March 10, 1977
WORK PLAN
EPIDEMIOLOGIC STUDY CONDUCTED IN POPULATIONS LIVING AROUND
NONFERROUS SMELTERS TO DETERMINE BODY TISSUE BURDENS OF
SELECTED NONFERROUS METALS
EPA Contract No. 68-02-2442
RTI Project No. 31U-1372
Chemistry and Life Sciences Group
and
Statistical Sciences Group
Research Triangle Institute
Post Office Box 12194
Research Triangle Park, N. C, 27709
Prepared for
Enviroamemtai Protection Agency
Resaarc.lt Triangle Park, M, C. 27711
RESEARCH T R t A H © L e PARK, NORTH- CAROLINA 27709
-------
TABLE OF CONTENTS
LIST OF TABLES vi
LIST OF FIGURES vii
1.0 Survey Design 1-1
1.1 Sampling Personnel 1-1
1.2 Overview 1-2
1.3 Target Population 1-5
1.4 The Sampling Frame 1-10
1.5 Sample Selection Techniques 1-13
1.5.1 Survey Participants 1-13
1.5.2 Air Sampling 1-14
1.5.3 Sampling for Soil Contamination 1-14
1.5.4 Sampling Tap Water 1-15
1.5.5 Quality Control 1-16
1.6 Sample Sizes and Sampling Error 1-17
1.6.1 Allocation of the Sample of Individuals. . . . 1-17
1.6.2 High-Volume Air Samples 1-18
Appendix 1.1: Characteristics of Survey Sites 1-23
Appendix 1.2: Sample Sizes and Allocation For Air Sampling 1-42
Appendix 1.3: Wind Roses for Smelter Sites 1-46
Appendix 1.4: Resumes of RTI Project Staff 1-53
Appendix 1.5: References 1-59
2.0 Field Operations 2-1
2.1 On-Site Project Operations (At RTI) 2-1
2.1.1 Project Staff 2-1
2.1.1.1 Overall Supervision 2-1
2.1.1.2 Survey Director 2-1
2.1.1.3 Site Administrator(s) 2-4
2.1.1.4 Data Receipt Control, Scan-Edit,
and Direct Entry 2-4
2.1.1.5 Training Manual 2-5
2.1.1.6 Training Session(s) 2-5
2.1.2 Data Receipt Control and Entry 2-7
2.1.2.1 Receipt Control 2-7
2.1.2.2 Visual Scan-Edit 2-7
2.1.2.3 Direct Data Entry 2-8
2.1.2.4 Quality Control 2-8
ii 3-10-77
-------
- TABLE OF CONTENTS (Continued)
2.1.3 Confidentiality of Project Data
2.1.4 Protection of Human Subjects Certification . .
2.2 Off-Site Project Operations (At Smelter Locations). . 2-14
• 2.2.1 Performance Sites 2-14
2.2.1.1 Selection 2-14
2.2.1.2 Public Relations 2-14
2.2.1.3 News Releases 2-16
2.2.2 Independent Subcontractors 2-17
2.2.2.1 Recruitment 2-17
2.2.2.2 Training 2-24
2.2.2.3 On-Site Consultants 2-25
2.2.3 Household Data Collection 2-26
2.2.3.1 Screening 2-26
2.2.3.2 Participant Consent Form 2-27
2.2.3.3 Study Questionnaire 2-29
2.2.3.4 Sample Collection 2-30
2.2.3.5 Quality Control 2-32
2.2.4 Central Data Collection 2-33
2.2.5 Site Administrator's Responsibilities 2-34
2.2.5.1 Coordination of Field Operations;
Data Management 2-34
2.2.5.2 Sample Collection 2-35
2.2.5.3 Data Storage, Packaging and Shipment. 2-35
2.2.6 Quality Control 2-37
2.2.6.1 Training 2-37
2.2.6.2 Supervision 2-37
2.2.6.3 Sample Collection 2-38
2.2.6.4 Duplicate Sample Collection 2-39
2.2.6.5 Reinterview 2-39
2.2.7 Respondent/Participant Burden 2-40
2.3 Anticipated Problems 2-41
2.3.1 Smelter Resistance 2-41
2.3.2 Recruiting Independent Subcontractors 2-41
2.3.3 Nonparticipants 2-41
2.3.4 Incomplete Data Sets 2-42
2.3.5 Missing Data 2-42
2.4 Schedules for Field Operations 2-43
2.4.1 Time Schedule 2-43
2.4.2 Cost Schedule 2-46
Appendix 2.1: Resumes of RTI Project Staff and
Consultants 2-48
Appendix 2.2: Tentative Training Manual Outline 2-76
Appendix 2.3: Survey Instruments 2-84
iii 3-10-77
-------
TABLE OF CONTENTS (Continued)
Appendix 2.4: Pretest Considerations 2-99
Appendix 2.5: Relevant Correspondence 2-105
Appendix 2.6: Sample Collection Methodology 2-109
Appendix 2.7: References 2-132
3.0 Physical Methods of Analysis 3-1
3.1 Atomic Absorption Analysis 3-1
3.1.1 Biological Samples 3-2
3.1.1.1 Blood 3-2
3.1.1.2 Urine 3-2
3.1.1.3 Scalp Hair 3-2
3.1.2 Environmental Samples 3-3
3.1.2.1 Tap Water 3-3
3.1.2.2 Dust 3-3
3.1.2.3 Air Particulates 3-3
3.1.2.4 Soil 3-4
3.1.3 Arsenic Analysis 3-4
3.1.4 Market Basket Samples 3-5
3.2 Spark Source Mass Spectrometric Analysis 3-5
3.3 Free Erythrocyte Protoporphyrin (FEP) Analysis . . . 3-5
3.4 Quality Control and Analytical Protocol 3-6
3.4.1 Instrumentation 3-6
3.4.2 Limits of Detection 3-7
3.4.3 Routine Analytical Protocol 3-7
3.4.4 Analytical Priorities 3-8
3.4.5 Quality Control Procedures 3-8
3.4.5.1 Instrument Performance 3-8
3.4.5.2 Accuracy and Precision 3-9
3.4.5.3 Inter laboratory Comparison 3-10
3.4.6 Calibration of High Volume Air Samplers. . . . 3-10
3.5 Determination of Total Particulate Solids in Air. . . 3-10
3.6 Personnel 3-12
3.7 References 3-12
Appendix 3.1: Analytical Data Sheets 3-13
Appendix 3.2: Resumes of RTI Project Staff 3-27
4.0 Statistical Methods of Analysis 4-1
4.1 Confidentiality of Data Files 4-1
4.2 Data Analysis 4-2
4.2.1 Analysis of Environmental Levels 4-2
4.2.2 Analysis of Tissue Levels 4-3
iv 3-10-77
-------
TABLE OF CONTENTS (Continued)
Page
i
4.3 Potential Problems 4-5
4.3.1 Missing Observations 4-5
4.3.2 Trace Metal Intake Due to Diet 4-8
4.4 Personnel 4-9
Appendix 4.1: Resumes of RTI Project Staff 4-10
Appendix 4.2: References 4-17
5.0 Cost and Labor Projection 5-1
3-10-77
-------
LIST OF TABLES
Table Page
1.1. Tentative sample allocation for individuals at
the study sites 1-19
1.2. Tentative sample allocation for air samples. . . . 1-21
1.1.1. Selected population characteristics of survey sites 1-24
1.1.2. Population residing in the tentative study area
near Ajo, Arizona 1-27
1.1.3. Population residing in the tentative study area
near Anaconda, Montana 1-29
1.1.4. Population residing in the tentative study area
near Bartlesville, Oklahoma 1-31
1.1.5. Population residing in the tentative study area
near Bixby, Missouri 1-33
1.1.6. Population by stratum residing in the study area
near Corpus Christi, Texas 1-35
1.1.7. Population residing in the tentative study area
near Herculaneum, Missouri 1-37
1.1.8. Population residing in the tentative study area
near Palmerton, Pennsylvania 1-39
A-l.2.1. Lead content of air, yg/cu m 1-43
A-l.2.2. Random assignment of days for high volume air
samples: an example 1-45
A-2.6.1. Tentative sample allocation for air samples. . . . 2-114
A-2.6.2. Exemplary format for presenting survey and labora-
tory results for study element: lead 2-116
vi 3-10-77
-------
LIST OF FIGURES
Figure Page
1.1. Preliminary distance-stratification for a target
population based upon Zn and Cd content of topsoil
according to Miesch and Huffman in East Helena,
Montana 1-9
1.1.1. Geographic location of study smelter and tentative
delineation of the study population, Ajo 1-28
1.1.2. Geographic location of study smelter and tentative
delineation of the study population, Anaconda. . . . 1-30
1.1.3. Geographic location of study smelter and tentative
delineation of the study population, Bartlesville. . 1-32
1.1.4. Geographic location of study smelter and tentative
delineation of the study population, Bixby 1-34
1.1.5. Geographic location of study smelter and tentative
delineation of the study population, Corpus Christi. 1-36
1.1.6. Geographic location of study smelter and tentative
delineation of the study population, Herculaneum . . 1-38
1.1.7. Geographic location of study smelter and tentative
delineation of the study population, Palmerton . . . 1-41
2.1. Research Triangle Institute administrative structure 2-2
2.2. Project administrative structure 2-3
2.3. Location and number of interviewers from the current
RTI listing living in counties within a reasonable
distance of the Ajo, Arizona, performance site . . . 2-19
2.4. Location and number of interviewers from the current
RTI listing living in counties within a reasonable
distance of the Bixby and Herculaneum, Missouri,
performance sites. 2-20
2.5. Location and number of interviewers from the current
RTI listing living in counties within a reasonable
distance of the Anaconda, Montana, performance site. 2-21
vii 3-10-77
-------
LIST OF FIGURES (Continued)
Figure Page
2.6. Location and number of interviewers from the
current RTI listing living in counties within a
reasonable distance of the Bartlesville, Oklahoma,
performance site 2-22
2.7. Location and number of interviewers from the
current RTI listing living in counties within a
reasonable distance of the Palmerton, Pennsyl-
vania, performance site 2-23
2.8. Field operations time table 2-44
2.9. Field operations cost and labor projections .... 2-47
A-2.4.1. Location and number of interviewers from the
current RTI listing living in counties within
a reasonable distance of the Corpus Christi, Texas
potential Pretest site 2-102
A-2.4.2 Location and number of interviewers from the
current RTI listing living in counties within
a reasonable distance of the Hayden, Arizona,
potential Pretest site 2-103
A-2.6.1. Geographic and temporal placement of high-volume
air samples: a partial hypothetical example
depicting only the first two days of the survey . . 2-115
3.1. Calibration of Sierra Instrument Orifice, Model 330 3-11
5.1. Sampling design cost and labor-hour projections . . 5-2
5.2. Field operations cost and labor-hour projections. . 5-3
5.3. Field supervision and shipping costs and labor-hour
projections 5-4
5.4. Chemical analysis cost and labor-hour projections . 5-5
5.5. Statistical analysis cost and labor-hour projections 5-6
5.6. Projected monthly costs by activity 5-7
viii 3-10-77
-------
1.0 Survey Design
1.1 Sampling Personnel
Professional staff in the Sampling Research and Design Center
(SRDC) have a broad range of experience in sampling theory and statistical
applications, including unequal probability sampling methods and theory,
response error modeling, optimization procedures, controlled selection
procedures, variance estimation for complex surveys, data analysis, ran-
domized response techniques, and other areas. Dr. James R. Chromy is
Center Director and will have general supervision of sampling in this
study, especially for those tasks involving probability sampling tech-
niques.
The selection of the study participants and the survey design for
air sampling will be under the direct supervision of Mr. Stephen R.
Williams, Senior Statistician in SRDC. Mr. Williams, assisted by Mr.
Lanny Piper, Statistician in SRDC, will be responsible for on-site de-
lineation of the target population, its stratification, and the accumula-
tion of pertinent extant information about the study communities. Addi-
tional support will be provided by SRDC research assistants and other
support staff, who have extensive experience in the preparation of sampling
materials and in the selection of probability samples. These and other
related tasks will be completed by SRDC staff in close coordination with
the Chemistry and Life Sciences Group and the other Research Triangle
Institute (RTI) centers that are involved in this study. Resumes of
the professional sampling personnel that will be substantively involved
in the study are presented in appendix 1.4.
1-1 3-10-77
-------
1.2 Overview
Sampling methodology to be used for obtaining a sample of the
household population is a stratified area sample in which a sequential
sample of persons is to be selected for participation in the study
survey. An area sample is commonly used in population surveys that
must result in a high degree of accuracy. This is because no complete,
current listing is readily available from which to sample the target
population; the area frame comprises a complete "listing" of this
population. Also, a probability sample of sites and days is to be
selected for the purpose of obtaining high-volume air samples. Selective
sampling may necessarily be used to collect samples of tap water, house
dust, and soil if probability sampling for these data is deemed
impractical; several random-sample methodologies are being investigated
at the Pretest site.
Note that the specific methods proposed for measuring environment-
related factors differ somewhat among the various types of data being
sought. These differences reflect several considerations, such as the
extent to which surrogate variables reflect the factors of interest,
the quality control of data collection, and the suitability and cost of
data collecting techniques under actual survey conditions. However, the
planned methodology stresses probability sampling techniques wherever
possible in order to facilitate valid statistical analyses and to
increase the degree of control over data collection. Field enumerators
will follow explicit, nonjudgmental procedures throughout. These
procedures will range, as outlined in the following sections, from
obtaining small, possibly selective samples of relatively homogeneous
factors, such as tap water at a particular residence or school, to
obtaining large stratified random samples from a highly variable item,
1-2 3-10-77
-------
such as air quality in a smelter community.
Specifically, the survey will result in the selection of a
stratified probability sample of persons who reside at various distances
downwind from nonferrous smelters in selected communities. Approximately
240 persons, aged 35 and under, will be selected at varying distances
from the emission source in each of six smelter communities (a selective
sample of study sites was identified by the Project Officer on the
basis of prior investigation). Additionally, 80 residents aged 60 and
older will be selected in each of three of these communities. Blood,
urine, and scalp hair samples will be obtained and analyzed for these
persons and will comprise the basis for estimating community uptake
coefficients of lead, zinc, arsenic, copper, manganese, and cadmium.
To estimate the exposure levels of the "downwind" residents and an
"upwind" control group to these six elements, residence data and samples
of soil, household dust, and tap water will be obtained at each of the
six communities selected for study. To estimate levels of atmospheric
exposure, high-volume air samples will be obtained at random locations
throughout the target area and at random points in time throughout
the survey period. The number of dust and tap water samples will be
equivalent to the number of households that have individuals in the
sample—that is, less than or equal to 1,680, the total number of
individuals to be selected. Additionally, RTI anticipates that a minimum
of 90 high-volume air samples will be taken at each smelter site, a
total of approximately 540 (90 x 6) air samples for the study. Two soil
samples at each pre-schooler play area, and one composite soil sample
at each school playground and high-volume air sampling site will be
collected.
1-3 3-10-77
-------
Prior to the studies in the six sample communities, a Pretest or
pilot study will be conducted at Corpus Christi, Texas. The method-
ology will be identical to that planned for the survey sites except that
a smaller sample of persons will be selected to participate and the
survey period will be shorter. Approximately seven persons per age/sex
cohort will be selected from each of the two geographic strata repre-
senting the extremes of potential exposure and one person per cohort
will be selected from each of the remaining six strata. This allocation
will result in a total of approximately 120 individuals in the Pretest
study and is such that the hypothesis of no significant difference in
uptake can be tested with reasonable power. The survey design for air
sampling will also be equivalent to that planned for the main study
sites except that the period of time sampled will be reduced from 20
to 10 days—that is, approximately 45 high-volume air samples will be
collected during the Pretest.
Each study site (community) will be visited prior to the survey in
order to ascertain the appropriate delineation of target (high-risk)
population and to develop sampling materials. The actual sampling plans
will be conceptually equivalent but will necessarily be developed
individually to suit the particular circumstances of the community,
such as availability of mapping materials, prevailing atmospheric
patterns, geographic topography, type and location of the smelter and
other major emission sources, and population densities. Tentatively, RTI
expects to obtain a balanced sample of five individuals from each cohort
from each of approximately eight distance strata (40 persons in each
cohort). These strata will generally increase in size (land area) as
the distance from the stack emission increases, in order to optimize the
1-4 3-10-77
-------
sample design according to the usual pattern of particulate fallout.
Although the actual number of high-volume air samples will ultimately
depend upon the site circumstances, the number of air samples per stratum
will range from approximately two obtained on each of 3 days to three obtained
on each of 7 days. The number of observations, both locations and days,
will increase as the distance from the emission source increases. The
number of electric connections needed to accommodate the air samplers at
each of the study sites is expected to range from 8 to 18 depending
upon the number of strata used for sampling at the particular site.
Often, studies of environmental quality present emphasis and
analyses that are based on purposefully selected samples of population
and environmental factors. Such findings are highly susceptible to
biases and often are not valid. In contrast, the methodology presented
in the present study stresses random probability sampling techniques
which will facilitate valid statistical analysis.
The following sections address specific components of the survey
design including target population, construction of the sampling frame,
sample selection techniques, sample size, and the estimation precision.
1.3 Target Population
The primary target population consists of the relatively high-risk
human population that resides "downwind" of lead, zinc, and copper
smelters in selected U.S. smelter communities. Specifically, American
Smelting and Refining Company (zinc), Corpus Christi, Texas, will be
used as a pilot test; the six study smelters consist of:
St. John Mineral Corporation (lead), Herculaneum, Missouri;
Missouri Lead Operating Company, Bixby, Missouri;
1-5 3-10-77
-------
Anaconda Company (copper), Anaconda, Montana;
Phelps Dodge Corporation (copper), Ajo, Arizona;
National Zinc Company, Bartlesville, Oklahoma; and
New Jersey Zinc Company, Palmerton, Pennsylvania.
In appendix 1.1, the sites are characterized according to population,
migration, and age characteristics. Other neighboring communities, some
of which are listed in appendix 1.1, may also be included in the
target populations. Also, figures in appendix 1.1 depict the population
and its stratification for Corpus Christi, Texas and the tentative
population delineations for the study sites. Characterization of the
target population presented there is indicative of the technique that
will be used on the study sites.
Delineation of the target population will be based largely on pre-
vailing wind patterns. Tentatively, the high-risk population is
defined as all persons residing within 30 km of the emission source
(this limit may differ according to prevailing fallout patterns) and in
sectors that experience winds from the direction of the emission source
more than 3 percent of the time. The 3 percent cutoff generally excludes
areas receiving 10 percent or less of the total fallout from the study
source. It is planned that the target population will comprise all
persons in this high-risk population that are members of the categories being
studied. Additionally, an "upwind" area segment will be sampled as a
control group to facilitate the isolation of effects from the particular
emission source under study. The target population is thus restricted so
that the available resources can best be utilized to answer questions
about the potentially high-risk population, although this restriction
precludes valid inferences about the entire population in some of the
1-6
3-10-77
-------
study communities (in other communities, such as Ajo, Arizona, the wind
patterns and the population distribution are such that the entire community
comprises the high-risk population.) Wind roses (see appendix 1.3) have
been developed for all test sites. These diagrams depict the relative
frequency of wind velocity and direction. At Anaconda, for example,
westerly winds prevail 85 percent of the time, largely at 7 to 21 miles
per hour. The target population for Anaconda, therefore, would ideally
comprise all persons (with exceptions noted below) residing in a fan-
shaped area to the east of the smelter.
The population in these communities is additionally restricted to
the relatively young (preschool, school age, and age 20 to 35), and to
the relatively old (age 60 and older) that have not had occupational
exposure at the community smelter within the preceding 12 months. The
exact delineation of this population will differ by site depending on
local circumstances such as those alluded to in the previous section.
Presurvey site visits are planned for the purpose of gaining the pertinent
local information needed to supplement extant materials in the construc-
tion of a sample frame (see section 1.3).
Several aspects of the study present somewhat unique sampling
problems. For example, most smelter communities are relatively small
(population 1,000 to 5,000) and show net outmigration during the past
decade. In this stereotype community, relatively few of the 20 to 35
age group will remain in the community. The minimum size for each
stratum will be imposed by the expected number in the population of the
most scarce cohort, usually the pre-school group. The approximate
1-7 3-10-77
-------
stratification guidelines presented in figure 1.1, therefore, will
necessarily differ by site. Obviously, sampling from such populations
can guarantee adequate cohort representation over the range of distances
and potential exposures only to the extent that these cohorts are con-
tained in that population. In other words, RTI anticipates, depending
on the community, that virtually all of the families residing near the
emission source will need to be screened in order to obtain adequate
information about uptake of some of the cohort groups in that area.
Figure 1.1 reveals that the area near the smelter represented by the
steep portion of the curve contains a highly variable particulate content.
The curve presented in figure 1.1 was developed on the basis of
results from several prior studies [Refs. 1.1, 1.2, 1.3]. These works
reveal that the particulate dropout rates for varying distances from the
smelter follow a somewhat similar pattern for several of the elements to
be investigated in the study. Distance-fallout data were compared for
zinc, cadmium, lead, and arsenic on the basis of air, surface soil,
and blood samples. Surface soil samples reflect the fallout rates and
the atmospheric mobility of lead [Ref. 1.4]. The general shape of this
curve is useful in describing relatively homogeneous strata, which
contain approximately equal variances for element accumulation. Equally
spaced readings on the vertical axis, therefore, identify distance
strata for which equal-size samples of persons will yield approximately
equal reliability for each stratum estimate. Actually, the stratum
boundaries are being based on potential exposure according to methodology
in appendix 1.1; this refinement is expected to be a more effective
stratification and will still serve as a quasi-stratification of distance
from the smelter.
1-8 3-10-77
-------
ro
I
0 0.3 0.7 1.1 1.6
2.2
3.0 5.0
km from emission source
Fig. 1.1. Preliminary distance-stratification for a target population based upon Zn and Cd content of
topsoil according to Miesch and Huffman [Ref. 1.1] in East Helena, Montana.
-------
It is noteworthy that stratum 8 in figure 1.1 Cf^om 5 to 8 kilo-
meters downwind of the smelter) is generally considered to be beyond
the range of atmospheric transport and, therefore, will serve to some
extent as a control group with minimal exposure. More accurately,
however, the mobility of individuals in the area can be expected to
result in some exposure for most individuals living in the community,
thus precluding selection of a true control group from a smelter community.
In fact, the exposure levels at Corpus Christi, according to the standard
dispersion models, are substantial even beyond 30 km, hence, the decision
to sample upwind for the control group.
1.4 The Sampling Frame
The first requirement for a probability sampling of any nature is
the establishment of a frame. A frame is a collection of sampling units
that may be unambiguously defined and identified. A list of persons,
families, or houses might be a sufficient frame for certain types of
samples. For the planned survey, one must assume that a complete list
of the target population will not be available and will be costly to
develop. Therefore, an area sampling frame will be developed. Such
a frame will result in a probability sample—that is, all persons in tar-
get populations as tentatively defined in appendix 1.1 will have a known,
nonzero probability of being selected for the study. The method and
materials used to obtain a stratified area sample may vary somewhat by
site but will follow the same basic methodology. As shown in appendix 1.1,
the sites to be studied are generally characterized by such small pop-
ulations that Census of Population data are not sufficiently detailed to
use as a sampling frame.
1-10 3-10-77
-------
Corpus Christi, the one exception to this characterization, is a
tracted area for which the Census material constitutes a suitable base
for constructing an area frame. The frame construction for Corpus
Christi will involve the following tasks:
1. Obtain the pertinent Census materials; these are already
available at RTI and include 16 sheets of enumeration district
(ED)/block maps and block and ED statistics;
2. Obtain county highway maps showing roads and other boundaries
useful for constructing area segments and showing locations
of dwelling units outside the urban area;
3. Obtain pertinent stratification information from local sources,
such as health departments and weather services;
4. Delineate target area and strata boundaries;
5. Select for each stratum an ED or block with probability
proportional to the 1970 population for the ED in which the
first sample segment will be located.(a sample segment will
comprise a cluster of from 6 to 14 households);
6. Continue task 5 using with-replacement sampling until a
sufficient number of segments have been assigned to yield
the requisite cohort samples; the procedure of tasks 5 and 6
will be repeated within each sample ED and block to identify
specific sample segments and their survey sequence.
The process of developing the sampling frame for less populated
areas encompasses the same tasks except that aerial photography,
geological survey maps, and street maps will be used to delineate the
primary sampling units (PSUs). To facilitate the selection of sample
segments, the sample PSUs will be cruised and subsegmented and households
will be listed according to methodology developed at RTI [Ref. 1.5].
The information that is expected to be pertinent for stratifying
the target population may include several factors as noted earlier in
section 1.1. Basically, the target population will be stratified,
first according to exposure potential from the emission source (essentially
1-11 3-10-77
-------
a distance-from-source stratification) and second, according to age
and sex within the exposure Cor distance) strata. Other factors,
which undoubtedly influence exposure and uptake of elements, such as
cigarette smoking and proximity to automobile traffic, will be
addressed through statistical analysis. Care will also be taken
during the statistical analysis to account for the fact that the data
result from a stratified cluster sample and not from a simple random
sample. Additionally, each stratum should be sufficiently large to
yield the requisite sample. The minimum size stratum for each site can
be anticipated by viewing the smallest cohort proportion and making
allowances for possible nonresponse and occupational exposure. Using
Ajo, Arizona as an example, approximately 7 percent of the population
is male and 60 or older. According to the 1970 Census, 71 (i.e., 5/.07)
persons will be needed to produce the requisite sample of five in this
cohort if all participate, if none have had occupational exposure within
the preceding 12 months, and if all have lived in Ajo for at least a
year. Therefore, the 71 persons plus additional to account for possible
nonresponse and occupational exposure suggests that the minimum stratum
size may be approximately 125. What actually constitutes a reasonable
allowance for these sample losses, however, will be ascertained from
local sources and site experience. This minimum stratum size, the re-
latively small site populations, and the increasing stratum areas as the
distance from the source increases suggests that fewer than 8 strata
will be feasible for some sites. The actual number of strata used will
depend on several factors including what constitutes the downwind population.
1-12 3-10-77
-------
1.5 Sample Selection Techniques
1.5.1 Survey Participants
The major considerations outlined in this section involve the need
to obtain randomized samples from an adequate representation over a wide
range of distances from smelters for 6 to 8 cohort groups. To accomplish
this objective, the downwind population in each "distance stratum" will
be partitioned, as described in section 1.3, into small segments such as
city blocks. Instructions to data collection field staff will contain
the following information:
A list of segments to be surveyed and the order of visiting
these segments and households in the sample segments;
Maps showing segment locations and specific boundaries;
A form on which a tally will be maintained for each cohort
group for each stratum;
A form for recording a count of all eligible persons in those
segments visited, which of them were asked to participate, and
which did participate.
The field enumerator will continue to visit segments in the pre-
designed order in each stratum until either the cohort samples (5 in
each cohort group) are obtained or until all households in the stratum
have been either contacted or verified as not containing any of the
eligible individuals still needed. Except for eligible individuals that
do not cooperate, this technique will result in a probability sample of
the target populations that will facilitate valid inferences and analyses
of the data. The use of cash incentives is expected to hold the nonresponse
and hence the departure from a probability sample to a minimum level.
In a similar study, the voluntary response rate without the use of
incentives was 80 percent [Ref. 1.6].
1-13 3-10-77
-------
1.5.2 Air Sampling
The placement of the air sample locations will coincide with the
first segments selected in each stratum for the sample of individuals.
Also, for each air sample location, a list of days during which the 24-
hour samples are to be obtained will be provided to the Site Administra-
tor. This list of days comprises a probability sample of time periods
throughout the survey period. From 4 to 6 air samplers will be operating
virtually throughout the survey period, and the requisite number of
electric connections is expected to range from 8 to 18 for each smelter
site depending on the number of strata. Constraints on the allocation
require that no more than 2 strata are designated for monitoring on a
particular day, and that no stratum will be assigned more than 3 monitors
on any single day. The procedure is as follows (see also table 1.2.2):
1. Randomly select 3 days from the first 19 days of the survey
period without replacement and assign these to stratum 1—two
locations proximate to the first two segments (household
sampling units) will be monitored on each of these 3 days;
2. Repeat the procedure of number 1 for stratum 2;
3. Repeat the procedure for the remaining strata except that
days already assigned twice are ineligible, and the number of
days to be assigned to each stratum increases for strata that
are more distant from the smelter.
1.5.3 Sampling for Soil Contamination
Samples of surface soil are to be collected in play areas of all
study children. Two soil samples will be obtained from residential play
areas for pre-school age study participants at each smelter site, and one
composite sample will be taken from each school yard where study children
attend (and each air sampling location).
1-14 3-10-77
-------
Variation in the soil content of study elements throughout the play
areas, both for different locations and times, is expected to be small,
relative to variation in the air samples for example, but will undoubtedly
be sufficiently large to consider random sampling. For this reason,
a methodology is being investigated in the Pretest which would result
in a reasonably unbiased sample of the surface soil in play areas of the
sample children. This method involves a random point sampling which
would essentially ensure that all locations in the play area would have
a nonzero (and equal) probability of being selected. Two points will
be selected in each play area in the Pretest and will be analyzed before
aggregation so that variance components and requisite sample size can
be ascertained. If the Pretest reveals that random sampling is impractical,
a selective composite sample will be relied upon at the study sites to
measure element exposure from soil in the play area. In either case,
the enumerators will first establish the boundaries of the most commonly
used play area and will then select surface soil samples from scattered
points in the play area. These samples, which will be obtained con-
currently with the interview, will comprise the soil sample(s) for that
play area.
1.5.4 Sampling Tap Water
A sample of tap water will be obtained during the interview at the
residence of each study participant. The tap water sample will be
obtained from the kitchen tap or other source commonly used for drinking
and/or cooking. It is anticipated that two tap water samples will be
obtained, one sample taken from the first drawn water and another
1-15 3-10-77
-------
sample taken after the water has been allowed to run for three minutes.
•
The underlying assumption is that the element content of most ingested
water is between these two extremes. The feasibility of this methodology
will be investigated at the Pretest site by analyzing the "before and
after" samples seperately for a subsample of the households. Random
sampling at different locations and times (except the before and after
flush sampling) was not proposed for this measure of exposure, because
it should be relatively homogeneous within a household, and because what
little improvement in data that might result from a suitable randomization
of this measure does not appear to justify the accompanying increase in
respondent and interviewer burden.
1.5.5 Quality Control
Analytical errors—that is, errors in the laboratory analyses—can
constitute a serious problem [Ref. 1.4]. Several methods for controlling
these errors are described more fully in the data collection and laboratory
analysis sections of this Work Plan, but one aspect of the quality
control is described briefly here because it relates to sample random-
ization. To the extent possible, the sample data will be stored in the
laboratory and analyzed in random groups rather than in batch groups as
they are sent in from the field in order that analysis error can be
identified as error rather than as factor effect. Also, the forms used
for tallying eligibles in the sample segments will identify some 10
percent of certain eligibles as quality control individuals; duplicate
samples of blood and hair will be obtained for selected adult participants
and duplicate samples of tap water and dust will be taken at selected
1-16 3-10-77
-------
dwellings. Also, duplicate soil samples will be taken for 10 percent of
the school yards and air sampling locations. The purpose of these
quality control observations is to measure the possible influence of
sample acquisition, packaging, shipping, and laboratory analysis.
Additionally, 10 percent of the sample individuals will be reinterviewed
at a later date to verify the information obtained on the survey ques-
tionnaire; the identity of these persons will be unknown to the initial
interviewer.
1.6 Sample Sizes and Sampling Error
The sampling errors and sample sizes are presented here in two
sections, for individuals and for high-volume air samples. An apparent
inconsistency exists between the proposed sample allocation of persons
and that for air samples. This apparent inconsistency reflects the
anticipated small within-stratum variation of long-range, average
conditions, such as element absorption in soil [Ref. 1.1], and the
relatively greater within-stratum variation anticipated for certain
unstable conditions, such as atmospheric composition at a specific
location on a particular day [Ref. 1.2]. This results in a slightly
larger sample of high-volume air samples being taken in the strata more
distant from the smelter, while, for persons (and soil samples), equal
sample sizes are to be taken from each stratum.
1.6.1 Allocation of the Sample of Individuals
If estimates of population totals or averages are sought, the optimum
sample allocation in stratified sampling is a function of stratum vari-
ances, costs, and stratum sizes, according to the following equation:
1-17 3-10-77
-------
"h= n(W /ch}/* NhV /cn)
where ru = the optimum sample size for stratum h for an overall sample
of size n, N, = the number of elements in stratum h of the population,
S, = the standard deviation of stratum h, and C, = the cost of sampling
h h
from stratum h.
To meet the objectives of this study, however, accurate estimates
are needed of mean exposure at various distances from the emission source.
The N, , therefore, are dropped from equation 1. Also, C, in the
n h
proposed study will be approximately constant for -all strata. The
optimum n, can then be obtained by using equation 1 and the fact that
the S, are also approximately equal (see figure 1.1):
L
^ = n V E sh
- n/L
= 40/8
= 5
where L is the number of strata (8 or less), n is the number of
individuals per cohort (40), and other notation is as defined for equation
1. The desired sample allocation of the 1,680 sample persons is described
in table 1.1, although, as noted earlier, the actual stratum sizes may
differ among smelter sites. Based on prior studies [Ref. 1.7, 1.8,
1.9 and 1.10, for example], this sample size should result in a reasonable
capability (Type I and Type II error both at 0.05) for detecting a lead
difference, for example, of 5yg/100 ml blood; 40 is commonly accepted
as the concentration above which health problems are likely to exist.
