 1964.  Duke University Medical Center, Durham, North Carolina 27710.
   Research Assistant, Department of Psychiatry, Division of Electroencephalography
   (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; prepara-
   tion of Keysort data cards for classification and condensation 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.

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.
                                         2-54                         12-17-76

-------
   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."  Accepted for publication in 1975
        in the South Carolina Magazine.
January 1975
                                       2-55                         12-17-76

-------
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.

          1942-1961:   United States Department of Agriculture, Standards and
          Research Division, Statistical Research Laboratory, Institute of
          Statistics, North Carolina State University, Raleigh, North Carolina.
          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

-------
                                CURRICULUM VITAE
                                   Carl  M. Shy

  I.  Born:  October 23, 1931 - Milwaukee, Wisconsin
      Married:  June 6, 1959
      Wife:  Eve Carol  (nee Rudich)
      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-2nres

Medical Student, M.D.
 received June 1962

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 1967
 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.
(Now tho  Environmental
 Protection Acj-nncy)
 Durham,  North Carolina •
 Epidemiologist and Chief,
  Epidemiology Branch,
  Division of Health Efff:C<
  Research
                                2-57
                                  12-17-76

-------
                                    -2-
2.  1971-1972
3.  9/72-12/73
4.  1968-1973



5.  1969-Present



6.  1970-Present

7.  197.1-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 Professor
 of Epidemiology (Part-time-
 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

-------
                                     -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

-------
                                       -4-
VI.  Publications:
     1.  Shy, C.M.  and Meade,  R.C.:   The hippuric acid radio isotope renogra;n,
     Harquotte Msd.  Rev.   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.
     Marquette Med.  Rev.  27:61-67, 1962.

     5.  Shy, C.M.:   Of Man and Machines (Student Editorial).   Marquette Had.  Rev
             *
     6.  Associate  editor of Vol.  27, No. 3  (March 1962)  issue  of  Marquette Med.
     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 volurna,
     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., McClai'n, 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. anc
     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,  W.R. and Ncv/ill,  V.A.:  Air
     Pollution  Episodes:  Guides  for Health Departments  and  Physicians.   HSMHA Meal
     Reports, June 1971.

     13.  Hammer,  D.I.,  Finklea,  J.F.,  Hendricks,  R.H.,  Shy, C.M. and Morton, R.O.I-:
     Ha-ir Trace Motal  Levels and Environmental Exposure.  t\mnr. J.  Epic!.  93:84-92,
     February 1971.


                                2-60                      12-17-76

-------
                                   -5-

 14. Pearl man,  M.E.,  Pinkie?.,  J.F.,  Shy,  C.M.,  VanBruggen,  J.B.  and  fiewill,
 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.D.
 and Morton,  R.J.M.:  Nitrogen  Dioxide and Lov/er Respiratory Illness, Pediatri
 47(2), February 1971.

 16. Shy,  C.M.:  Environmental  Epidemiology.  Chapter  in Environmental Hancibo'
 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. Cohen, A.A.,  Bromberg, S.,  Buechley,  R.W.,  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. S<
 and Techno!. 6:890-894, October 1972.                 .   .

 20. Shy, C.M., Hasselblad, V.,  Heiderscheit, L.T. and Cohen, A.A.:  Environs
 Factors in Bronchial Asthma.   Published  in Environmental  Factors in Respiratt
 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., Bueckley} 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 Proceedings of  the Sixth Berkeley Symposium on Moth?
 tical  Statistics and Probability, Vol. VI, Effects of Pollution on Health,
 University of  California Press,  1972.
                           2-61                      12-17-76

-------
                                   -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  Lower  Respiratory  Illness.
 Published in October 18,  1971 issue of Modern Medicine.   (Abstract)

 26.  Shy,  C.H.:   Referee  for Article "Air Pollution:  A Major Public Health
 Problem"  by  Ayres, Evans  and  Buehler.  Published as CRC Critical Reviev/ 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 New 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, J.:  Family  Surveys of  Irritation Symptoms During Acute Air
 Pollution Exposures: 1970 Summer and 1971  Spring Studies.  0. 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, V.'.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,
 Mew  York-London, 1972.

 31.   Shy, C.M., C.J. Nelson,  F.B. Benson,  R.S. Chapman, VJ.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, VI.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 'Consiecticut
 Conference on Transportation, Connecticut Lung Association, 1973, In pr-:-5S.

                            2-62                      12-17-76

-------
                                      -7-
VII.  In-House Technical  Reports  and  Inter-Agency  Experience  in  Federal
      •Government:

      1.   Shy, C.M.»  Hairier,  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 photochemical 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. H.
          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 Harm,
          June 13, 1972.

                              2-63                      12-17-76  '

-------
                                  -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
     Written  for Revision  of Air Quality Criteria for Sulfur Oxides,
     June 1972 (Unpublished).
                          2-64                     . 12-17-76

-------
                                     -9-
VIII.  Papers Presented at Scientific and Other Public Meetings

       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  Epidenn'ologic Research,
           Washington,  D.C.,  May, 1968.

       2.  The determinants of the one second  forced expiratory volume in an
           epldemlologic study of a total  community  (Tecumseh, Michigan).
        •  Presented at the annual  meeting of  the American Public Health As-
           sociation, Detroit, Michigan, November, 1963.

       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 epidemiologic 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.  [a)   A National  Health Effects  Surveillance Network.

           G>1   Atr 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  School  Children Study.  Effect of Atmospheric Nitro-
           gen  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.H.  Health  Hazards of Proposed Fossil Fueled Power Plant in
           Astoria,  Queens, New York.  Citizens for Clean Air, New York, Mew
           York,  October,  1970.
                                  2-65                       12-17-76

-------
                                 -TO-
 IL   Shy,  C.M.   Repeat of-above.   New  York  City CoM-.fr.on 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 S-tudies.
      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.   Say,  C.M.   A  Program of  Co~nr.ur.fty 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.
i
 18.   Ftnfxlea, J.F.,  Cranmer,  M.F., Hammer,  D.I., McCabe, L.J., Nevrill,
      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., Norn's,  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.M., 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 Maasure
      Biologic Response to Environmental Pollution.  Annual fleeting of
      Society for Epidemic logic  P.esearch, Atlanta, Georgia, May,  1971.

 22.   Shy,  C.M.   Asthma and Air-Pollution.   Presented at annual seating
      of Southeastern Allergy  Association, Asiieville, M.C., October, 1971.
                           2-66                      12-17-76

-------
23.  Shy, C.M. and associates.   Effect of Atmospheric  Particulate
     Matter and Sulfur Dioxide  on Yen til a tory Performance  of
     Children.  Presented at annual  ir.eeting  of American  College
     of Chest Physicians, Philadelphia, Pa.,  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,  New  Jersey,
     March, 1972.             .       •    .                '   .

26.  Report on Health Consequences of Sulfur Oxides:   A Report  from
     CHESS 1970-71 to the National Air Quality Criteria Advisory
     Committee, Washington, D.  C., November 16, 1972.

27.  Presentation at the. EPA Research Seminar for Federal  Agencies,
     Washington, 0. C., -iovefnbar 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 S09 and Particulate Emissions.
  4                               •       C*           '
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, N. 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 Ccuncil, December 9, 1972.
                        2-67                      12-17-76

-------
34.  Shy, C.M.  Adverse Health Effects of Transformed Products of S0?
     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, 0. C.,
     February 26, 1973.

