RESEARCH TRIANGLE
N S T I T U T E
December 17, 1976
WORK PLAN
EPIDEMIOLOGIC STUDY CONDUUfED IN POPULATIONS LIVING AROIM)
NONFERROUS SMELTERS TO DETERMINE BODY TISSUE BURDENS OF
SELECTED NONFERROUS METALS
EPA Contract No. 68-02-2442
RTI Project No. 31U-1372
Chemistry and Life Sciences Group
and
Statistical Sciences Group
Research Triangle Institute
Post Office Box 12194
Research Triangle Park, N. C. 27709
Prepared for
Environmental Protection Agency
Research Triangle Park, N. C, 27711
!l A R C H TRIANGLE PARK, NORTH CAROLINA 27709
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TABLE OF CONTENTS
LIST OF TABLES. . .' vi
LIST OF FIGURES vii
1.0 Survey Design 1-1
1.1 Sampling Personnel 1-1
1.2 Overview 1-2
1.3 Target Population 1-5
1.4 The Sampling Frame 1-9
1.5 Sample Selection Techniques 1-11
1.5.1 Survey Participants 1-11
1.5.2 Air Sampling 1-12
1.5.3 Sampling for Soil Contamination 1-13
1.5.4 Sampling Tap Water 1-13
1.5.5 Quality Control 1-14
1.6 Sample Sizes and Sampling Error 1-14
1.6.1 Allocation of the Sample of Individuals. . . . 1-15
1.6.2 High-Volume Air Samples 1-17
Appendix 1.1: Population Characteristics of Survey Sites. 1-19
Appendix 1.2: Sample Sizes for Air Sampling 1-21
Appendix 1.-3: Wind Roses for Smelter Sites , 1-24
Appendix 1.4: Resumes of RTI Project Staff 1-30
Appendix 1.5: References 1-36
2.0 Field Operations 2-1
2.1 On-Site Project Operations (At RTI) 2-1
2.1.1 Project Staff '2-1
2.1.1.1 Overall Supervision 2-1
2.1.1.2 Survey Director 2-1
2.1.1.3 Site Administrator(s) 2-4
2.1.1.4 Data Receipt Control, Scan-Edit,
and Direct Entry 2-4
2.1.1.5 Training Manual 2-5
2.1.1.6 Training Session(s) 2-5
2.1.2 Data Receipt Control and Entry 2-7
2.1.2.1 Receipt Control 2-7
2.1.2.2 Visual Scan-Edit 2-7
2.1.2.3 Direct Data Entry 2-8
2.1.2.4 Quality Control 2-8
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TABLE OF CONTENTS (Continued)
2.1.3 Confidentiality of Project Data
2.1.4 Protection of Human Subjects Certification . .
2.2 Off-Site Project Operations (At Smelter Locations). . 2-14
2.2.1 Performance Sites 2-14
2.2.1.1 Selection 2-14
2.2.1.2 Public Relations 2-14
2.2.1.3 News Releases 2-16
2.2.2 Independent Subcontractors 2-17
2.2.2.1 Recruitment 2-17
2.2.2.2 Training 2-24
2.2.2.3 On-Site Consultants 2-25
2.2.3 Household Data Collection 2-26
2.2.3.1 Screening 2-26
2.2.3.2 Participant Consent Form 2-27
2.2.3.3 Study Questionnaire 2-29
2.2.3.4 Sample Collection 2-30
2.2.3.5 Quality Control 2-32
2.2.4 Central Data Collection. 2-33
2.2.5 Site Administrator's Responsibilities 2-34
2.2.5.1 Coordination of Field Operations;
Data Management 2-34
2.2.5.2 Sample Collection 2-35
2.2.5.3 Data Storage, Packaging and Shipment. 2-35
2.2.6 Quality Control 2-37
2.2.6.1 Training 2-37
2.2.6.2 Supervision 2-37
2.2.6.3 Sample Collection .... 2-38
2.2.6.4 Duplicate Sample Collection 2-39
2.2.6.5 Reinterview 2-39
2.2.7 Respondent/Participant Burden 2-40
2.3 Anticipated Problems 2-41
2.3.1 Smelter Resistance 2-41
2.3.2 Recruiting Independent Subcontractors 2-41
2.3.3 Nonparticipants 2-41
2.3.4 Incomplete Data Sets .-..'.... 2-42
2.3.5 Missing Data ' 2-42
2.4 Schedules for Field Operations 2-43
2.4.1 Time Schedule 2-43
2.4.2 Cost Schedule 2-46
Appendix 2.1: Resumes of RTI Project Staff and
Consultants 2-48
Appendix 2.2: Tentative Training Manual Outline 2-78
Appendix 2.3: Survey Instruments 2-86
iii 12-17-76
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TABLE OF CONTENTS (Continued)
Appendix 2.4: Pretest Considerations 2-100
Appendix 2.5: Relevant Correspondence . 2-106
Appendix 2.6: Sample Collection Methodology 2-109
Appendix 2.7: References 2-129
3.0 Physical Methods of Analysis 3-1
3.1 Atomic Absorption Analysis 3-1
3.1.1 Biological Samples . 3-2
3.1.1.1 Blood 3-2
3.1.1.2 Urine 3-2
3.1.1.3 Scalp Hair . 3-3
3.1.2 Household Samples . 3-3
3.1.2.1 Tap Water 3-3
3.1.2.2 Dust. ..... 3-3
3.1.3 Environmental Samples 3-4
3.1.3.1 Air Particulates 3-4
3.1.3.2 Soil 3-4
3.2 Spark Source Mass Spectrometric Analysis 3-4
3.3 Free Erythrocyte Protoporphyrin (FEP) Analysis. . . . 3-5
3.4 Urinary Creatinine Analysis 3-5
3.5 Quality Control and Analytical Protocol 3-6
3.5.1 Instrument Calibration 3-6
3.5.2 Limits of Detection 3-6
3.5.3 Routine Analytical Protocol 3-7
3.5.4 Analytical Priorities 3-7
3.5.5 Quality Control Procedures .... 3-7
3.5.5.1 Instrument Performance 3-7
3.5.5.2 "Accuracy and Precision 3-8
3.5.5.3 Interlaboratory Comparison 3-9
3.5.6 Calibration of High Volume Air Samplers. . . . 3-9
3.6 Determination of Total .Particulate Solids in Air. . . 3-11
3.7 Personnel 3-11
3.8 References , 3-11
Appendix 3.1: Resumes of RTI Project Staff 3-13
4.0 Statistical Methods of Analysis 4-1
4.1 Confidentiality of Data Files 4-1