1.6.2 High-Volume Air Samples
The high-volume air samples are needed to estimate exposure levels
1-18 3-10-77
-------
Table 1.1. Tentative sample allocation for individuals*
at the study sites .
Number of
Geographic
Site
Lead (1)
Lead (2)
Zinc (1)
Zinc (2)
Copper (1)
Copper (2)
Preschool
Male Female
5
5
5
5
5
5
5
5
5
5
5
5
Individuals by Cohort Group in Each Stratum
School Age
Male Female
5
5
5
5
5
5
5
5
5
5
5
5
20-35 Years
Male Female
5
5
5
5
5
5
5
5
5
5
5
5
60 Yrs
Male
5
0
5
0
5
0
& Older
Female
5
0
5
0
5
0
*Assuming, tentatively, eight strata as depicted in figure 1.1: 0.0 - 0.29 km,
0.3 - 0.69 km, 0.7 - 1.09 km, 1.1 - 1.59 km, 1.6 - 2.19 km, 2.2 - 2.99 km,
3.0 - 4.99 km, and 5.0 - 7.99 km.
1-19
12-17-76
-------
at varying distances from the emission source, at varying distances from
the transit line of the downwind pattern (corresponds to primary wind
direction), and at varying wind velocity and direction.
All air samples will be collected by the Chemistry and Life Sciences
Group of RTI. Each of these high-volume samples will be collected
over 24 hours on fiberglass filters.
Two sampling questions need to be answered about the high-volume
air survey:
1. How many sampling points are needed in each stratum?
2. How many locations should be observed during a sample day?
Several 24-hour readings are needed in each stratum in order to measure
the variation over time [Ref. 1.2] as well as the need to measure the
influence on exposure of different wind velocities and directions. The
basic sample size and allocation are presented in table 1.2, but they
necessarily will be tailored to suit the individual site circumstances.
Methodology for estimation of sample size and allocation is described
in appendix 1.2. The per-site sample size totals 87 location-days.
This size sample is expected to produce a coefficient of variation for
element content of atmosphere of 0.20 or less at the stratum level.
As mentioned above, the stratification and sample allocation will
vary somewhat among sites so that the examples presented for
clarification—namely, the fall-out curve in figure 1.1, the sample
allocation in table 1.2, and the random assignment scheme for air samples
presented in table 1.2.2—should be considered flexible. Another
noteworthy point on the air sampling is that it is primarily to be
used to assess the past average exposure of the target population.
1-20 3-10-77
-------
Table 1.2. Tentative sample allocation for air samples*.
Type of Observation
Locations (A)
Days (B)
24-hour samples (A x B)
Ratio, days/locations
Sl
2
3
6
1.5
Number
S2
2
3
6
1.5
of Observations,
S3
2
4
8
2.0
S4
2
4
8
2.0
S5
2
5
10
2.5
Si, in
S6
2
5
10
2.5
Each
S7
3
6
18
2.0
Stratum
Y
3
7
21
2.3
Total
18
-
87
-
*Based on data presented in appendix 1.2 [Ref. 1.2].
1-21
12-17-76
-------
Because it samples such a short time period (20 days), little measure of
seasonal effect will result. Resource constraints have imposed this
relatively short sample period; admittedly a longer time period and
even a one-to-one matching between high-volume air samples and sample
persons might be desirable. Basically, therefore, what is expected from
the proposed design is a measure for each distance stratum of the atmospheric
condition during the survey period and of how well the standard dispersion
models perform [Ref. 1.11]. This information can be used to adjust these
models so that historical climatic data can be used more effectively
to estimate average past exposure. The same type of seasonal
adjustments will be used" on other "seasonal" factors in the analysis
to the extent seasonal effects are revealed over the course of the study.
Another characteristic of the air sampling methodology is the
continuous sampling of predesignated points on specified days. While
one might be tempted to shift the samplers away from "unusual" atmospheric
conditions, such variations would result in biased estimates.
1-22 3-10-77
-------
APPENDIX 1.1
CHARACTERISTICS OF SURVEY SITES
1-23 3-10-77
-------
Table 1.1.1. Selected population characteristics of survey sites.*
I
NJ
„ Smelter
State
town
Arizona Ajo
Missouri Bixby
Herculaneum
Montana Anaconda
Oklahoma Bartlesville
Pennsylvania Palmerton
Texas Corpus Christ i
(Pretest site)
Neighboring
towns
Rowood
Bass
Buick
Viburnum
Festus
Crystal City
Horine
Povely
Gregson
Warmsprings
Dewey
Tuxedo Park
Population
number
5,881
<1,000
-
520
1,885
7,530
3,898
517
9,771
29,683
3,958
5,620
204,525
Net migration .
j inm Age groups, percent
since lyou,
percent 1-5 6-17 20-35 60+
-16.6 12 25 19 14
-18.9 10 22 18 19
6.4 10 20 20 17
-5.4 9 17 20 22
22.0 11 26 19 12
*Based on the 1970 Census of Population.
o
i
-------
METHODOLOGY FOR CHARACTERIZING THE
STUDY POPULATION IN CORPUS CHRISTI, TEXAS
Estimates of particulate concentration surrounding the ASARCO, Inc.
smelter at Corpus Christi, Texas were made using the Climatological
Dispersion Model (COM) of the EPA UNAMAP Library. The COM is described
in detail by Calder [Ref. 1.12] and in less detail by Busse and Zimmer-
man [Ref. 1.13]. A brief description of the model and its application
follows.
The average annual concentration (ground level) was estimated for
Pb, Mn, Cu, As, and Zn resulting from- the nine sources at ASARCO that
emit these elements. The models used to estimate these concentrations
rely on such information as:
Relative frequency of wind speed (6 categories) and direction
(16) for each of six atmospheric stabilities,
Mixing height of atmosphere [Ref. 1.14],
Temperature (outside and stack gas),
Emission height,
Stack diameter, and
Emission rate and velocity.
These concentrations were calculated for a 60 km square area around
ASARCO. Concentrations were calculated each 0.8 km up to 8 km from
2
ASARCO and each 1.6 km for the remaining area in the 3600 km area.
Gradients of these concentrations were plotted on maps depicting pop-
ulation location and Census defined areas (Blocks, Enumeration Districts
[EDs], and Tracts). These gradients revealed several pertinent con-
siderations:
1-25 3-10-77
-------
Most of Corpus Christ!'s population resides "upwind" of the
ASARCO plant.
Individuals residing downwind (largely to the northeast) are
apparently exposed to substantial concentrations (from ASARCO)
even beyond 30 km from the source; 75 yg/m^ was estimated at
30 km.
- The gradients also revealed useful strata boundaries for use
in the sampling components of the investigation.
Based on the concentration estimates, it was concluded that the
study population should be taken within 30 km even though this distance
will not result in an adequate control group. The control sample will
be selected from Corpus Christi residents to the southeast where con-
3
centrations of only 10 yg/m were estimated. Additionally, to obtain
the maximum possible information about individuals throughout the full
range of exposure potential, the upwind (wind from the direction of the
smelter less than 3 percent of the time) population—except for the control—
was excluded. Also, to hold the public relations activities to a reasonable
level, the study area was restricted to Nueces county; approximately 3,800
persons reside within the 30 km limit in San Patricio county but this
constitutes only 4 percent of the total downwind population.
The tentative study populations delineated for the other study
sites will probably have similar exclusions—that is, counties with a
small proportion of the population will be excluded and the distance
limit (30 km) may be reduced or increased depending on particulate
dispersion and population location.
1-26 3-10-77
-------
Table 1.1.2. Population residing in the tentative study
area near Ajo, Arizona*
County
Pima
Total
Census Division
Ajo
Town or Area
Ajo
Other
Population
5,881
412
6,293
Based on 1970 Census of Population
1-27
3-10-77
-------
'' • •,-. BOUNDARY | ;'p ' ^ '_ill_ "' '' ' : ! _ '
•~—y '•• '• • • -A .'. . '•' /•• • : i •>', \ '« I
Oen
^«-:'.-4i-
~ * . •'<-•. \
33
.. 34
> r-f*v-'~- =
V:.- :ii- ;
i
35
•A/'
i
a: <•
,,
31
VX32
1. ^\ ".:
Figure 1.1.1. Geographic location of study smelter and
tentative delineation of the study population, Ajo
•.r.v:, ,M—-*--—r/i •
. .. ^ . • .,.-,
''• s| • ^ •'-„ C |.V""'> ' v Cardiaan-"' '•'-•'-• . f-V-i « :4CamelbackM'
•/.. Jtf-i8^;-\., e^re-SET".' v *. -S^ A.^-''-'--"^!-""-:•-'v_ mn^'si
;5M_^r ' *» r :^w M.: ,«• «jj 11979'
''^^;2^iX^::rSiT'' ;>•
;jVT3-"'•.-:«' ••/• ''V^>--j-.>x' /* r.p* ' fe».-l(1r':;' ^"y-5 '.!>•' n ' ''!"'.\': Ki / -8V .;-'-/K./slv' •• .N
"? ™« S •' IS ; * '
'"^ ••-•
»
--' i
• '/** 1 . /7*O i *,s ' -** ' ' '
i - •
\ ' / l
i '. /
" "1-28- """
3-10-77
-------
Table 1.1.3. Population residing in the tentative study area
near Anaconda, Montana*
County
Deer Lodge
Silver Bow
Powell
Total
Census Division
Anaconda
Deer Lodge Valley
Butte
Ro eke r-Rams ey
Walkerville-Browns
Cottonwood
Town or Area
Anaconda
Butte
Walkerville
Other
Population
9,771
3,255
23,368
980
1,097
285
816
39,572
Based on 1970 Census of Population
1-29
3-10-77
-------
Sl.ilt Hd'u
'•• • • -'- ;,. _— "• i\
\- •-/*i •."'• .:. : f)ppoi-tunity ^
\
_
KKIt I.OliCK rVEw LQDGC I-
ccr >Tv*Li-tT /• * ||
i uJ::
-------
Table 1.1.4. Population residing in the tentative study area
near Bartlesville, Oklahoma*
County
Washington
Osage
Rogers
Nowata
Total
Census Division
Cop an
Dewey
Bartlesville
Bartlesville Southeast
Ochelato-Ramona
Pawhuska
Barnsdall
Oolagah-Talalo
South Coffeyville-Wann
Town or Area
Copan
Other
Dewey
Other
Bartlesville
Ochelato
Ramona
Other
Avant
Barnsdall
Other
Wann
Other
Population
558
845
3,958
1,240
29,672
1,026
330
600
1,897
909
439
1,579
485
513
135
525
44,771
Based on 1970 Census of Population
1-31
3-10-77
-------
\,
2>
/•C^jj;(
Figure 1.1.3. Geographic location of study smelter and
tentative delineation of the study population, Bartlesville
__ j. orvix i
»:•;•.>..,35 •;;
F.ili.H" «'\.i
•'• >,.;%:-^,x
»**" TWASMINOTON fe"" t-"n-» • NOWAI
S ' CO pim.WfrtT.iiit.1
/• •_ c.». |J i-J-^^
'
^ I OCMtVAT*. I KOGEH^CO.
-- "•«" /
<»- -, I /.,«» I
^
1-32
3-10-77
-------
Table 1.1.5. Population residing in the tentative study area
near Bixby, Missouri*
County
Iron
Reynolds
Madison
Wayne
Crawford
Total
Census Division
Arcadia township
Iron township
Kaolin township
Liberty township
Union township
Carroll
Lesterville township
Webb township
Polk township
St. Francois township
Liberty township
Central township
Twelvemile township
Logan township
Cedar Creek township
Osage
Town or Area
Arcadia
Ironton
Pilot Knob
Other
Annapolis
Des Arc
Other
Centerville
Dillard
Population
627
1,452
582
2,046
1,116
245
478
330
222
1,049
209
762
205
398
268
279
210
129
325
144
36
11,112
Based on 1970 Census of Population.
1-33
3-10-77
-------
location of study smelter and
of the study population, Bixby
/ | l-,u< K»*O I MADISON CO. I M'"
. lf . —— .—1 O"<*"'«1 \ 1 "'
/ I | .,J I -•—,&
K-) )-v.'•• "'^ w m-- (r^,, --.•
I '"•'-(~—^ l \. \\° v -: ^?-(
KI V .Ku^Cenji.; : . \\ \\*^*T'v'''/'! '—
hf^^5>=i====;-j(i V^: i ;IMO°~
V'••-'-,\V\. „, , .^=J\l.oM-'t.<
-------
Table 1.1.6. Population by stratum residing in the study area
near Corpus Christi, Texas
Stratum
Potential exposure
3**
yg/m
Population Sample size
1 (Control) <25
2 25 - 150
3 150 - 300
4 300 - 450
V
5 450 - 600
6 600 - 800
7 800 - 1,600
8 >1,600
Total
54,265
76,747
14,296
872
302
356
591
741
148,170
42
6
6
6
6
6
6
_42
120
Based on 1970 Census of Population.
**
Based on atmospheric dispersion model described in appendix 1.1.
1-35
3-10-77
-------
-------
Table 1.1.7.
Population residing in the tentative study area
near Herculaneum, Missouri*
County
St. Louis
Census Division
Town or Area
Population
Jefferson
Ste. Genevieve
Monroe (Illinois)**
Total (in Missouri)
Lemay
Concord
Meramec
Rock
Joachim
Central
Big River
Valle
Jackson
Bella Villa
Lemay (part)
Other
Concord
Lemay (part)
Sunset Hills
Other
Parkdale
Other
Kimmswick
Other
Crystal City
Festus
Herculaneum
Pevely
Other
Hillsboro
Other
-
De Soto
Other
Bloomsdale
Other
1,419
36,759
22,381
21,217
3,356
92
12,979
836
7,640
268
44,403
3,898
7,530
1,885
517
8,108
432
4,995
1,316
5,984
1,995
411
647
all except
Prairie DuLong
17,491
189,068
Based on 1970 Census of Population.
**
Tentatively excluded from the study area.
1-37
3-10-77
-------
^/^^'^S^-^^^^.-^.^\4 .-V•-•{- (-.<"--Sxr'':-
^^i^^SM^^:, .,..uv. ,',_„• A. V-
, \
\ \
1
i'i
?/ l\
y i^
^
/!
1
! / c
V ~
ft «
/
Si h \'!
Figure 1.1.6. Geographic, location of study smelter and
tentative delineation of the study population, Herculaneum
^^;r...^fy^so--p
"—«*•<- •/- /si-w-N£<-_ ••••••(;
^Kl ' ..-*c ^x ^vC:j^ y *"
-
t )
-------
Table 1.1.8.
Population residing in the tentative study area
near Palmerton, Pennsylvania*
County
Carbon
Monroe
Northampton
Census Division
Kidder township
Penn Forest township
Towamensing township
Lower Towamensing
Palmerton borough
Franklin township
East Penn
Tunkhannock. township
Chestnuthill township
Jackson
Polk
Hamilton
Ross
Eldred
Lehigh township
Walnut borough
Moore township
Chapman borough
Bushkill
Wind Gap borough
Plainfield
Slockerton borough
Upper Nazareth
Lower Nazareth
East Allen
Bath borough
Bethlehem township
Bethlehem city
Hanover
Allen
Northampton
North Catasaugua borough
Town or Area
Other than
Weissport East
Eastlawn Garden
Other
Population
298
423
1,096
2,360
5,620
514
659
159
2,021
404
1,284
995
998
990
6,086
1,942
3,791
191
3,387
2,270
2,144
753
1,613
1,992
2,091
2,737
1,829
4,536
52,065
5,434
1,856
8,389
2,941
1-39
3-10-77
-------
Table 1.1.8.* (Continued)
County Census Division Town or Area Population
Lehigh • Catasaugua borough - 5,702
Hanover - 1,217
Whitehall Fullerton(U) 7,908
Other 10,415
North Whitehall - 6,819
South Whitehall - 14,210
Allentown city - 109,527
Upper Macungie - 4,390
Weisenberg - 1,737
Lynn - 2,047
Heidelberg - 1,532
Lowhill - 1,002
Washington - 3,732
Slatington borough - 4,687
Coplay borough - 3,642
Berks Albany - 555
Schuylkill West Penn - 2,636
Total 305,626
Based on 1970 Census of Population.
1-40 3-10-77
-------
_^^^V^A'quash!(^la^
^^v^'^^f^V^?^^
*^^^^S*+ ' '«&
^f
Sub /Vj
s*a-.--;v!'ftr
-------
APPENDIX 1.2
SAMPLE SIZES AND ALLOCATION FOR AIR SAMPLING
1-42
3-10-77
-------
The requisite sample sizes and allocations are based tentatively
on data presented in table 1.2.1 [Ref. 1.2]. These allocations will
ultimately reflect also the specific smelter-site characteristics,
which will be obtained from site visits.
The variances (based on table 1.2.1 data) equal 891 and 305 for
strata 6 and 8, respectively. Sample sizes of 10 and 23 for these
two strata will yield estimates with less than a 20 percent coefficient
of variation (CV). If a regression estimator proves effective, say with
a correlation coefficient (R .123...p) of 0.8, then the CV would be
approximately 12 percent.
Table 1.2.1. Lead fcontent of air, yg/cu m.*
Day
1
2
3
4
Stratum
(2.2
13.0
84.0
18.0
-
6; 2 locations
- 3.0 km)
30.0
68.0
66.0
-
Stratum
(5.0
1.3
15.0
9.6
24.0
8; 3
- 8.0
7.6
36.0
3.2
60.0
locations
km)
4.2
25.0
4.2
29.0
*Based on reference 1.2.
2 - 2
The variances were calculated according to: S = |. (X.. - x) /(nm-1)
where
X = Pb readings for day i and location j with i ranging from
1 to n and j ranging from 1 to m.
1-43
3-10-77
-------
The coefficients of variation are calculated according to:
C = S / x /nm
e
where
Se = S /1-R .12...p and the other terms are as defined above.
y
Also, the following ratio of standard deviations for each stratum
suggests that the sample ratio for day/locations should be approximately
2.2:
mn/m = SQ/SL
where
S and S are the standard deviations for days and locations,
D Li
respectively.
An example of the assignment of the air samplers by location
and day within each stratum is presented in table 1.2.2.
1-44 3-10-77
-------
Table 1.2.2. Random assignment of days for high volume air samples: an example*
—2- Electric drops.
Stratum 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 required number
1
JS
Ln
U)
1
O
•vj
1 XX
2 x
3 xx
4 x
5 x xx
6 x xx
7 xx
8 x x
Each x represents 2 or 3 sampling locations
drops.
x 2
xx 2
x x 2
xx x 2
xx 2
xx 2
xxx x 3
xxx x x 3
for each stratum-day as indicated by the requisite number of electric
-------
APPENDIX 1.3
WIND ROSES FOR SMELTER SITES
1-46 3-10-77
-------
KJO -
7.1
6-1,
6.0
7.7
•—r—
n i r
1-47
3-10-77
-------
3-5
'-.I
/ V'y /"->'
\V c^- •)
\/- ^^-J
, c'-vr-> c1 -^
pERl'ctNT CCCURRENC
,3. r. l|T2l Z*S5
1-48
3-10-77
-------
'M-icLL. . OK. ,;;U;jr-i
.=,
•j.
O\
^
D ',.;
^ ^
! A>» 'I - I
-------
Bl 11. K-fJLUVrK-Hl'RCULfr-i: I.'M . H'J
7.3
• <*x "^ [L
0.7
I
CL.CC;
'"* .1 f [ [ • C ^ 1 •"»
-Cr.Nl OCCURKENCL
0 .1
," ~ 1 Lll j
t
1-50
3-10-77
-------
CORPUS CHRISTI, TEXAS
9.9
0.00
0.05 0.10 0.15
Per-cent Occurence
I
0.20
17.0
1 1
1 1
1--* A-fi
7-1 n
11-16 17-21 Over 21
1-51
3-10-77
-------
r KLi'ii.K i 1.1 N ' ' M .
M .'j
"•' fi^ \\ \\
#$^ \\\\
:M\
/^
,-. r*,-\ r- f* .< *"» f-o O t **
J-OU *J • O ' * »J • y J -J-lt.
PE:R.-CLNT OCCURRENCE.
f
I
1-52
3-10-77
-=«-5>%'>rrr-.:..'j..-.-'-.^--.--:: -^•/-v':^'y-r';-'.V:«-:''y .*'.'-::s-v—•:•;-.• •••:.•• "..>-; ^.t ^--/wvv-Trw1^:
a^^;^\>^^--^V^^-^^>^^^
-------
APPENDIX 1.4
RESUMES OF RTI PROJECT STAFF
1-53 3-10-77
-------
JAMES R. CHROMY, Senior Statistician and Director,
Sampling Research and Design Center
Professional Experience
1966 to date. Research Triangle Institute, Research Triangle Park,
North Carolina 27709.
1976 - date: Director, Sampling Research and Design Center.
Responsible for coordinating research program in sampling statistics
and for coordinating sampling and other statistical support for a
wide variety of projects being conducted throughout the Institute.
1972 - 1975: Manager, Sampling Department and Senior Statistician,
Statistics Research Division. Responsible for the development of survey
designs and sampling techniques for a wide variety of projects in which
data are collected by means of sample surveys. Supervised a permanent
staff of thirteen professional statisticians, nine support personnel
and many additional temporary support staff at peak periods.
1968 - 1971: Head, Sampling Section and Senior Statistician,
Statistics Research Division. Developed sample designs for the
National Assessment of Educational Progress in 1969 and 1970. This
task included both the selection of 9-year-olds, 13-year-olds, and
17-year-old students in-school by means of a school frame and 17-year-
olds and young adults (ages 26-35), out-of-school through an area frame.
, Was responsible for the design of samples selected for other studies.
1966 - 1968: Statistician, Statistics Research Division. Develop-
ment of optimal sample designs in terms of minimum cost and maximum
precision. Assisted in the development of computer micro-simulation
population models.
1962 - 1965. Statistical Reporting Service, USDA, Lincoln, Nebraska.
Agricultural Statistician. Assisted in field office operations of agricul-
tural area surveys and objective yield estimates. Conducted monthly
cattle-on-feed mail surveys and nonresponse interview surveys.
Education
B.S., Technical Agricultural Economics, University of Nebraska, Lincoln,
Nebraska, 1964.
M.E.S., Experimental Statistics, North Carolina State University, Raleigh,
North Carolina, 1966.
Ph.D., Statistics, North Carolina State University, 1974.
Professional Activities
Alpha Zeta
American Association for Public Opinion Research
American Statistical Association
Biometric Society
Gamma Sigma Delta
International Association of Survey Statisticians
Phi Kappa Phi
1-54 3-10-77
-------
JAMES R. CHROMY (Continued)
Selected Publications
Chromy, J. R. and Hendricks, W. A. [1967]. Further Investigations of
Sampling Plans for Estimating NASO Budget Requirements. Project SU-284
Final Report, Research Triangle Institute.
Chromy, J. R. [1967], Matrices of Transitional Probabilities for a
Demographic Simulation Model. Working Paper No. 7 developed for the
Demographic Micro-Simulation Model Project. Research Triangle Institute.
Chromy, J. R. [1968]. A Generalization of the' Matrix of Probabilities
Approach for Population Micro-Simulation. Working Paper No. 19 developed
for the Demographic Micro-Simulation Project. Research Triangle Institute.
Chromy, J. R. [1968]. Methods for Assigning Ages in the Initial Population.
Working Paper No. 25 developed for the Demographic Micro-Simulation Project.
Research Triangle Institute.
Chromy, J. R. and Horvitz, D. G. [1970]. "Appendix C: Structure of
Sampling and Weighting;" Report 1, 1969-1970 Science; National Results
and Illustration of Group Comparisons. Washington, D.C.: Government
Printing Office.
Chromy, J. R., Moore, R. P., and Clemmer, Anne [1972]. "Design Effects
in the National Assessment of Educational Progress Survey," Proceedings,
Social Statistics Section, American Statistical Association, pp. 48-52.
Chromy, J. R. (Editor) [1973]. A Study of the SES and STOC Stratification
for NAEP Samples. Project 25U-796-6 Final Report, Research Triangle
Institute.
Moore, R. P., Chromy, J. R., and Rogers, W. T. [1974]. National Assess-
ment's Approach to Sampling - Year 02. National Assessment of Educa-
tional Progress, Denver, Colorado.
Chromy, J. R. [1974]. Pairwise Probabilities in Probability Non-replacement
Sampling. Ph.D. dissertation, North Carolina State University, Raleigh, N.C.
Chromy, J. R. and Horvitz, D. G. [1974]. "The Use of Monetary Incentives
in National Assessment Household Surveys." Proceedings, Social Statistics
Section, American Statistical Association, pp. 171-179.
Piper, Lanny L. and Chromy, J. R. [1975]. "Design Effects for Alphabetic
Cluster Samples." Proceedings, Social Statistics Section, American
Statistical Association.
March 1976
1-55 3-10-77
-------
LANNY L. PIPER, Statistician
Professional Experience
1972 to date. Research Triangle Institute, Research Triangle Park,
North Carolina 27709. Statistician, Sampling Research and Design
Center. Design and analyze survey samples.
Education
B.S., Mathematics, Miami University, Oxford, Ohio, 1970.
M.S., Statistics, North Carolina State University, Raleigh, North
Carolina, 1972 (National Science Foundation Fellowship)
Professional Activities
American Statistical Association, member.
Selected Publications
Chromy, J. R. and Piper, L. L. [1973]. A Survey of High School Seniors
to Determine Responses to the Job Skills Sampling Questionnaire.
Project 25U-814 Final Report, Research Triangle Institute.
Mason, R. E. and Piper, L. [1973]. Technical Report Children's
Television Workshop Surveys 1972-1973. Project 25U-683, Research
Triangle Institute.
Piper, Lanny L. and Chromy, James R. [1975]. Design Effects for
Alphabetic Cluster Samples. Presented at the 1975 Annual Meetings
of the American Statistical Association.
April 1976
3-10-77
-------
STEPHEN R. WILLIAMS, Senior Statistician
Professional Experience
1975 to date. Research Triangle Institute, Research Triangle Park,
North Carolina 27709. Senior Statistician, Sampling Research and
Design Center. Involvement in the sample design and analysis for a
variety of studies. Project or sampling leader in several large-
scale dental surveys.
1970 - 1975. Southern Research Institute, Birmingham, Alabama 35205.
Senior statistician, Economic Research and Planning Section. Project
leader on a study to design and assist in the implementation of a
statewide information system for health planning. Project leader on
numerous health studies in the areas of epidemiology, ambulatory-
health care, health-facilities planning, information systems, and the
characterization of hospital inpatients and their care. Statistics
instructor at the University of Alabama. Econometrician and bio-
statistician support on numerous and varied studies in the social
sciences field.
1960 - 1970. United States Department of Agriculture. Survey
statistician and mathematical statistician in the Research and Develop-
ment Branch. Primary responsibilities in nationwide surveys involving
area- and multiple-frame and other types of probability sampling.
Mathematics instructor at Rollins College, Winter Park, Florida.
Education
B.S., Economics, University of Wyoming, Laramie, Wyoming, 1958.
M.S., Economics, University of Wyoming, Laramie, Wyoming, 1959.
M.S. coursework requirements in Statistics, Iowa State University,
Ames, Iowa, 1963.
Completed additional courses in Statistics at George Washington
University and University of Florida, 1963-1967.
Presently pursuing Ph.D., Biostatistics, University of Alabama,
Birmingham, Alabama.
Selected Publications
Williams, S. R. [1971]. "Forecasting Florida Citrus Production,
Methodology and Development." U.S. Department of Agriculture .
Bulletin.
Williams, S. R. and Schaffer, S. [1971]. Selected Population, and
Housing Characteristics From a Sample Survey of Households in Greene
County, Alabama. Project Final Report, Southern Research Institute.
1-57 3-10-77
-------
STEPHEN R. WILLIAMS (Continued)
Williams, S. R., Tropper, P., and Schaffer, S. [1972].- A Local-Area
Information Generation System for Transportation, Housing, and
General Urban Development. Project Final Report, Southern Research
Institute.
Williams, S. R. [1974]. Ambulatory Health Care; Survey and Fore-
casting Methodology. Project Final Report, Southern Research Institute.
Williams, S. R. and Nash, E. [1974]. Factors Associated with the
Incidence of Congenital Anomolies; A Localized Investigation.
Project Report, Southern Research Institute.
Williams, S. R. and Schaffer, S. [1975]. "Health Information Systems,"
Southern Research Institute Bulletin, pp. 12-17.
Williams, S. R. and Folsom, R. E. [1976]. Bias Resulting From School
Nonresponse; Methodology and Findings. Project Report, Research
Triangle Institute.
April 1976
1-58 3-10-77
-------
APPENDIX 1.5
REFERENCES
1-59 3-10-77
-------
REFERENCES
1.1 Miesch and Huffman, "Abundance and distribution of lead, zinc,
cadmium, and arsenic in soils in Helena Valley, Montana." Area
Environmental Pollution Study (EPA Office of Air Programs
Publication No. AP-91), p. 65.
1.2 Djurie, D., et al., "Environmental contamination by lead from
a mine and smelter." Archives of Environmental Health, Vol. 23,
pp. 275-279, October 1971.
1.3 Oyanguren, H., and E. Perez, Archives of Environmental Health,
Vol. 13, p. 185, 1966.
1.4 Seeley, J. L., et al., "Determination of lead in soil." Applied
Spectroscopy, Vol. 26, No. 4, pp. 456-460, 1972.
1.5 Research Triangle Institute, Field Sampling Manual. Research
Triangle Park, North Carolina: Research Triangle Institute,
1976.
1.6 Hammer, D. I., et al., American Journal of Epidemiology, Vol. 93,
p. 84, 1971.
1.7 Barltrop, D., et al., "Significance of high soil lead concentrates
for childhood lead burdens." Environmental Health Perspectives,
Washington, D.C.: Government Printing Office, Vol. 7, pp. 78-81,
1974.
1.8 Chisolm, J. J., et al., "Variations in hematological responses
to increased lead absorption in young children." Environmental
Health Perspectives, Washington, B.C.: Government Printing Office,
Vol. 7, pp. 7-12, 1974.
1.9 David, 0., "Association between lower level lead concentrates
and hyperactivity in children." Environmental Health Perspectives,
Washington, D.C.: Government Printing Office, Vol. 7, pp. 17-25,
1974.
1.10 Anderson, D., and J. Clark, "Neighborhood screening in the
communities throughout the nation for children with elevated blood
lead levels." Environmental Health Perspectives, Washington, D.C.:
Government Printing Office, Vol. 7, pp. 3-6, 1974.
1.11 Turner, D. B., Environmental Protection Agency. Workbook of
Atmospheric Dispersion Estimates. Washington, D.C.: Government
Printing Office, 1970.
1.12 Calder, K. L., "A climatological model for multiple source air
pollution." Proceedings Second Meeting of the Expert Panel on
Air Pollution Modeling, NA 70 Committee on the Challenge of Modern
Society, Paris, France, p. 33, July 1971.
1-60 3-10-77
-------
REFERENCES (Continued)
1.13 Busse, A. D., and J. R. Zimmerman, Users Guide for the Climatological
Dispersion Model, EPA-R4-73-024. Research Triangle Park, North
Carolina, p. 133, 1973.
1.14 Holzworth, G. C., Mixing Height, Wind Speed, and Potential for
Air Pollution Throughout the Contiguous United States. Research
Triangle Park, North Carolina: Environmental Protection Agency,
Office of Air Programs (AP-101), p. 118, 1972.
1-61 3-10-77
-------
2.0 Field Operations
2.1 On-Site Project Operations (At RTI)
2.1.1 Project Staff
2.1.1.1 Overall Supervision
Field operations will be under the general supervision of James D.
Bates, Director of the Survey Operations Center (SOC) in the Statistical
Sciences Group (SSG) of the Research Triangle Institute (RTI). All SSG
activities for this research effort will be coordinated under the general
supervision of Dr. W. Kenneth Poole, Director of the Statistical Methodology
and Analysis Center (SMAC). The RTI and project administrative structures
are presented graphically in figures 2.1 and 2.2, respectively, with
RTI units likely to be involved in this research effort shaded in figure
2.1.
2.1.1.2 Survey Director
Benjamin S. H. Harris, III, Health Survey Specialist within SOC
will serve as Survey Director, assisted by survey assistant Martha L.
Smith and other survey specialists and survey assistants as required.
Working in close coordination with representatives of SMAC, the Sampling
Research and Design Center (SRDC - see section 1.0), and the Chemistry
and Life Sciences Group (CLSG - see section 3.0), the Survey Director
will be responsible for supervising the Field Operations, including the
following tasks:
. Training RTI project staff in study objectives and data collection
procedures;
Public relations at the performance sites;
2-1 3-10-77
-------
Treasurer
W. II. Perkins, Jr.
Office of Accounting
R. S. McLean
Corporate V. P.
S. C. Asbton
Office of Research
Contracts
J. C. Ragan
ro
I
to
Center for
Population
and Urban-Rural
Services
Acting
Director
Q. W. Lindsey
'////////////
/Chemistry and Life Sciences /
/ / Vice President '///
/// M. E. Wall ////
Center for
Educational
Research and
Evaluation
Director
J. A. Davis
Social Sciences
Vice President
W. C. Eckerman
Center for
the Study of
Social Behavior
Director
A. M. Cruze
Center for
Health
Studies
Director
J. T. Wakelcy
Statistical Sciences
Vice President
D. G. Horvitz
Chief Scientist
B. V. Shah
r
Center for
Development
and Resource
Planning
Director
J. A. Street
Senior Statist!