36.  Shy, C.M.  Air Pollution Epidemiology.  Presented to Sophomore Medice
     Students, Duke University Medical Center, .Durham, N. C., February 27.,
     1973.

37.  Shy, C.M.  Briefing on CHESS Program for Science Newswriters, Washir.r
     D. C., March 2, 1973.       .                                 .       "

38.  Shy, C.M.  Effects of Low Levels of Oxi.dants and NC>  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, Mat,
     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,  Denvr
     Colorado, April 17, 1973.

42.  Shy, C.M.  Transportation and Health, Presented at the Connecticut
     Conference on Transportation, Hartford,  Connecticut, May 16, 1973.
*s\
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

-------
                                     -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 1952
     Alpha Omega Alpha National  Honorary  Medical Fraternity, June 1961
     Second Place,  Gram!ing Memorial  Student Medical Essay, September 1960
                             2-69                      12-17-76

-------
MARTHA LILLIAN SMITH, Survey Assistant


Professional Experience:

     1973 to Date.  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.

     1972 to 1973.  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.

     1965 to 1972.  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.

     1964 to 1965.  Union Pines High School, Cameron, North Carolina.  Teacher
                    of health, P. E., and government.  Coached varsity and
                    junior varsity basketball.

     Summer.

     1962 to 1963.  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.

     1966 & 1970.   Director of programming and counseling, Camp Mountain Lake,
                    Hendersonville, North Carolina.

     1971 & 1972.   Trip director, Tripp Lake Camp,  Poland Maine.
                                        2-70                       12-17-76

-------
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

-------
 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 (WIC).  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

-------
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, ot-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 ct,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

-------
THOMAS G. VIRAG, SR.,  Senior Survey Specialist


Professional Experience

     1969 to date.  Research Triangle Institute, Research Triangle Park, North
     Carolina 27709.  Senior Survey Specialist in the Survey Operations Center
     of the Statistical Sciences Group.   Planning, organizing, and supervising
     the collection and analysis of survey data for a variety of research projects.
     Participation in a list of selected Research Triangle Institute projects is
     shown below.

         1975 - 1976:   National Study to Determine the Incidence, Prevalence, and
         Costs of Head and Spinal Cord Injuries — Project Leader for a large
         data collection effort involving approximately 300 hospitals yielding
         9,000 medical record abstractions, 3,000 patient tracing cases, and
         1,000 personal health cost interviews using a field staff of 52 site
         administrators.

         1975 - 1976:   Follow-Back Study of Children Receiving Diagnostic Doses
         of Radioactive Iodine Over the Period 1946 - 1960 — Provided management
         support for the project involving data collection efforts in approximately
         10 medical centers in the United States; approximately 1,500 medical record
         abstractions were completed with subsequent tracing operations conducted
         with the identified patient population.

         1975 - 1976:   Evaluation of Hospital Discharge Survey — Provide manage-
         ment support for project activity of survey specialists to review current
         design of the Hospital Discharge Survey (HDS) to develop and test alternative
         data collection procedures, and to offer recommendations for the continua-
         tion of the HDS.

         1974 - 1975:   National Survey to Evaluate the Organization of Fire Service
         Delivery — Project Leader for data collection effort involving mail,
         telephone, and in-person survey techniques.  Questionnaires administered
         to fire chiefs, city managers,  and building inspectors approximately 1,300,
         400, and 500 completed questionnaires respectively.  In-person interviews
         completed with a staff of approximately 50 field interviewers.

         1974 - 1975:   Pilot Study to Establish Protocol for the Conduct of the
         National Study to Determine Incidence, Prevalence, and Costs of Head and
         Spinal Cord Injuries — Project Leader for a large-scale pilot study in
         eight geographic areas to test data collection methodology to design a
         cost-effective and feasible protocol for a national study.  Involved
         contacting office-based physicians, hospitals, nursing homes, and other
         providers of health care/treatment to test data collection procedures
         utilizing a field staff of 23 individuals.

         1973 - 1974:   Senior Survey Specialist, National Assessment of Educational
         Progress Administration Department, Statistics Research Division.  Field
         Director for Out-of-School Assessment.  Responsible for nationwide field
         staff of 13 full-time supervisors and over 100 part-time interviewers.
         Develop and conduct training programs for field staff; formulate all
         field procedures; and coordinate data check-in and Verification, assess-
         ment scheduling, and budgeting.
                                     2-76                         12-17-76

-------
         1970 - 1973:  Survey Specialist, Survey Group of Statistics Research
         Division.  Southeast Regional Supervisor, Northeast Regional Supervisor,
         and Eastern United States Field Coordinator.  As a Regional Supervisor,
         responsible for supervising District Supervisors, each responsible for
         completing the assessment in one to three states.  Hiring, training, and
         maintaining a field staff to work with the schools involved, etc.  As Field
         Coordinator, responsible for two Regional Supervisors and their staff of 15
         District Supervisors.

         1971 - 1972:  Survey Specialist, Survey Group of Statistics Research
         Division.  Survey of Practicing Physicians at six sites across the United
         States.  Served as Field Director and was responsible for pretesting sur-
         vey questionnaire, assisted in questionnaire development, prepared training
         materials, trained and supervised the data collection at one of the sites.

     1966 to 1969.  California Area Schools, California, Pennsylvania.  Teacher-
     principal, supervising student teachers, and directing pilot school research
     study in the area of modern mathematics.

     1964 to 1966.  Gateway Union Schools, Monroeville, Pennsylvania.  Teacher,
     self-contained classroom.

Education

     B.S., Education, California State College, California, Pennsylvania, 1964.
     M.S., Education, California State College, California, Pennsylvania, 1969.

Professional Activities

     National Education Association, 1964 - 1967.

Selected Publications

     "A Study to Determine Factors Physicians Take Into Consideration in Deciding
     Whether to Accept Assignment, Billing Arrangements Physicians Make to Cope with
     the Deductible and Co-Insurance Features of Reimbursement, and the Nature of
     These Billing Practices—Volume I:  Study Design and Pilot Survey," J.T. Wakeley,
     W.C. Eckerman, R.E. Mason, and T.G. Virag, August, 1972.

     "Working Paper No. 1—Pilot Study Protocol for the Head and Spinal Cord Injury
     Project," W.D. Kalsbeek, T.G. Virag, K.D. Nash, and J. Lessler, Research
     Triangle Institute, January, 1975.

     "Qut-of-School Field Operations and Data Collection Activities—National
     Assessment of Educational Progress for the Period of January 1, 1974 -
     September 30, 1974," W.K. Grogan and T.G. Virag, Research Triangle Institute,
     July, 1975.

     "Evaluating the Organization of Service Delivery: Fire—Final Report Data
     Collection Operations," T.G. Virag, Research Triangle Institute, September, 1975.
March, 1976
                                     2-77                         12-17-76

-------
          APPENDIX 2.2
TENTATIVE TRAINING MANUAL OUTLINE
                2-78                          12-17-76

-------
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 ..
                     2-79                       12-17-76

-------
     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




            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
                2-80                       12-17-76

-------
     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  Urine

     4.5.5  Scalp Hair

     4.5.6  Blood

4.6  Central Data Collection

     4.6.1  Overview

     4.6.2  Scalp Hair Sample

     4.6.3  Blood Sample

     4.6.4  Hematocrit

     4.6.5  Urine Sample

     4.6.6  Quality Control:  Duplicate Samples

     4.6.7  Problems
                2-81                       12-17-76

-------
                 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 Questionnaire

                 6.1.1.1  Receipt

                 6.1.1.2  Batching

                 6.1.1.3  Scan-Edit

                 6.1.1.4  Direct Data Entry

          6.1.2  Household Screening Log

                 6.1.2.1  Receipt

                 6.1.2.2  Batching

                 6.1.2.3  Scan-Edit

                 6.1.2.4  Direct Data Entry
                     2-82                       12-17-76

-------
     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




     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
                2-83                       12-17-76

-------
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

     7.3  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  Tap Water

                 7.3.2.4  Housedust
                     2-84                       12-17-76

-------
                        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
                                    2-85                       12-17-76

-------
   APPENDIX 2.3
SURVEY INSTRUMENTS
        2-86                         12-17-76

-------
                             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)
Household
Number











































































Street Address

























Eligible
Household
Member(s)
Yes

























No

























Member(s)
Agree (s) to
Participate
Yes-

























No

























Number
of
Participants





































•










•

Reason (s) for Nonparticipation, Nonresponse, or
Ineligibility


























-------
                                                                                 QMS NO.
                                                                                 Approval ExpirtS
                                 RESEARCH TRIANGLE INSTITUTE

                       STUDY OF HUMAN TISSUE HEAVY METAL BURDEN IN
                              NON-FERROUS SMELTER COMMUNITIES
    NOTICE: All information recorded on this doeumtnt which would permit identification of en individual will be held in
    nrict confidence, will be toed only by penora engaged in or for the purposes rated for this nudy. end will not be
    disclosed or released to other persons or used for eny other purpose without the consent of the individual.
                        HOUSEHOLD SCREENING QUESTIONNAIRE

 I. Site Number  |   |               2.  Segment Number | -  |   |              3.  Interviewer Number

 4. Household Number  |   |   |   |                      5. Date   [   |   |  ~ |   |   |  ~ |   |   |
                                                            IMonthl     (Deri      lYarl

 B. What is the exact address of this residence?
          (Street Number and Namel
                                                                         (Aoermetn Number!
         (Off)                             (Stetel



7. a.  Do you have a telephone?  | 1 ! Yes IGo to Question 7bl  \ *  I No (Go to Question 7cl

  b.  If yes. what is the number?
                                                                                      (Zip Code)
                                                cm-cm-mo:
                                                (Ana Codal
   c.  If no. what is the number of the nearest telephone?    I   I   I   I ~ [   |   |   | ~  I  I   I   I   I
                                                (Ant Code)
                                                \ 1 I  Do not know

 B. How many persons reside at this address?    |   [  |

 9. For each person in your household, including yourself, pleese indicate the age. tairthdata, 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)




















Birthdete

onth




















Day




















Year




















Sax











Length of Residence
At this
Address
Un










ts










MP.
orY










In th
Commu
Units




















s
nlty
M,0.
crY










Occupation*!)
During Past
12 Month!










Relationship
to
Respondent










Participant
Number




















10. a.   Has anyone in your household worked at the smelter at any time during the past 12 months?

       |  ' I  Yes (Go to Question tOb)    \ a [  No   | 3 I  Oo not know
   b.   If yes, indicate relationship to respondent.
      and household member number(s) from question 9
   If it is apparent that the household contains no persons eligible to participate in this study, thank the respondent and
   proceed to the next household. However, if persons in the household appear to be eligible to participate in this study.
   continue to question 11.
11. Would you participate in a health nudy as a paid volunteer?   (  1  > Yes    2 j No


12. In your opinion, would other members of your household participate in a health survey as a paid volunteer?

       |  1  | Yes. all   | 2 | Yes, some   | 3 | No    I e \ Do not know

-------
                                                                                                  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) 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  in young children. I understand that the survey is being conducted in order to measure the health
 effect(s), if any, of heavy metal 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) a  four  ounce sample of cold tap water  from a  source commonly  used  for drinking  and cooking, (2) a sample  of
 housedust  from a small area (0.25m3) on the surface of the living room floor using a small vacuum device, (3) a small (approximately
 four ounces) early morning urine sample, (4) a small sample of scalp hair, and (5) a small (approximately 10 cc) blood sample to  be
 taken from an  arm vein.  I understand that a four ounce composite sample 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.  I  further understand that I am to deliver  my urine specimen to

 (Address of designated central data collection facility)	

 on  (Day of week)	,   (Date)	  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 soil, 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,  I would/

 would not like a copy of this report sent to my family physician, Dr".	
 Address:  	;	
 If important facts about my personal health should be found in the course of the study, I will be provided that information, and I
 also would/would not like a copy of that information sent to my  personal physician. I understand, however, that my name will not
 otherwise be voluntarily disclosed, that all information collected 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)	  telephone number	or
 (State health department representative)	  telephone number	
 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.
                                                    Participant's Name (Print)
 Date       ,
         ~T~—:.   '     '  , '     ~~—,             Participant Number
          (Month)     (Day)       (Year)
 Site Number                               Segment Number                              Household Number

 Signatures:
                                                             Witness:
       Participant
Parent, guardian, or other                             Interviewer Number
legal representative of
participant*
 'If the participant is a minor (under 18 years of age), this consent form must be signed by the parent or legal guardian.

-------
                                                                     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
                        QUESTIONNAIRE
         THE RESEARCH TRIANGLE INSTITUTE OF RESEARCH TRIANGLE PARK, NORTH CAROLINA
         IS  UNDERTAKING A RESEARCH STUDY FOR  THE U.S. ENVIRONMENTAL PROTECTION
         AGENCY OF THE HEALTH EFFECTS, IF ANY, OF HEAVY METAL ABSORPTION BY PERSONS
         LIVING IN COMMUNITIES NEAR NON-FERROUS SMELTERS. WE WILL BE ASKING SEVERAL
         QUESTIONS ABOUT YOU AND YOUR FAMILY. YOUR COOPERATION, ALTHOUGH ENTIRELY
         VOLUNTARY, IS ESSENTIAL TO ASSURE THE SUCCESS OF THIS STUDY.
                                       IMPORTANT

         ALL  INFORMATION  RECORDED  ON THIS  DOCUMENT  WHICH WOULD PERMIT
         IDENTIFICATION OF AN INDIVIDUAL WILL BE HELD STRICTLY CONFIDENTIAL, WILL BE
         USED ONLY BY.PERSONS ENGAGED IN OR FOR THE PURPOSES OF THIS RESEARCH STUDY,
         AND WILL NOT BE DISCLOSED OR RELEASED TO OTHER PERSONS OR BE USED FOR ANY
         OTHER PURPOSE.
                           Study Number
Site Number
Segment Number
Household Number
Participant Number

-------
                                        A.  HOUSEHOLD INFORMATION
1.   For each person in your household, including yourself, please indicate age and educational level, beginning with the oldest and
    proceeding to the youngest (enter responses in matrix below):
Household
Member
Number
01
02
03
04
05
06
07
08
09
10
Age
(Years)




