Paul G. Home
Energy, Engineering, and
Environmental Sciences
Vice President
J. J. B. Worth
:ian
yer
'//////
//Computer /
S Applications >
/. Center //
/ Director /
R. 11. Thornton'
/ Statistical '/
f Methodology and /
, Analysis Center ,
s Director /
O'W. K. Poole •'/
National Assessment
Administration Center
Director
W. K. Grogan, Jr.
X/Survey //
/ Operations '/
'/ Center //
/ Director //
'/I. D. BatesV/
1
'// ita/xy
/Research and /
s Design Center /
/ Director //
J. R. Chromy >
Fig. 2.1. Research Triangle Institute administrative structure.
-------
N>
I
U)
UNC
C. M. Shy
Epidemiologist
Program Advisor
Research Assistant
M. E. Wall
Program Director
CLSG '
R. W. Handy
Chemist
Program Advisor
SSG
W. K. Poole
Senior Biostatistician
Program Advisor
1
J . Kearney
1
Laboratory
Assistants
SRDC
J . Chromy
S. Williams
L. Piper
L. Bressler
SOC
D. Bates
B. Harris
M. Smith
SMAC-CAC
T. Hartwell
L. Bressler
Field Operations Personnel
Survey Specialists
Survey Assistants
Survey Clerks
Independent Subcontractors
Fig. 2.2. Project administrative structure,
-------
Recruitment and briefing of independent subcontractors;
Pretest of data collection instruments and procedures;
. Receipt control, verification, and entry of data; and
Quality control procedures relevant to the foregoing tasks.
2.1.1.3 Site Administrator(s)
Data collection, coordination and validation at the performance
sites will be conducted by a CLSG professional acting as Site Administrator
(SA) and independent subcontractors, with overall supervision by the
RTI Survey Director and backup administrative assistance available from
RTI's national staff of Field Supervisors (see below). The SA will be
responsible for overall coordination and quality control of data collection
at each performance site; for the collection of all air samples, general
soil and water samples, and market basket samples (see below); and for
coordination and shipment of data from the performance site to RTI.
An SA will remain at the site for the duration of data collection; the
same SA(s) at the very least will oversee such activities at sites representing
the same type smelter. At the present time, RTI anticipates that J.
Kearney will be one SA, with backup from Project Leader Handy and Survey
Director Harris (see figure 2.2).
2.1.1.4 Data Receipt Control, Scan-Edit, and Direct Entry
Data receipt control, scan-edit, and entry at RTI will be under
the general supervision of Mildred C. Pennington. Throughout planning
for and conduct of receipt control, scan-edit and entry, one experienced
Survey Assistant will be assigned to the project to provide overall supervision
of these tasks. Experienced survey clerks will check in survey instruments,
perform the scan-editing, maintain manual logs, and refer problem cases to
the Survey Assistant or Survey Director for resolution. Direct data entry
2-4 3-10-77
-------
will also be conducted under the supervision of Survey Assistant Smith,
with overall guidance from the Survey Director as needed.
Resumes of individuals named in the preceding paragraphs will be
found in appendices 2.1 and 3.1.
2.1.1.5 Training Manual
A training manual will be developed by RTI for use in training RTI
project staff and briefing independent subcontractors. This manual will
address study objectives; data collection instruments; detailed rationale
and procedures for collecting environmental and biological samples;
coding and editing instructions for all survey instruments; instructions
for administration, coordination, and quality control of all field operations;
and discussions of anticipated problems. A tentative outline for this
training manual appears in appendix 2.2.
2.1.1.6 Training Session(s) .
Before data collection begins at the first performance site, RTI
will conduct an intensive one week training session for RTI project staff,
in particular the prospective SA(s) who will be responsible for coordination
of data collection activities at the performance sites, and staff who will
be responsible for data receipt control and entry at RTI. The training
session agenda will in general resemble the training manual outline in
appendix 2.2 and will address study objectives; data collection instruments;
rationale and detailed procedures for collecting environmental and biological
samples; instructions for administration, coordination, and quality control
of all field operations; coding and editing instructions for all survey
instruments; and discussions of anticipated problems. Since data collection
2-5 12-17-76
-------
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 survey instruments appear in appendix
2.3.
Each completed survey instrument will be checked in by identification
(ID) number by project personnel on the day received; at the same time,
the document will be assigned to a batch for control purposes. Completed
survey instruments will be maintained in batches while they are in RTI's
custody.
. 2.1.2.2 Visual Scan-Edit
Following check-in and receipt acknowledgement, each document will
be scan-edited on an item-for-item basis to detect omissions, incon-
sistencies, and/or illogical or incompatible entries. Specifically, this
review is designed to verify:
That the executor understood and followed the question sequences
and intent correctly and that entries seem reasonable and
consistent;
That any sampling or skip sequences were correctly followed
and that no applicable items were omitted; and
2-7 3-10-77
-------
That each instrument is properly identified and that all items
required for verification of the individual's work were
completed.
2.1.2.3 Direct Data Entry
Following scan-edit and error resolution by telephone or other action
(see below), complete survey instruments will be coded by use of communications
terminals permitting direct data entry operations. Direct data entry means
simply that programmable terminals with keyboards and cathode ray tube
display screens are used instead of manual coding and keypunch. A programmed
format specifically designed for the survey instrument appears on the display
screen. As the terminal operator looks at the hard-copy documents, he or she
keys the responses into the terminal. The keyed data then appear instantaneously
on the display screen. The data are recorded on magnetic tape cassettes for
transmission to a computer facility. Hence, the direct data entry process
accomplishes in one step what previously has taken two steps. In addition,
time savings are substantial because of quality control opportunities
cited below.
2.1.2.4 Quality Control
RTI will use three types of quality control in processing the survey
data: a check of the survey data at the source; at the data entry point,
since the data will be entered through programmable terminals; and the
\
traditional concept of verification through re-keying.
. Reinterview: As a quality check of the interview process, RTI plans
to reinterview by telephone, personal visit, or mail, in that order of
preference, approximately ten percent of the population for whom completed
2-8 3-10-77
-------
questionnaires are obtained. The actual method of reinterview (mail,
telephone, or personal visit) will be determined according to which is
more convenient, cost-effective, and/or appropriate; telephone would
be the preferred method. RTI does not anticipate that the reinterview
process would involve the entire SQ. This procedure will actually permit
a two-fold verification: that the interview was conducted, and that
responses are consistent. In the event that inconsistent responses are
detected, an attempt will be made to determine if the inconsistencies
are due to variations in participant response or interviewer error or
misinterpretation; in the latter case, .the interviewer will be contacted
in an effort to resolve the problem.
. Visual Scan-Edit; Should a completed survey instrument fail
the visual edit check, two procedures will be implemented. First, an
attempt will be made to resolve the problem by telephone from RTI/SOC
to the site of instrument completion. Second, should the problem be
critical enough to necessitate further action, the document will be trans-
mitted to the appropriate person with specific instructions for resolution.
. Direct Data Entry; Programmable terminals, referred to in numerous
articles as -intelligent terminals, have proven to be very effective devices
for converting data to machine-readable form. These devices allow editing
at the point of data entry in a manner that was previously unavailable.
Error rates drop because operators can easily correct keystroke errors
which are normally left for the verifier when keypunches are used. Even
if the operator must go back to a previous field to make a correction,
no already keyed data are lost. As the data are entered, the terminal
checks the data for proper range or invalid punches, and if an error is
2-9 3-10-77
-------
detected, locks the keyboard. If necessary, the editing supervisor or
survey assistant can aid the data entry clerk in resolving the error.
The basic philosophy associated with direct data entry is to provide
a device that allows the operator to make easy corrections of keystroke
errors and to detect at data entry time any errors that may be corrected
by review of the hard copy instrument. Beyond these checks, it is desirable
to have a minimum of ten percent verification by re-keying to insure that
the data are converted to machine-readable form with a very low error
rate. Should an error rate of more than one percent per operator be discovered
through re-keying, 100 percent verification of that operator's work will
be carried out. The Survey Director will be provided regular reports
of the results of direct data entry quality control procedures.
2-10 3-10-77
-------
2.1.3 Confidentiality of Project Data
There are two basic areas where there should be concern about maintaining
data confidentiality: source documents (survey instruments/questionnaires)
and data tape files. RTI recognizes the need to maintain these project
documents under strict controls to insure confidentiality and record integrity.
Storage for hard-copy source documents (HSQ, PCF, and SQ) shall be in
a secure, well-ventilated, vault-like room in the basement of the Ragland
building on the RTI central campus at Research Triangle Park, North Carolina.
The room has about 600 square feet of floor space and has both wall and
free-standing shelving. Access is by one locked door, with controlled,
i.e., signed for, entry only on authority of one of the project staff
in charge of receipt control and coding operations. Materials will be
stored here, with such working amounts as are necessary being removed,
signed for by record identification, and worked on in a secure space under
supervision. Materials will be received in the mail on a daily flow basis
and, insofar as possible, be dealt with on a flow basis, with real-time receipt
control records being maintained for all processing steps. Overnight
storage of processing batches will be in a locked and secure work space.
When processing has been completed, all source documents will be filed *
in an ordered, accessible manner. During all stages of processing and
storage, project personnel will control access to and removal and replacement
of survey instruments from specified working and storage areas.
2-11 3-10-77
-------
Data tape files will be maintained on a strict need-to-know basis
throughout the extent of the project; at no time will these files be
readily accessible except under specific authority of a senior professional
working on the project. However, only the PCF will provide a link between
the various ID numbers and a specific participant's name, and the PCF
will never be converted to machine-readable form - that is, the data tape
files will never contain participant's names or addresses.
2-12 3-10-77
-------
2.1.4 Protection of Human Subjects Certification
The Department of Health, Education and Welfare has determined
that RTI should operate under the special assurance provisions of the
Protection of Human Rights regulations. Upon notification, the
Institute's Committee on Human Rights is prepared to review the data
collection forms and protocol for this study. The membership of the
Institute's Committee on Human Rights consists of:
Dr. J. N. Brown
Dr. W. C. Eckerman
• Dr. D. G. Horvitz
Dr. M. E. Wall
Mr. S. C. Ashton
Mr. R. L. Welborn
2-13 3-10-77
-------
2.2 Off-Site Project Operations (At Smelter Locations)
2.2.1 Performance Sites
2.2.1.1 Selection
The Project Officer has specified the following smelter locations
as performance sites for this research effort:
Anaconda, Montana;
. Palmerton, Pennsylvania;
Herculaneum, Missouri;
Bartlesville, Oklahoma;
Bixby, Missouri; and
Ajo, Arizona,
2
most likely in that order (see section 2.4 - Schedules for Field Operations)-?-
2.2.1.2 Public Relations
RTI plans to establish communication with certain agencies/organizations
at/regarding each performance site. These agencies/organizations will
include but not necessarily be limited to the following:
. Various federal agency representatives, including regional EPA
representatives, EPA1s Industrial Environmental Research Laboratory, and
the Center for Disease Control (CDC): These agencies have had various
interests and contacts in/with environmental studies of smelter communities,
including a recent CDC study [Ref. 2.2]; such contacts/experience may
prove useful to this research effort.
State and local health agency representatives; These agencies
may also have had various levels of interest and experience regarding
2 i/
—— In addition, RTI will perform a Pretest at one additional smelter
location, probably Corpus Christi, Texas - see appendix 2.4.
2-14 3-10-77
-------
environmental/health studies of smelter communities; such interest/
experience is expressed in correspondence such as that reproduced as
appendix 2.5 and may prove useful to this research effort. RTI will
contact appropriate representatives of these agencies in an attempt to
secure their cooperation, assistance, endorsement and participation.
In particular, RTI hopes that the assistance of these agencies might be
enlisted in securing qualified field staff and sites for training field
staff and central data collection (see below). During initial contact
with appropriate agencies, RTI hopes to make arrangements for the follow-
up of participants for whom study data collected indicate medical attention,
and participants will be informed of such arrangements (see below).
. Local education authorities; RTI will contact appropriate representa-
tives of these agencies in an attempt to secure their cooperation, assistance,
participation, and endorsement. The cooperation of appropriate education
authorities is considered essential since it will be necessary to collect
soil and water samples at each school where study children participants
attend. In addition, schools are potential sites for training field staff
and central data collection.
. Smelter representatives; RTI anticipates meeting with represen-
tatives of the smelter industry and individual smelter firms in an attempt
to secure their cooperation and inform them of study activities. The
role chosen by the smelters may have a significant impact on the cooperation
of potential participants in the smelter communities.
2-15 3-10-77
-------
. Other; In addition to the agencies listed in the preceding
paragraphs, RTI plans early meetings/discussions/investigations regarding
other elements in the smelter communities related to the logistics of
this research effort, including local electric utilities regarding power
drops for air sampling devices; transportation alternatives for independent
subcontractors, participants, and in particular the shipment of study
materials to and from RTI; hotels/motels for training and accommodation
of field staff; and municipal agencies such as the police department to
inform them of study activities.
2.2.1.3 News Releases
Once the various levels of public relations have been completed,
and the positions and levels of participation of the various agencies
have been determined, RTI plans a series of news releases, approved by
the Project Officer, through the appropriate federal, State, or local
agency to inform the public of the study's objectives and activities in
an attempt to improve cooperation by potential study participants. RTI
anticipates that all involved agencies, including the smelter(s), will
have an opportunity to review these news releases before they are released.
RTI anticipates involvement of local and area newspapers, radio, and tele-
vision in this publicity campaign utilizing news releases and public service
announcements which would explain succinctly the reasons for and potential
benefits of the study. This publicity campaign will probably start at
each performance site approximately two weeks before data collection is
to begin.
2-16 3-10-77
-------
2.2.2 Independent Subcontractors
2.2.2.1 Recruitment
While at the smelter location to contact appropriate federal, State
and/or local agencies related to the study, RTI will initiate recruitment
of field staff/independent subcontractors to participate in the actual
study data collection. RTI plans to retain two types of staff who will
work as independent subcontractors to perform data collection in the field,
coordinated by the SA:
. Field Interviewers (FI's) who would be responsible for contacting
and screening households, completing questionnaires, measuring paint lead
levels, and collecting dust and water samples and some soil samples; and
. Medical personnel such as Registered Nurses or medical technicians
to obtain the blood and hair samples, collect the urine samples, and perform
the hematocrit and urine protein and specific gravity determinations.
With regard to recruiting the field staff at each location, RTI
anticipates three potential sources:
. RTI listings: RTI has been conducting national surveys for
over 16 years and has conducted other studies involving surveys in various
parts of the nation. As a result, a current list is available of some
2,500 persons who have served RTI on one or more projects or have indicated
their availability. This list will serve as the starting point in securing
qualified individuals. Many of the persons on this list have at least
some health-related training and/or experience. For example, figures
2-17 3-10-77
-------
2.3 through 2.7 present graphically the number of interviewers from the
current RTI listing living in counties within a reasonable distance of the
performance sites in Arizona, Missouri, Montana, Oklahoma, and Pennsylvania,
respectively. That is not to say that all of these individuals would be
available or suitable for this research effort (see below).
. State and local agency contacts; RTI hopes that some qualified
field personnel might be retained through the assistance of State and local
agencies, particularly health agencies (see appendix 2.5). RTI may offer
such agencies an active role in the collection of biological samples from
household survey participants by subcontracting that aspect of the data/
sample collection to such agencies, by engaging agency personnel to work
for RTI during their off time, or by assisting RTI in retaining qualified
individuals to serve as independent subcontractors.
. Newspaper advertisements; Appropriate advertisements will be
placed in local or area newspapers.
. Interviews; Once potential field staff have been located, they
will be screened and interviewed by RTI staff, most likely the Survey
Director, in order to determine their qualifications and availability
for this research effort. At each site, RTI anticipates retaining at
a minimum three FI's and two medical staff members; an additional FI
will most likely be retained at each of the three sites where individuals
over 60 years of age will be surveyed, so that data collection can be
completed at each site in approximately one month (see below).
2-18 3-10-77
-------
LEGEND
® Places ol 100.000 01 more inhabitants
• Places of 50.000 to 100.000 inhabitants
O Places of 25,000 to 50.000 inhabitants outside SMSA's
Standard Metropolitan
Statistical Areas (SMSA's)
Fig 2.3. Location and number of interviewers from the current RTI listing
living in counties within a reasonable distance of the Ajo, Arizona,
performance site [Source: Ref. 2.3, p. 972].
2-19
12-17-76
-------
I
t-0
O
LEGEND
® Places ol 100.000 or mo'e inhabitants
• Places ol 50.000 lo 100.000 inhabitants
O Places ol 25.000 lo 50.000 inhabitants outside SMSA's
•:TT~) Standard Metropolitan
Statistical Areas iSMSA'sl
Fig. 2.4. Location and number of interviewers from the current RTI listing living in counties
within a reasonable distance of the Bixby and Herculaneum, Missouri, performance sites
[Source: Ref. 2.3, p. 995].
-------
10
to
ISJ
I
BILLINGS
YELLOWSTONE
•
BIKINGS
SCALE
O IO 2O 3O 4O SO MILC5
LEGEND
• Places of 50,000 to 100.000 inhabitants
O Places of 25.000 to 50.000 inhabitants outside SMSA's
Standard Metropolitan
Statistical Areas (SMSA's)
Fig. 2.5. Location and number of interviewers from the current RTI listing living in
counties within a reasonable distance of the Anaconda, Montana, performance site
[Source: Ref. 2.3, p. 996].
-------
to
to
to
BARTLESVILLE**
OKLAHOMA CITY -
CANADIAN ^ OKLAHOMA .
OKIAHOMA cirr
LEGEND
® Places ot 100.000 or more inhabitants
• Places of 50.000 to 100.000 inhabitants
O Places ol 25.000 to 50.000 inhabitants outside SMSA's
,*—i Standard Metropolitan
Statistical Areas (SMSA's)
10
I-1
^J
SCALE
IO »O 3O 4O 9O MILC9
Fig. 2.6. Location and number of interviewers from the current RTI listing living in counties
within a reasonable distance of the Bartlesville, Oklahoma, performance site
[Source: Ref. 2.3, p. 1006].
-------
BINGHAMTON
NJ
NJ
CO
N)
-»4
ON
I ( f ^ . /^^^l^T^ Al I CMTrMAIM
IWN r'BETHLE H EM • E ASTON
LEGEND
(•) Places ol 100.000 or more inhabitants
• Places ol 50.000 to 100,000 inhabitants
D Central cities ol SMSA's with (ewer than 50.000 inhabitants
O Places ol 25.000 to 50.000 inhabitants outside SMSA's
Standard Metropolitan
Statistical Areas (SMSA's)
SCALC
_IO JO JO
Fig. 2.7. Location and number of interviewers from the current RTI listing living in counties
within a reasonable distance of the Palmerton, Pennsylvania, performance site
[Source: Ref. 2.3, p. 1008].
-------
. Qualifications; Potential FI's should ideally be known to and/or
recommended by RTI, various State or local agencies, and/or similar organiza-
tions; present evidence of relevant survey, environmental, and/or health-
related experience; live within a reasonable distance of the performance
site; have an automobile available; be available to work irregular hours
and/or weekends; and be physically capable of carrying the survey equipment
and materials. The medical independent subcontractors should ideally
meet the above criteria, and be awcrently employed in some area requiring
acquisition of blood samples, preferably from children. In certain areas,
such as Arizona, RTI will attempt to retain experienced independent sub-
contractors who are bilingual - that is, speak English and Spanish, although
a recent RTI study demonstrated no significant difference in performance
between monolingual and bilingual interviewers working with elementary
school children and adults with limited English-speaking ability in four
areas of the United States, including parts of Texas and Arizona [Ref. 2.4].
2.2.2.2 Training
After the independent subcontractors have been recruited and before
data collection activities begin, RTI will conduct two-day briefing sessions
at each performance site to acquaint the independent subcontractors with
study objectives; survey instruments; rationale and detailed procedures
for collecting environmental and biological samples; administrative and
quality control considerations; and anticipated problems, in order to
2-24 3-10-77
-------
increase the relevance and quality of the data collected. The training
session agenda will follow closely the outline and content of the training
manual, a tentative outline of which is presented in appendix 2.2.
The training sessions will be conducted by the Survey Director,
RTI Senior Chemists, and consultants, and will be attended by the RTI
professional SA and the independent subcontractors. During the training
sessions, the independent subcontractors will be carefully instructed in
all aspects of the field work. Considerable emphasis will be placed on
the objectives and significance of the study and the nature of the data
collection. Practice interviews will be conducted to insure that each
FI becomes thoroughly familiar with household screening and interviewing
techniques and use of the survey instruments. During the first day of
household contact, which will hopefully follow immediately the training
session, the Survey Director and SA will accompany the FI's to assist
them with their first household contacts. If it becomes apparent that
any independent subcontractor needs additional training, such instruction
will be provided before the field work assignment is given.
2.2.2.3 On-Site Consultants
As a contingency, RTI plans to enlist the services of physician con-
sultants on-site to serve as points of contact for the field staff in
the event that any problems or questions are encountered in the data
collection process, particularly in regard to the acquisition of biological
samples. For example, the existence of certain disease entities such as
bleeding tendencies may preclude the acquisition of a blood sample from
a given participant.
2-25 3-10-77
-------
2.2.3 Household Data Collection
2.2.3.1 Screening
Once RTI/SRDC has designated the data collection areas/grids within
each performance site related to distance downwind from the smelter; data
collection instruments and forms have been approved by the Office of Manage-
ment and Budget (OMB); and the field staff have been retained and trained,
household data collection will begin.
FI's will be primarily assigned to specific areas or grids within
the smelter community; this procedure should facilitate the FI's familiarity
with and recognition within that area or grid. Data will be collected
by door-to-door interview. Each residence unit encountered in each data
collection grid will be visited in sequence. Within each residence unit
so encountered, households will be screened to determine those containing
eligible individuals - that is, those (1) with no direct occupational
exposure to the smelter within the preceding 12 months, (2) who have lived
within the smelter study area for at least the preceding 12 months, and
(3) who fall within one of the four study age groups: pre-school 1-5 years
or 12-72 months of age, school age 6-18 years of age, and adults 20-35
years of age (with an option to age 40), and in three sites 60 years of
age or greater. Such eligibility will be determined by the FI as part
of the household data collection process. A residence unit within the
data collection grid may contain more than one household containing an
eligible study participant. Similarly, such a household may contain more
than one eligible study participant. Each eligible person in those residence
units will be invited to participate in the study until the required number
and distribution of participants is obtained.
2-26 3-10-77
-------
At the time of first household contact, the FI will introduce himself
as a representative of RTI and EPA; present study identification and
(hopefully) copies of letters from appropriate federal, State and local
agencies; and explain the nature and purpose of the study. The FI will
maintain a log record of residence units and households visited and screened
on a Household Screening Log (HSL - see appendix 2.3). Screening of the
household to determine whether or not it contains eligible individuals
will be determined by administration of the HSQ (see appendix 2.3). RTI
anticipates a certain number of nonrespondents, or households which cannot
be screened; nonparticvpants or refusals; and -ineligibles, . or households
which contain no eligible respondents. If an eligible person refuses to
participate in the study, the refusal and the reason(s) therefore will
be noted on the HSL. Visits to screen potential households or to enlist
participants will be limited to three.
2.2.3.2 Participant Consent Form
When an eligible person within a household agrees to participate,
the precise location of the residence unit will be noted on a map at
the time of the enlistment, so that the distance of the residence unit
from the smelter can be accurately calculated. In addition, the
individual will be required to sign a Participant Consent Form (PCF - see
appendix 2.3) in order to participate in the study.
2-27 3-10-77
-------
The PCF will introduce the study; explain its objectives,
sponsorship (the relationship and roles of RTI and EPA), and re-
quirements of and risks, burdens, and benefits to participants; and
stress that participation is completely voluntary and that all data
collected will be kept confidential. The PCF will hopefully contain
an indication of the support and/or involvement of appropriate State and
local agencies; the names and telephone numbers of appropriate authorities
so that participants may obtain additional information if desired; and
inform the participants of arrangements with these agencies for appropriate
follow-up of any study participants for whom study data collected indicate
a need for medical attention. The PCF will be signed by the participant
or, in the case of persons under age 18, the parent or other responsible
guardian, and will contain an agreement to provide the necessary information
and samples, including a specific release and arrangements (appointed
time and place) to draw blood. Participants may freely withdraw from
the study at any time; however, in order to encourage participation RTI
will offer an incentive of ten dollars to each participant to be paid
after the blood sample is obtained. Again, confidentiality of data will
be stressed, including steps taken to disassociate the name of the par-
ticipant from the data once collected; for example, the PCF is the only
data collection instrument which will bear the name of the participant
and allow its association to study identification numbers, but will be
2-28 3-10-77
-------
maintained in hard copy only and stored in a restricted area, as indicated
in a previous section. To further emphasize this disassociation, the
incentive will be paid in cash rather than by check or money order, although
the participant or his/her guardian will sign a receipt indicating that
the incentive was received. The PCF will make two copies, one for the
head of the household and one for the participant or his/her guardian;
the original will be attached to the questionnaire until it is received
at RTI and verified. Where required, the PCF will be available in more
than one language - for example, English and Spanish for Arizona.
2.2.3.3 Study Questionnaire
The Study Questionnaire (SQ - see appendix 2.3) is divided into four
parts, Part A related to the household and which will be completed only
once for each household containing at least one participant; Part B related
to the individual participant; Part C providing information on the interviewer
and respondent; and Part D recording paint lead levels and the results
of hematocrit and urine protein and specific gravity determinations,
and indicating whether or not corresponding and duplicate environmental
and biological samples were obtained, and the date, time, and place of
acquisition of such samples. Participants will be identified by a unique
study number used to correlate and cross-identify the questionnaires
and samples (see below) by way of pre-printed self-adhesive labels.
Household information includes questions related to family socioeconomic
status (occupations, educational levels), and questions related to food
2-29 3-10-77
-------
sources and preparation. Information on individual participants includes
demographic characteristics such as age, sex, race, marital status,
occupation, and education level; residence information; health informa-
tion such as current health status and history of exposure to heavy
metals, including questions related to symptoms of clinical and sub-
clinical toxicity; personal characteristics such as exposure to cigarettes
and various drugs and sundries, and average number of hours spent outside
each day; and dietary information such as exposure from foods high
in heavy metal content [Ref. 2.5] and history of pica, the ingestion of
non-food substances such as paint, clay, and plaster. In addition, for
children participants, information will be collected on location of play
area(s) and school(s) attended.
2.2.3.4 Sample Collection
The specific methods proposed by RTI for measuring environment-
related factors differ somewhat among the various types of exposure.
These differences reflect several considerations such as the extent to
which surrogate variables reflect the factors of interest, the measur-
ability of factors, the variability of factor measurements, the quality
control of data collection, and the suitability of data collection techniques
under actual survey conditions. The proposed methodology stresses random
sampling techniques wherever possible to facilitate valid statistical
analyses and to increase the degree of control over data collection;
FI's will follow explicit, nonjudgmental procedures throughout. These
2-30 3-10-77
-------
procedures will range, as described in appendix 2.6, from obtaining small
selective samples of relatively homogeneous items, such as tap water
at a particular residence, to obtaining large stratified random samples
for a highly variable item, such as air quality in a smelter community.
As indicated in preceding sections, data collection will be divided
among the various field staff. The collection of environmental samples
will be divided between the SA and the FI. The SA will be responsible
for collecting air, market basket, and general soil and water samples
such as soil and water samples from each school where study children
participants attend; RTI anticipates that more than one school age child
participant may attend the same school. The FI will be responsible for
the selection and screening of residence units, households, and eligible
participants; acquisition of the PCF and administration of the SQ; collection
of dust and tap water samples for each participating household, and soil
samples from the appropriate play area for each pre-school child participant;
measurement of paint lead levels; explanation of the procedure for collecting
the urine sample; and arrangements for the participant to go to a central
location for acquisition of the biological samples and disbursement of
the incentive. At that central location, the urine, blood and hair samples
will be collected by the medical independent subcontractor, who will
also perform the hematocrit and urine protein and specific gravity deter-
minations.
For each household containing a study participant, paint lead levels
will be measured, samples of housedust and tap water will be collected,
and the precise location of the residence noted on a map so that the distance
of the residence unit from the smelter can be accurately calculated. For
2-31 3-10-77
-------
each study participant, RTI shall endeavor to obtain a completed PCF and
SQ, and samples of blood, urine, and scalp hair; in addition, soil samples
will be collected from the appropriate play area for each pre-school child
participant and from each school yard where study children participants
attend.
2.2.3.5 Quality Control
Two aspects of quality control will directly involve the participating
households and individuals - duplicate samples and reintewLew. For
households/participants for whom duplicate samples are to be collected,
the purpose and procedures for collecting the duplicate samples (see below)
will be explained. Each person completing an HSQ or an SQ will be informed
that they may be selected for reinterview.
2-32 3-10-77
-------
2.2.4 Central Data Collection
As indicated in preceding sections and paragraphs, RTI plans to arrange
for the collection of biological samples at a central location which would
be manned by at least one medical staff member and probably an FI for
four hours in the evening Monday through Friday and eight hours during
the day on Saturdays. Participants would come to this location to deposit
their urine samples and permit the collection of blood and scalp hair
samples. In addition, hematocrits and urine protein and specific gravity
determinations will be performed at this location. In the event that
a participant does not have transportation to the location, RTI will be
prepared to provide transportation. In the event that the participant's
physical condition makes travel impractical, such as an elderly, disabled,
or otherwise infirm person, the medical staff member may have to go to
the home in order to obtain the necessary samples. Ideally, the biological
samples will be collected the day after the participant is enlisted or
during the day on the next Saturday.
2-33
3-10-77
-------
2.2.5 Site Administrator's Responsibilities
At each performance site, the SA will have three areas of responsibility:
(1) general supervision and coordination of field operations; (2) collection
of certain general samples; and (3) data management, handling, and shipment.
2.2.5.1 Coordination of Field Operations; Data Management
«
As indicated in preceding sections, an RTI professional will serve
as SA and as such be responsible for the coordination and quality control
of data collection; these individuals will remain at each site for the
duration of data collection at that site, and at the very least the same
individual(s) will oversee such activities at sites representing the same
type smelter. The SA will work in close communication with the Survey
Director and other professionals at the RTI central facility at Research
Triangle Park, North Carolina, in order to coordinate and supervise immediate
field operations at each performance site. The SA will have to coordinate
his own project activities with those of the independent subcontractors
to ensure that various project activities proceed as effectively and efficiently
as possible with regard to both time and cost. The SA will also serve as
a trouble-shooter.
Among the field operations which the SA will have to coordinate
are:
Obtaining household mapping information, copies of HSLs, HSQs,
and administrative forms, and soil, tap water, and housedust samples from
the FI's;
2-34 3-10-77
-------
Scheduling and transportation of participants to the central
data collection facility for collection of biological samples, including
delivery of the completed PCF and SQ to the central data collection facility;
and
Retrieval of the completed PCFs, SQs and biological samples
from the central data collection facility.
2.2.5.2 Sample Collection
As intimated and discussed in preceding sections and appendix 2.6,
the SA will be responsible for collecting random air samples in the
smelter community, composite soil samples from the smelter community at
large as well as from each school yard where study children participants
attend, water samples from each school where study children participants
attend, and market basket samples.
2.2.5.3 Data Storage, Packaging and Shipment
With regard to survey instruments, the SA will only be responsible
for shipping the completed PCFs and SQ's to RTI/SOC, although he will
receive copies of HSLs, HSQs, and various administrative forms from the
appropriate independent subcontractors for review and reference as needed.
All samples will be chilled to 0°-5°C (not frozen) after collection
and will be shipped in this condition via Federal Express. Shipment by
Federal Express eliminates the possibility of sample contamination due
to pressure gradients in transit. High density polyethylene containers
will be used for tap water, urine and soil samples; Poly-Seal caps will
be used to provide a leak-proof seal without contamination. Plastic containers
will be shipped in styrofoam blocks in which depressions are cut to exactly
hold each container. RTI experience with such shippers has resulted in no
container damage and a minimum of sample temperature change during transit.
2-35 3-10-77
-------
Zip-Loc plastic containers will be used for air, scalp hair and dust
samples. RTI experience with Zip-Loc plastic containers indicates that
the Zip-Loc seal insures containment protection eliminating sample loss
and contamination. The plastic bags will be shipped in a styrofoam-lined
box.
Blood samples will be shipped to RTI in specially designed 8-tube
Vacutainer shippers. As with other samples, blood samples will be chilled
(not frozen) in order to reduce losses due to hemolysis and volatilization.
2-36 3-10-77
-------
2.2.6 Quality Control
2.2.6.1 Training
In order to standardize the quality of data collection techniques
and procedures from the outset, a training manual will be developed by
RTI for use in training RTI project staff and briefing field interviewers.
This manual will address study objectives; data collection instruments;
detailed rationale and procedures for collecting environmental and
biological samples; instructions for administration, coordination, and
quality control of all field operations; instructions for data receipt
control, scan-edit, and entry; and discussions of anticipated problems
(see appendix 2.2). In addition, RTI will conduct training sessions for
RTI project staff and independent subcontractors which will address study
objectives and procedures in order to increase the quality and relevance
of data collected. One major objective of the training activities will be
to provide explicit, nonjudgmental procedures for the field staff to follow.
2.2.6.2 Supervision
The RTI Survey Director will supervise and coordinate the field
operations, providing flexibility of coverage should additional pro-
fessional level effort be required at any time during the data
collection period. An SA will remain at the performance site until
data collection is completed, and the same SA(s) will be used at least
for sites of the same smelter type. RTI plans to enlist the services
of physician consultants on-site to serve as points of contact for the
field staff in the event that any medical problems or questions are
2-37 3-10-77
-------
encountered in the data collection process, particularly in regard to
the acquisition of blood samples.