Educa-
tional
Level
(Years)




















Currently
Employed at
Smelter
1 = Yes 2 = No










Normally
Spend Day
at Home
1 = Yes 2 = No










Excess Metal Absorption
Screened










Diagnosed










Partici-
pant
Number




















2.  Does anyone in your household currently work at the smelter? (Enter responses in matrix above.)
3.  Which members of your household normally spend their day at home? (Enter responses in matrix above.)
4.  Has anyone in your household ever been screened for excess heavy metal absorption?
            Yes
                   No
          3    Do not know      (Enter response in matrix above.)
5.  Has any member of your household ever been diagnosed as having excess heavy metal absorption?
1    Yes
No
                                     3    Do not know      (Enter response in matrix above.)
6.  Male head of household:

    a.   Household member number:
                                                           b.   Occupation
    c.   Highest educational level completed:

         |  1 | 8th grade or less           [ 4 |  College - incomplete
                                                           7   Technical school beyond high school
           2  High school - incomplete
                                    College graduate
           3  High school graduate

7.  Female head of household:

    a.   Household member number:
                                 6  Graduate school
                                        8  Do not know
                                        9  Other (Specify)
                                                                  b.  Occupation
    c.   Highest educational level completed:
              8th grade or less
                                    College - incomplete
          2   High school - incomplete     5  College graduate
          3   High school graduate
                                    Graduate school
                                           Technical school beyond high school
                                                           8  Do not know
                                       9   Other (Specify)
                                                        -2-

-------
8.  What is the approximate age of your house?
                                                         Years
                                                                    1   Do not know
9.  What type of structure is your house? (51 percent or more of exterior surface.)


                                                                        I  7 I  Wood frame
           Solid brick, concrete, or rock
           Brick or rock veneer
                                               Asbestos
                                               Aluminum siding
                                                                          8  Do not know
        3  Stucco
                                            6  Composition siding
10. Is there evidence of flaking paint present in the home?
                                                               Yes
                                                                          9  Other (Specify)



                                                                             No
11.  Are paint chips present in the soil surrounding the home?     II Yes
                                                                              No
                                                                                             Do not know
12.  Do you cool your home with any of the following appliances? (Check all that apply.)


           Central air conditioning
                                            Window fan(s)
                                                                       None of these
        2  Window air conditioner(s)
        3  Evaporative cooler(s)
                                         5  Ceiling exhaust fan(s)     8  Do not know
                                         6  Circulating fan(s)
                                                                    9  Other (Specify)
13. Are any of the following articles used in storing, preparing, and/or serving food in your household? (Check all that apply.)


            Unglazed pottery (home-made or craft)
        1
                                                           None of these
           Glazed pottery (home-made or craft)
                                                           Do not know
        3  Hand-painted flatware


14. Does your household grow any of its own food in a home garden?    |  1  |  Yes   | 2 |  No


15. Where does your household obtain fresh fruit and/or vegetables?   (Specify)  	


16. What is the primary source of your water for drinking?


      I 1  | Bottled water
                                         Tap - community well       5   Tap - cistern
                                                                                           3  I  Do not know
       2  I Tap - municipal supply      4  Tap - private well
17. What is the primary source of your water for cooking?
                                                                   6   Do not know
                                                                    7   Other (Specify)
           Bottled water
       2   Tap - municipal supply
                                         Tap - community well
                                         Tap - private well
                                                                       Tap - cistern
                                                                   6   Do not know
                                                                        Other (Specify)
18. Has anyone in your family ever been treated for:
                               No       Yes     Relationship to respondent and/or household member number:

                              I	1
    a.   Seizures?


    b.   Hyperactivity?


    c.   Mental retardation?
I.

1
1




2

2
2
(Specify)

(Specify)
(Specify)
                                                        -3-

-------
                                      B. PARTICIPANT INFORMATION
      IF THE PARTICIPANT IS UNDER 18 YEARS OF AGE, THIS SECTION OF THE QUESTIONNAIRE MAY HAVE
      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.

1.  Sex (by observation):
Male    2   Female
2.   Race (by observation):
3  American Indian
       6   Unknown
White
                       Asiatic

                       Other
                       (Specify).
                                   Black
                                          Spanish
                                          surname
3.   What was your/the participant's age in years at last birthday?

                            Years
                                                    4.  What is your/the participant's birth date?
                                                             (Month)      (Day)      (Year)
                             5.  What is your/the participant's approximate weight  in
                                 pounds?
                                                           6.  What is your/the participant's marital status?
                                                                   1
                                        Married    2   Never married     3   Widowed
                                        Divorced   5   Separated
                                                                  6   Other (Specify).
Next, I would like to ask some questions about your/the participant's education.

7.   Are you/is the participant in school now?
                 Yes (Go to question 8)
                                                                    No (Go to question J1)
8.   What type of school do you/does the
    participant attend?
                                      1
           Nursery school or kindergarten (Go to question 10)
                                          Elementary school
                                          Junior high school
                                          Senior high school
                              (Go to question 9)
9.  What grade are you/is the participant in?

10. What is the address of the school?—
                 (Continue)
                                       (Street)
11. Highest educational level completed:
           None
          8th grade or less
           High school - incomplete
           High school graduate
           College - incomplete
           College graduate
                                                                                 Junior college
                                                                                 College
                                                                                 Graduate school
                                                                                 Technical school
                                                                                 Other
                                                                                 (Specify)	
                                                                                                   (Go to question 12)
                                                                (Go to question 12)
                                                                   (City)
                                                                  Graduate school
                                                              8  Technical school beyond high school
                                                                  Other (Specify)

-------
 Next, I would like to ask some questions about your/the participant's occupation and residence.
 12.  Are you/is the participant presently employed in any capacity?
                                                                      Yes (Go to question 14)
                                                                No  (Co to question 13)
 13.  If not presently employed, which of the following best describes your/the participant's status?

         1   Housewife                              4  Unemployed
                           (Go to question 20)     	
            Student                                5  Retired             (Go to question 15)
            Child (Go to question 23)
                                                      Disabled
14. If presently employed, which of the following best describes your/the participant's status?

                                                                 3   Employed part-time
            Self-employed
Employed full-time
15. What is/was your/the participant's usual occupation? (Specify)
16. Are you/is the participant presently employed in this occupation?
                                                                     Yes
                                                                             2   No
17. 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?

18. If you are/the participant is presently employed, what is the nature of the company for which you/the participant worlds)?
    (Specify) 	'.	
19. How long have you/has the participant been employed by your/the participant's present employer?
                                                                                            Units
                                                                                                            Months
                                                                                                            Years
20. How many times have you/has the participant changed occupations during the past 5 years?

21. Does your/the participant's occupation usually take-you/the participant away from home?

22. Have you/has the participant worked at a smelter at any time during the past 12 months?
                                                                                             Yes
                                                                  No
                                                                                            Yes (STOP!)
                                                                          No (Continue)
23. Have you/has the participant ever worked at or lived within 2 miles of:
                                      Worked at
                                     Yes      No
                                      1
                                      1
    a.   Paper/wood industry

    b.   Smelting industries

    c.   Glass manufacturing plant     ll

    d.   Pesticide manufacturing plant  [  1  |
                    Lived near
                  Yes       No
                             2
                                                           1
                    1
    e.   Mining area
                                      1
                                                                                                                Hours
24. How many hours of the day, on the average, do you/does the participant normally spend away from home?

25. How many hours of  the day, on the average, do you/does the participant normally spend more than 2 miles from home?

                                                                               Years (If less than 1 year, STOP!
                                                                                                                               Hours
26. How many years have you/has the participant lived in this city or town?

27. How long have you /has the participant lived at this address?
                                                                     Units
Days
2
Months
3
Years
28. How many times have you/has the participant changed living quarters during the last 5 years?
                                                         -5-

-------
Next, I would like to ask some questions regarding your/the participant's personal habits.
29.  What is the natural color of your/the participant's scalp hair?

                                          0
       Brown
                    Black
                                Red
                                           Blonde
Gray
                                                                    Bald
Other (Specify)
30. How many times per week, on the average, do you/does the participant shampoo your/the participant's hair?
31. Which of the following hair care products do you/does the participant use? (Check all that apply and specify the most frequently
                                               Brand                                               Brand
used brand.)

       Washing (Shampoo or soap)
           Setting .lotion
                                                                     Artificial coloring
                                                              5  Permanent             	
                                                                 Last application date (Month)       (Day)
                                                                                                                  (Year)
           Hair spray                    	

32. Do you/does the participant use any foot powder or toenail polishes?
    If yes, specify brand(s)	
                                                                        Yes
                                                                                       No
33. Do you/does the participant drink? (Check all that apply and indicate amount.)
                      How much/week?
      j_)J  Beer

       2    Wine
                                                               None of these
                                                               Other alcoholic beverage (Specify)
       3    Liquor
34. 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 (Co to question 35)
                                                              No (Go to question 39)
35. Do you/does the participant now smoke cigarettes?
                                                         Yes
                No
36. How old were you/was the participant when you/the participant first started smoking?
                                                                                           Years
37. If you/the participant no longer smoke(s), how old were you/was the participant when you/the participant last gave up smoking?

                  Years
38. On the average, how many cigarettes do (did) you/does (did) the participant smoke per day?
            Less than '/» pack (1-5 cigarettes)
        2  About V4 pack (6-14 cigarettes)
                                                             About 1 '/> packs (26-34 cigarettes)
                                                          5  About 2 packs (35 or more cigarettes)
           About 1 pack (15-25 cigarettes)
 39. What is the average number of hours that you/the participant spend(s) out of doors each day?
                                                                                                Hours
 40.  Do you/does the participant ever eat non-food substances such as paint, clay, dirt, or plaster?     1    Yes
                                                                                                        2    No

-------
 41.  (For children participants only)  Where does the participant play most frequently? (Check one.)
            At home indoors
            At home outdoors
                   0
On the same block indoors     |  5 |  On a different block indoors

On the same block outdoors     6  On a different block outdoors
            Other (Specify)
 Next, I would like to ask some questions regarding your/the participant's health.
 42.  What do you consider the current status of your/the participant's health?
1 Excellent 2
Good 3 F
43. Are you/is the participant currently taking any
0 None
1 Tranquilizer

2 Sedative
44. Do you/does the participar
a. . Loss of appetite
b. Weight loss
c. Fatigue
d. Nausea and/or
vomiting
e. Diarrhea

f. Abdominal pain
g. Sore throat
3
4

5
Analgesic
Hormone
Oral contracep
air I 4 [ Poor
prescription medication(s) on a regular daily basis? (Check all that apply.)
6 Antibiotics (Specify) 	 	 	


7 Oth°r (SpTify)






t suffer from any of the following symptoms?
If yes, specify If yes, specify
Yes No how long Yes No how long
1
I
1

1
1

1
1
2
[7]

2

2
0
s
I 2 I

h. Cough | 1 |
i. Changes in skin pigmentation | 1 j |
j. White lines across fingernails Mil
k. Pins and needles, numbness or -

I Weakness or wasting of the
muscles of the limbs

r» •
m. ram or soreness of the ™
mouth, nose, or eyes 1


2
2 I
2 |
2

2

2

Next, I would like to ask some questions regarding your/the participant's diet.
45. Which meal(s) do you/does the participant usually eat at home? (Check all that apply.)
         I 1  I Breakfast        |  2  | Lunch       | 3 [ Dinner

46. When you do not/the participant does not eat at home, where do you /does the participant eat? (Check all that apply.)
                                                           School
           1
              Meal prepared at home but eaten elsewhere
                                                           3   Work
                                                     Restaurant
          5   Other (Specify)
47. Are you/is the participant presently following any of the following dietary regimens? (Check all that apply.)
                                                                     0
Formula/prepared baby foods
          2   Bland food ulcer diet
              Diabetic diet
           Reducing diet
                                    Organic foods
                                    Vegetarian
None of these
                                   Other (Specify)
                                                        •7-

-------
48. On the average, how often do you/does the participant eat the following foods? (Check the appropriate box.)



Foodstuff




a. Shellfish
b. Fish
c. Liver
d. Kidney
e. Hamburger
f. Eggs
g. Milk
Canned Foods:
h. Tomatoes
i. Beans
j. Peas
k. Peaches
0)
u
c
o

CD

S CD
o §
:> a
1












CO
flj

c
o

o "5
A CD
< §
2












$
0)
..



3 CD
< CN
3












CO


o

XI O
< E
4












CD
S


c
a

W C
3 o

5

















S
z
6
















Foodstuff



Baby Foods:
I. Oranqe juice
m. Apple juice
n. Applesauce
o. Peaches
p. Spinach
q. Mixed vegetables
r. Beef

«
c
o
a
*•* -X
£ S
I5
«£ CO
1











S
c
o
^
0 "^
^ 0)
< S
2








>
>

?,
c
O «!
*J ^
0 9
3 s

-------
COMMENTS
   -9-

-------
                                                                                                                      ^BE
                             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.
'
e/j
ta

a
Q

<:
— =-
§
^
m
: 	 1_
CO

I
I

D
D
      Study Number
   1.  Site Number
                                 2.  Segment Number
                               3.  Household Number
                                                                           4.   Participant Number
5.
6.
7.
8.
9.
10.
Type of
Sample
Soil
Tap Water
Source:

House Dust
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






Interviewer
Number


















Duplicate Sample
Selected
Yes
1
1
1
1
1
"V "V
£x
No
2
2
2
2
2
xx
XX
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






11.   Hematocrit
                                             (Month)       (Day)       (Year)
                             %       Date
                                                                                                  COMMENTS:
12.   Urine Protein
Interviewer Number
                                                                                  -10-

-------
      APPENDIX 2.4
PRETEST CONSIDERATIONS
          2-100                        12-17-76

-------
                        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 at least some 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









                                2-101                      12-17-76

-------
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.
                                 2-102                      12-17-76

-------
O
U>
 I
H1
•~1


0\

                                                         ...... ],.„«> ! ,.„.,. I M.,lo, I .... 1"%,
                                                             LUBBOCK
                                                                 V«)ltfl(XI I •€.!•»

                                                                     l.o^•t I
                                                                              • IM.  .MOl
                                                                                          WICHITA FALLS
                                                               O««VM| K>.M»
                                                              MIDLAND
                                                               • 41 tM, 1 «G***D . *K«tll