The Institute has a field operations staff of Field Supervisors (FSs)
located at key points across the country who have coordinated the work
of field data collection staffs for a variety of projects and will be
available to assist with supervision and/or coordination of data collec-
tion for this project if required. These area supervisors are currently
based in or near the following major metropolitan areas: Boston, New
York, Washington, Atlanta, Pittsburgh, Detroit, Chicago, St. Louis,
Houston, Los Angeles, and San Francisco. At the very least, the appropriate
FSs will be made aware of project activities and provided a copy of the
training manual; depending upon time and cost considerations, the appropriate
FS may be invited to attend the training session at the performance site.
In order to facilitate supervision, both RTI/SOC and the SA will re-
ceive copies of the HSLs, HSQs and various administrative forms completed
by independent subcontractors which will provide an opportunity to monitor
the production and activity of the field staff.
As indicated in preceding sections, the Survey Director and SA will
accompany the independent subcontractors during the first day of data
collection at each performance site. The SA will be encouraged to meet
frequently with independent subcontractors to review study progress and
problems, and independent subcontractors will be observed occasionally in
the performance of their duties. Survey instruments will be edited upon
receipt at RTI/SOC.
2.2.6.3 Sample Collection
Each sample will be properly labeled as it is collected. Each individual
sample will be treated the same as all other samples of that particular type.
2-38 3-10-77
-------
2.2.6.4 Duplicate Sample Collection
As a check on the quality or precision of collecting certain
of the biological and environmental samples, RTI plans to collect
duplicate soil, housedust, tap water, blood, and scalp hair samples (the
last two from adult participants only) from ten percent of the sample
sources, using the same technique and as nearly as possible the same sites
as the original sample (see appendix 2.6). In the event that problems
are detected, an attempt will be made immediately to determine the cause
and appropriate resolution of the problem.
2.2.6.5 Reinterview
As a quality check of the interview process, RTI plans to reinter-
view by telephone, personal visit, or mail, in that order of preference,
approximately ten percent of the population for whom completed questionnaires
are obtained. The actual method of reinterview (mail, telephone, or
personal visit) will be determined according to which is more convenient,
cost-effective, and/or appropriate; telephone would be the preferred
method. RTI does not anticipate that the reinterview process would .involve
the entire SQ.
This procedure will permit a two-fold verification - that the interview
indeed took place and that responses are consistent. In the event that
inconsistent responses are detected, an attempt will be made to determine
if the inconsistencies are due to variations in participant response or
FI error or misinterpretation; in the latter case, the FI will be contacted
in an effort to resolve the problem.
2-39 3-10-77
-------
2.2.7 Respondent/Participant Burden
The only anticipated risk to participants will involve the acquisition
of the blood sample, and the burden will consist of the time to respond
to the questionnaire(s), the time and inconvenience of allowing the FI
into the household to collect the household environmental samples; and
the time, inconvenience and perhaps minor discomfort of providing the biological
samples (see below). In order to complete household data collection,
approximately two hours of time may be required of each participant, including
travel and the collection of all relevant samples. More specifically,
RTI anticipates that 45 minutes will be required to complete the question-
naire (s) for each participant, 30 minutes will be required to collect
the household environmental samples, and 20 minutes will be required to
obtain the biological samples, leaving 25 minutes for travel time to the
central data collection facility.
To offset this burden, RTI will offer the incentive of ten dollars
per participant and an opportunity to obtain some health measurements, such
as the hematocrit, urine protein, and the various analyses for metal burden.
Potential participants will be informed of arrangements with appropriate
area agencies for the followup of study participants for whom study data
indicate medical attention.
2-40 3-10-77
-------
2.3 Anticipated Problems
RTI has identified the following potential problem areas which may have
a significant impact on project time, cost or validity.
2.3.1 Smelter Resistance
RTI has assumed that the smelter industry will provide at the very
least a promise of verbal cooperation or passive resistance. In the event
that the smelter takes.a position of active resistance, project performance
at a given site might be seriously jeopardized, since most of the performance
sites are relatively small communities whose economy is significantly influenced
by the smelter.
2.3.2 Recruiting Independent Subcontractors
Since the six performance sites were not specified prior to the
signing of the contract, RTI predicated field operations costs on the
assumption that qualified independent subcontractors could be retained
at, or within a reasonable distance of, the smelter community performance
site. Should RTI be unable to find qualified independent subcontractors
at, or within a reasonable distance of, the performance site, they will
have to be brought into the performance site from more distant points
at an additional expense for travel and subsistence.
2.3.3 Nonparticipants
As indicated in preceding sections, RTI anticipates a certain number of
nonrespondents, nonparticipants, and ineligibles. However, in some of these
small smelter communities, these various categories of nonparticipants may
significantly reduce the number of data sets available for analysis. Through
callbacks and the incentive, RTI hopes to keep nonrespondents and non-
2-41
3-10-77
-------
participants at a minimum, but eligibility is determined by established criteria.
In some of these small smelter communities, for example, the number of
adult men without direct occupational exposure may be small.
2.3.4 Incomplete Data Sets
Even though an individual may agree to participate in the study and
sign a PCF, a complete set of questionnaires and samples for that individual
may not be obtained for a variety of reasons such as baldness, inability
or refusal to provide a scalp hair or urine sample, or refusal to provide
a blood sample. RTI has anticipated some of the potential problems in
obtaining complete data sets and made appropriate provisions, such as
offering an incentive to be paid only after collection of the blood sample;
transportation to and from the central data collection facility; and
arranging for the medical independent subcontractors to visit the participant
at home to collect the biological samples if necessary. Nonetheless,
participation in this survey is voluntary and the small size of most
of these smelter communities limits the number of eligible volunteers.
Therefore, RTI will accept as a minimum data set a blood sample and completed
HSQ, PCF, and SQ.
2.3.5 Missing Data
Since various data elements must be shipped to RTI from the performance
site via Federal Express and/or mail, the possibility exists for those data
elements to be lost or damaged so as to not be useable. In the past, RTI
has had little problem with regular first class mail.
2-42 3-10-77
-------
2.4 Schedules for Field Operations
2.4.1 Time Schedule
Figure 2.8 presents graphically a time schedule for the field
operations, including preparations, data collection in the field, and
data processing. In figure 2.8, tasks at RTI are as follow:
Task 1 - Preparation of work plan and data collection instruments;
Task 2 - Review and revision(s) of work plan and data collection
instruments;
Task 3 - Preparation of training manual;
Task 4 - Training session;
Task 5 - Data receipt control, edit and direct entry;
Task 6 - Reinterview; and
Task 7 - Preparation of final report.
For each performance site, Phase I refers to public relations,
recruitment of independent subcontractors, and publicity; Phase II
refers to training; and Phase III refers to data collection. This
time table is predicated on approval of study protocol and data
collection instruments by EPA and OMB early in 1977. In order to
minimize interviewer and participant burden, RTI anticipates that
field operations at each site would be conducted during temperate
weather; some studies have indicated that weather plays a significant
role in project efficiency and participation. [Ref. 2.6]
At this point in time, RTI anticipates that the performance
sites would be studied in the following order:
Pretest - Corpus Christi, Texas;
Performance site 1 - Anaconda, Montana;
2 - Palmerton, Pennsylvania;
3 - Herculanuem, Missouri;
2-43 3-10-77
-------
to
I
I
M
O
RTI
PRETEST
PERFORMANCE
SITE 1
2
3
4
5
6
TIME
FRAME
TASKI
P^ '"k *,
l*.'...*..~f '
0 N D
1976
iisK'i' '„ '^V/'.j
...'....{ "^''.Sl5. ,./Jm.j
TASK 3i:;:i;:^|TASK 4
>99<>?$^>6<5<>^^
TASK| 11 | | | 1
ii
i i,*;i
ii
i | i !
ii
r i «.i
ii
• i » i
ii
1 \ 1 »« 1
II
i | m i
n
1 • 1 *-
J F M A M J J A S 0 1 N D
1977 1977
S56I
TASK 7
J F M
1978
Fig. 2.8. Field operations time table.
-------
4 - Bartlesville, Oklahoma;
5 - Bixby, Missouri; and
6 - Ajo, Arizona.
It is further anticipated that the elderly age group will be studied
at Herculanuem, Bartlesville, and Ajo.
2-45 12-17-76
-------
2.4.2 Cost Schedule
Figure 2.9 presents graphically cumulative estimated cost (exclusive
of fee) and labor (man-months) projections by month for the field operations.
These cost and labor projections are based on figure 2.8 and predicated
on the same assumptions.
2-46 3-10-77
-------
I
M
?
• • MAN-MONTHS
• COST
Fig. 29 Field operations cost and labor projections.
-------
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
2-50 12-17-76
-------
CURRICULUM VITAE
V . , STEPHEN HUNTER CEHL3ACH
Born; January 14, 1942, in Moline, Illinois
Education; Academic; Received A.B. degree, Harvard College 1964.
Graduated from Case Western Reserve School of
Medicine (1963)
Internship and Residency; Mixed medical-pediatric internship
at the Royal Victoria Hospital in
. * Montreal, Quebec
• *
One year residency in pediatrics
• at Childrens1 Hospital Medical Center
in Boston
1 v<
/.:'./' One year residency in pediatrics at
>:; • . . ..Duke Medical Center
Military Service: Served tvo years in U. S. Public Health Service assigned to
the North Carolina State Board of Health as Field Epidemiologist
working primarily in the field of general-communicable disease j-_
control
Llcensure; North Carolina, December, 1971 •• . • '
Publications; (coauthor): "Haernolytic Anaemia in Infectious Mononucleosis Due
Inapparent Congenital Spherocytosis," Scand. J. Haemat.,
' •' . '7: 141-144, 1970.
(coauthor): '"Clinical Reactions Following Rubella Vaccination,"
JAMA, 220: 1569-1572, 1972.
(coauthor): "Coccidioidomycosis," Arch. Int. Med., 131: 254-255,
1973.'
(coauthor): "Spread of Disease by Fecal-Oral Route in Day
Nurseries," HSMHA Health Reports, 83: 320-322, 1973.
2-51
12-17-76
-------
PUBLICATIONS: Gehlbach, S., Cooper, B., "Haemolytic Anaemia in Infectious
Mononucleosis Due Inapparent Congenital Spherocytosis,"
Scand. J. Haemat., 7: 141-144, 1970.
1 Grand, M., Wyll, S., Gehlbach, S., "Clinical Reactions Following
Rubella Vaccination," JAMA, 220: 1569-1572, 1972.
Gehlbach, S., Hamilton, J., Conant, N., "Coccidioidomycosis,"'
Arch. Int. Med., 131: 254-255, 1973.
Gehlbach, S., MacCormack, J., Drake, B., Thompson, W., "Spread of
Disease by Fecal-Oral Route in Day Nurseries," HSMHA Health Reports,
88: 320-322, 1973. . ; '
Gehlbach, S., Williams, W., Woodall, J., Freeman, J., "Pesticides
and Human Health - An Epidemiologic Approach," Health Service
Reports, 89: 274-277, 1974. '.
Gehlbach, S., Williams, W., Perry, L., Woodall, J., "Green Tobacco
Sickness - Ann Illness of Tobacco Harvesters," JAMA, 229: 1880-
1883, 1974. • .
Roe, C., Schonberger, L., Gehlbach, S., et. al.: "Enzymatic
Alterations in Separate Outbreaks of Reye's Syndrome:
Prognostic Implications", presented to the Reye's Syndrome
-^Conference, Columbus, Ohio, October, 1974.
Gehlbach, S., Williams, W.: "Pesticide Containers.: Their
Contribution to Poisoning," Arch. Env. Health, 30: 49-50, 1975.
Landrigan, P.J., Gehlbach, S.H., Rosenblum, B.F., etc."Epidemic
lead absorption near an ore smelter, N.E.J.M. 292: 123-219,
1975.
Roe, C. R., Schonberger, L.B., Gehlbach, S.H., Wies, L.A. and
Sidbury, J.B., "Enzymatic alterations in Reye's syndrome:
Prognostic implications", Pediat. 55: 119-126, 1975.
Gehlbach, S.H., Gutman, L.T., Wilfert, C.M., Brumley, G.W.,
and Katz, S.L. "Recurrence of skin disease in a nursery:
Ineffectually of hexachlorophene bathing", Pediat. 55:
422-424, 1975.
Gehlbach, S.H., Williams, W.A., et.al.: "Nicotine absorption
by workers harvesting green tobacco", Lancet 1: 478-480, 1975.
Gehlbach, S.H., and Williams, W.A.: "Epidemiology of pesticide
poisonings in North Carolina", (Abstract) Pediat. Res., 4:
297, 1975.
2-52 12-17-76
-------
BENJAMIN S. H. HARRIS, III, Health Survey Specialist
Professional Experience
1964 to Date. Research Triangle Institute, Research Triangle Park,
North Carolina 27709.
1974 - date: Health Survey Specialist, Survey Operations
Center, Statistical Sciences Group. Currently Project
Leader of a follow-back study of children who received
diagnostic doses of radioactive iodine over the period
1946-1967; Survey Director of a study of heavy metal
absorption by persons living near non-ferrous smelters;
Task Leader of tasks related to establishment and coordina-
tion of an Advisory Committee, training and quality con-
trol of record'abstractors, and hospital nonresponse in
a national survey of the incidence, prevalence, and costs
of traumatic injury to the central nervous system; Task
Leader of off-site and data collection activities related-
to the evaluation of, and exploration of alternatives to,
the Hospital Discharge Survey; also involved in a study
of the outcomes of alternative modes of treating prostatic
carcinoma. Major contributor to the evaluation of the
Mecklenburg County, North Carolina, Alcohol Safety Action
Project and the establishment and maintenance of a national
registry of chronic intermittent dialysis patients; and
monitored grant review committees for the National Institute
on Alcohol Abuse and Alcoholism (NIAAA).
1971 - 1974: Medical Science Analyst, Center for Health
Studies. Project Leader of a study of diagnosis and deter-
mination of disability in alcoholism; the preparation of a
directory of State and local alcoholism services; and a pilot
follow-back study of patients treated for tuberculosis in the
North Carolina Sanitorium system during the period 1930-1950
by pneumothorax and pneumoperitoneum with fluoroscopy. Super-
vised survey of Medicare procedures used by physicians in
selected metropolitan areas; major contributor to a study
involving the collection and analysis of data relating to civ-
ilian techniques in international development assistance, and a
survey of attitudes and capabilities of major hospitals in
North Carolina regarding the handling of patients involved in
radioactive accidents. Coordinated site visits to alcoholism
treatment centers sponsored by NIAAA and prepared a summary and
evaluation of the site visit process, assisted with the Third
Annual Alcoholism Conference of NIAAA, and involved in the
medical evaluation of the supplemental food program for Women,
Infants, and Children. Assisted in the preparation of new con-
tract proposals related to health services, and served as a
consultant to the Craven County (N.C.) Health Department in the
preparation of a proposal to the North Carolina Regional Medical
Program.
2-53 12-17-76
-------
-2-
1966 - 1971: Health Services Analyst, Operations Research
and Economics Division. Principal Investigator on studies of
hospital utilization in the last year of life and the economic
costs of kidney disease; major contributor to study of the post
nuclear attack prevention and control of communicable respi-
ratory diseases; supervised survey of drug usage among arrestees
for serious crimes in selected metropolitan areas; research on
the economic costs of alcoholism and excessive fertility.
1964 - 1966: Biologist, Natural Products Laboratory. Respon-
sible for biological assays and pharmacologic evaluation of
synthetic and naturally-occurring toxic agents, the Immediate
operation of the Institute's animal colony, coordinating the
Laboratory's bio-assay program, and assisting in the preparation
of new contract proposals in bio-medical areas.
1961 to 1964. Duke University Medical Center, Durham, North Carolina 27710.
Research Assistant, Department of Psychiatry, Division of Electroencephalo-
graphy (EEC). Research activities included portable EEC, the EEC in various
types of epilepsy, guides for teaching EEC, neurophysiologic changes in
the brain of the cat after administration of hallucinogens, and changes
in electrical activity resulting from drowsiness and psychopharmacologic
agents; preparation of Keysort data cards for classification and conden-
sation of EEC's; and recording EEC's in operating rooms during neurosurgical
procedures. • During this time also served as junior staff psychiatrist,
John Umstead (State mental) Hospital, Butner, North Carolina.
Education
B.A., Zoology, Duke University, Durham, North Carolina, 1960.
Graduate work in medicine, Duke University School of Medicine, 1960-1965.
Course in Operations Research, Georgia Institute of Technology, Atlanta,
Georgia, 1968.
San Diego Summer School of Alcohol Studies, University of California,
San Diego, 1972.
Honors
President, Pre-med scholastic honorary society, Duke University, 1959-60.
NIMH student research stipends, summers of 1961 and 1963.
Who's Who in North Carolina, 1973.
2-54 12-17-76
-------
-3-
Selected Publications
"Experience with Portable Electroencephalography in a General Hospital."
Electroencephalography and Clinical Neurophysiology. 1963, 15:1047
(Abstract of paper presented to Southern EEC Society, Durham, N.C.,
November 17, 1962).
"Psychiatric Problems in Children with Frontal, Central and Temporal Lobe
Epilepsy." Southern Medical Journal, 1966, 59:49-53, coauthor.
"Murine Toxicity of Cochliobolus carbonum." Applied Microbiology. 1968,
16(11):1710-1722, coauthor.
"Interictal Focal or Lateralized Discharges Occurring in the Electroencepha-
lograms of Patients Suffering From Centrencephalic Epilepsy." Confinia
Neurologica. 1968, 30:368-374, coauthor.
The Economic Cost of Kidney Disease and Related Diseases of the Urinary
System (PHS Pub.' No. 1940). Washington, D.C.: U.S. Government Printing
Office, 1970.
"Estimation of a Potential Hemodialysis Population." Medical Care. 1970,
8(3):209-220, coauthor.
"The Number and Cost of Medicines Prescribed for the Treatment of Patients
with Selected Diseases." Inquiry. 1970, 7(3):38-50.
Postattack Communicable Respiratory Diseases. Research Triangle Park, N.C.:
Research Triangle Institute, 1970, coauthor.
Care in Hospitals and Institutions During the Last Year of Life by Cause of
Death; United States, 1962-1965 Deaths. Washington, D.C.: U.S. Depart-
ment of Commerce, National Technical Information Service, '1972 (NTIS
Accession No. PB-208-639).
Military Civic Action Final Report, Volume I: Evaluation of Civilian Tech-
niques in International Development Assistance. Research Triangle Park,
N.C.: Research Triangle Institute, 1972.
Medical Facilities - Control of Radioactive Materials in North Carolina
Transportation Accidents (RM-24U-754). Research Triangle Park, N.C.:
Research Triangle Institute, 1973.
"Alcohol Abuse: An Overview." Adit; Approaches to Drug Abuse and Youth,
1973, 2(1):1-2, 11-15.
Mecklenburg Alcohol Safety Action Project; An Analysis of Ultimate
Performance Measures to Determine Total Project Impact. Research
Triangle Park, N.C.: Research Triangle Institute, 1974.
"Edgar Allan Poe on Sullivan's Island." South Carolina Magazine, 1975,
39(2):8-15.
Evaluation Reports I and IV; Hospital Discharge Survey Evaluation Study.
Research Triangle Park, N.C.: Research Triangle Institute, 1976, coauthor.
2-55 12-17-76
-------
MILDRED C. PENNINGTON, Research Assistant II
Professional Experience
1973 to date. Research Triangle Institute, Statistics Research Division,
Research Triangle Park, North Carolina 27709. Research Assistant to the
manager and supervisor of the clerical staff of the Survey Methodology and
Operations Department.
1942-1973. United States Department of Agriculture
1961-1973: United States Department of Agriculture, Statistical
Reporting Service and the North Carolina Department of Agriculture,
Division of Agricultural Statistics, Raleigh, North Carolina. Sta-
tistical Assistant to the statistician and supervisor to the clerical
staff of the Input and Collection unit.
r
1942-1961: United States Department of Agriculture, Standards and
Research Division, Statistical Research Laboratory, Institute of
Statistics, North Carolina State University, Raleigh, North £arolina.
Act as assistant to the statistician and supervisor to the clerical
staff of the Survey Operation Group.
Education
Needham Broughton High School, Raleigh, North Carolina 1935
Attend one week course on Supervision and Group Performance, Atlanta,
Regional Training Center, Atlanta, Georgia, 1971
Professional Activities
Association for Coordination Interagency Statistics, North Carolina State
Departments, 1971-1972; member.
February 1973
2-56 12-17-76
-------
CURRICULUM VITAE
Carl M. Shy
I. Born: October 23, 1931 - Milwaukee, Wisconsin
Married: June 6, 1959
Wife: Eve Carol (nee Ruciich) • '
Children: Leslie (3/26/60) •
Rosalie (4/2/62)
Ann (6/4/65) ' ; .
II. Pre-Medical Education: 1. A.B. St. Louis University,.1956
Major in Philosophy and Economics
2. St. Louis and Marquette Universities, 1956-57
Graduate Studies in Philosophy and Economics
III. Medical Education:
Year
1.' 1958-1962
Location
Marquette University.
School of Medicine
2. 1960 (Summer) Marquette University
School of Medicine
3. 1962-1963
4. 1963-1964
"5. 1964-1965
6. 1965-1967
University of Michigan
University of Michigan
Medical Center
University of Michigan
School of Public Health
University of Michigan
School of Public Health
Appointment and D?gres
Medical Student, M.D.
received June 1952
Student Fellowship
(2 months) in Physiology
Intern (Straight Medicine)
Resident I in Internal
Medicine
Student in Department of
Epidemiology: M.P.H.
Received May 1965
Student in Department of
Epidemiology: Dr.P.H.
Received April 1957
IV. Post-Doctoral Public Health, Medical and Academic Experience:
Year Location Appointment
1.- 1967-1971
U.S. Public Health Service
National Air Pollution
Control Administration
(Mow the Environmental
Protection Acjr.vicy)
Durham, North Caroline. •
Epidemiologist and Chief,
Epidemiology Branch,
Division of Health Effect
Research
2-57
12-17-76
-------
-2-
2. 1971-1972
3. 9/72-12/73
4. 1968-1973
5. 1969-Present
6. 1970-Present
7. 1971-Present
8. 1968-Present
1971-Present
9. 1/74-Present
Environmental Protection
Agency, Office of Research
and Monitoring, Division
of Health Effects Research,
Research Triangle Park,
North Carolina
Environmental Protection
Agency, Office of Research
and Monitoring, National
Environmental Research
Center, Research Triangle
Park, North Carolina
University of North
Carolina
Department of Epidemiology
Duke University
Deputy Director
Division of Health
Effects Research
Director, Human Studies
Laboratory (Final Civil
Service Grade was GS-16)
Adjunct Assistant Professor
Assistant Clinical Professo;
of Epidemiology (Part-tinse-
Appointment)
Journal of Chronic Diseases Editorial Consultant
Wake County Hospital
State of Ohio
State of North Carolina
University of North Carolina
Staff Member, Medical Night
Clinic (General Pediatric
and Internal Medicine
Practice)
Medical Li censure
Medical Li censure
Director, Institute of
Environmental Studies
Lecturer, Department of
Epidemiology, School of
Public Health
2-58
12-17-76
-------
-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 radioisotope ranograrn,
Harquotte Msd. Rov. 26:139-147, 1951.
2. Shy, C.M.: Diagnostic procedures for determining hypertension of renal
origin. Marquette Msd. Rev. 26:194-199, 1961.
3. Meade, R.C. and Shy, C.M.: The evaluation of individual kidney function
using radioiodohippurate sodium. J. Urol. 86:163-170, 1961.
4. Shy, C.M.: A comparison of psychoanalytic and philosophical thought.
Harquette Ned. Rev. 27:61-67, 1962.
5. Shy, C.M.: Of Man and Machines (Student Editorial). Marquette Mad. Rev
*
6. Associate editor of Vol. 27, No. 3 (March 1962) issue of Marquette Mad.
Rev.
7. Shy, C.M.: The pituitary-thyroid relationship in Graves' disease.
Marquette Med. Rev. 27:162-166, 1962. •
8. Shy, C.M.: The determinants of the one-second forced expiratory volume,
as a measure of chronic obstructive lung disease, in a.total population stud;
Doctoral dissertation submitted and accepted in partial fulfillment of the
requirements for the degree of Doctor of Public Health, April 1957. Dissert?
is available in microfilm form from University Microfilms, Ann Arbor, Michig;
9. Shy, C.M., Creason, J.P., Pearlman, M.E., McClain, K.E., Benson, F.B. anc
Young, M.M. The Chattanooga School Children Study: Effects of Community
Exposure to Nitrogen Dioxide. 1. Methods, Description of Pollutant Exposure
and Results of Ventilatory Function Testing. J. Air Pollution Control Assoc.
20:539-545, August 1970.
10. Shy, C.M., Creason, J.P., Pearlman, M.E., McClain, K.E., Benson, F.B. and
Young, M.M. The Chattanooga School Children Study: Effects of Community
Exposure to Nitrogen Dioxide. 2. Incidence of Acute Respiratory Illness.
J. Air Pollution Control Assoc. 20:582-588, September 1970.
11. Shy, C.M.: Health Effects. Chapter in National Emissions Standards
Study, A Report to Congress, 1970.
12. Cohen, A.A., Shy, C.M.,'Benson, F.B., Riggan, V.'.R. and Hcv/ill, V.A.: Air
Pollution Episodes: Guides for Health Departments and Physicians. HSMHA Heal
Reports, June 1971.
13. Hammer, D.I., Finklea, J.F., Hendricks, R.H., Shy, C.M. and Hoi-ton, R.J.M
Hair Trace Metal Levels and Environmental Exposure. Amor. J. Epic!. 93:B4-92,
February 1971.
2-60 12-17-76
-------
-5-
14. Pearlman, M.E., Finklea, J.F., Shy, C.M., VanBruggen, J.B. and Newill,
V.A.: Chronic Oxidant Exposure and Epidemic Influenza. Environmental
Research, June 1971.
15. Pearlman, M.E., Finklea, J.F., Creason, J.P., Shy, C.M., Young, M.O.
and Horton, R.J.M.: Nitrogen Dioxide and Lower Respiratory Illness, Pediatri;
47(2), February 1971.
16. Shy, C.M.: Environmental Epidemiology. Chapter in Environmental Hancibor
for .International Students. University of North Carolina, (In Press), 1972.
17. Hammer, D.I., Finklea, J.F., Hendricks, R.H., Hinners, T.A., Riggan, W.B.
and Shy, C.M.: Trace Metals in Human Hair as a Simple Epidemiologic Monitor
of Environmental Exposure. Trace Substance.in Environmental Health, Vol. 5,
1972.
f
18. Cohan, A.A., Dromberg, S., Buechley, R.'.-/., Heiderscheit, L.T. and Shy,
C.M.: Asthma and Air Pollution from a Coal-Fueled Power Plant. Arnsr. J.
Public Health 62:1181-1188, September 1972.
19. Mauser, T.R. and Shy, C.M. Position Paper: NO Measurement. Environ. Sc
and Techno!. 6:890-894, October 1972. X
20. Shy, C.M., Hasselblad, V., Heiderscheit, L.T. and Cohen, A.A.: Environmc
Factors in Bronchial Asthma. Published in Environmental Factors in Respiratc
Disease, 1972.
.21. Love, G.J., Shy, C.M., Calafiore, D.C., Benson, F.B. and Finklea, J.F.:
The Strategy for Determining the Effects of Environmental Pollution on Human
Health. Environ. Letters 3(1):13-20, 1972.
22. Pinkerton, C., Creason, J.P., Shy, C.M., Hammer, D.I., Bueckleys R.W. anc
Murthy, G.K.: Cadmium Content of Milk and Cardiovascular Disease Mortality.
Trace Substances in Environ. Health, Vol. 5, 1972.
23. Riggan, W.B., Hammer, D.I., Finklea, J.F., Hasselblad, V., Sharp, C.R.,
Burton, R.M. and Shy, C.M.: CHESS - A Community Health and Environmental
Surveillance System. Published in Proceedings of Sixth Berkeley Symposium or
Mathematical Statistics and Probability, Vol. VI, Effects of Pollution on
Health, University of California Press, 1972.
24. Finklea, J'.F., Cranmer, M.F., Hammer, D.I., McCabe, L.F., fiewill, V.A.
and Shy, C.M.: Health Intelligence for Environmental Protection: A Demandir
Challenge. Published in Procacdings of the Sixth Berkeley Symposium on Mith;:
tical Statistics and Probability, Vol. VI, Effects of Pollution on Health,
University of California Press, 1972.
2-61 12-17-76
-------
-6-
25. Pearlman, M.E.., Finklea, J.F., Creason, J.P., Shy, C.M., Young, M.M.
and Morton, R.J.M.: Nitrogen Dioxide and Lov/er Respiratory Illness.
Published in October 18, 1971 issue of Modern Medicine. (Abstract)
26. Shy, C.M.: Referee for Article "Air Pollution: A Major Public Health
Problem" by Ayres, Evans and Bue'nler. Published as CRC Critical Review in
Clinical Laboratory Sciences, January 1972.
27. Shy, C.M., Hasselblad, V., Burton, R.M., Nelson, C.J. and Cohen, A.A.:
Effects of Air Pollution on Ventilatory Function of U.S. School Children:
Results of Studies in Cincinnati, Chattanooga and Mew York. Arch. Environ.
Health 27:124-128, September 1973.
28. Nelson, C.J., Shy, C.M., English, T., Sharp, C.R., Andleman, R., Truppi,
L. and VanBruggen, 0.: Family Surveys of Irritation Symptoms During Acute Air
Pollution Exposures: 1970 Summer and 1971 Spring Studies. J. Air Poll. Ccntr.
Assoc. 23:81-86, February 1973.
29. Shy, C.M. and J.F. Finklea. Air Pollution Affects Coraiunity Health.
Environ. Sc. and Techn. 7:204-208, March 1973.
30. Shy, C.M., J.F. Finklea, D.C. Calafiore, F.B. Benson, W.C. Nelson and
V.A. Newill. A Program of Community Health Surveillance Studies (CHESS).
.Published in Determination of Air Quality - Proceedings of the ACS
Symposium on Determination of Air Quality, p. 41-48, Plenum Press,
New York-London, 1972.
31. Shy, C.M., C.J. Nelson, F.B. Benson, R.S. Chapman, W.B. Riggan and V.A.
Newill. Ventilatory Function in School Children: 1967-1958 Testing in
Cincinnati Neighborhoods. Published in Health Consequences of Sulfur Oxides:
A Report from CHESS 1970-1971. In press.
32. Shy, C.M., V. Hasselblad, J.F. Finklea, R.M. Burton, M. Pravda, R.S.
Chapman, and A.A. Cohen. Ventilatory Function in School Children 1970-1971
Testing.in New York Communities. Published in Health Consequences of Sulfur
Oxides: A Report from CHESS 1970-1971. In Press.
33. Shy, C.M., W.B. Riggan, W.C. Nelson, R.C. Dickerson, F.B. Benson, J.F.
Finklea, A. Colucci, D.I. Hammer, and V.A. Newill. An Overview of CHESS.
Published in Health Consequences of Sulfur Oxides: A Report from CHESS
1970-1971. In press. . .
34. Finklea, J.F., C.M. Shy, G.J. Love, C.G. Hayes, W.C. Nelson, R.S. Chapman
and D.E. House: Health Consequences of Sulfur Oxides: Summary and
Conclusions Based Upon CHESS Studies of 1970-1971. Published in Health
Consequences of Sulfur Oxides: A Report from CHESS 1970-1971. In press.
35. Shy, C.M.: Transportation and Health. In Proceedings of the Coni^cticut
Conference on Transportation, Connecticut Lung Association, 1973, I.", prc-ss.
2-62 12-17-76
-------
-7-
VII. In-House Technical Reports and Inter-Agency Experience in Federal
Government:
1. Shy, C.M., Hammer, D.I., Goldberg, H.E., Newill, V.A. and
Nelson, W.C. Health Hazards of Environmental Lead. (To be
submitted for publication.) Revised March, 1972.
2. Love, G.J., Shy, C.M., Calafiore, D.C., Benson, F.B. and
Finklea, J.F. The Strategy for Determining the Effects of
Environmental Pollution on Human Health.
3. Member of combined EPA-DHEW Environmental Health Task Force to
prepare a report to Congress entitled "Human Health and Environ-
mental Pollution." April-May, 1971, published in 118 Congressional
. . Record S. 4169, March 17, 1972.
4. Staff member in preparation of Air Quality Criteria documents for
nitrogen oxides, carbon monoxide and photochemicel oxidants.
March-September, 1970.
5. Member of EPA Health Planning Task Force to identify EPA health
• research needs in relation to legislative mandates and agency
directives, and to plan a consolidated EPA health research pro-
gram: July - November, 1971.
6. Member of EPA Task Force to revise existing air quality criteria
for sulfur oxides: May-July, 1972.
7. Assistant to Dr. Vaun Newill, Chief, Health Effects Branch, EPA
Headquarters in developing submission to the President's New
...-;:... Technology Initiatives Program, Washington, D. C., November -
December 1971. Submission was accepted and funded for FY
. 1973-1977.
8. Member of Federal Inter-Agency Ad Hoc Committee on Classification
of Toxic Substances: November 1972 - present (December 1972).
9. Co-Chairman with Dr. David Rail for Project "Biological and Genetic
Effects of Pollution" as part of the US/USSR Environmental
Agreement, November 1972 - Present.
10. Submission of contract proposal "Environmental and Familial Determinants
of Respiratory Disease in Adolescents" for National Heart and Lung
Institute, March 7-April 7, 1972; Shy, Chapman, House, and DeSantis.