                                                                     blC
                                                                             ,. .4-  - [--
                                                                                 ~»J  ,«4
                                                                                 ABILENE
                                                                                                         SHERMAN DENISON
                                                                                                                               TEXARKANA


                                                                                                                                   IfXAtXANA
                           ,"• •  I *«lwtlOH fC«*MOMA|W>7  ,1 *	*-Vj»ljONGV««
                       	L "•» I ~ Y- • -f—VI    VYU« IJH^—-«
                            1   \ «nno I *».«to*l     \	1	-X i  iTVI FR    I
                            FORT WORTH  1     -^    . ^( >"''"*   .".*oi«i

^u   ;	   _  I    I	 3-x^"  '\ i.«'-« >'  /    M  "••*"° V-  " "I \  1    l     x

u.m-\  s\ «».•  .""""*       Vo....^y'\«>>oui '\ ,~^,  >_^-;.  V°"""v. \J'v    *"*   )
  "" /• SAN ANGELO <»"""'~"\ ..'......^WACO V.,.(i \   *£U) -— X ^   v\V' \
                                                                                                                                    \  °./
                                                                                                              Wn |..Jlr-""M V"U_ ',-    (BEAUMONT-
                                                                                                             '"^ySatcpM-iiONV^T    PORT ARTHUR
                                                                   <        -.o. j  ....,^--r-- |^ \^T>< lM^»;5?__L..M-,:f	.\J;"^;.^:.\ORANGE

                                                                 ••  p— -p  •'- -|- -I	/ A^^^X^v^Vr^I^



                                                                       ^^   i     ' CAW AMTnrjtnt •*.'*"  'i  y*-0*"'11/ ....i.\ ^   \  —,    \Sjr'—c....»\'o»
                              LtGfND

                     <•''  Hlacti ol 100 000 01 man .nlubitjnu

                     •  PlMcs 01 bO.OOO 10 100000 mhibitinlt

                     Q  Cenliil cilm ol SMS*'t oilh lc«« lh
-------
         LEGEND
®   Places ol 100.000 01 more mhaBitanls
•   Placet ol 50.000 to 100.000 mnabitants
O   Places of 25.000 to 50.000 inhabitants outside SMSA's
         Standard Metropolitan
         Statistical Areas (SMSA's)
  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].
                                       2-104
12-17-76

-------
     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 independent subcontractors within a reasonable dis-




tance 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).




     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.  The outcome of the Pretest may have some impact on RTI's




time and cost projections.
                               2-105                      12-17-76

-------
     APPENDIX 2.5
RELEVANT CORRESPONDENCE
          2-106                             12-17-76

-------
OTHO H WHITENIECK. O.DS.. •oestDe'»

ROBERT 0. McCULLOUGH. O.O.. v.ce P


THOMAS OONICA. M.O., secneT-.v


GLEN (.. BERKENB1LE. M.O.


WALLACE BVRO. M.O.


ARNOLD HELVEY

EUGENE A. OWENS. MO.


». A. TATE- TAYLOR


HAROLD A. TOAZ
                                                                    Vc
                                                             R. LEROY CARPENTER. M.D.. M.P.H.
Nortneast 10th Street & 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.
                                      2-107
                              12-17-76

-------
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
                               2-108                  12-17-76

-------
        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 collection,


and 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 (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 and general soil samples such as soil samples from each school yard


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.  The collection of biological samples
                                   2-110                      12-17-76

-------
will be divided between the independent subcontractors.  The FI will be

responsible for the explanation of the procedure for collecting 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 sub-

contractor, the hematocrit will be determined by the medical independent

subcontractor, and the scalp hair sample will be obtained, perhaps by a

barber.

    For each household containing a study participant, samples of housedust

and tap water will be collected.  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 and soil samples will be collected for the

overall smelter community.
— In addition to the environmental and biological samples specified in
  Exhibit A:  Scope of Work for this contract, the Project Officer has asked
  RTI to consider two additional measurements, paint and dietary lead, which
  might increase the significance of data collected in this research effort.
  Since these measurements are not part of the Scope of Work, procedural and
  cost considerations are presented in a separate document.
                                    2-111                      12-17-76

-------
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 high-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 rather 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:
                                     2-112                       12-17-76

-------
     Stratum                       Days on which a high-volume air sample is to be
                                     taken (day 1 = first day of survey at site)

       Sx                                              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 S0, 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.2.6]:
                              V = air volume samples (m )

                              Q. = initial air flow (m /min)
                                                    3
                              Q  = final air flow (m /min)

                              T = sampling time (min.)
                                     2-113                      12-17-76

-------
  Table A-2.6.1.   Tentative  sample  allocation for air samples.*
Type of Observation
                                 liumber of Observations  in Each  Stratum,  Si
                                    S2
S4
S6
SB
Locations per day



Days



Ratio, days/locations
                               22222233



                              '3      34       4       5       5       6      7



                             1.5    1.5     2,0     2.0     2.5     2.5     2.0    2.3
 Based on the following data from Djuric  [2]:
Day
                   Stratum 6; 2  locations

                   (2.2 - 3.0 km)
  Stratum 8; 3 locations

  (5.0 - 8.0 km)
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
with approximate estimates of variance: sr - - r-
                                          o   nm— L
                                                           2              2
                                                            = 891;  and  s0  "  697
                                                                         o
suggesting a total sample size, nm, needed for a 20 percent c.v.:  rim,8*  (..    )  =•  9
a ratio;
          s, days
                                                                    nn8  = 20



                     suggests that sample size ratio days/locations should be
          s,. locat.
           o
          approximately 2.2


                 2    1  n  _  - 2
          where s, = —r I (x.-x)   and  (nm), is total sample size  in stratum  h.
                 6   n-1     i               n
                              2-114  '
                                                         12-17-76

-------
 to
 M
 G
I
•-J
         Fig.  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.

-------
 CT.
N)
*-4
0\
             Table A-2.6.2.  Exemplary format for presenting survey  and  laboratory  results  for study element:  lead.
 N)
 i
Observation
number
1
2
3
Pb reading,
mg . per
cubic meter
4.2
36.0
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

-------
      2.  Soil




      The basic sampling protocol will call for the collection of single




composite 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.  Approximately 80 (or




less to the extent that some families may have more than one study child




participant) of these soil samples will be obtained from residential play




areas, one for each pre-school age child participant; one composite sample




will come from each school yard where study children attend and from each




air sampling location.




      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.  A small composite sample,




therefore, will be relied upon to measure element exposure from soil in play




areas.  The boundaries of the most commonly used play area will be established




and 3-5 surface soil samples collected from random points in the play area




using a random number table.  These samples will comprise the composite




sample for that play area.




      Samples will be taken from the top 2.0 cm of soil with a plastic scoop,




and collected in appropriately labeled four ounce plastic bottles for shipment




to RTI.
                                                             12-17-76

-------
    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.  2.7].