11. Finklea, J.F., M. J. Cranmer, D. I. Hammer, L. J. McCabe, and C. M.
Shy.- Health Intelligence for Environmental Protection: A Demanding
Challenge.
12. Love, G. J., C. R. Sharp, J. F. Finklea, C. M. Shy and J. Knelson.
Atmospheric Levels of Air Pollution Producing Significant Ham;,
June 13, 1972.
2-63 12-17-76 •
-------
-8-
13. Shy, C. M. Health Effects of Various Ambient Air Concentrations
of Lead. EPA Position Paper Developed at Request of Director,
National Environmental Research Center, RTF, N.C., October 12,
1971.
14. Shy, C. M. Health Research and Air Quality Criteria. Chapter
VIritten for Revision of Air Quality Criteria for Sulfur Oxides,
June 1972 (Unpublished).
2-64 . 12-17-76
-------
-9-
VIII. Papers Presented at Scientific and Other Public Hastings
1, The Cincinnati School Children Study. The effects of air pollution
on ventilatory performance of elementary school children. Presented
at the annual meeting of the Society for Epidemiologic Research,
Washington, D.C., May, 1968.
2. The determinants of the one second forced expiratory volume in an
epidemic logic study 'of a total community (Tecumseh, Michigan).
Presented -at the annual meeting of the American Public Health As-
sociation, Detroit, Michigan, November, 1968.
3. The Cincinnati and Chattanooga School Children Air Pollution Studies.
• . Presented at the meeting of the U.S. -Japan Cooperative Science
Group, Boston, Massachusetts, February, 1969.
4. An epidemic! ogic study of the effects of nitrogen dioxide exposure
on a population. Presented at the annual meeting of the Tennessee
Public Health Association, Nashville, Tennessee, October, 1959.
5. Ca] A national Health Effects Surveillance Natv/ork.
Cb'l Air Pollution and Asthma.
(c) Air Pollution and Acute Respiratory Disease.
(dj Cigarette Smoking and Epidemic Influenza. Papers presented
at the Arizona Chest Disease Symposium, Tucson, Arizona,
March, 20-22, 1970.
6. Monitoring the Health Effects of Air Pollution Control. Presented
at the Southeastern Industrial Health Conference, Gatlinburg,
. Tennessee, October 1, 1970.
7. Health Hazards of Automobile Emissions. Presented at the Mid-
Atlantic sectional meeting of the Air Pollution Control Association,
Harrisburg, Pennsylvania, October 8, 1970.
8. The Chattanooga Schoolchildren Study. Effect of Atmospheric Nitro-
ge'n Dioxide Exposure on the Incidence of Acute Respiratory Disease.
Presented at the 98th annual meeting of the American Public Health
Association, Houston, Texas, October 26, 1970.
9. Air Pollution and Acute Respiratory Disease. Presented at the Third
Annual New York State Conference on Air Pollution, Albany, New York,
October 29, 1970.
10. Shy, C.M. Health Hazards of Proposed Fossil Fueled Powar Plant in
Astoria, Queens, New York. Citizens for Clean Air, New York, New
York, October, 1970.
2-65 12-17-76
-------
11. "Shy, C.M. Repeat of above. New York City Common Council Hearings.
New York, New York, December, 1970.
12. Shy, C.M. Health Hazards of Carbon Monoxide. West Virginia
State Medical Society Annual Meeting, Charleston, West Virginia,
January 30, 1971.
13. Shy, C.M. Asthma and Air Pollution. West Virginia State Medical
Society Annual Meeting, Charleston, West Virginia, January 31, 1971.
14. Shy, C.M. Community Health and Environmental Surveillance Studies.
Colloquim for Foreign Scientist-Visitors, Duke University, January
16, 1971.
15. Shy, C.M. Briefing on Mercury, Cadmium .and Lead as Hazardous
Substances. Presented to National Air Quality Criteria Advisory
Committee, Rockville, Maryland, March 18, 1971.
16. Shy, C.M. A Program of Co-tunity Health and Environmental
Surveillance Studies (CHESS). Presented at the annual meeting
.of the American Chemical Society, Los Angeles, April, 1971.
17. Shy, C.M., Hammer, D.I., Hendricks, R.H., Hinners, T. and
Finklea, J.F. Hair as an Epidemiologic Tool to Quantitate
Trace Element Body Burdens. Presented at the Fifth Annual
Conference on Trace Substances and Health, Columbia, Missouri,
June, 1971.
»
18. FinJOea, J.F., Cranmer, M.F., Hammer, D.I., McCabe, L.J., Nev/ill,
V.A, and Shy, C.M. Health Intelligence for Environmental Protection:
A Demanding Challenge. Presented at the Sixth Berkeley Symposium
on Mathematical Statistics and Probability, Berkeley, California,
July 19, 1971.
19. Burton, R., Morris, C., Shy, C.M., Benson, F.B. and Heiderscheit, L.
A Community Survey of Cigarette Smoking and Alveolar Carbon Monoxide.
Presented at the 99th annual American Public Health Association,
Minneapolis, Minnesota, October 11-15, 1971.
20. Shy, C.M., Hasselblad, V., Burton, R.H., Cohen, A.A., Pravda, M.
and Deutscher, S. Is Air Pollution in New York City Associated
With Decreased Ventilatory Function in Children. Presented at the
99th annual American Public Health Association, Minneapolis,
Minnesota, October 11-15, 1971.
21. Shy, C.M. Chairman, Symposium on Epidemioloqic Methods to Measure
BioloGic Response to Environmental Pollution. Annual Meeting of
Society for Epidemiologic Research, Atlanta, Georgia, Hay, 1971.
22. Shy, C.fl. Asthir.a and Air Pollution. Presented at annual necjti'ng
of Southeastern Allergy Association, Asiieville, fl.C., October, 1071.
2-66 12-17-76
-------
23. Shy, C.M. and associates. Effect of Atmospheric Participate
Matter and Sulfur Dioxide on Ventilatory Performance of
Children. Presented at annual treating of American College
of Chest Physicians, Philadelphia, Fa., October, 1971.
24. Shy, C.M. Health Effects of Motor Vehicle Emissions. Presented
at annual Southeastern Industrial Health Conference, Gatlinburg,
Tennessee, November, 1971.
25. Shy, C.M. Evaluation of Health Hazards of Fuels and Fuel Additives.
Presented at Annual Public Hearing on Long Range Medical Aspects of
Air Pollution, Rutgers Medical School, Piscatav/ay, Mew Jersey, _
March, 1972. .
26. Report on Health Consequences of Sulfur Oxides: A Report from
CHESS 1970-71 to the iiational Air Quality Criteria Advisory
Committee, Washington, D. C., November 16, 1972.
27. Presentation at the EPA Research Seminar for Federal Agencies,
Washington, D. C., ••oveinber 20, 1972.
28. Chairman, Workshop on Multiple Factors in Disease at the New York
Academy of Sciences International Symposium on Pulmonary Reactions . •
to Organic Dusts, New York, November 8, 1972.
29. Shy, C. M., et al. Effects of Air Pollution on Ventilatory Function
'' of U. S. School Children: Results of Studies in Cincinnati, Chattanc
and New York. Presented at the American Medical Association, Air
Pollution Medical Research Conference, Chicago, Illinois, October
2-3, 1972.
30. Shy, C. M. Health Consequences of Environmental Deterioration.
Presented at the Conference on the Environment, Chapel Hill, North
Carolina, December 1, 1972.
31. Shy, C. M. Testimony at Court Hearing, Tampa, Florida, April 26,
1972, Regarding Health Effects of S0_ and Participate Emissions.
S Cf
32. Shy, C.M. Air Pollution and Its Relation to Respiratory Disease
(CHESS).. Presented at the Scientific Session, Association of
Pediatric Pulmonary Centers, American Academy of Pediatrics, New
York, M. Y., October 14, 1972.
33. Shy, C.M. Reported Results of the CHESS Program at Regional Meeting
of the Council on Environmental Quality, Public and Occupational
Health.of the American Medical Association, Washington, D.C.,
December 1, 1972; and v/ith Dr. Finklea summarized EPA's health
research program to the same AMA Council, December 9, 1972.
2-67 12-17-76
-------
34. Shy, C.M. Adverse Health Effects of Transformed Products of SCL
Emissions - Resulted from CHESS Program. Presented at Weather and
Air Pollution Committee Session, American Academy of Allergy,
Washington, D. C., February 9, 1973.
35. Shy, C.M. Additional Analysis of 7-City Lead Study. Presented to
EPA's Hazardous Materials Advisory Committee, Washington, D. C.,
February 26, 1973.
36. Shy, C.M. Air Pollution Epidemiology. Presented to Sophomore Medica
Students, Duke University Medical Center, .Durham, N. C., February 27.
1973.
37. Shy, C.M. Briefing on CHESS Program for Science Nev/sv/riters, Washing
D. C., March 2, 1973.
>
38. Shy, C.M. Effects of Low Levels of Oxi.dants and N0? Upon Humans.
Presented at CRC Automotive Air Pollution Symposium, Washington, D. C
March 8, 1973.
39. Shy, C.M. Health Intelligence for Air Quality Standards. Presented
Meeting of the President's Air Quality Advisory Board, St. Louis, Mar
27, 1973. .
40. Shy, C.M. Assessing Environmental Health Effects in Populations.
Presented at Annual Meeting of N. C. Tuberculosis and Respiratory
Disease Association, Wrightsville Beach, N: C., April 13, 1973.
41. Shy, C.M. Health Effects of Environmental Contaminants. Presented
at Annual Meeting of the American Industrial Health Conference, Denva
Colorado, April 17, 1973.
42. Shy, C.M. Transportation and Health, Presented at the Connecticut
Conference on Transportation, Hartford, Connecticut, May 16, 1973.
-'i
43. Shy, C.M. Human Health Effects of Nitrogen Dioxide Exposure: A
Review. Presented at the National Academy of Science, National
Research Council Conference on Health Effects of Air Pollutants,
October 4, 1973.
2-68 12-17-76
-------
-13-
IX. Awards and Honors
Superior Service Medal, U.S. Public Health Service, June 1971
Quality Increase (GS 14/2 to 14/3} February, 1970
Delta Omega National Honorary Public Health Society, May 1955
Scientific Writing Award, Marquette Medical Review, June 1962
Alpha. Omega Alpha National Honorary Medical Fraternity, June 1961
Second Place, Gram!ing Memorial Student Medical Essay, September 1960
2-69 '. 12-17-76
-------
MARTHA LILLIAN SMITH, Survey Assistant
Professional Experience:
1973 to Date.
1972 to 1973.
1965 to 1972.
1964 to 1965.
Summer.
1962 to 1963.
Research Triangle Institute, Statistics Research Division
Research Triangle Park, North Carolina.
Survey Assistant on New Towns Study, National Longitudinal
Study of High School Class of 1972, Supervisor of
Microfilming Department, Survey Assistant on a Thyroid
Neoplasm Study and Study of Head and Spinal Cord Injury.
Resident Counselor, Smith College, Northampton, Mass.
Assisted Dr. Betty Spear, Chairman, University of Mass.,
Department of Women's P. E. in Developing a historical
research project for a national convention of the
American Association of Health P. E. and Recreation.
President, graduate class.
Western Guilford High School, Greensboro, North Carolina,
Teacher of health, P. E., and mathematics. Coached varsity
track and field, basketball and golf. Chairman of boys
and girls P. E. Department. Chaired department's self study
for Southern Assoc. of Accredtion. Supervisor of student
teachers. Advisory Committee on Girls Athletics of the
N. C. High School Athletic Association.
Union Pines High School, Cameron, North Carolina. Teacher
of health, P. E., and government. Coached varsity and
junior varsity basketball.
General counselor, Camp Lakeside, Hendersonville, North
Carolina.
Director of the girls camp, Camp Lakeside, Hendersonville,
North Carolina.
Head tennis counselor, Camp Ton-A-Wanda, Hendersonville,
North Carolina.
Director of programming and counseling, Camp Mountain Lake,
Hendersonville, North Carolina.
Trip director, Tripp Lake Camp, Poland Maine.
2-70
12-17-76
-------
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 (WIG). Director of Biochemistry Laboratory. July 1973 to present.
Presentations
Annual Meeting of the American Society of Biological Chemists, San Francisco,
California, June 16, 1971.
Annual Meeting of the Tissue Culture Association, Lake Placid, New York, June 7,
1971.
Annual Meeting of the North Carolina Academy of Sciences, Wilmington, North
Carolina, May 3, 1969.
Annual Meeting of the Federation of American Societies for Experimental Biology,
Atlantic City, April 9, 1974.
Teaching Experience
The University of North Carolina 1972-present.
1. NUTR 200, Cell Biology (lecture) and NUTR 201 Cell Biology Laboratory
taught jointly with Dr. John J.B. Anderson.
2. NUTR 202, Nutritional Biochemistry taught jointly with Dr. J.C. Edozien
and Dr. John J.B. Anderson.
3. Faculty member of 1973 Summer Program in Health Sciences sponsored by
North Carolina Health Manpower Development Program.
4. BIOC 8, Biochemistry for Dental Hygiene Students, taught jointly by
several faculty members.
5. BIOC 226, Biochemical Regulations, taught jointly by several faculty
members.
Research advisor for 1 or 2 students and have not directed any masters or
doctoral dissertation research previously.
2-73
-------
Special Assignments
Self-study Report of the Department of Nutrition, 1972.
Self-study Report of the School of Public Health, 1972.
Task Force Report for the Research and Development Board of the North Carolina
Public Health Association, March to August 1973.
Member of the Vitamin A Panel of the Institute of Nutrition, Jan. 1973 to
present.
Chairman of Doctoral Advisory Committee in the Department of Nutrition, 1974
to present.
Chairman of M.P.H. Comprehensive Examination Committee in the Department of
Nutrition, October 1974 to present.
Chairman of the Fellowship and Traineeship Committee, School of Public Health,
1974-75.
Member of the Safety Committee, School of Public Health, 1974-75.
Member of the Board of Scientific Directors, Institute of Nutrition, Feb. 1975
to present.
2-74 12-17-76
-------
Boyd Ray Switzer, Ph.D.
BIBLIOGRAPHY
1. Bowman, N.S., Rice, D.E., and Switzer, B.R. Magnetic Nonequivalence in
Derivative of a-Hydroxy Acids. J. Am. Chem. Soc. 89:4477, 1965.
2. Switzer, B.R., Waters, M.D., and Summer, G.K. Studies on Regulation of
Alkaline Phosphatase Activity and Collagen Biosynthesis in Human Skin
Fibroblasts (abstract). Fed. Proc. 28:901, 1969.
3. Switzer, B.R., Summer, G.K., and Waters, M.D. Protein Biosynthesis in
Mammaliam Cell Cultures (abstract). J. Elisha Mitchell Society 85:115,
1969.
4. Switzer, B.R. and Summer, G.K. Improved Method for Hydroxyproline Analysis
in Tissue Hydrolysates. Anal. Biochem. 39:487, 1971.
5. Switzer, B.R. and Summer, G.K. A Modified Fluorometric Micromethods for
DNA. Clin. Chim. Acta. 32:203, 1971.
6. Switzer, B.R. Studies on Collagen Biosynthesis in Human Skin Fibroblasts.
Dissertation, 1971.
7. Switzer, B.R. and Summer, G.K. Effect of Ascorbate and Medium Change on
Human Fibroblasts in Culture (abstract). In Vitro 6:383, 1971.
8. Switzer, B.R. and Summer, G.K. Studies on Collagen Biosynthesis in Human
Skin Fibroblasts (abstract). Fed. Proc. 30:1195, 1971.
9. Switzer, B.R. and Summer, G.K. Collagen Synthesis in Human Skin Fibro-
-blasts. Effect of Ascorbate, a-Ketoglutarate and Ferrous Ion on Proline
Hydroxylation. J. Nutrition 102:721, 1972.
10. "Switzer, B.R. and Summer, G.K. Inhibition of Collagen Synthesis by a,a'-
Dipyridyl in Human Skin Fibroblasts in Culture. In Vitro 9:160, 1973.
11. Waters, M.D., Summer, G.K., Switzer, B.R., Moore, R.D. and Heitkamp, D.H.
Alkaline Phosphatase Activation and Collagen Synthesis in Human Skin
Fibroblasts in Culture. Exptl. Cell Res. 80:170, 1973.
12. Switzer, B.R., Zand, T., Niehaus, N.J., and Edozien, J.C. Effect of Diet
on Fasting Plasma Immunoreactive Insulin (abstract). Fed. Proc. 33:669,
1974.
13. Edozien, J.C., Niehaus, N.J. and Switzer, B.R. Effect of Diet on Fasting
Plasma Catecholamines in Rat (abstract). Fed. Proc. 34:881, 1975.
2-75 12-17-76
-------
APPENDIX 2.2
TENTATIVE TRAINING MANUAL OUTLINE
2-76 3-10-77
-------
1.0 Introduction
1.1 Research Triangle Institute (RTI)
1.2 Environmental Protection Agency
1.3 Background: Related and Previous Studies
1.4 Study Objectives
1.5 RTI Project Staff and Structure
1.6 Project Timetable
2.0 Preparations for Field Operations
2.1 Involvement of Other Agencies
2.2 News Releases
3.0 Overview of Field Operations
3.1 Introduction and Purpose
3.2 Sampling Considerations
3.3 Survey Instruments
3.4 Household Data Collection
3.5 Confidentiality
3.6 Quality Control
3.7 Supplies Required for Conduct of Field Work
3.8 Disposition of Supplies
4.0 Household Contact and Data Collection
4.1 Preparation
4.2 Screening
4.2.1 Assignment of Field Staff
4.2.2 Sampling Considerations
4.2.3 Explaining the Study ..
2-77 3-10-77
-------
4.2.4 Household Screening Questionnaire
4.2.5 Household Eligibility
4.2.6 Household Screening Log
4.2.7 Problems
4.2.7.1 Nonrespondents
4.2.7.2 Nonparticipants
4.2.7.3 Ineligibles
4.3 Household Data Collection
4.3.1 Participant Consent Form
4.3.2 Study Questionnaire
4.3.3 Sample Collection
4.3.3.1 Household
Soil (Pre-school age only)
. Tap Water
House Dust
. Paint Lead
4.3.3.2 Individual
. Urine
Scalp Hair
. Blood
4.3.4 Incentive
4.3.5 Liaison with Central Data Collection Facility
4.3.6 Quality Control
4.3.6.1 Labels
4.3.6.2 Duplicate Samples
4.3.6.3 Reinterview
2-78 3-10-77
-------
4.3.7 Problems
4.3.7.1 Refusals
4.3.7.2 Incomplete Data Sets
4.3.7.3 Transportation for Participants to Central
Data Collection Facility
4.4 Survey Instruments: Administration
4.4.1 Household Screening Questionnaire
4.4.2 Participant Consent Form
4.4.3 Study Questionnaire
4.4.3.1 Household Information
4.4.3.2 Individual Information
4.4.3.3 Interviewer/Respondent Information
4.4.3.4 Sample Information
4.5 Sample Collection Methodology
4.5.1 Soil
4.5.2 Tap Water
4.5.3 House Dust
4.5.4 Paint Lead
4.5.5 Urine
4.5.6 Scalp Hair
4.5.7 Blood
4.5.8 Quality Control: Duplicate Samples
4.6 Central Data Collection
4.6.1 Overview
4.6.2 Scalp Hair Sample
2-79 3-10-77
-------
4.6.3 Blood Sample
4.6.4 Hematocrit
4.6.5 Urine Sample
4.6.5.1 Urine Protein
4.6.5.2 Specific Gravity
4.6.6 Quality Control: Duplicate Samples
4.6.7 Problems
4.6.7.1 Incomplete Data Sets
4.6.7.2 Adverse Participant Reaction
4.7 Work Schedule
5.0 Administrative Procedures
5.1 Reporting
5.1.1 Household Screening Log
5.1.2 Production, Time and Expense Reporting
5.2 Contacts
5.2.1 RTI Staff
5.2.2 Site Administrator
5.2.3 Central Data Collection Facility
5.2.4 Local Consultants and Agencies
5.3 Special Problems
6.0 Data Receipt Control and Entry (RTI Staff and Site
Administrator(s) Only)
6.1 Survey Instruments
6.1.1 Household Screening Log
6.1.1.1 Receipt
6.1.1.2 Batching
6.1.1.3 Scan-Edit
6.1.1.4 Direct Data Entry
2-80 3-10-77
-------
6.1.2 Household Screening Questionnaire
6.1.2.1 Receipt
6.1.2.2 Batching
6.1.2.3 Scan-Edit
6.1.2.4 Direct Data Entry
6.1.3 Participant Consent Form
6.1.3.1 Receipt
6.1.3.2 Batching
6.1.3.3 Scan-Edit
6.1.4 Study Questionnaire
6.1.4.1 Receipt
6.1.4.2 Batching
6.1.4.3 Scan-Edit
6.1.4.4 Direct Data Entry
6.2 Results of Chemical Analysis
(Chemical Analysis Report Form)
6.2.1 Receipt
6.2.2 Batching
6.2.3 Scan-Edit
6.2.4 Direct Data Entry
6.3 Quality Control
6.3.1 Scan-Edit
6.3.1.1 Visual
6.3.1.2 Direct Data Entry
6.3.2 Re-keying
6.3.3 Reinterview
6.3.3.1 Household Screening Questionnaire
6.3.3.2 Study Questionnaire
2-81 3-10-77
-------
7.0 Site Administrator Responsibilities (RTI Staff and
Site Administrator(s) Only)
7.1 Coordination of Field Operations
7.1.1 Training Sessions
7.1.2 Local Agencies
7.1.3 Independent Subcontractors
7.1.4 On-Site Consultants
7.1.5 Field Supervisors
7.1.6 Central Data Collection Facility
7.2 Sample Collection
7.2.1 Air
7.2.2 Soil
7.2.3 Water
7.2.4 Market Basket
7.3 Data Management and Shipment
7.3.1 Survey Instruments
7.3.1.1 Household Screening Questionnaires
7.3.1.2 Household Screening Logs
7.3.1.3 Participant Consent Forms
7.3.1.4 Study Questionnaires
7.3.1.5 Independent Subcontractors' Production,
Time and Expense Reports
7.3.2 Environmental Samples
7.3.2.1 Air
7.3.2.2 Soil
7.3.2.3 Water
7.3.2.4 House Dust
2-82 3-10-77
-------
7.3.3 Biological Samples
7.3.3.1 Urine
7.3.3.2 Scalp Hair
7.3.3.3 Blood
7.4 Special Problems
APPENDIX: Glossary of Terms
2-83 3-10-77
-------
APPENDIX 2.3
SURVEY INSTRUMENTS
2-84 3-10-77
-------
RESEARCH TRIANGLE INSTITUTE
OMB No.
Approval Expires
STUDY OF HUMAN TISSUE HEAVY METAL BURDEN IN
NON-FERROUS SMELTER COMMUNITIES
HOUSEHOLD SCREENING LOG
Site Number
Segment Number
Interviewer Number
Date
Day of Week
(Month)
(Day) (Year)
tsehold
mber
•
Street Address
i
Eligible
Household
Member(s)
Yes
No
Member(s)
Agree(s) to
Participate
Yes
No
Number
of
Participants
Reason (s) for Nonparticipation. Nonresponse, or
Ineligibility
•
2-85
3-10-77
-------
OMB No.
AD pro vf I ExpirM
RESEARCH TRIANGLE INSTITUTE
STUDY OF HUMAN TISSUE HEAVY METAL BURDEN IN
NON-FERROUS SMELTER COMMUNITIES
NOTICE: The information recorded on this questionnaire wilt b« held in strict confidence, and will b« usad >olaly for medical
rasaarch into tha effect! of environmental factors on public haalth. All result! will be summarized for groups of people; no
information about individual parsons will ba ralaasad without tha consant of tha individual. This questionnaire is authorized by law
(43 U.S.C. 1857 as amended). While you are not required to respond, your cooperation is needed to make the results of tha survey
comprehensive, accurate, and timely.
HOUSEHOLD SCREENING QUESTIONNAIRE
1. Site number: [ | 2. Segment number: | [ | 3. Interviewer number | | | |
4. Household number: | | | | 5. Date: | | | - | | | - | | |
(Monthl
lYearl
8. What is the exact address of this residence?
(Street Number and Nemel
(Apartment Humbert
(Citrl (Sate)
7. a. Do you have a telephone? | 1 | Yes /Go to Question 761
b. If yes. what is the number?
(Zip Codel
I 2 I No (Go to Question 7cl
(Am Codel
If no, what is the number of the nearest telephone? I j I ! - I I I I —
(Ant Codel
I | Co to Question SI
3. How many persons reside in this household?
| ' I Do not know
CD
9. For each person in your household, including yourself, please indicate the age, birthdate, sex, length of residence at this address and in
this community, occupation, and relationship to you, beginning with the oldest and proceeding to the youngest:
Household
Member
Number
01
02
03
04
05
06
07
08
09
10
Age
(Years)
Btrthdate
Month
O.y
Veer
Sex
(M or F)
Length of Res
At this
Address
Units
MO.
orY
dence
In tli
Commu
Units
is
nitv
M.O,
orY
Occupation^)
During Pan
12 Months
Relationship
to
Respondent
Participant
Number
10. a. Has anyone in your household worked at the smelter at any time during the past 12 months?
[jj Yes (Go to Question 10b>
jTJNo
I 3 | Do not know
b. If yes, indicate relationship to respondent
and household member number(s) from question 9
If it is apparent that tha household contains no persons eligible to participate in this study, thank tha respondent and proceed to the
next household. However, if parsons in the household appear to be eligible to participate in this study, continue to question 11.
11. Would you participate in a health study as a paid volunteer? | 1 I Yes j 2 | No
12. In your opinion, would other members of your household participate in a health survey as a paid volunteer?
[jj Yes. all [z] Yes, some [jjj NO (JJJ Do not know
2-86
3-10-77
-------
OMB No.
Approval Expires
RESEARCH TRIANGLE INSTITUTE
STUDY OF HUMAN TISSUE HEAVY METAL BURDEN IN
NON-FERROUS SMELTER COMMUNITIES
PARTICIPANT CONSENT FORM
I understand that the Research Triangle Institute is engaged in a study of heavy metal (arsenic, cadmium, copper, lead,
manganese, and zinc) exposure and absorption by persons living in communities near non-ferrous smelters. I understand that this
survey is being conducted because increased amounts of heavy metal absorption have recently been discovered among persons living
near smelters in the United States, particularly young children. I understand that the survey is being conducted in order to help
measure the levels of heavy metal exposure and absorption by persons living in communities near non-ferrous smelters, and is limited
to the purpose stated. I further understand that the survey is being conducted under the auspices of the United States Environmental
Protection Agency in cooperation with the Center for Disease Control of the United States Public Health Service and the
(State and local health departments) .
I do hereby freely consent to participate in this study of heavy metal absorption and understand that my participation will
consist of providing answers to a questionnaire related to heavy metal exposure and the following environmental and biological
samples: (1) two four ounce samples of cold tap water from a source commonly used for drinking and cooking, (2) a sample of
housedust from a small area (0.25m2) from the surface of the floor of a room commonly used for family activities using a small
vacuum device, (3) a small (approximately four ounces) early morning urine sample, (4) a small sample of scalp hair, (5) a small
(approximately 10 cc) blood sample to be taken from an arm vein, and (6) measurement of paint lead levels using a special portable
apparatus. I understand that two four ounce samples of surface soil will be taken from the play area(s) of each pre-school child
participant and that in some small children the blood sample may be obtained from a finger or heel. I understand that an agent of the
Research Triangle Institute will administer the questionnaire in my home and at the same time collect the tap water, housedust, and
soil samples, and measure the paint lead levels. I further understand that I am to deliver my urine specimen to
(Address of designated central data collection facility)
on (Day of week)
(Data)
.at (Time)
.a.m./p.m. where an agent of the Research
Triangle Institute will obtain the scalp hair and blood samples and where I will receive an incentive of ten dollars for my full
participation in this study. I understand that a small number of households and individuals will be selected for the collection of
duplicate tap water, housedust, scalp hair, and blood samples and reinterview, but that such selection would not entitle me to further
compensation.
I understand that a report of my test results will be sent to the State and local health authorities. In addition, t would/would
not like a copy of this report sent to my family physician. Dr.
Address: ;
I understand that my name will not otherwise be voluntarily disclosed, that all information collectad in this study will be compiled
into a general summary which will be strictly confidential, and that my name will not be referred to in any way when compiling and
evaluating the results of the study.
I understand that participation in this study may result in no direct benefits to me, other than those described herein, and that I
am free to withdraw from this study at any time. It has been explained to me that there are no significant risks to me from
participation in this study. I further understand that while participating in the study I will be free to ask any questions concerning
the study; if I have any further questions about the project, I know that I am free to contact
(Local health department representative)
(State health department representative)
telephone number
telephone number
or
or Mr. Benjamin S. H. Harris, III, Survey Operations Center, Research Triangle Institute, Research Triangle Park, North Carolina
27709, telephone number 919-549-8311, extension 2700.
Date:
Participant's Name;
(Month)
(Day)
(Year)
Site Number:
Segment Number:
Participant Number:
Household Number:
Signatures:
Witness:.
| I Participant
Parent, guardian, or other legal representative of participant*
Interviewer Number:
• If the participant is a minor (under 18 years of age), this consent form must be signed by the parent or legal guardian.
2-87
3-10-77
-------
OMB No.
Approval Expires
STUDY OF HUMAN TISSUE HEAVY METAL BURDEN IN
NON-FERROUS SMELTER COMMUNITIES
Sponsored by:
Health Effects Research Laboratory
Environmental Protection Agency
Research Triangle Park. North Carolina 27711
Conducted by:
Research Triangle Institute
P.O. Box 12194
Research Triangle Park, North Carolina 27709
THE RESEARCH TRIANGLE INSTITUTE OF RESEARCH TRIANGLE PARK, NORTH CAROLINA, IS
UNDERTAKING A RESEARCH STUDY FOR THE U.S. ENVIRONMENTAL PROTECTION AGENCY
OF LEVELS OF HEAVY METAL ABSORPTION BY PERSONS LIVING IN COMMUNITIES NEAR
NON-FERROUS SMELTERS. THE INFORMATION RECORDED IN THIS QUESTIONNAIRE WILL BE
HELD IN STRICT CONFIDENCE AND WILL BE USED SOLELY FOR MEDICAL RESEARCH INTO
THE EFFECTS OF ENVIRONMENTAL FACTORS ON PUBLIC HEALTH. ALL RESULTS WILL BE
SUMMARIZED FOR GROUPS OF PEOPLE; NO INFORMATION ABOUT INDIVIDUAL PERSONS
WILL BE RELEASED WITHOUT THE CONSENT OF THE INDIVIDUAL. THIS QUESTIONNAIRE IS
AUTHORIZED BY LAW (42 U.S.C. 1857 AS AMENDED). WHILE YOU ARE NOT REQUIRED TO
RESPOND, YOUR COOPERATION IS NEEDED TO MAKE THE RESULTS OF THIS SURVEY COM-
PREHENSIVE, ACCURATE, AND TIMELY.
Study number:
Site number:
Segment number:
Household number:
Participant number:
2-88
3-10-77
-------
-2-
1.
A. HOUSEHOLD INFORMATION
For each person in your household, including yourself, please indicate age, beginning with the oldest and proceeding to the
youngest (Enter responses in matrixbelaw ):
Household
Member
Number
01
02
03
04
05
06
07
08
09
10
Age
(Years)
Educa-
tional
Level
Currently
Employed at
Smelter
1 = Yes 2 = No
Normally
Spend Day
at Horns
1 = Yes 2 = No
Excess Metal Absorption
Screened
Diagnosed
Partici-
pant
Number
2. For each person in your household, including yourself, please indicate educational level, again beginning with the oldest and
proceeding to the youngest (Enterresponses in matrix above using codes listed below for highest educational level completed):
8th grade or less
High school - incomplete
High school graduate
[ 4 [ College - incomplete
5 College graduate
Technical school beyond high school
Do not know
6
Graduate school
9 {Other
3. Does anyone in your household currently work at the smelter? (Enter responses in matrix above.)
4. Which members of your household normally spend their day at home? (Enter responses in matrix above.)
5. Has anyone in your household ever been screened for excess heavy metal absorption?
Yes
No
Do not know
(Enter response in matrix above.)
6. Has any member of your household ever been diagnosed as having excess heavy metal absorption?
No
Yes
Do not know
(Enter response in matrix above.)
7. For male head of household, indicate:
a. Household member number:
8. For female head of household, indicate:
a. Household member number:
9. What is the approximate age of your house?
b. Current occupation:
b. Current occupation:
Years
Do not know
2-89
3-10-77
-------
-3-
10. What type of structure is your house? (51 percent or more of exterior surface.)
Solid brick, concrete, or rock
Brick or rock veneer
Stucco
Asbestos
Aluminum siding
Composition siding
Wood frame
Do not know
Other (Specify)
No
11. Is there evidence of flaking paint present in the home? 1 Yes
12. Are paint chips present in the soil surrounding the home? 1 Yes
13. Do you cool your home with any of the following appliances? (Check all that apply.)
Interviewer observation
No
Central air conditioning
I 2 I Window air conditioner(s)
Evaporative cooler(s)
3
Window fan(s)
Ceiling exhaust fan(s)
Circulating fan(s)
None of these
Do not know
Other (Specify)
14. Are any of the following articles used in storing, preparing, and/or serving food in your household? (Check all that apply.)