A single sample will be taken from the floor in the central area of the  living



room, away from the walls.  The sampling area will be delineated and standardized



using a 0.5 x 0.5 m Lucite template placed on the surface, thereby allowing



results to be reported on an area basis as well as on a weight basis.  In


                                                            2
taking each dust sample, one pass will be made of the 0.25 m  area with  a



special vacuum holder utilizing a special nylon filter holder, a glass fiber



paper insert, and a portable pump as the vacuum source.  The vacuumed dust



will be trapped in the upper chamber of the nylon holder; the used filter



and dust gathered will then be placed in appropriately labeled, tighfely



secured Zip-Loc bags for shipment to RTI.  Disposable plastic gloves will be



worn when handling dust samples.



    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                      12-17-76

-------
   • 4.  Tap Water




    At each household, the FI will collect a sample of cold tap water in




a four ounce plastic bottle, from the kitchen tap or other source commonly




used for drinking and cooking, in a single pass after the water has been




allowed to run for ten seconds.  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 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.
                                   2-120                      12-17-76

-------
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 the FI to the




participant'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 one or two such commercial




disposable absorbent diapers and an appropriately labeled Zip-Loc bag,
                                   2-121                      12-17-76

-------
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.




     RTI is considering a qualitative  test for proteinuria using a dipstick




procedure.
                                   2-122                      12-17-76

-------
     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 scissors or 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.




     To facilitate the collection of an adequate scalp hair sample,




and to reduce the resultant trauma to the participant, RTI is considering




two methods of obtaining the scalp hair sample:  (1) to allow the partici-




pant or some member of the participant's family to collect the sample




under the supervision of the independent subcontractor, and/or (2) to




have a barber collect the scalp hair samples.  Scalp hair samples will




be collected at the central data collection facility using disposable




plastic gloves, 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




KTI for analysis.
                               2-123                      12-17-76

-------
     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 accomplished




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 some 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
                               2-124                      12-17-76

-------
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




and held.  The finger or heel is then washed with 0.1 molar hydrochloric




acid on a sterile gauze pad; the finger or heel is wiped vigorously to




mobilize surface heavy metal contaminants thus rendering the puncture site




relatively free of heavy metal contamination.  The finger or heel is then




wiped with a dry gauze pad.  Next, the finger or heel is 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 milking




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 contamination.




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
                                    2-125                       12-17-76

-------
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.
                                   2-126                      12-17-76

-------
     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 on the appropriate Study




Questionnaire (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.
                                                         12-17-76

-------
D.  Quality Control




     Each sample will properly labeled as it is collected.  Each individual




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 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




site(s) as the original sample.




     The duplicate soil samples will be collected from the same area as the




original using the same collection" procedures.  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




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.
                                   2-128                      12-17-76

-------
APPENDIX 2.7




 REFERENCES
     2-129                             12-17-76

-------
                              REFERENCES






2.1.  Landrigan, P. J., et al., Epidemic lead absorption near an ore smelter:




     the role of partioulate 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. Bureau of Foods, Compliance Program Evaluation, FY 1974 Heavy Metals




     in Foods Survey (7320.130, Chemical Contaminants Project), June 19, 1975.




2.5. 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.




2.6. Federal Register,  Vol. 36, p. 8192, 1971.




2.7. 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.
                                 2-130                       12-17-76

-------
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, and soil 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 bio-




logical samples from each age-sex group by Commercial Testing and




Engineering, 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 extent of chronic exposure to lead.  A




microspectrofluorometric procedure will be employed.   Since only a




partial overnight urine sample will be taken, a measure of excreted




creatinine will be used to estimate 24-hour urinary volume.  In this




manner, amounts of metals excreted over, a 24-hour period may be cal-




culated.  Creatinine will be assayed by a spectrophotometric procedure.




     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.  All calibration procedures




will be carried out by the method of standard additions.




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.   Sample




injection will be accomplished with an Eppendorf pipet.





                                3-1                             12-17-76

-------
     All glassware used in sample preparation will be soaked overnight



in 1% HNCL, rinsed well with deionized water and dried.  Precleaned



volumetric pipets will be used for reagent and sample deliveries.  All



HNCL solutions will be prepared from analytical reagent grade material



and deionized water.



     Sample preparation procedures are described below for each matrix.



     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% HNCL 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 0.5% HNCL and analyzed directly



for the metals of interest'.  Results will be reported as weight of



metal/ml urine and weight of metal/estimated 24 hr urinary volume.

            WC

     v    = —°-
      24e   C
             u
       C  = creatinine coefficient (mg/kg)
            C  = 18 (females)
             c


            C  - 23 (males)
             c


       C  = creatinine concentration in urine (mg/ml) (see Section 3.4)



     V2,  = estimated 24 hr urinary volume (ml)



        W = body weight (kg)



        M = M  V0.
             u  24e


        M = weight of metal in estimated 24 hr urinary volume
                               3-2                               12-17-76

-------
       M  = metal concentration (mg/ml)



        M = M  WC /C
             u   c  u


     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 with a 10% Prell (liquid)



solution, rinsed well with deionized water and dried at 105°C.  A 100 mg



(approximately) portion of the washed hair collection will be weighed



and digested at 85° 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.



     3.1.2  Household Samples



     The samples included in this category are tap water and dust col-



lected at the homes of the study participants.



     3.1.2.1  Tap Water



     Fifty microliters of concentrated HNO, will be added to 10 ml of



tap water and the solution 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 removed from the 23 mm glass fiber filter and



screened on a 30 mesh ASTM sieve.   The samples will be weighed and



digested at 85° with 1:1 HNO-.  Deionized water will be added to a



reference volume, filtered and the filtrate analyzed directly for the



metals of interest.   Results will be reported as weight of metal/gm



dust.
                                3~3                                12-17-76

-------
     3.1.3  Environmental Samples


     Samples in this category include air particulate samples collected


according to the sample design described in Section 1.4.2. and soil


samples taken at the air sampling locations, from the play area of pre-


schoolers and the school yard of school-age subjects.


     3.1.3.1  Air Particulates


     Air particulate samples will be eluted from a 2.0 x 20.3 cm strip


of the glass fiber filtering media with 5% HNCL in an ultrasonic bath.


The filter will be removed and the acid mixture heated at 85°.  The


concentrate will be diluted to a reference volume with deionized water,


filtered and analyzed directly for the metals of interest.  Results will

                                3
be reported as weight of metal/m  air (see Appendix 2.6, B.I for calcu-


lation of air sample volume).


     3.1.3.2  Soil [Ref. 3.2]


     The soil sample will be screened on a 10 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% H^ 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.


3.2  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.

                                3-4                              12-17-76

-------
3.3  Free Erythrocyte Protoporphyrin (FEP) Analysis



     A fluorometric method based on the procedure reported by S. Granick



et al. [Ref. 3.3] will be used to determine FEP.  The method requires



only 2 microliters of whole blood.  The ethyl acetate-acetic acid extraction



and the free porphyrin separation with aqueous HC1 will be carried out



in the cuvette 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 authentic porphyrins will be used for



calibration purposes.



     Approximately 90% of the total free erythrocyte porphyrin content



is protoporphyrin.  However, correction will be made for the presence of



small amounts of uroporphyrin and coporphyrin.  The presence of these



compounds will result in a lower 608 nm/658 nm peak intensity ratio.



     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.



3.4  Urinary Creatinine Analysis [Ref.  3.4]



     One ml of urine will be diluted to 100 ml with deionized water.