Articles
1 . Unglazed pottery
(homemade or craft)
.2. Glazed pottery
(homemade or craft)
3. Hand-painted flatware
Uses
Storing food(s)
No
1
1
1
Yes
2
2
2
Specify food(s)
Preparing food(s)
No
1
1
1
Yes
2
2
2
Specify food(s)
Serving food(s)
No
1
1
1
Yes
2
2
2
Specify food(s)
[ * | None of these
Do not know
15. Does your household grow any of its own food in a home garden?
If yes, specify food(s)
Yes
No
Do not know
16. Where does your household ordinarily shop for groceries? (Specify)
17. Where does your household obtain fresh fruit and/or vegetables? (Specify)
18. What is the primary source of your water for drinking?
m
Bottled water
Tap - municipal supply
Tap - community well
Tap - private well
Tap - cistern
Do not know
[ 7 [ Other (Specify)
19. Is that the same primary source of water for drink mixes such as coffee, tea, Kool-Aid, etc.?
Yes
No
If no, how does it differ? (Specify) .
20. What is the primary source of your water for cooking?
Bottled water
Tap - municipal supply
Tap • community well
Tap - private well
5 I Tap - cistern
6 Do not know
Other (Specify)
2-90
3-10-77
-------
-4-
21. Has anyone in your family ever been under medical care for:
No Yes Relationship to respondent and/or household member number:
a. Seizures?
b. Hyperactivity?
c. Mental retardation?
d. Skin conditions other
than acne?
e. Kidney stones?
f. Broken bones?
'
1
1
1
•
1
2
2
2
2
2
2
(Specify)
(Specify!
(Specify)
(Specify)
(Specify)
(Specify)
B. PARTICIPANT INFORMATION
IF THE PARTICIPANT IS UNDER 18 YEARS OF ACE, THIS SECTION OF THE QUESTIONNAIRE MAY HA VE TO
BE ADMINISTERED IN WHOLE OR IN PART TO THE PARENT OR GUARDIAN. AND MUST BE ADMINISTERED
IN THAT PERSON'S PRESENCE. IF THE PARTICIPANT SUFFERS FROM A SPEECH OR HEARING DEFICIT, THIS
SECTION OF THE QUESTIONNAIRE MAY HAVE TO BE ADMINISTERED TO THE SPOUSE OR ANOTHER
SPOKESMAN-SEE SECTION C
First, I would like to ask some general questions about you/the participant.
Male 2 Female
White
1. Sex (by observation):
2. Race (by observation):
American Indian
Unknown
Asiatic
Other
(Specify)
5. What is your/the participant's birthdate?
(Month) (Day) (Year)
Black
Spanish
surname
6. What is your/the participant's approximate weight in pounds?
3. Household member number (from A-1):
4. What was your/the participant's age in years at last birthday?
Years
7. What is your/the participant's marital status?
Married 2 Never married
Widowed
Divorced 5 | Separated
I i
[_6j Other (Specify).
Next, I would like to ask some questions about your/the participant's education.
8. Are you/is the participant in school now?
1 Yes (Continue) | 2 | MO (Go to Question 11)
9. What type of school do you/does the | 1 | Kindergarten, nursery, play, or day care school (Continue)
participant attend?
2 I Elementary school
3 Junior high school
Senior high school
(Continue) 6
Junior college
College
Graduate school
(Go to question 11)
\ 8 i Technical school
-------
•5-
Next, I would like to ask some questions about your/the participant's occupation and residence.
11. Are you/is the participant presently employed in any capacity? 1 Yes (Go to question 13)
12.' If not presently employed, which of the following best describes your/the participant's status?
(Co to question 18)
No (Continue)
Housewife J
Student )
Unemployed
Retired
Child (Go to question 21)
13. What is/was your/the participant's usual occupation? (Specify).
6 Disabled
(Continue)
14. Are you/is the participant presently employed in this occupation?
Yes
2 No
15. If yes to above question, how many years have you/has the participant been employed in that occupation?
If no to above question, how many years were you/was the participant employed in that occupation?
16. If you are/the participant is presently employed, what is the nature of the company for which you/the participant work(s)?
(Specify)
17. How long have you/has the participant been employed by your/the participant's present employer?
18. How many times have you/has the participant changed occupations during the past 5 years?
Units
Months
Years
19. Does your/the participant's occupation usually take you/the participant away from home?
20. Have you/has the participant worked at a smelter at any time during the past 12 months?
1 Yes
2 No
Yes (STOP!) 2 No (Continue)
21. Have you/has the participant ever worked at or lived for as long as 12 months within 2 miles of:
Worked at Lived near
>
a. Paper/wood industry
b. Smelting industries
c. Glass manufacturing plant
d. Pesticide manufacturing plant
e. Mining area
22. How many hours of the day, on the average, do you/does the participant normally spend more than 2 miles from home?
Yes
1
1
n
i
1
No
2
2
2
2
2
Yes
1
1
1
1
1
No
2
2
2
2
2
23. How many years have you/has the participant lived in this city or town?
Hours
Years (If less than 1 year. STOP!;
24. How long have you/has the participant lived at this address?
Units
1 Days 2 Months 3 Years
25. How many times have you/has the participant changed living quarters during the last 5 years?
2-92
3-10-77
-------
-6-
IMext, I would tike to ask some questions regarding your/the participant's personal habits.
26. What is the natural color of your/the participant's scalp hair?
Brown
Black
Red
Blonde
Gray
Bald
Other (Specify)
27. How many times per week, on the average, do you/does the participant shampoo your/the participant's hair?
28. Which of the following hair care products do you/does the participant use? (Check all that apply and specify the most frequently
used brand.)
Brand ' Brand
1
Washing (Shampoo or soap)
2 Setting lotion
Hair spray
Artificial coloring
5 Permanent
Last application date
(Month) (Day) (Year)
29. Have you/has the participant ever smoked as many as 5 packs of cigarettes-that is, as many as 100 cigarettes during your/the
participant's entire life?
| 1 [Yes (Continue)
30. Do you/does the participant now smoke cigarettes?
No (Go to Question 34)
Yes
No
37. How old were you/was the participant when you/the participant first started smoking?
Years
32. If you/the participant no longer smoke(s), how old were you/was the participant when you/the participant last gave up smoking?
Years
33. On the average, how many cigarettes do (did) you/does (did) the participant smoke per day?
[ 1 [ Less than V4 pack (1-4 cigarettes)
About I'/j packs (25-34 cigarettes)
About Vt pack (5-14 cigarettes)
About 1 pack (15-24 cigarettes)
5 About 2 packs (35-49 cigarettes)
More than 2 packs (50 or more cigarettes)
34. What is the average number of hours that you/the participant spend(s) out of doors each day?
35.. Do you/does the participant ever eat non-food substances such as paint, clay, dirt, or plaster?
36- (For children participants only) Where does the participant play most frequently? (Check one.)
| 1 [ At home indoors
2 At home outdoors
Hours
Yes
No
On the same block indoors
4 On the same block outdoors
On a different block indoors
6 On a different block outdoors
Other (Specify)
2-93
3-10-77
-------
-7-
Next, I would like to ask some questions regarding your/the participant's health.
37. What do you consider the current status of your/the participant's health?
1
38. Are you/
0
1
2
Excellent 2 C
s the participant curre
None
Tranquilizer
Sedative
>ood 3 Fair 4 Poor
ntly taking any prescription medication(s) on a regular daily basis? (Check all that apply.)
3
4
5
Analgesic 6 Antibiotics (Specify) .._
Hormone 7 Othe' (Specify) . _
Oral contraceptive
39. Do you/does the participant currently have any 'of the following symptoms?
If yes, specify
how long
Yes No Yes
a. Loss
b. Weig
c. Fatic
d. Naus
vom
e. Diar
of appetite 1
2
h. Cough 1
ht loss 1
,ue []]
ea and/or 1
ting
hea 1
f. Abdominal pain 1
2
2
i. Changes in skin pigmentation 1
j. White lines across fingernails 1
2
2
2
k. Pins and needles, numbness or 1
pain of the limbs
Weakness or withering of the 1
muscles of the limbs
m. Pain or soreness of the mouth, 1
nose, or eyes
g. Sore throat 1
2
n. Skin irritation 1
If yes. specify
how long
No
2
2
2
R
2
2
2
Next, I would like to ask some questions regarding your/the participant's diet.
40. Which meal(s) do you/does the participant usually eat at home? (Check all that apply.)
Breakfast
Lunch
Dinner
41. When you do not/the participant does not eat at home, where do you/does the participant eat? (Check all that apply.)
Meal prepared at home but eaten elsewhere 2 School [ 3 [ Work
Restaurant
Other (Specify)
42. Are you/is the participant presently following any of the following dietary regimens? (Check all that apply.)
I 1 I Formula/prepared baby foods | * [ Reducing diet
Bland food ulcer diet
Diabetic diet
Organic foods
Vegetarian
None of these
Other (Specify) .
2-94
3-10-77
-------
-8-
43. On the average, how often do you/does the participant eat the following foods? (Check the appropriate box.)
Foodstuff
a. Shellfish
b. Fish
c. Beef liver
d. Roast beef
e. Hamburger
f. Chicken
g. Frankfurters
h. Bacon
i. Eggs
j. Whole milk
k. Breakfast cereal
1. White bread
m. White rice
o
c
o
r
£8
o 5
1
a
o
u
c
o
n-*
O Qi
JJ 0
< 5
2
o
o
u
c
O i»
3 O
n °
a 3
-------
-9-
COMMENTS
2-96 3-10-77
-------
D. SAMPLE INFORMATION
For each sample collected for a given household or individual,
attach the appropriate label to the appropriate container
before collecting the sample. Complete section D below when
appropriate.
1. Study number:
2. Site number:
3. Segment number:
LABELS
to
^^^^3
4. Household number:
5. Participant number:
6. Paint lead measurements: I Exterior toward smelter II Exterior away from smelter III Interior dust -1 IV Interior dust - 2 V Interior dust - 3 VI Interior kitchen
1
VO
8.
9.
10.
11.
CO
1
012.
Type of
Sample
Soil
Tap Water
Sou/re:
House Dust
Surfacu:
-- Scalp Hair
Blood
Urine
Original Sample
Collected
Yes
1
1
1
1
1
1
No
2
2
2
2
2
2
If Collected, Date
Month
Day
Year
If Not Collected,
Reason
I nterviewer
Number
Duplicate Sample
Selected
Yes
1
1
1
1
1
NX NX
/\/\
y\x
No
2
2
2
2.
2
NX NX
X\/\
y\x
Collected
Yes
1
1
1
1
1
1
No
2
2
2
2
2
2
If Collected, Date
Month
Day
Year
If Not Collected,
Reason
13. Hcmatocrit:
15. Specific gravity:
(Month) (Day) (Year)
COMMENTS:
14. Urine protein:
16. Date:
17. Interviewer number:
-------
RESEARCH TR.LANC3LE INSTITUTE
STUDY OF HUMAN TISSUE HEAVY METAL BURDEN
NON-FERROUS SMELTER COMMUNITIES
Chemical Analysis Report Form
Sample Number
-
ro
1
vo
00
-r
i-1
_ o
-4
^4
Motal
Symbol
Units
Determination No. 1
i
,
Completed by (RTI ID iwinbor):
Determination No. 2
i
,
,
ode
Sample
Dato completed:
Number
^ ^
Metal
Symbol
Units
Determination No. 1
(
>
i
i
,
i
•
i
Determination No. 2
i
,
,
4
,
Cc
-
-
(Montli)
(Day)
-------
APPENDIX 2.4
PRETEST CONSIDERATIONS
2-99 3-10-77
-------
PRETEST CONSIDERATIONS
In order to test and standardize the data collection instruments
and procedures, RTI will conduct a Pretest of this Work Plan in a limited
number of households at a non-ferrous smelter site not selected for the
main study effort, most likely Corpus Christi, Texas, with the approval
of the Project Officer. The Pretest will be conducted by the RTI project
staff and consultants with on-site assistance by independent subcontractors.
The Pretest will simulate the main study as closely as possible and will
therefore follow the Work Plan as closely as possible, including sampling,
field operations, and chemical analysis. If no major problems are encountered
with the Work Plan such that modifications are minimal or unnecessary,
then the data from the Pretest would provide at least some limited data
on a seventh non-ferrous smelter community. If problems are encountered
which require modifications of the data collection instruments or procedures
before proceeding with the main data collection effort, some of the data
collected in the Pretest may still be useful (other than as a justification
for the modification), depending upon the nature of the problem and/or
the required modification. The decision in favor of Corpus Christi (over
Hayden, Arizona) has been based on a number of considerations related
to the logistics of executing the study protocol at a site for the first
time, in particular the availability and costs of, and problems and staff
burden associated with, various ancillary and support services including:
1. Attitude of the smelter; Both of the smelter firms with
operations at Hayden are involved in various litigations, although
only the Asarco plant at Hayden is specifically involved in such
litigation. In addition, there is information that the smelter
2-100 3-10-77
-------
industry may undertake an epidemiological study at Hayden.
2. Attitude of federal, State, and local agencies; RTI would
prefer a Pretest site where the appropriate federal, State and local
agencies would be interested, perhaps experienced, and hopefully could
be actively involved, in such a study. At a meeting at Phoenix,
Arizona, on November 23, 1976, RTI was encouraged by support expressed
by the Arizona Department of Health Services and the University of
Arizona College of Medicine; however, the primary focus of that meet-
ing was Ajo.
3. Availability of independent subcontractors; The Pretest
will attempt to simulate the main study as closely as possible, except
on a smaller scale, and will therefore follow the Work Plan as closely
as possible, including involvement of independent subcontractors. Fig-
ures A-2.4.1 and A-2.4.2 present graphically the number of inter-
viewers from the current RTI listings living in counties within a
reasonable distance of the sites in Texas and Arizona respectively,
which were under consideration for the Pretest. That is not to say,
however, that all of those individuals would be available or suitable
for this research effort. For example, RTI has two other major survey
research efforts planned for the Phoenix area in early 1977 which
would deplete the number of available interviewers in Maricopa county
during that time. More important, however, is the distance which the
interviewers must travel to reach the site and the cost and burden
associated with that travel.
2-101 3-10-77
-------
O
10
CO
O
TEXARKANA
HXAtKANA
,Mlcnw
SHERMAN DENISJON
•v.N*H"v
-,.—
-S — t- \ - -- •
j i >»"<» i ••"«' "" r i ,
-r - -
— ~
.... A\
I X/io-
jy* /i
T 1 "jQyQORPUS/CHRIST!
LEGEND
<•) Places ot 100000 or mo>e inhabitants
• Places ol 50.000 to 100000 inhabitants
O Central cities ot SMSA's *ith lewer than Ml.OOO inhabitants
O Places ot 25.000 to 50.000 inhabitants outside SMSA's
. Standard Metropolitan
Statistical Areas iSMSA'sl
fOlNSUftG £)
MC ALLEN PHARR^^/ .„,»•! OH"UiN<^f< BROWNSVILLE HARLINGEN SAN BENITO
EOINBURG —' nn '
Fig. A-2.4.1. Location and number of interviewers from the current RTI listing living in counties
within a reasonable distance of the Corpus Christi, Texas, potential Pretest site
[Source: Ref. 2.3, p. 1013].
-------
'-r --• ;• TUCSON/;••- - :;„;
®JUCSON
LEGEND
® Places of 100.000 Of more inhabitants
• Places of 50.000 to IOO.OOO mhaBilants
O Places of 25.000 to 50.000 inhabitants outside SMSA's
Standard Metropolitan
Statistical Areas (SMSA's)
« «=*«
•0 to IOO
Fig. A-2.4.2.
Location and number of interviewers from the current RTI
listing living in counties within a reasonable distance of
the Hayden, Arizona, potential Pretest site [Source: Ref.
2.3, p. 972].
2-103
3-10-77
-------
4. Nature of the Site; RTI would prefer a community large
enough to permit some flexibility in the event of a large number of
nonparticipants, and so that the logistics of implementing the field
operations for the first time would not be too involved. Both of the
Pretest sites under consideration would present a bilingual popula-
tion. However, Hayden and Winkelman, Arizona, which together make up
the Hayden smelter community, have a combined population of less than
2,000, have extremely limited transportation and medical facilities,
and are approximately two hours driving one way from the nearest
transportation facilities and sources of supplies and support services.
5. Cost; Since the performance sites for the main study
were not known when the proposal was written, one of the smelter
communities in the St. Louis area was considered as a Pretest site for
the purpose of estimating Pretest cost. Several of the considerations
cited in preceding paragraphs will have some impact on cost, particularly
the availability of qualified independent subcontractors within a reasonable
distance of the site, the magnitude of the Pretest, and the site itself.
For example, round trip tourist air fare Raleigh to Corpus Christi is
$230, and Raleigh to Tucson is $308 (plus ground transportation to Hayden).
The outcome of the Pretest may have some impact on RTI's time and cost
projections.
Some of these same considerations entered into the choice of the
three performance sites where elderly persons will be studied, in that
RTI will need a larger population base and additional independent sub-
contractors.
2-104 3-10-77
-------
APPENDIX 2.5
RELEVANT CORRESPONDENCE
2-105 3-10-77
-------
OTHOR. WMITEMECK. D.D S-. MM-DCNT
I ROBERT 0. McCULLOUGH. O.O.. vice .HCSIOCNT
THOMAS DONICA. M.O.. stc«£T«.»
GLEN L. BERKENBIIE. M.O.
IWALLACE BVRO. M.O.
IAANOLO HELVEY
EUGENE A. OWENS. MO.
|».A,-TAT6-TAYLOR
|H«ROLOA.TOAZ
R. LEROY CARPENTER, M.D.. M.P.H.
Northeast 10th Street I* Stonewall
Post Office Box 53551
Oklahoma City, Oklahoma 73105
September 17, 1976
Carl Hayes, Ph.D.
Air Pollution Control Division
Research Triangle Park,
North Carolina 27711
Dear Dr. Hayes:
I very much appreciate talking with you about the studies on the
Heavy Metal Absorption conducted in Bartlesville in the Spring of
1975. I had previously discussed the findings with Dr. Phillip
Landrigan at the Center for Disease Control.
I feel much more comfortable with your assurance that the final
report when released to the public will be modified. I expressed
to you our anxiety about some of the language in the preliminary
report and I am pleased that you are planning to modify this
language to indicate that the levels obtained in the children in
the Bartlesville survey are not of sufficient magnitude to warrant
immediate and concentrated reappraisal.
I am pleased that the EPA plans to conduct follow-up studies in
some of the towns to further delineate the epidemiological
significance of the levels found in the children. I would
strongly urge that Bartlesville, Oklahoma be selected as one of
the towns for further study. As we discussed on the telephone
Bartlesville was the first town to be studied and you and I both
realize that some of the technical aspects of the study were some-
what less than satisfactory especially in the areas of specimen
collection and in the methodology of sampling. I would like to
suggest that this is one very good reason for going back to
Bartlesville with a follow-up study. In addition I would like
to emphasize that some of the highest levels of cadmium and lead
were found in children in Bartlesville and feel that this finding
would be an important factor in selecting Bartlesville as one of
the towns for further study.
2-106
3-10-77
-------
Carl Hayes, Ph.D. 2 September 17, 1976
Although I am unable at this time to commit the resources of the
State Health Department's Epidemiology Program to assist in further
follow-up studies I can assure you of our interest and we would be
happy to evaluate the extent of the follow-up studies and the
degree to which we could participate. Bartlesville is located in
a county that does not have a local health department and for this
reason the Epidemiology Program at the State Department of Health
would assist in any further investigation of this problem.
At the present time we are not taking any action on the preliminary
report which you forwarded some three weeks ago. I indicated to
you that we felt that it would be important before the final report
is released to the public that a meeting be arranged between the
management of the National Zinc Company in Bartlesville and the
local physicians in Bartlesville and representatives of the State
Department of Health. We do not plan to ask for this meeting until
such time as we receive the final draft copy of the report.
*
Sincerely yours,
Armond H. Start, M.D.
Director, Division of
Communicable Disease
AHS/mls
2-107 3-10-77
-------
OTMOfl. VWITENFCK. 0 0 S.. •or«ioc«T
^OfiERTD McCULLOUCH. 00. vet ».r«-nt«.
•HOMAS OONICA. M 0 . irt.tT*«v
GIENL. BEnxtrjaiiE.wo
WALLACE 8VHQ. MO
bo MELVEY
E A. OWENS. M.D.
W. * -TATE- TAYlOfl
IABOLO A. TO«
WALTER D. ATKINS. O.O.S., M.P.H.
Northeast 10th Street 4 Stonewall
Post Office Box 53551
Oklahoma City, Oklahoma 73105
January 24, 1977
Warren Galke
Health Scientist
Population Studies Division
U.S. Environmental Protection Agency
Health Effects Research Laboratory
Research Triangle Park,
North Carolina 27711
EPA Contract No. 68-02-2442
RTI Project No. 31U-1372
Dear Mr . Galke :
I appreciate the opportunity to review the draft work
plan. I am very impressed by the quality and the detailed
methodology found in the plan. I have discussed the plan
with members of the Epidemiology Program staff and we have
no comment or suggestions for incorporation into the final
product. We consider appropriate communication to be an
essential element in working with a project involving
people of a community. We commit ourselves to assist this
project within the limits of our resources.
Sincerely yours,
Armond H. Start, M.D.
Director, Division of
Communicable Disease Control
AHS/mls
2-108
3-10-77
-------
APPENDIX 2.6
SAMPLE COLLECTION METHODOLOGY
2-109 12-17-76
-------
SAMPLE COLLECTION METHODOLOGY
A. General Considerations
The specific methods proposed by RTI for measuring environment-related
factors differ somewhat among the various types of exposure. These differences
reflect several considerations such as the extent to which surrogate
variables reflect the factors of interest, the measurability of factors,
the variability of factor measurements, the quality control of data collec-
tion, and the suitability of data collection techniques under actual
survey conditions. The proposed methodology stresses random sampling
techniques wherever possible to facilitate valid statistical analyses
and to increase the degree of control over data collection; Field Interviewers
o
(FI's) will follow explicit, nonjudgmental procedures throughout. These
procedures will range, as described in subsequent sections, from obtaining
small selective samples of relatively homogeneous items, such as tap
water at a particular residence, to obtaining large stratified random
samples for a highly variable item, such as air quality in a smelter
community.
Sample collection will be divided among the various field staff.
The collection of environmental samples will be divided between the Site
Administrator (SA) and the FI. The SA will be responsible for collecting
air, market basket, and general soil and water samples such as soil and
water samples from each school where study children participants attend;
the FI will be responsible for the collection of dust and tap water samples
for each participating household and soil samples from the appropriate
residential play area for each pre-school child participant, and the
measurement of household paint lead levels. Responsibility for the collection
2-HO 3-10-77
-------
of biological samples will be shared by the independent subcontractors.
The FI will be responsible for the explanation of the procedure for collect-
ing the urine sample, and arrangements for the participant to go to a
central location for collection of the biological samples; at that central
location, the urine and blood samples will be collected by the medical
independent subcontractor, the hematocrit and urine protein and specific
gravity will be determined by the medical independent subcontractor,
and the scalp hair sample will be obtained, either by the medical independent
subcontractor or an FI.
For each household containing a study participant, samples of housedust
and tap water will be collected, and paint lead levels will be measured.
For each study participant, RTI shall endeavor to obtain samples of blood,
urine, and scalp hair; soil samples will be collected from the appropriate
play area for each pre-school child participant and from each school
yard where study children participants attend. In addition, air, soil,
and market basket samples will be collected for the overall smelter community,
and drinking water samples will be obtained from each school where study
children participants attend.
2-111 3-10-77
-------
B» Environmental Samples
1. Air
Twenty four hour air particulate samples will be collected by the SA
using high-volume sampling units (Fisher Scientific, Cat. No. 1-037-40) on
pre-washed Tape A 8" x 10" glass fiber filters (Fisher Scientific, Cat. No.
9-730-68).
The highr-volume air samples will be obtained at random points, which
are coincidental with a subsample of the random blocks (segments) containing
sample individuals. This matching is not intended to provide matched
observations between individuals and air samples, but rather1 to expedite the
selection of a random point sample that is dispersed throughout the target
population and that is representative of the area over time. These samples
will be taken at random points in time concurrently with the other data
collection activities at each performance site. At any point in time during
the survey period, approximately five high-volume units will be operating
at the site being investigated.
The SA will be provided with a list of sample days numbering from
approximately 1 to 19. The randomization process will involve assigning,
for example, three numbers from 1-19, selected at random and without replace-
ment, and subject to the constraint that each day is assigned at most to
three strata at each site. The constraint will facilitate maximum utilization
of the high-volume air sampling equipment. The following partial table
represents a hypothetical example of such a randomized list:
2-H2 12-17-76
-------
Stratum Days on which a high-volume air sample is to be
taken (day 1 - first day of survey at site)
S 8, 12, 17
S2 2, 8, 15
Sg 2, 3, 9, 10, 12, 14, 19
According to this schedule, two and three air samples (see table A-2.6.1)
would be taken in strata S_ and SQ, respectively, on the second day of the
/ o
survey, and so on until approximately 87 operation sets are taken at that
site (see figure A-2.6.1). Table A-2.6.2 presents the type of format which
might be used to describe the survey and lab results for one of the study
elements, such as lead.
The sampling units will be placed at locations prescribed by the
stratum-day sampling scheme shown in figure A-2.6.1. Power drops will be used
as required.
3
The initial air flow, approximately 1.7 m /min. , and the final flow
will be accurately read from the pressure gauge and related to total sample
volume by the following expression [Ref.2.7]:
3
V = air volume samples (m )
Q± = initial air flow (m3/min)
Q = final air flow (m /min)
T = sampling time (min.)
2-113 3-10-77
-------
Table A-2.6.1. Tentative sample allocation for air samples.*
Number of Observations in Each Stratum, Si
Type of Observation S1 S2 ^3 54 85 Sg Sy SQ
Locations per day 22222233
Days "33445567
Ratio, days/locations 1.5 1.5 2.0 2.0 2.5 2.5 2.0 2.3
Based on the following data from Djuric [Ref. 1.2].:
Day Stratum 6; 2 locations Stratum 8; 3 locations
(2.2 - 3.0 km) (5.0 - 8.0'ktn)
1
2
3
4
13.0
84.0
18.0
«_..«
30.0
68.0
66.0
« — ««•
1.3
15.0
9.6
24.0
7.6
36.0
3.2
60.0
4.2
25.0
4.2
29.0
21 2 2
with approximate estimates of variance: s., = r- (xij-'x) = 891; and s0 ~ 697
o nm~1 o
suggesting a total sample size, nir>, needed for a 20 percent c.v.: ™r>,= (_— ) = 9
° '2 x
a ratio;
2 ' * 2°
s,. days
suggests that sample size ratio days/locations should be
s, locat.
o
approximately 2.2
2 1 n _ = 2
where s, = —r- T. (x.-x) and (nm). is total sample size in stratum h.
b n-1 ^ i n
2-H4 3-10-77
-------
Smelter
NJ
Fig. A-2.6.1.
Geographic and temporal placement of high-volume air samples:
depicting only the first two days of the survey.
a partial hypothetical example
-------
Table A-2.6.2. Exemplary format for presenting survey and laboratory results for study element: lead.
Pb reading,
Observation mg. per
number cubic meter
1 4.2
2 36.0
3 60.0
Distance
from source,
km
2.5
1.2
1.3
Direction from
source, degrees
from transect
0.4
-5.2
-10.1
Wind
velocity,
km/hr
35.1
20.4
2.4
Wind
direction,
degrees from
transect
-10.5
-10.4
-5.3
Ground
level
temp . ,
°C
32.1
34.5
35.1
Upper
atmosphere
temp . ,
°C
30.0
33.1
40.0
87
7.8
5.0
35.6
2.4
-2.1
38.1
34.0
-------
Wind direction, wind speed and extent of precipitation will be noted
for each sampling day.
Although each sampler will be calibrated at RTI, the air flow calibration
data will be validated at the site with an EPA audit device.
After the collection period, the filter will be removed from the sampler,
folded so that only surfaces with collected particulates are in contact and
placed in a tightly secured plastic Zip-Loc bag for shipment to RTI.
2-117 12-17-76
-------
2. Soil
The basic sampling protocol will call for the collection of samples
of surface soil at air sampling sites, from the residential play areas
of pre-school age study children participants, and from the school yard(s)
where study children participants attend. Two soil samples will be obtained
from the primary residential play area of each pre-school age child partic-
ipant; if a given household contains more than one pre-school age study
participant, these soil samples may represent more than one child. One
soil sample will come from each air sampling location and one from each
school yard where study children participants attend.
Variation in the soil content of study elements throughout the sample
collection areas, both for different locations and time, is expected
to be small relative to variation in the air samples. Nonetheless, two
samples will be taken from each residential play area of pre-school age
study participants in order to obtain some measure of variation in element
exposure from soil in play areas. The boundaries of the most commonly
used play area will be established and the two surface soil samples collected
from random points in the play area using a random number table. Samples
will be collected in appropriately labeled four ounce plastic bottles
for shipment to RTI.
3-10-77
-------
3. House Dust
A sample of settled dust will be collected for each household by
the FI using a vacuuming technique after that of Solomon and Hartford
[Ref. 2.8], A single sample will be taken from the floor in the central
area of the room which is the most frequent site of common family activity,
away from the walls. The sampling area will be delineated and standardized
using a 0.5 x 0.5 m template placed on the surface. In taking each dust
2
sample, one pass will be made of the 0.25 m area utilizing a portable
vacuum source. The vacuumed dust will be trapped in a special chamber;
the dust gathered will then be placed in appropriately labeled, tightly
secured Zip-Loc bags for shipment to RTI. In the event that part of the
floor of the selected room is carpeted and part bare, a section of carpeted
floor will be selected for acquisition of the dust sample.
Random sampling at different locations and time is not proposed for
this measure of exposure, because the sample should be relatively homogeneous
within a household, and because what little improvement in data that might
result from a suitable randomization does not seem to justify the accompanying
increase in participant and interviewer burden.
2-119 3-10-77
-------
4. Tap Water
At each household, the FI will collect two samples of cold tap water
in four ounce plastic bottles, from the kitchen tap or other source commonly
used for drinking and/or cooking. The first sample will be £aken immediately
upon turning on the water, without flushing; the second sample will be
taken after the water has been allowed to run for three minutes. Time
will be measured using a stop watch. Random sampling at different locations
and time is not proposed for this measure of exposure, because the samples
should be relatively homogeneous within a household, and because what
little improvement in data that might result from a suitable randomization
does not seem to justify the accompanying increase in participant and
interviewer burden.
2-120 3-10-77
-------
5. Paint Lead Measurement
At the time of household data collection, the FI will measure paint
lead levels using a Princeton Gamma-Tejch Portable Paint Lead Analyzer
such as that shown in figure 2.10. Six paint lead measurements will
be taken, one on an exterior wall considered to be closest to the smelter
(I), one on an exterior wall considered to be farthest from the smelter
(III), three at different points on one interior wall in the same room
where the house dust sample is obtained (III-V), and one in the approximate
center of an interior kitchen wall (VI). The readings will be recorded
in Part D of the SQ (see appendix 2.3). Paint lead measurement is not
part of the Scope of Work of this contract; impact on project cost projections
will be assessed after the Pretest.
2-121 3-10-77
-------
Portable Lead Paint Analyzer
-
Model XK-3
Sensitivity - 0.5 mg/cm2 Full Scale - 99.9 mg/cm2
Penetration - 85% through Weight - 51/2 pounds
25 paint layers Dimensions - 9.5" x 3.75" x 7"
PRINCETON GAMMA-TECH
Box 641 • Princeton, N.J. O854O • Tel: 60S 984-7310 • Cable PRINGAMTEC • Telex: 843488
Fig. 2.10.
2-122
3-10-77
-------
C. Biological Samples
1. Urine
At the time that the participant is enlisted, arrangements will
be made for the collection of a urine sample in a four ounce plastic
bottle. A twenty-four hour urine sample would be considered ideal, but
is considered impractical to collect from children, and adults who work
away from home. The interviewer will leave the appropriately labeled
specimen bottle with the participant, explaining that the participant
is to collect a urine specimen from the first micturation on the morning
that the participant is to have the blood sample drawn; the urine specimen
will then have to be refrigerated by the participant until it is delivered
to the central data collection facility. In the event that a participant
arrives at the central data collection facility without a urine specimen,
an attempt will be made to obtain one at that time, with appropriate
labeling and notation; if the morning urine sample was collected but
left at home, arrangements will be attempted to send an FI to the partic-
ipant's home to retrieve the urine sample. Where RTI provides participant
transportation to the central data collection facility, this last step
may be avoided. In some instances, RTI may ultimately have two urine
samples for some participants. The central data collection facility
must have toilet facilities.
If children participants are not toilet-trained, special procedures
may have to be implemented in order to obtain a urine specimen. RTI
is considering testing commercial disposable absorbent diapers for this
purpose in the Pretest. The mother would be provided two such commercial
disposable absorbent diapers and an appropriately labeled Zip-Loc bag,
2-123 3-10-77
-------
with instructions to place the disposable diaper next soiled by urine
only in the Zip-Loc bag for delivery to the central data collection facility
with interim refrigeration as required. In the event that the disposable
absorbent diapers are not workable, adhesive plastic bags will be considered.
At the central data collection facility, the medical independent
subcontractor will determine urinary protein using reagent strips and
specific gravity using a urinometer. Results will be entered in Part D
of the SQ (see appendix 2.3). Measurement of urine protein and specific
gravity are not part of the Scope of Work of this contract; impact on
project cost projections will be assessed after the Pretest.
2-124 3-10-77
-------
2. Scalp Hair
From each study participant from whom the collection of such a sample
is feasible, a full-length sample of scalp hair of sufficient quantity
for chemical analysis will be obtained using thinning shears. Although
the amount of scalp hair available from the participant will ultimately
determine the size of the scalp hair sample, a concerted effort will
be made to collect as large a sample as possible from each participant
up to the minimum amount needed for chemical analysis.
Scalp hair samples will be collected at the central data collection
facility and placed in appropriately and individually labeled Zip-Loc
plastic bags; the scalp hair sample will be completely enclosed within
the plastic bag which will be locked carefully and returned to RTI for
analysis.
2-125 3-10-77
-------
3. Blood
An attempt will be made to collect a blood sample from each participant
from a brachial vein by venipuncture using a heavy metal-free 10 ml.
Vacutainer tube containing liquid EDTA as an anticoagulant. Prior to
venipuncture, blood flow in the selected arm will be restricted using
a tourniquet; the venipuncture site will be prepared by cleansing with
an individually wrapped sterile alcohol swab. Venipuncture will be accom-
plished by a disposable 20 G x 1 1/2 inch Vacutainer needle contained
in a reusable Vacutainer holder. After collection of the blood sample,
the Vacutainer tube will be appropriately labeled and then inverted several
times to insure mixture with the anticoagulant; the venipuncture site
will again be cleansed with an individually wrapped sterile alcohol swab,
pressure applied to retard hematoma formation, and a sterile adhesive
bandage applied.
Where venipuncture by Vacutainer presents problems, as in the very
young, obese, or elderly, alternatives may have to be employed at the
discretion of the individual collecting the sample. In most instances,
venipuncture may still be accomplished using a disposable needle and
syringe with Immediate transfer of the blood sample to a heavy metal-
free 10 ml. Vacutainer tube containing liquid EDTA as an anticoagulant.
The syringe would permit gradual and variable withdrawal of blood and
be therefore less likely to collapse the vein. The preparation of the
venipuncture site and the handling of the sample would be identical to
that described in the preceding paragraph.
In the case of children participants, blood samples (0.5 ml.) may
have to be drawn via finger (children over two years of age) or heel
(children less than two years of age) stick using long point microlances
2-126 3-10-77
-------
and heparinized capillary tubes. The method of drawing blood samples
by finger or heel involves several steps. After the child is secure
or even before, his hand or foot must be cleansed of all noticeable dirt,
grime and anything else, such as food stains, with a cotton swab. After
that, the finger tip (usually the index finger) or heel to be stuck is
selected, held, and wiped with an individually wrapped sterile alcohol
swab. After this, the finger or heel is massaged by applying gentle
pressure towards the puncture site, thereby pushing the blood up toward
the puncture site. When the puncture site appears somewhat red and engorged
with blood, the site is punctured with an individually packaged long
point microlance. The first drop of blood thus elicited is wiped away
with an individually wrapped dry sterile gauze pad. The free-flowing
blood is then collected with a gentle milk-ing motion into two or preferably
three heparinized capillary blood collection tubes of approximately 280
microliters in volume to within one inch of their top end. During the
blood collection procedure, care should be taken to see that the tip
of the capillary tube is held right on the point of puncture and the
blood collected there so that the blood does not run down the finger
or heel and then into the tube, thereby opening possibilities of contamina-
tion. The tube fills itself through capillary action; when each tube
is full, the blood collector places each tube on a clean level surface.
When blood sample collection is completed for a particular child (see
hematocrit section immediately following), the puncture site is wiped
with a dry sterile gauze pad pressed to the puncture to stop the bleeding,
and a sterile adhesive bandage is applied. The blood samples in the
capillary tubes will then be transferred to an appropriately labeled
vial for refrigeration and shipment to RTI for analysis.
2-127 3-10-77
-------
4. Hematocrit Determination
Hematocrit will be determined at the performance site by the
microhematocrit method using a microhematocrit centrifuge. Hematocrit
values will be read with a reader and recorded in Part D of the SQ (see
appendix 2.3).
In the case of Vacutainer blood samples, two microhematocrit
tubes will be filled three-fourths full from the blood in the Vacutainer
tube and one end of each hematocrit tube will be sealed with putty. The
microhematocrit tubes will then be centrifuged, the percentage of packed
red cells read on a hematocrit reader, and the value recorded on the SQ.
The stopper will be replaced in the Vacutainer tube which will then be
refrigerated for shipment to RTI for analysis.
In the case of the finger or heel stick, the procedure will
be the same as that in the preceding paragraph except that only one micro-
hematocrit tube will be filled per participant, directly from the puncture
site.
2-128 3-10-77
-------
D. Considerations of Dietary Heavy Metal Exposure
Diet is an important contributor of trace metal to an individual.
Moreover, the amount of trace metal in various diets may vary by several
orders of magnitude. Accordingly, it may be quite important to the success
of the present study to obtain some measure of the amount of trace metals
in the diets of the sample individuals. Procedures which have been suggested
for obtaining diet trace metal levels include:
1. Feces samples,
2. Analyzing duplicate diets or meals from sample individuals,
3. Questions regarding diet in the Study Questionnaire, and
4. Analyzing area grocery store food samples (Market Basket
procedure).
After review of the literature, discussions with consultants and
other experts, and careful deliberation, RTI decided to employ questions
regarding diet and the market basket approach together in order to obtain
some measure of the amount of trace metals in the diets of the sample
individuals. Those two procedures, while less precise than chemical
analysis of feces samples and duplicate meals, are considerably less
expensive, more suitable and practical under actual survey conditions,
and less of a burden to the participant and interviewer.
1. Dietary History
RTI has included several questions regarding eating habits and diet
in the SQ which will be completed for every participant by the FI during
household data collection, including the frequency with which the partici-
pant eats certain foodstuffs known to contribute to trace metal exposure
[Ref. 2.5]. RTI has planned that these questions would be part of the
2-129 3-10-77
-------
data collection process from the beginning; therefore, this method of
collecting information on dietary trace metal exposure results in no
additional significant cost.
2. Market Basket
In this approach, which is also relatively inexpensive, the RTI
Site Administrator would purchase exemplary market baskets of food from
grocery stores at the smelter sites. The food would then be returned to
RTI for analysis for trace metal content. RTI is in communication with
the Food and Drug Administration regarding the details of this procedure,
including the specific foods which comprise the market basket sample.
The market basket procedure is not part of the Scope of Work of
this contract; impact on project cost projections will be assessed after
the Pretest.
2-130 3-10-77
-------
E. Quality Control
Each sample will be properly labeled as it is collected. Each indi-
vidual sample will be treated the same as all other samples of that particular
type.
As a check on the quality or precision of the procedures and techniques
for collecting certain of the biological and environmental samples, RTI
plans to collect duplicate housedust, tap water, blood, and scalp hair
samples (the last two from adult participants only) from ten percent
of the sample sources, using the same technique and as nearly as possible
the same site(s) as the original sample.
The duplicate housedust sample will be taken from a floor area immediately
adjacent to the site of the original sample using the same collection
procedures. The duplicate tap water sample will be taken from the same
water source as the original after flushing sample using the same collection
procedure. The duplicate scalp hair sample will be taken using the same
collection procedure in an amount equal to the original sample (where
possible). The duplicate blood sample will be taken from the same venipuncture
using the same collection procedure as the original sample by changing
Vacutainer tubes. The duplicate samples will be taken by the same person
as the original sample and at the same approximate time.
2-131 3-10-77
-------
APPENDIX 2.7
REFERENCES
2-132 3-10-77
-------
REFERENCES
2.1. Landrigan, P. J., et al., Epidemio lead absorption near an ore smelter:
the role of particulate lead. New England Journal of Medicine,
Vol. 292, No. 3, pp. 123-129, January 1975.
2.2. Center for Disease Control, Protocol: nationwide survey of children
living near primary non-ferrous metal smelters.
2.3. U. S. Department of Commerce, Social and Economic Statistics Admin-
istration, Bureau of the Census. County and City Data Book, 1972;
Statistical Abstract Supplement. Washington, D. C.: U. S. Government
Printing Office, 1973.
2.4. Hartwell, T. D., et al. Design, Data Collection and Analysis of a
Field Test of Instruments and Procedures to Measure English Language
Proficiency. Research Triangle Park, N.C.: Research Triangle Institute,
April 1976.
2.5. Bureau of Foods, Compliance Program Evaluation, FY 1974 Heavy Metals
in Foods Survey (7320.130, Chemical Contaminants Project), June 19, 1975.
2.6. Hall, W. G., and L.'T. Slovic, U. S. Department of Commerce, National
Bureau of Standards. Survey Manual for Estimating the Incidence of
Lead Paint in Housing (NBS Technical Note 921). Washington, D.C.:
U. S. Government Printing Office, 1976.
2.7. Federal Register, Vol. 36, p. 8192, 1971.
2.8. Solomon, R. L., and J. W. Hartford, Lead and cadmium in dust and soils
in a small urban community. Environmental Science and Technology.
Vol. 10, No. 8, pp. 773-777, August 1976.
2-133 3-10-77
-------
3.0 Physical Methods of Analysis
This section describes the sample preparation procedures which will
be carried out on the blood, urine, scalp hair, tap water, dust, air
particulate, soil, and market basket samples collected at the smelter
sites. These materials will be analyzed for As, Cd, Cu, Mn, Pb and Zn
by atomic absorption spectrophotometry.
A spark source semiquantitative scan will be obtained on two biological
samples from each age-sex group by Commercial Testing and Engineering Company,
Golden, Colorado. This corresponds to a total of 252 samples from the
six smelter sites which will be analyzed in this manner.
Free erythrocyte protoporphyrin (FEP) content will be determined in
each blood sample to establish the extent of chronic exposure to lead.
A microspectrofluorometric procedure will be employed.
Quality control will play a prominent role in all routine analytical
operations. Both internal and external reference materials will be used
to insure continuing analytical accuracy.
3.1 Atomic Absorption Analysis
All atomic absorption analysis will be carried out on a Perkin-
Elmer Model 403 Atomic Absorption Spectrophotometer using an HGA-2000
Graphite Furnace with deuterium arc background correction. Absorption
peaks will be recorded with a Perkin-Elmer Recorder Model 056. Homogeneity
of the final sample will be insured by treatment in an ultrasonic bath
prior to analysis. Sample injection will be accomplished with an Eppendorf
pipet.
All glassware used in sample preparation will be soaked overnight
in 1% HNO,, rinsed well with deionized water and dried. Precleaned
volumetric pipets will be used for reagent and sample deliveries. All
3-1 3-10-77
-------
HNCL solutions will be prepared from analytical reagent grade material
and deionized water.
Sample preparation procedures are described below for each matrix.
Special workup conditions will be used for sample solutions slated for
arsenic analysis (see Section 3.1.4).
3.1.1 Biological Samples
Samples in this category include blood, urine and scalp hair speci-
mens collected from the study participants.
3.1.1.1 Blood
Blood samples will be diluted with 0.5% (v/v) HNO. and analyzed
directly for the metals of interest. Results will be reported as weight
of metal/100 ml blood.
3.1.1.2 Urine
Urine samples will be diluted with 1.0% (v/v) HNCL and analyzed
directly for the metals of interest. Results will be reported as weight
of metal/100 ml urine.
3.1.1.3 Scalp Hair
Scalp hair samples will be cut into approximately 1 cm sections
with stainless steel scissors and rinsed with a 1:1 methanol:ether
mixture. The hair material will be washed twice with a 10% Prell (liquid)
solution, rinsed well with deionized water and dried at 105°C. A 250 mg
(approximately) portion of the washed hair collection will be weighed
and digested at 85°C with a 1:1 HNO_ mixture. The concentrate will be
diluted with deionized water and analyzed directly for the metals of
interest. Results will be reported as weight of metal/gm hair.
3-2 3-10-77
-------
3.1.2 Environmental Samples
Samples in this category include dust collected at the homes of the
study participants, air particulate samples collected according to the
sample design described in section 1.6.2; tap water samples taken from
the homes of study participants and schools of school-age subjects; and
soil samples taken at the air sampling locations, from the play area of
pre-schoolers, and the school yard of school-age subjects.
3.1.2.1 Tap Water
Each tap water sample, already acidified with HNO_ at the collection
site, will be analyzed directly for the metals of interest. Results
will be reported as weight of metal/liter tap water.
3.1.2.2 Dust [Ref. 3.1]
Dust samples will be weighed and digested at 85°C with 1:1 HNO~.
Deionized water will be added to a reference volume, the suspension will
be filtered, and the filtrate analyzed directly for the metals of interest.
Results will be reported as weight of metal/gm dust.
3.1.2.3 Air Particulates
Air particulate samples will be eluted from a 2.0 x 20.3 cm strip
of the glass fiber filtering media with 1% (v/v) HNO- in a 50° - 60°C
water bath. The filter strip will be quartered, placed in a covered
beaker and warmed with dilute HNO_ for 30 minutes. The supernatant will
be drawn off and the filter sections treated for an additional 30 minutes
with a fresh portion of 1% (v/v) HNO~. The solution will be decanted,
combined with the original supernatant, diluted to a reference volume
with deionized water, filtered and analyzed directly for the metals of
interest. Results will be reported as weight of metal/m air (see appendix
2.6, B.I for calculation of air sample volume).
3-3 3-10-77
-------
3.1.2.4 Soil [Ref. 3.2]
The soil sample will be screened on a 20 mesh ASTM sieve and dried
at 105°C. A weighed soil sample will be slurried in a minimum volume of
deionized water and digested with concentrated HNO_ at approximately
100°C. To the cooled mixture will be added 30% H202 and the heating
continued with intermittent swirling. The cooled digestate will be
filtered, diluted to a reference volume with deionized water, and analyzed
directly for the metals of interest.
3.1.3 Arsenic Analysis
The analysis of arsenic by a graphite furnace procedure presents
certain problems unique to this relatively volatile and interference-
prone element. To overcome losses of arsenic from the furnace prior to
atomization, tap water, hair, dust, and air particulate sample solutions
will be "stabilized" with 1000 ppm nickel and will contain 1% (v/v) HN03
to. minimize the effect of small differences in acid strength on signal
intensity.
Blood, urine, and soil extracts will be subjected to an extraction
workup to remove matrix interferences. This procedure is based on
literature methods [Ref. 3.3, 3.4] and is outlined below:
• Overnight treatment with cone. HC1 at room temperature.
• Reduction of arsenic species with SnCl_/KI and extraction of these
products into benzene.
• Back-extraction of total arsenic into dilute dichromate containing
1% (v/v) HN03.
• Addition of 1/10 volume of 10,000 ppm nickel.
3-4 3-10-77
-------
3.1.4 Market Basket Samples
The food items collected at site grocery stores will be analyzed
for all six elements. Each sample will be subjected to acid hydrolysis
conditions and metal concentrations determined by standard additions.
Since this work area is not part of the originally proposed study,
an estimate of additional cost will be made after the Pretest.
3.2 Spark Source Mass Spectrometric Analysis
Two samples of each biological type from every age-sex group and
smelter site (total 252) will be submitted for spark source mass spec-
trometric analysis. A semiquantitative scan will be obtained by the
Instrumental Analysis Division of Commercial Testing and Engineering
Company, Golden, Colorado. The analysis will be run on an Associated
Electrical Industries (AEI) Model MS7 instrument.
3.3 Free Erythrocyte Protoporphyrin (FEP) Analysis
A fluorometric method based on the procedure reported by S. Piomelli
[Ref. 3.5] will be used to determine FEP. The method requires only 20
microliters of whole blood. The ethyl acetate-acetic acid extraction
and the free porphyrin separation with aqueous HC1 will be carried out
and the fluorescence of the lower porphyrin layer measured directly.
The excitation monochromator will be set at 400 nm and a scan obtained
with the emission monochromator at 500-700 nm (fluorescence emission
maxima occur at 608 and 658 nm with a relative intensity ratio of 2.08).
Standard solutions of coporphyrin will be used for calibration purposes.
This assay will detect FEP levels as low as 4.5 yg/100 ml whole
blood.
A Hitachi Perkin-Elmer Model MPF-2A Fluorescence Spectrophotometer
will be used for the FEP analysis.
3-5 3-10-77
-------
3.4 Quality Control and Analytical Protocol
3.4.1 Instrumentation
At the start of each analytical run, the atomic absorption spectro-
photometer will be calibrated for the element to be analyzed for, using
standard solutions containing known quantities of metal in the appropriate
control matrix material. Pooled collections of blood, urine, scalp
hair, tap water, dust and soil, shown to have minimal or nonelevated
metal concentrations, will serve as baseline matrix material. In each
case the actual metal concentration will be determined by the method of
standard additions. Potential control soil samples will be obtained at
a distant upwind location from the smelter in an attempt to simulate
soil type.
Air particulate calibration solutions will be prepared by spiking
glass fiber filter sections with known amounts of the metals of interest.
In the case of scalp hair, dust, soil and air particulate calibrations,
the standard additions will be done prior to sample workup.
These calibration solutions will serve as internal reference materials
as described below.
The calibration data will be fitted to the exponential equation, y =
ae + k, where
x = peak response, mV,
y - weight of metal, ng, and
a,b,k = constants.
The values assigned to the constants will be determined by a linear regression
program on a Monroe Model 1800 programmable calculator. Sample metal concen-
trations will be calculated from this exponential expression on a Texas Instru-
ments Model 51-11 calculator.
3-6 3-10-77
-------
3.4.2 Limits of Detection
Detection limit (DL) will be defined as that amount of metal which
will give a net signal two standard deviation units greater than the
mean matrix signal. This corresponds to that amount measurable at a
precision level of 50% Regular Standard Deviation (RSD). An analysis
giving a net signal less than two blank standard deviation units will be
reported as not detected (ND).
3.4.3 Routine Analytical Protocol
After the instrument has been calibrated for a specific metal in a
particular collection matrix, an analytical run (60-80 samples) will be
initiated by a team of two analysts. Duplicate sample injections will
be made on all samples, provided the intensity of the two signals satisfies
the following criterion:
First Signal, Maximum Permissible Permissible Range of
% of Full Scale Variation Second Signal. % of Full Scale
90 +10% 81-99
80 +10% 72-88
70 +10% 63-77
60 +10% 54-66
50 +10% 45-55
40 +15% 34-46
30 +17% 25-35
20 +20% 16-24
10 +25% 6-14
5 +40% 3-7
2 +50% 1-3
Depending on the total furnace program time, 20 to 30 samples will be
processed per hour. The analysts will alternate between sample injection
and data calculation; the metal concentration of each sample will be determined
3-7 3-10-77
-------
immediately after analysis. Matrices which vary widely in metal levels
(air particulates, soil, dust) may exhibit concentrations outside of the
linear working range. These samples will be set aside, suitably diluted
and analyzed as a group against appropriate calibration standards.
Sample weights/volume, dilution factors, calibration and raw analytical
data will be recorded on the Analytical Data Sheets, examples of which
are shown in appendix 3.1.
3.4.4 Analytical' Priorities
First priority will be given to the biological samples (urine,
blood and scalp hair). Included in this category is the blood FEP
assay. Tap water samples will be analyzed next. Dust, soil and air
particulate analysis will be performed as soon as the others have been
completed.
3.4.5 Quality Control Procedures
The quality control measures incorporated in the routine analytical
protocol will serve two major functions: to maintain constant instrument
performance and determine analytical precision and accuracy.
3.4.5.1 Instrument Performance
Instrument performance will be monitored by determining the signal
response of a reference material after every 10-15 samples. These
evaluations will be carried out with an original calibration solution
(internal reference) or, when available, an external reference material
with a metal concentration known to the analyst. These procedures are
not intended to assess precision or absolute accuracy but to establish
the validity of the original calibration data. If the reference sample
signal has changed by more than +10-15% or +2 standard deviation units,
3-8 3-10-77
-------
appropriate measures will be taken before continuing the analytical run
(e.g., changing the graphite tube, balancing the D~ arc-light source
intensities, recalibrating).
3.4.5.2 Accuracy and Precision
Accuracy will be assessed by analysis of external reference materials
approximately every 20 samples. This procedure will be carried out
blind. The reference materials will be coded and processed in the same
manner as field samples. External reference materials available for
this purpose are listed below:
• Blood (CDC) - Pb and FEP;
• Tap water (EPA/Cincinnati) - all metals;
• Air particulates (EPA/RTP) - As and Pb, others as they become
/
available.
Precision will be assessed by analysis of duplicate samples (see
Section 2.2.6.4). These materials will be coded at the smelter site; their
identity as a duplicate will be unknown to the analyst. Samples which
will be evaluated in this manner are listed below:
• Blood (10%) adult participants only,
• Scalp hair (10%) adult participants only,
• Tap water (10%) second sample after flushing,
• Dust (10%), and
• Soil (10%) from air sampling sites and school yards.
Evaluation of the tap water duplicates will serve two functions.
The two consecutively drawn samples will be analyzed and the results
used to estimate variability in water quality with time. Equal aliquots
from the duplicates will be combined, the blend split in two portions
and each analyzed to determine analytical reproducibility.
3-9 3-10-77
-------
3.4.5.3 Interlaboratory Comparison
An interlaboratory comparison study will be initiated. Samples to
be identified by the EPA Project Officer will be split for independent
analysis.
3.4.6 Calibration of High Volume Air Samplers
All high volume air samplers will be calibrated against a top
loading Orifice Calibration Unit Model 330 (Sierra Instruments, Inc.,
St. Paul, Minnesota). This device has been standardized against a
primary standard, positive displacement Rwots Meter by the Environmental
Protection Agency, Research Triangle Park, North Carolina (EPA/RTP).
The calibration data are presented in figure 3.1.
Each high volume sampler will be equipped with a pressure gauge for
monitoring air flow across the 20.3 cm x 25.4 cm glass fiber filter. To
calibrate the pressure gauge readout in terms of air flow, one, two, and
three, etc., glass fiber filters will be placed on the sampler to simulate
resistance to air flow. As the resistance to air flow changes, measurements
of the pressure drop across the orifice will be made with a water manometer
and related to the corresponding pressure gauge reading. With this
calibration data, the gauge on each sampler may be directly converted to
standard cubic meters air flow per minute across the filter medium.
Sampler calibration will be checked at the site with an EPA audit
device.
After use at a smelter site, brushes on the air samplers will be
changed and the unit recalibrated.
3.5 Determination of Total Particulate Solids in Air
Subsequent to filter prewashing with 5% HNO-, each filter will be
tared, inspected for imperfections, and handled in a manner consistent
3-10 3-10-77
-------
U)
I
M
O
I
,-J
Fig. 3.1. Calibration ofMSierralnstrument Orifice, Model 330.
-------
with the procedures described in the Federal Register [Ref. 3.5]. Each
filter will be stamped with an identification number and placed in a
Zip-Loc bag for transport to the site. On return to RTI, the filters
will be weighed as described [Ref. 3.6] and the net weight reported as
3
weight of total particulates/m air.
3.6 Personnel
All chemical analysis will be carried out at RTI under the direction
of Dr. Robert W. Handy, Senior Chemist in the Chemistry and Life Sciences
Group (CLSG). Dr. Monroe E. Wall, CLSG Director and RTI Vice President,
will provide overall coordination for all phases of this program.
Assisting Dr. Handy will be chemical professionals Gail T. Hess,
David F. Natchske, Karen Robbins and technician Carolyn Foust. Mrs.
Hess will direct and evaluate the routine quality control measures
during daily analytical runs.
Resumes of these individuals will be found in appendix 3.1.
3.7 References
3.1. Solomon, R. L., and J. W. Hartford, Environmental Science and
Technology, Vol. 10, p. 777, 1976.
3.2. Krishnamurty, K. V., E. Shpirt, and M. M. Reddy, Atomic Absorption
Newsletter, Vol. 15, p. 68, 1976.
3.3. Fitchett, A. W., et al., Analytic Chimica Acta, Vol. 79, p. 93,
1975.
3.4 Forehand, T. J., et al., Analytical Chemistry, Vol. 48, p. 999,
1976.
3.5 Piomelli, S., Journal of Laboratory and Clinical Medicine, Vol. 81,
No. 6, p. 932, 1973.
3.6 Federal Register, Vol. 36, p. 8192, 1971.
3-12 3-10-77
-------
APPENDIX 3.1
ANALYTICAL DATA SHEETS
3-13 3-10-77
-------
ANALYTICAL DATA SHEETS - AA ANALYSIS
INSTRUCTIONS
There is a separate form for reporting the analytical results of each
matrix. The individual forms have several features in common and some which
are unique for the matrix material being analyzed. The- following information
will be supplied in the appropriate space:
a) The chemical symbol of the element being analyzed.
b) The bound notebook reference will be cited for each analytical
run. This notebook will be used to record all operating con-
ditions and any observations or remarks concerning the analysis.
The notebook reference will also be noted on the strip chart
recording.
c) The date and the operator(s) initials will be shown.
d) All calibration standards will be injected in duplicate and the
corresponding peak height recorded.
e) A least squares regression analysis will be carried out on four
standard solutions run in duplicate and the equation representing
the best fit will be noted.
All samples analyzed during a run will be injected in duplicate. The
following data will be recorded for each matrix type:
a) Column 1.
Each sample will be identified by the same code numbers used to label the
sample container at the smelter site.
3-14 3-10-77
-------
b) Column 2.
Instrument response during atomization is measured as peak height,
expressed in units of millivolts (mv).
c) Column 3.
The weight of metal injected- is calculated from a calibration equation
of the form y = ae + k, where
y = weight of metal injected
x = peak height
a,b,k = constants.
d) Column 4.
F is a function of the volume of analytical solution injected into the
graphite furnace.
Volume injected I?
10 yl 100
25 pi 40
50 ul 20
e) Column 5.
The weight of metal contained in each ml of the solution injected into
the furnace is calculated by multiplying the number in Column 3 by F.
The remaining columns on the Data Sheet are treated differently for
each matrix.
a) Drinking Water -
To convert weight of metal/ml water to weight of metal/liter water
simply change the units of weight as follows:
Units wt/ml Equiv. units wt/1
Pg ng (ppt)
ng pg (ppb)
Pg mg (ppm)
3-15 3-10-77
-------
b) Urine -
The constant D (Column 6) is defined as the volume (ml) to which one
ml of urine sample is diluted prior to injectipn in the graphite furnace.
For example, if a 1:1 dilution is performed, D = 2; if a 1:49 dilution
is necessary, D = 50.
The weight of metal/100 ml urine (Column 7) is determined by mul-
tiplying the value in column 5 by 100D.
c) Blood -
As with urine, the constant D (Column 6) is defined as the volume (ml)
to which one ml of urine sample is diluted prior to injection in the graphite
furnace. For example, if a 1:9 dilution is carried out, D = 10.
The weight of metal/100 ml blood (Column 7) is determined by multiplying
the value in Column 5 by 100D.
d) Hair -
vf
D (Column 6) = V± (^-).
where, V. = volume (ml to which sample digest is diluted.
Vf = final volume (ml) of diluted aliquot.
A = volume (ml) of aliquot withdrawn from initial sample
volume (V.) for further dilution to V-.
NOTE - If no aliquoting of V. is performed, the term V../A = 1.
i i
D = V±
The weight of metal/gm hair (Column 8) is found by multiplying Column 5
by D and dividing this product by the sample weight, W (gm)(Column 7).
Wt. metal/gm hair = Column 5 (—)
Example; A 250 mg hair sample was digested and diluted to 5 ml. Two
ml of this solution was diluted to 10 ml prior to furnace injection.
3-16 3-10-77
-------
Vi = 5; Vf = 10; A = 2; W = *25
D = 5 <|£) = 25; |= 100
Wt. metal/gm hair = Column 5 (100).
e) Air Particulates
In the case of air particulate analysis, D is defined as follows:
V F
D (Column 6) = V±(^) ^-.
a
where, V. = volume (ml) to which the extract of the entire filter
strip is diluted.
V = final volume (ml) of diluted aliquot.
A = volume (ml) of aliquot withdrawn from initial sample
volume (V.) for further dilution to V_.
F = total filter area.
F = area of filter used in analysis.
cl
NOTE - If no aliquoting of V. is performed, the term Vf/A = 1, and
a
The weight of metal on the entire filter (Column 7) is determined
by multiplying Column 5 by D. Column 7 is divided by air volume (m )
(Column 8) to give weight of metal /m air (Column 9) . The calculation
of air volume is shown on the air collection log sheet.
Wt. metal/m air - Column 5 (D/air volume)
2
Example ; A 40.6 cm section of a 20.3 x 25.4 cm filter was treated
with acid and diluted to 100 ml. Two ml of this solution was diluted
3
to 5 ml prior to furnace injection. Air volume = 2500 m .
V
± = 100; Vf = 5; A - 2; F - 515.6; F& = 40.6
D = ioo(4) rrr = 25° (12-7) - 3175
£.
3-17 3-10-77
-------
Wt metal/m3 air = Column 5 (3175)/2500
= Column 5 (1.27)
f) Housedust
vf
D (Column 6) = V.^^).
where, V. = volume (ml) to which sample digest is diluted.
V = final volume (ml) of diluted aliquot.
A = volume (ml) of aliquot withdrawn from initial sample
NOTE
volume (V.) for further dilution to V-.
- If no aliquoting of V. is performed, the term V../A = 1, and
D = V±
The weight of metal/gm dust (Column 8) is found by multiplying
Column 5 by D and dividing this product by the sample weight, W(gm)
(Column 7).
Wt. metal/gm dust = Column 5 (—).
Example; A 250 mg dust sample was digested and diluted to 25 ml.
Two ml of this solution was diluted to 25 ml prior to furnace injection.
V± = 25; Vf = 25; A = 2; W = .25
D = 25 (|^) = 312.5; | = 1250
Wt. metal/gm dust = Column 5 (1250).
2
The total weight of metal in a .25 cm collection is found by either
multiplying Column 8 by the weight of sample collected over this area or
multiplying Column 5 by D.
g) Soil
Vf
D (Column 6) = V.(-rL').
X A
3-18 3-10-77
-------
where, V. = volume (ml) to which sample digest is diluted.
V = final volume (ml) of digested aliquot.
A = volume (ml) of aliquot withdrawn from initial sample
volume (V.) for further dilution to V...
NOTE - If no aliquoting of V. is performed, the term Vf/A = 1, and
D = V.
The weight of metal/gm soil (Column 8) is founding by multiplying
Column 5 by D and dividing this product by the sample weight, W(gm)
(Column 7).
Wt. metal/gm soil = Column 5 (—) .
W
Example; A 1.0 gm soil sample was digested and diluted to 250 ml.
One ml of this solution was diluted to 100 ml prior to furnace injection.
V± = 250; Vf = 100; A = 1; W = 1
D = 250 0^) = 25,000; | = 25,000
Wt. metal/gm soil = Column 5 (25,000).
3-19 3-10-77
-------
Matrix
- Housedust
Standard (wt/vol.)
1
Staple
(ode
2.
Peak
height
(mv)
3.
Wt.
metal
injected
ANALYTICAL DATA SHEET
Peak Height (mv)
4. 5.
Wt. metal/
ml anal.
F soln.
- AA ANALYSIS
Element -
Notebook No.
Date
Operator(s)
Calibration Equ.
6. 7. 8. 9. 10.
Wt. metal
Sample Wt. metal/ .25 cm^
D weight gm dust area Comment
3-20 3-10-77
-------
ANALYTICAL DATA SHEET
Matrix
- Air Particulates
Standard (wt/vol
1
Sample
•ode
2.
Peak
height
(mv)
3.
Wt.
metal
injected
.) Peak
4.
F
Height (mv)
,
5.
Wt. metal/
ml anal.
soln.
- AA ANALYSIS
Element -
Notebook No.
Date
Operator (s)
Calibration
6. 7.
Wt. metal
D on filter
Equ.
8. 9. 10.
Air Wt.
volume metal/
(m-*) m^ Comment
3-21
3-10-77
-------
ANALYTICAL DATA SHEET - AA ANALYSIS
I..
Sample
fode
Matrix -
Standard
2.
Peak
height
(mv)
Blood
(wt/vol.) Peak Height
9
9
3. 4.
Wt.
metal
injected F
Element -
(mv) Notebook No.
Date
Operator (s)
Calibration Equ.
5. 6. 7. 8.
Wt. metal/ Wt. metal/
ml anal. 100 ml
soln. D blood Comment
3-22
3-10-77
-------
ANALYTICAL DATA SHEET - AA ANALYSIS
1.
•ample
"code
Matrix -
Standard
2.
Peak
height
(mv)
Urine
(wt/vol.) Peak Height
3. 4.
Wt.
metal
injected F
Element -
(mv) Notebook No.
Date
Operator (s)
Calibration Equ.
5. 6. 7. 8.
Wt. metal/ Wt. metal/
ml anal. 100 ml
soln. D urine Comment
3-23
3-10-77
-------
ANALYTICAL DATA SHEET - AA ANALYSIS
1.
Sample
code
Matrix - Drinking Water
Standard (wt/vol.) Peak Height (mv)
»
»
>
»
2. 3. 4.
Peak Wt .
height metal
(mv) injected F
Element -
Notebook No.
Date
Operator (s)
Calibration Equ.
5. 6. 7.
Wt. metal/
ml anal. Wt. metal/
soln. 1. water Comment
3-24
3-10-77
-------
ANALYTICAL DATA SHEET - M ANALYSIS
1
Sample
Mjde
Matrix -
Standard
2.
Peak
height
(mv)
Soil
(wt/vol.)
3.
Wt.
metal
injected
Peak Height (mv)
»
»
»
>
4. 5.
Wt. metal/
ml anal.
F soln
Element -
Notebook No.
Date
Operator (s)
Calibration Equ.
6. 7. 8. 9.
Sample Wt. metal/
D weight gm soil Comment
3-25 3-10-77
-------
ANALYTICAL DATA SHEET - AA ANALYSIS
Matrix - Hair Element -
Standard
(wt/vol.)