Four ml of this solution will be mixed with 2 ml of an alkaline picrate



reagent.   Twenty minutes later the optical density will be read at 520



nm.  A blank and standard solution (1.0 mg/ml) will be prepared and



processed in the same manner.  The creatinine concentration will be



calculated in the following way:



                   , n   .      Optical Density (sample) x 100
     mg creatinine/ml urine =  r - „.—r—-—*-~—,r .',	
      &                          Optical Density (st'd)



                                3~5                               12-17-76

-------
     A Parkin-Elmer Model 402 UV-Visible Spectrophotometer will be used




for this analysis.




3.5  Quality Control and Analytical Protocol




     3.5.1  Instrument Calibration




     At the start of each analytical run, the atomic absorption spec-




trophotometer 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 mate-




rial.  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 calibra-




tions, the standard additions will be done prior to sample workup.




     These calibration solutions will serve as internal reference mate-




rials as described below.




     Calculation of analytical curves and determination of unknown




sample concentrations will be carried out on a programmable calculator.




     3.5.2  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 blank signal.  This corresponds to that amount measurable at a









                                3~6                              12-17-76

-------
precision level of 50% RSD.  An analysis giving a net signal less than




two blank standard deviation units will be reported as not detected (ND).




     3.5.3  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.  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 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.




     3.5.4  Analytical Priorities




     First priority will be given to the biological samples (urine,




blood and scalp hair).  Included in this category are the blood FEP and




urinary creatinine assays.  Tap water samples will be analyzed next.




Dust, soil and air particulate analysis will be performed as soon as the




others have been completed.




     3.5.5  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.




     3.5.5.1  Instrument Performance




     Instrument performance will be monitored by determining the signal




response of a reference material after approximately every 15 samples.




                                3-7                               12-17-76

-------
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 proce-




dures 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, appropriate measures will be taken before continuing the analytical




run (e.g., changing the graphite tube, balancing the D~ arc-light source




intensities, recalibrating).




     3.5.5.2  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%) participants over age 18 only,




         • Scalp hair (10%) participants over age 18 only,




         • Tap water (10%),









                                3~8                              12-17-76

-------
          • Dust (10%), and




          • Soil (10%).




     3.5.5.3  Interlaboratory Comparison




     An interlaboratory comparison study will be initiated.  Samples to




be identified by the EPA Project Officer will be split for independent




analysis.




     3.5.6  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 calibrated 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 8" x 10" glass fiber filter.  To calibrate




the pressure gauge readout in terms of air flow,  a long term air sampling




experiment will be carried put with each high volume unit.   As the




resistance to air flow increases, periodic 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.   Alternatively,




two or three filters will be placed on the sampler to simulate resistance




to air flow.




     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.



                                3-9                              12-17-76

-------
 •vj
>cr>
                         A2 C.oocH
          0.00019
                       Fig. 3.1.  Calibration of\SierrI°Instrument Orifice, Model 330.

-------
3.6  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


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. 3.5] and the net weight reported as

                              3
amount of total particulates/m  air.


3.7  Personnel


     All chemical analysis will be carried out at RTI and will be 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.


3.8  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.
                                  3-11                              12-17-76

-------
3.3.  Granick, S., et al.,  Procedings of the National Academy of




      Science. Vol. 69, p.  2381,  1972.




3.4.  Hanok, A., Manual for Laboratory Clinical Chemistry.   Los Altos,




      California:  Geron-X, Inc., 1969, pp.  147-151.




3.5.  Federal Register, Vol. 36,  p.  8192, 1971.
                              3_12                           12-17-76

-------
        APPENDIX 3.1




RESUMES OF RTI PROJECT STAFF
             3-13                             12^17-76

-------
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 quantitation 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-(g-Diethylatninoethyl)-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 -»• llo) Aboestrogens.  Delination of the
     Role of Steric Effects in the Biochemistry of Steroids," C. G. Pitt
     and R. W. Handy, Tetrahedron, 27, 527 (1971).
                                3-14                              12-17-76

-------
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


                                 3-15                             12-17-76

-------
DAVID F. NATSCHKE, Chemist
Professional Experience

     September 1976 to date.  Research Triangle Institute, Research
     Triangle Park, North Carolina 27709.  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


                                 3-16                         12-17-76

-------
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


                                 3-17                              12-17-76

-------
KAREN W. ROBBINS
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.  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 o£ North
     Carolina at Chapel Hill.  Research assistant on various
     pathology problems.
                                  3-18                         12-17-76

-------
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                              12-17-76

-------
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 + eijk                           (1)

where
     Y.-t(M) = concentration of metal M in either air, water, soil, or dust
               samples for the i   distance, j   wind speed,
               and k   wind direction,
           u = mean metal M level,

                                4-2                         12-17-76

-------
          D. = i   distance effect



          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           fc


     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 + Di + Sj + Wk + 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                            12-17-76

-------
particular, the following type of model will be analyzed for each trace



metal:



     Y..k(M) - u + A. + S. H- BlXlk + B2X2k
             + B,X,.  + B.X..  + B.X..  + e. ..                       (3)
                3 3k    4 4k    5 5k    ijk
where
         Y..*(M) = concentration of metal M in either blood, hair or


                   urine samples for the k   individual in the i   age

                            ,  .th
                   group and j   sex group;



               u = mean metal M level;



              A. = age effect for the i   age group;



              S. = sex effect for the j   sex group;



       B,, ...,B,. = regression coefficients to be estimated;



     X,k,...,X_k = 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..,...,Bc.  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                            12-17-76

-------
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                             12-17-76

-------
          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,xl] 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                            12-17-76

-------
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 unmeasurable

observations based upon the estimated distribution.
             9

     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. 4.3] 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

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!].  Thus, the following

inputed value would be used for a missing y..:

               ^           ^
               y.., if 0 ^ y. . < .y'.


               0, if y± * 0
               y! otherwise
                                4-7                            12-17-76

-------
where

     y*. is the imputed value for the missing y..  value,
     /N
     y.. is the first-stage estimate of the missing y ., and

     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.(QQ + 6^] + (l-I.j)e2 + e.j                          (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,

     6, are parameters to be estimated, and

     e. is a stochastic error term.

     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
                                                                  12-17-76

-------
        (i)  feces samples,




      (ii)  analyzing duplicate diets from sample individuals,




     (iii)  adding questions about diet to the individual's question-




            naire, and




      (iv)  analyzing area grocery store food samples.




     At the present time, EPA and RTI personnel are investigating these




procedures to determine if one or more of them should be incorporated




into the present study.  Accordingly, it may be appropriate to field




test these procedures to determine their accuracy and feasibility.




4.4  Personnel




     The analysis of the data for the current project will be under the




direction of Senior Statistician Dr. Kenneth Poole who is the manager 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.
                                4-9                              12-17-76

-------
        APPENDIX 4.1




RESUMES OF RTI PROJECT STAFF
            4-10                               12-17-76

-------
W. KENNETH TOOLE, 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
                                                               12-17-76

-------
"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, Ellen 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                             12-17-76

-------
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 N0_ 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                             12-17-76

-------
"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 Txvo-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  NO- 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 SO ," 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.
                       i-1 L
                                                        12-17-76

-------
"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                             12-17-76

-------
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                                 12-17-76

-------
APPENDIX 4.2




 REFERENCES
     4-17                            12-17-76

-------
                              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                            12-17-76

-------