Peak Height (mv)
Notebook No.
, Date
, Operator (s)
, Calibration Equ.
1. 2.
Peak
Sample height
•code (mv)
3.
Wt.
metal
injected
4. 5.
Wt. metal/
ml anal.
F soln.
6. 7. 8. 9.
Sample Wt. metal/
D weight gm hair Comment
3-26 . 3-10-77
-------
APPENDIX 3.2
RESUMES OF RTI PROJECT STAFF
3-27 3-10-77
-------
ROBERT W. HANDY, Senior Chemist
Professional Experience
1975 to date. Senior Chemist, Chemistry and Life Sciences Division,
Research Triangle Institute, Research Triangle Park, North Carolina.
Development of trace metal analysis techniques by atomic absorption
spectrometry and general analytical methodology. Monitoring gas and
aerosol levels in environmental chamber studies using instrumental
and wet chemical methods. Analysis of environmental and biological
materials for trace metals by atomic absorption spectrometry. Isola-
tion, identification and quantitatiori of drug metabolites from various
biological fluids using radiochemical tracers, gas and liquid chro-
matographic techniques.
1965 to 1975. Chemist, Chemistry and Life Sciences Division, Research
Triangle Institute, Research Triangle Park, North Carolina. Synthesis
of substituted cinnamylidene malononitriles; research in modified
steroid synthesis and drug metabolism.
1954 to 1964. Research Chemist, Kay-Fries Chemicals Co., Inc., West
Haverstraw, New York. Synthesis and bench-scale process development
of fine organic intermediates; orthoesters, pyrimidines and miscel-
laneous polyfunctional compounds.
Education
B.S., Chemistry, Brown University, Providence, Rhode Island, 1954.
M.S., Organic Chemistry, Stevens Institute of Technology, Hoboken,
New Jersey, 1964.
Ph.D., Medicinal Chemistry, University of North Carolina, Chapel Hill,
North Carolina, 1971.
Professional Societies
American Chemical Society
Selected Publications
"Reactions of some 4-Piperidones with Olefin-forming Phosphorus
Reagents," M.S. Thesis (1964).
"The Synthesis of Some l-(B-Diethylaminoethyl)-2-(p-ethoxybenzyl)-
5-substituted Benzimadazoles," F. I. Carroll, R. W. Handy, J. A.
Kepler and Joan A. Gratz, J. Heterocyclic Chem., 4^ 262 (1967).
"Metabolism of Antifertility Steroid IV - The Synthesis of 6-Chloro-
17-hydroxypregna-4,6-diene-3,20-dione-4-^C-acetate (Chlormadinone
Acetate)," K. H. Palmer, R. W. Handy and M. E. Wall, J. Labelled
Compounds, 7_, 16 (1971).
"The Total Synthesis of 7 (8 ->• lla) Aboestrogens. Delination of the
Role of Steric Effects in the Biochemistry of Steroids," C. G. Pitt
and R. W. Handy, Tetrahedron, 27, 527 (1971).
3-28 3-10-77
-------
R. W. HANDY
Page 2
"An in vitro and Correlated in vivo Study of the Metabolism of
Chlormadinone Acetate," Ph.D. Dissertation (1971).
"Metabolism of Antifertility Steroid VII - Chlormadinone Acetate,"
R. W. Handy, K. H. Palmer and M. E. Wall, The Pharmacologist, 13_
(2) 221 (1971).
"Comparative Metabolism of Chlormadinone Acetate," R. W. Handy, T.
R. Hess and M. E. Wall, The Pharmacologist, 15_ (2) 228 (1973).
"The Metabolism of Antifertility Steroids: The In Vitro Metabolism
of Chlormadinone Acetate," R. W. Handy, K. H. Palmer, M. E. Wall
and C. Piantadosi, Drug Metabolism and Disposition, 2_ (3), 214
(1974).
"Metabolism of Norethynodrel in Thrombophlebitic - Thromboembolic
Subjects," R. W. Handy, Dawn Dominquez, Marsha Poirer, M. E. Wall,
C. E. Cook, C. D. Christian and R. Bressler, Experientia, 31, 446
(1975).
"Quantitative Determination of Codeine in Plasma by Gas Chromato-
graphy," Ruth A. Zweidinger, F. M. Weinberg and R. W. Handy, J.
Pharm. Sci., 65_, 427 (1976).
"Estimation of Permissible Concentrations of Pollutants for Con-
tinuous Exposure," Robert Handy and Anton Schindler, EPA-600/2-76-155
(1976).
"Analysis of Aluminum Chlorohydroxide by Selective Ion Electrode
Potentiometry," paper accepted for presentation at 1977 Pittsburgh
Conference.
Patents
U.S. Patent 3,121,751, "Production of Purified Orthoformic Esters,"
1964.
U.S. Patent 3,223,713, "Cyclic Malonaldehyde Diacetals," 1965.
U.S. Patent 3,258,496, "Purified Orthoformic Esters," 1966.
U.S. Patent 3,323,925, "Wax Polishes," 1967.
U.S. Patent 3,415,846, "2,6,7-Trioxabicyclo (2.2.2) octanes," 1968.
November 1976
3-29 3-10-77
-------
TERESA ROBERTS HESS, Junior Chemist
Professional Experience
1972 to date. Junior Chemist, Chemistry and Life Sciences, Division,
Research Triangle Institute, Research Triangle Park, North Carolina.
Research on metabolites of chlormadinone acetate in rat liver, rhesus
monkeys and humans. Investigation into the deposition of estradiol
benzoate, testosterone propionate, progesterone, and their metabo-
lites, in bovine tissue. Metabolic studies of trichlorocarbanilide
in rats, rabbits, monkeys and humans. Analysis of rat blood, brain
and femur for lead. Identification of components related to energy
wastes and effluents.
October 1970 to August 1971. Lab Technician under Dr. Kenneth Vick,
U.S. Department of Agriculture, Entomology Research Division,
Gainesville, Florida. Research centered around the determination
of the structure of the sex pheromones of Black Carpet beetle,
T. Inclusum and T. Galabrum, and the biological aspects of the phero-
mones, for example, limits of detection of the insects for the phero-
mones .
June 1970 to September 1970. Summer Lab Technician with St. Regis
Paper Company, Jacksonville, Florida,
Education
B.S., Chemistry, University of Florida, 1971.
June 1976
3-30 3-10-77
-------
DAVID F. NATSCHKE, Junior Chemist
Professional Experience
September 1976 to date. Research Triangle Institute, Research
Triangle Park, North Carolina 27709. Junior Chemist, Chemistry and
Life Sciences Division. Analyze biological and environmental
samples by atomic absorption. Methods development.
June 1974 - July 1975. Phelps-Dodge Corp., Morenci, Arizona.
Assistant Chemist. Analysis of a variety of samples by classical
methods. Some programming.
September 1972 - May 1973. New Mexico Bureau of Mines, Socorro,
New Mexico. Student Analyst. Analyzed samples by atomic absorption
and classical methods.
Education
Military Electronics School, 1966-1967.
B.S., Chemistry, New Mexico Institute of Mining & Technology,
Socorro, New Mexico, 1974.
Graduate School in Chemistry, University of North Carolina,
Chapel Hill, N.C., 1975-1976.
Professional Activities
American Chemical Society, member.
ACS Undergraduate Award in Analytical Chemistry, 1974.
October 1976
3-31 3-10-77
-------
KAREN W. ROBBINS, Junior Chemist
Education
B.A., Chemistry, University of North Carolina, Chapel Hill,
North Carolina, 1974.
Computer Science, Durham Technical Institute, 1975.
Experience
1976 to present. Research Triangle Institute, Research Triangle
Park, N. C. Junior Chemist. Materials experience in preparation
of piezoelectric films and optical coatings. Analysis of basic oxide
furnace materials and processes.
1973 to 1974. Pathology Laboratory, University of North Carolina at
Chapel Hill. Research assistant on various pathology problems.
March 1977
3-32 3-10-77
-------
4.0 Statistical Methods of Analysis
4.1 Confidentiality of Data Files
In carrying out its statistical analyses, RTI will utilize machine-
readable data files maintained at the Triangle Universities Computation
Center (TUCC) located in the Research Triangle Park. To maintain the
confidentiality of these data files, RTI will use an encrypting of data
procedure.
The encrypting procedure involves the use of a routine which scrambles
data passed to the routine so that they are meaningless to anyone unless
they are decrypted. The routine draws random numbers and adds a different
number to each character of the data. The starter for the random number
generator, referred to as the key, is passed to the routine in the
calling sequence. Thus with the same starter to the random number
generator, the data can be decrypted when required for processing. An
encrypting procedure has the advantage of not splitting the primary data
base and not having to depend on computer center personnel (non-RTI
personnel) to maintain the confidentiality of a link file.
In addition to the encrypting procedure, TUCC has developed an
extensive security system which RTI programmers use to protect computer
account codes and data from other users. This is accomplished through a
password protection system for account codes, data sets, and data storage
volumes. These facilities are different from and replace the similar
features provided by IBM. This system is described in TUCC publication
GI-066-0, TUCC Security Features [Ref. 4.1]. Copies of this publication
are available on request.
4-1 3-10-77
-------
4.2 Data Analysis
RTI will use the TUCC IBM 370/165 computer facility for its data
analysis. The data will be stored on 9-track tapes written at 1000 bpi
with an OS standard label.
In its analysis, RTI will examine the following relationships:
(a) the relationship between environmental levels of the trace
metals of interest (i.e., levels of metals in air, water, soil
and dust samples), the distance from the smelter, wind speed,
and wind direction; and
(b) the relationship between tissue levels of the trace metals
(i.e., levels in hair, blood and urine), environmental levels,
and sociodemographic variables (e.g., age, sex).
As is now envisioned, the principal statistical techniques that will
be used to examine these relationships are the analysis of variance,
multiple regression and stepwise regression. In addition, it may also
be worthwhile to examine some multivariate techniques (i.e., techniques
which consider the above relationships for more than one trace metal at
a time).
4.2.1 Analysis of Environmental Levels
In particular, for the relationships in (a) above, the following type of
model will be analyzed for each trace metal being studied:
Y.jk(M) - u + D. + S. + Wk + e.jk (1)
where
Y.., (M) = concentration of metal M in either air, water, soil, or dust
i * u -th ^- -th • ,
samples for the i distance, j wind speed,
and k wind direction,
u = mean metal M level,
4-2 3-10-77
-------
D. = i distance effect
i
S. = j wind speed effect,
W, = k wind direction effect, and
e. ., = random error.
ijk
In the above model, the independent variables (distance from smelter,
wind speed, wind direction) have been categorized and indexed by i, j,
and k, respectively. This allows for a general type of relationship
between the levels of the metals and the independent variables rather
than imposing a functional relationship as does regression. With this
model, one may use the technique of analysis of variance to test for the
effects of different distances from the smelter, differences in wind
speed, and also differences in wind direction. These correspond to
tests of equality of the D., the S., and the W, , respectively.
i J K
As required by the subject Request for Proposal (RFP), the analyses of
the environmental levels, whether they be air, water, dust, or soil,
will be done separately for each site. If differences between sites are
also of interest, this may be investigated by including a site variable,
L, , in model (1) to produce
Yhijk(M) ' U + Lh + °i + Sj + \ + ehijk . (2)
Site differences may then be tested by testing the equality of the L,
and the differences may be exhibited by displaying the adjusted site
means from model (2).
4.2.2 Analysis of Tissue Levels
For the relationships in (b) above, the analysis will again be done by
site and in this case will also be done by broad age categories, since
soil samples are taken only for school and preschool children. In
4-3 3-10-77
-------
particular, the following type of model will be analyzed for each trace
metal:
Y..k(M) - u + A. + S . + B^ + B2X2k
+ B,X,. + B.X.. + BCXC. + e. .. (3)
3 3k 4 4k 5 5k ijk v '
where
Y.., (M) = concentration of metal M in either blood, hair or
J i i
urine samples for the k individual in the i age
, .th
group and j sex group;
u = mean metal M level;
t*h
A. = age effect for the i age group;
S. = sex effect for the j sex group;
B,,...,B. = regression coefficients to be estimated;
X,, , ...,X,., = corresponding concentration of metal M in the air,
water, soil, and dust samples, respectively,
for the k individual; and
e. ., = random error.
ijk
The above model will permit the examination of the effect of age and sex
as well as environmental levels on metal M tissue levels. A similar
model may also be used to examine the effects of distance and wind
direction on metal M tissue levels. In model (3), testing for age and
sex effects corresponds to testing the equality of the A. and S. while
testing for the relationship between tissue levels and environmental
levels corresponds to testing the nullness of B,,...,Br. When the
parameters in model (3) have been estimated, the resulting fitted equation
may serve as a predictive model for the reference population.
In order to help determine the form of model (3) for the various
metals, it may be worthwhile to employ the technique of stepwise regression.
4-4 3-10-77
-------
This technique can be used to give insight into the relative strengths
of the various demographic, environmental and meteorological variables
in predicting tissue levels in humans. In essence, this technique selects
those variables (in a stepwise manner) which best predict the dependent
variable of interest (i.e., tissue levels).
In addition to using the various statistical models given above,
other techniques which will be employed to examine the relationships of
interest include: computing correlations between pairs of variables;
examining scatter plots of tissue levels versus the demographic, environ-
mental, and meteorological variables; and computing means of the demo-
graphic, environmental, and meteorological variables for various cate-
gories of tissue levels and then plotting these means.
4.3 Potential Problems
4.3.1 Missing Observations
Because of the nature of the data being collected for the present
study, there undoubtedly will be a large number of missing observations.
These missing observations may consist of all or only selected observations
from a sample individual (e.g., the individual refuses to give any data
at all or he gives all the data desired except a urine sample). In
order to carry out the analyses described in section 4.2, it will be
necessary to determine how these missing observations are to be handled,
keeping in mind that the easiest solution of only analyzing individuals
with complete observations is probably unsatisfactory because too many
individuals with partial observations would have to be discarded.
The specific techniques to be used for handling missing observations
will be determined during the analysis, and will depend upon several
considerations. Some of the pertinent considerations include the
following:
4-5 3-10-77
-------
The reason for the missing observation,
The type of measurement (e.g., tissue level) for which the
observation is missing,
The type of analysis or estimate for which the missing obser-
vation is needed,
The number of missing observations for that measurement,
The minimum measurable level if the observation is missing
because it is less than that level, and
The information available from that and other individuals that
may facilitate the estimation of the missing observation.
The methodology decided upon will be made available for Project Officer
review and will be fully documented in the final report. The following
methodologies will be among those considered.
If relatively few observations are approximately "randomly" missing
for a particular measurement, cohort means will probably be substituted
for the value and the degrees of freedom will be appropriately modified.
If relatively few observations are missing because they are below a
x'
i
measurable minimum, the range midpoint of this observation, —j, may be
substituted for the missing value, particularly if the range is small
(i.e., if [0,x!] is small where x! is the smallest measurable value for
X.). However, if the number or range of unmeasurable observations is
large, a more refined technique may be used. Under this condition,
methodology for the estimation of distributional location and scale
parameters under the situation of singly censored samples, would be
appropriate for the initial analysis. In Sarhan and Greenberg [Ref. 4.2],
order statistics are used to obtain unbiased best linear estimates of
4-6 3-10-77
-------
location and scale parameters from samples of size 20 or smaller and
unbiased "nearly best" linear estimates from larger samples in which
single censoring occurs. Once the distributional parameters are estimated,
it will then be possible to substitute values for the untneasurable
observations based upon the estimated distribution.
In running the regression analyses described in section 4.2, one
may encounter either missing dependent (Y) or missing independent (X)
variables. To handle this problem, one might use a model in which an
indicator variable reflects the missing independent variables and "two-
stage" estimation models [Ref. A.3] are used to predict missing dependent
variables. The two-stage method is used in SAS [Ref. 4.4], one of the
software systems utilized by RTI. The method uses a least squares
solution to obtain parameter estimates from the available observations,
and then uses estimates of missing values from this preliminary model in
place of the missing values—the analysis can then be conducted as if
the data were complete except for changes in degrees of freedom. However,
if information is known about the range of the dependent variable, i.e.,
that 0 < y.. < y! where y! is the minimum detectable level for Y., then
— ij — i i i
the two-stage estimation alone would ignore this useful bit of informa-
tion. Therefore, the two-stage estimation (estimating missing data on
the basis of complete observation vectors) would be used to set., values
when they fall below the minimum measurable level, but only if these
estimated values were within the known range [0,y!j. Thus, the following
imputed value would be used for a missing y..:
y*.
0, if y. < 0.
y! otherwise
4-7 3-10-77
-------
where
y*. is the imputed value for the missing y.. value,
A
y.. is the first-stage estimate of the missing y.., and
J J
y! is the minimum detectable level of Y..
The indicator variable model suggested above for accommodating
missing X variables in regression analysis might be of the following
type:
y.. = I..[B0 + 0^] + (1-I.)62 + Ej (4)
where
y. is an observed dependent variable for individual j,
I. is an indicator variable (0,1) according to whether the X obser-
vation is present or missing because it is below measurability,
(3, are parameters to be estimated, and
1C
e. is a stochastic error term.
J
4.3.2 Trace Metal Intake Due to Diet
At the present time, it is anticipated that environmental levels of
air, water, soil, and dust will be sampled to determine human exposure
to the trace metals of interest. However, it is well known that diet is
also an important contributor of trace metal to an individual. For
example, EPA personnel have indicated that the proportion due to diet of
the total lead absorbed by individuals may be as high as .66. In
addition, the amount of lead in various diets may vary by several
orders of magnitude. Accordingly, it may be quite important to the
success of the present study to obtain some measure of the amount of
trace metals in the diets of the sample individuals. Procedures which
have been suggested for obtaining diet trace metal levels include:
4-8 3-10-77
-------
Feces samples
• Analyzing duplicate diets from sample individuals,
• Adding questions about diet to the individual's question-
naire, and
• Analyzing area grocery store food samples.
EPA and RTI personnel have investigated these procedures to determine
if one or more of them should be incorporated into the present study.
At the present time, RTI plans to ask questions about diet in the study
questionnaire and to collect and analyze area grocery store food samples.
Hopefully, these two procedures will provide some estimates of the
relative levels of trace metal intake due to diet.
4.4 Personnel
The analysis of the data for the current project will be under the
direction of Senior Statistician Dr. W. Kenneth Poole who is the Director
of RTI's Statistical Methodology and Analysis Center (SMAC). Working
with Dr. Poole in analyzing the data will be Senior Statistician Dr.
Tyler Hartwell who is also a member of SMAC. In addition, Programmer
Ms. Lois Bressler from the Computer Applications Center (CAC) will
assist Drs. Poole and Hartwell with the data processing. Resumes of
these individuals will be found in appendix 4.1.
4-9 3-10-77
-------
APPENDIX 4.1
RESUMES OF RTI PROJECT STAFF
4-10 3-10-77
-------
W. KENNETH POOLE, Head, Statistical Methodology Department
Professional Experience
1967 to date. Research Triangle Institute, Research Triangle Park, North
Carolina, 27709. Statistician, Statistics Research Division. Consults
in matters relating to the theory and application of stochastic processes.
Does applied research in reliability, regression analysis and estimation.
Education
B.S., Mathematics, Austin Peay State University, Clarksville, Tennessee,
1961.
M.P.H., Biostatistics, University of North Carolina, Chapel Hill, North
Carolina, 1963.
Ph.D., Statistics, University of North Carolina, Chapel Hill, North
Carolina, 1968.
Held a one-year traineeship at Vanderbilt University during 1961-1962.
Attended a six-week summer session on Biostatistics at Stanford University,
1962.
Professional Activities
American Statistical Association, member.
Institute of Mathematical Statistics, member.
Selected Publications
"Particle Size Distribution and Hopper Flow Rates," with E. D. Sumner,
Journal of the Pharmaceutical Sciences, Vol. 55, No. 12, December 1966.
"Water Absorptive Properties of Selected Solids in a Lipophilic Base I,"
with E. D. Sumner, D. N. Entrekin, and A. F. Ike, Journal of the
Pharmaceutical Sciences, Vol. 58, No. 1, January 1969.
"Some Aspects of Linear Prediction in Stationary Time Series," Institute
of Statistics Mimeo Series, No. 566, University of North Carolina,
Chapel Hill, North Carolina, 1968.
"An Investigation of Certain Physical and Mechanical Properties of Wood-
Plastic Combination," with Eric Ellwood, Robert Gilmore, and James A.
Merrill. ORO-638, Isotopes-Industrial Technology, Division of Technical
Information, United States Atomic Energy Commission.
"Fertility Measures Based on Birth Interval Data." Theoretical Popula-
tion Biology. Vol. 4, No. 3, pp. 357-387, September 1973.
"Some Methodological Issues in Cohort Analysis of Archival Data," with
K. 0. Mason, H. H. Winsborough, and William M. Mason, American Socio-
logical Review. Vol. 38, pp. 242-258, April 1973.
"Estimating the Effect of Unwanted Fertility of a Post-Parturn Re-
cruitment Strategy," with J. R. Udry. American Journal of Public Health,
Vol. 64, No. 7, pp. 696-699, July 1974.
4-11 3-10-77
-------
"The Estimation of Examiner Error and the True Transition Probabilities
for Teeth or Surfaces in Dental Clinical Trials," with B. V. Shah and
A. C. Clayton. Archives of Oral Biology, Vol. 18, pp. 1291-1302, 1973.
"Estimation of the Distribution Function of A Continuous Type Random
Variable Through Randomized Response," Journal of the American Sta-
tistical Association, Vol. 69, No. 348, December 1974.
"An Index of The Economic Welfare of Rural Families," Frances M.
Magrabi, Jean L. Pennock, W. Kenneth Poole and J. Valley Rachal.
Journal of Consumer Research. Vol. 2, #3, pp. 178-187, December 1975.
"Diphenylhydantoin and Phenobarbital Concentration In Saliva and Plasma
of Man Measured by Radioimmunoassay," C. E. Cook, EJ.len Amerson,
W. Kenneth Poole, Philip Lesserr and Lorcan O'Tauma. Clinical Phar-
macology and Therapeutics, Vol. 18, //6, pp. 742-747, December 1975.
"A Computer Program for Multiple Decrement Life Table Analyses" with
P. C. Cooley, to appear in Computer Programs in Biomedicine.
9/76
4-12 3-10-77
-------
TYLER D. HARTWELL, Senior Statistician
Professional Experience
1964 to date. Research Triangle Institute, Research Triangle Park,
North Carolina, 27709. Statistician, Statistical Methodology and
Analysis Center. The work has involved the application of statistical
methods to a wide variety of research areas. Considerable experience
in using statistical computer packages to analyze laboratory and sur-
vey data. Research areas have included: analysis of the impact on
environmental variables of nuclear power plants, estimation of the
incidence and prevalence of head and spinal cord injuries, analysis
of survey instruments and procedures designed to measure English
language proficiency, use of ridge regression in copper smelter gas
blending for control of sulfur dioxide, investigation of the role of
leadership in preventing drug abuse in the army, evaluation of
training methods designed to help army leaders reduce social problems
in their units, investigation of the relationships between drugs and
crime, projecting the supply of nursing manpower, evaluating sampling
techniques as related to a national assessment of education, simulat-
ing hospital utilization, projecting U. S. manpower requirements for
short-term general hospitals, method comparison of NC- air-monitoring
instruments, investigation of the relationships between atmospheric
oxidant and various pollutant and meteorological variables,- time
series analysis of non-stationary rocket vibration data, design of
chemical experiments, and estimating tolerance limits from censored
samples.
1962 to 1964. North Carolina State University, Raleigh, North Carolina.
Graduate work in the Department of Experimental Statistics.
1961 to 1962. Autonetics, a Division of North American Aviation,
Downey, California, Mathematical Analysis Group. The work included
systems reliability, data analysis and developing computer programs.
Education
B.S., Mathematics, University of Michigan, Ann Arbor, Michigan, 1961.
M.E.S., Statistics, North Carolina State University, Raleigh, North
Carolina, 1964.
P.h.D., Statistics, North Carolina State Universtiy, Raleigh, North
Caroina, 1971.
Professional Activities
American Statistical Association, member.
Biometric Society, member.
Phi Eta Sigma
Phi Kappa Phi
Selected Publications
"Expected Mean Squares for Nested Classifications," with D. W. Gaylor,
Biometrics. Vol. 25, pp. 427-430, 1969.
4-13 3-10-77
-------
"Simulation of Hospital Utilization," with D. G. Horvitz and
J. R. Batts, Proceedings of the American Statistical Association,
Social Statistics Section, pp. 129-138, 1970.
"Estimating Variance Components for Two-Way Disproportionate Data
with Missing Cells by the Method of Unweighted Means," with
D. W. Gaylor, Journal of the American Statistical Association,
Vol. 68, pp. 379-383, 1973.
"Compariability of Nine Methods for Moitoring N0_ in Ambient Air,"
with C. A. Clayton, Environmental Monitoring Series, EPA-650/4-74-012,
1974.
"Head and Spinal Cord Injury: A Pilot Study of Morbidity Survey
Procedures," with W. D. Kalsbeek, submitted to American Journal
of Public Health. 1976.
"Estimating Morbidity Trends by Means of a Source Panel Design," with
W. D. Kalsbeek. Paper presented at 104th Annual Meeting of the
American Public Health Association, Miami Beach, Florida, October,
1976.
"Investigation of the Role of Multihearth Roaster Operations in
Copper Smelter Gas Blended Schemes for Control of S07," with
B. H. Carpenter and K. J. C. Smith, submitted to Environmental Science
and Technology, 1976.
"Preliminary Analysis of Nonradiological Environmental Data at the
Zion Nuclear Power Plant," Research Triangle Institute, Research
Triangle Park, North Carolina, 1976.
"Design, Data Collection and Analysis of a Field Test of Instru-
ments and Procedures to Measure English Language Proficiency,"
Research Triangle Institute, Research Triangle Park, North Carolina,
1976.
"Examining the Properties of Qualified Observer Opacity Readings
Averaged Over Intervals of Less Than Six Minutes," Research Triangle
Institute, Research Triangle Park, North Carolina, 1976.
"An Experimental Evaluation of Three Training Methods Designed to
Help Company Level Army Leaders Reduce the Incidence of Social
Problems in Their Units," Research Triangle Institute, Research
Triangle Park, North Carolina, 1975.
"The Role of Company Level Leadership in Preventing Drug Abuse in
the Army," Research Triangle Institute, Research Triangle Park,
North Carolina, 1974.
"Review of Methods of Estimating Number of Narcotic Addicts,"
Research Triangle Institute, Research Triangle Park, North Carolina
1975.
4-14 3-10-77
-------
"Trends in Registered Nurse Supply," Research Triangle Institute,
Research Triangle Park, North Carolina, 1975.
"Relationship of Criminal Behavior and Drug Abuse: Phase I: The
Identification, Evaluation, and Possible Utilization of Available
Data Sets," Research Triangle Institute, Research Triangle Park,
North Carolina, 1975.
"Examination of the Relationships Between Atmospheric Oxidant and
Various Pollutant and Meteorological Variables," Research Triangle
Institute, Research Triangle Park, North Carolina, 1975.
"Investigation of Motion Control and Fiber Lab Instrument Performance
in Determining the Characteristics of Cotton Samples," Research Triangle
Institute, Research Triangle Park, North Carolina, 1972.
"Evaluation of Sampling Plans which Determine the Characteristics of
a Bale of Cotton," Research Triangle Institute, Research Triangle
Park, North Carolina, 1972.
"Effects of Nitrogen Oxide Levels on Health Characterisitcs of Persons
in Chattanooga, Tennessee," Research Triangle Institute, Research
Triangle Park, North Carolina, 1973.
"Ten Year Projections of U.S. Manpower Requirements for Short-Term
General Hospitals in Five Personnel Categories, Research Triangle
Institute, Research Triangle Park, North Carolina, 1973.
"Estimation of Annual Ingestion of Strontium-90 from Two Diets in
Selected Segments of the U.S. Population," Research Triangle Institute,
Research Triangle Park, North Carolina, 1966.
"Advanced Studies of Stochastic Processes: Power Spectral Analysis
in Non-Stationary Models," Research Triangle Institute, Research
Triangle Park, North Carolina, 1967.
"Methodology for Assessing the Harzards of Electromagnetic Radiation
to Ordinance: Statistical Tolerance Limit Calculations With and
Without Censoring of the Data," Research Triangle Institute, Research
Triangle Park, North Carolina, 1968.
10/76
4-15 3-10-77
-------
LOIS D. BRESSLER, Programmer
Professional Experience
1969 to date. Research Triangle Institute, Research Triangle Park, North
Carolina 27709. Programmer, Computer Applications Center. IBM 370/165 OS,
FORTRAN, and statistical package programs.
1967-1969. General Telephone Company of the Southeast, Durham North Carolina.
Programmer and systems programmer. IBM 360/30 and 40 DOS, PL/I and Assembler
Language, billing applications and systems programming.
Education
B.A., Mathematics, University of North Carolina, Asheville, North Carolina,
1966.
Graduate work in linguistics and computer science, University of North Carolina,
Chapel Hill, North Carolina, 1970-1972.
Selected Publications
Improved Exposure Measurements. S. B. White, C. A. Clayton and L. D. Bressler.
Prepared for U.S. Department of Transportation, National Highway Traffic
Safety Administration, Washington, D.C., September 1975.
North Carolina Educational Policy Plans for the 1970's. Alvin M. Cruze,
Stephen A. Johnston and Lois A. Bressler. Prepared for North Carolina
Department of Administration, Raleigh, N.C., April 1974.
January 1976
4-16 3-10-77
-------
APPENDIX 4.2
REFERENCES
4-17 3-10-77
-------
REFERENCES
4.1. Triangle Universities Computation Center (TUCC), Memorandum:
TUCC Security Features (General Information Series Document
No. GI-066-1). Research Triangle Park, North Carolina: TUCC,
February 1976.
4.2. Sarhan and Greenberg, Contributions to Order Statistics. New
York: John Wiley & Sons, Inc., 1962.
4.3. Cochran, W. G. and G. M. Cox, Experimental Designs. New York:
John Wiley & Sons, Inc., 1962.
4.4. Service, J., A User's Guide to the Statistical Analysis System
(SAS). Raleigh: North Carolina State University, 1972.
4-18 3-10-77
-------
5.0 Cost and Labor Projections
Cumulative projected costs (exclusive of fee) and monthly direct
labor charges for this study have been estimated and are shown graphi-
cally in Figures 5.1 through 5.6.
Figure 5.1 shows cost and labor projections for the sampling design
phase of this work. Figure 5.2 shows the same information for field
operations and is identical to Figure 2.9 on page 2-47. Figure 5.3
gives cost and labor estimates for the field supervision activities
at the smelter sites. Included in these projections are costs for
sample shipment to RTI. These estimates assume the pretest study will
take place during March 1977 and that the final smelter will be sampled
during November 1977. Figure 5.4 shows the projections for chemical
analysis. An essentially constant monthly level of effort is projected
for this work area. Figures 5.6 gives the monthly statistical analysis
projections and shows an increased effort during the data evaluation
phase of the study. Figure 5.6 shows the comparative monthly costs .
(exclusive of fee) for each of the 5 work areas. The projected costs
are based on the same estimates used in constructing Figures 5.1
through Figures 5.5.
5-1 3-10-77
-------
- 24.00O
• • MAN - MONTHS
COST
J F M A M J
0 N D
A S 0 N 0
TIME FRAME
Fig. 5.1. Sampling design cost and labor-hour projections.
-------
Fig. 5. 2. Field operations cost and labor-hour projections.
-------
- 70,000
• MAN-MONTHS
- -• COST
JFMAMJJASOND
TIME FRAME
Fig. 5.3 Field supervision and shipping costs and labor-hour projections
-------
CO
80
70
60
50
V I
£ 30
20
10
-« MAN-MONTHS
•• COST
Fig. 5.4. Chemical analysis cost and labor-hour projections.
-------
35,000
Fig. 5-5. Statistical analysis cost and labor-hour projections.
-------
I
^J
CO
I
o
I
KEY:
I-SAMPLE DESIGN
2-FIELD OPERATIONS
3 FIELD SUPERVISION AND SHIPPING
o
27POO
X
I6.OOO
15,000
14,000
I3j000
12,000
11.000
iqpoo
9,000
8,000
7,000
6DOO
5,000
4.000
3.000
2,000
1,000
/.
_x
-
-
-
-
-
-
-
-
-
-
_
-
-
-
-
4
A,
2
r-
3
**"
5
OCT-DEC 1976
4-CHEMICAL ANALYSIS
4
2
J_
3
5_
JAN 1977
4
2
1
3
4
2
5 '
3
5_
MAR
5- STATISTICAL ANALYSIS
4
2
1
^
3
5
APR
J_
4
3
2
5
MAY
4
2
1
ji
5_
JUNE
2
1
3
•«
4
5
1
JULY
Tl ME FRAME
Fig.5.6. Projected monthly costs by activity.
-------
KEY:
I-SAMPLE DESIGN
2-FIELD OPERATIONS
3- FIELD SUPERVISION AND SHIPPING
4-CHEMICAL ANALYSIS
5-STATISTICAL ANALYSIS
16.000
15,000
14,000
13,000
12,000
11,000
Ln
4
3
2
5
AUG 1977
4
•3
P
b
3
5
SEPT
4444
4
2
1
3
4
O
5
OCT
1
f.
2
""'
5
NOV
2
41.
5
DEC
^
ft
5
JAN 1978
2
5
FEB
2
ins
5
MAR
TIME FRAME
Fig. 5-6.(Cont'd). Projected monthly costs by activity
------- |