4.2 Data Analysis 4-2
4.2.1 Analysis of Environmental Levels 4-2
4.2.2 Analysis of Tissue Levels 4-3
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TABLE OF CONTENTS (Continued)
Page
4.3 Potential Problems '....'.,..- 4-5
4.3.1 Missing Observations 4-5
4.3.2 Trace Metal Intake Due to Diet 4-8
4.4 Personnel 4-9
Appendix 4.1: Resumes of RTI Project Staff . . 4-10
Appendix 4.2: References . 4-17
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LIST OF TABLES
Table Page
1.1. Tentative sample allocation for individuals at the
study sites 1-16
1.2. Tentative sample allocation for air samples 1-18
1.1.1. Selected population characteristics of survey sites. . 1-20
1.2.1 Lead content of air, yg/cu m 1-22
A-2.6.1. Tentative sample allocation for air samples 2-114
A-2.6.2. Exemplary format for presenting survey and
laboratory results for study element ... 2-116
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LIST OF FIGURES
Figure Page
1.1. Preliminary distance-stratification for a target
population based upon Zn and Cd content of topsoil
according to Miesch and Huffman in East Helena,
Montana 1-7
2.1. Research Triangle Institute administrative structure . 2-2
2.2. Project administrative structure 2-3
2.3. Location and number of interviewers from the current
RTI listing living in counties within a reasonable
distance of the Ajo, Arizona, performance site .... 2-19
2.4. Location and number of interviewers from the current
RTI listing living in counties within a reasonable
distance of the Bixby and Herculaneum, Missouri,
performance sites 2-20
2.5. Location and number of interviewers from the current
RTI listing living in counties within a reasonable
distance of the Anaconda, Montana, performance site. . 2-21
2.6. Location and number of interviewers from the current
RTI listing living in counties within a reasonable
distance of the Bartlesville, Oklahoma, performance
site 2-22
2.7. Location and number of interviewers from the current
RTI listing living in counties within a reasonable
distance of the Palmerton, Pennsylvania, performance
site 2-23
2.8. Field operations time table 2-44
2.9. Field operations cost and labor-hour projections . . . 2-47
A-2.4.1. Location and number of interviewers from the current
RTI listing living in counties within a reasonable
distance of the Corpus Christi, Texas, potential
Pretest site 2-103
vii 12-17-76
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LIST OF FIGURES (Continued)
Figure Page
A-2.4.2. Location and number of interviewers from the current
RTI listing living in counties within a reasonable
distance of the Hayden, Arizona, potential Pretest
site 2-104
A-2.6.1. Geographic and temporal placement of high-volume air
samples: a partial hypothetical example depicting
only the first two days of the survey 2-115
3.1. Calibration of Sierra Instrument Orifice, Model 330. . . 3-10
viii 12-17-76
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1.0 Survey Design
1.1 Sampling Personnel
Professional staff in the Sampling Research and Design Center
(SRDC) have a broad range of experience in sampling theory and statistical
applications, including unequal probability sampling methods and theory,
response error modeling, optimization procedures, controlled selection
procedures, variance estimation for complex surveys, data analysis, ran-
domized response techniques, and other areas. Dr. James R. Chromy is
Center Director and will have general supervision of sampling in this
study, especially for those tasks involving probability sampling tech-
niques.
The selection of the study participants and the survey design for
air sampling will be under the direct supervision of Stephen R. Williams,
•
senior statistician in SRDC. Mr. Williams, assisted by Mr. Lanny
Piper, statistician in SRDC, will be responsible for on-site delineation
of the target population, its stratification, and the accumulation of
pertinent extant information about the study communities. Additional
support will be provided by SRDC research assistants and other support
staff, who have extensive experience in the preparation of sampling
materials and in the selection of probability samples. These and other
related tasks will be completed by SRDC staff in close coordination with
the other Research Triangle Institute (RTI) centers that are involved in
this study and the Chemistry and Life Sciences Group at RTI. Resumes
of the professional sampling personnel that will be substantively involved
in the study are presented in appendix 1.4.
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1.2 Overview
Sampling methodology to be used for obtaining a sample of the
household population is a stratified area sample in which a sequential
sample of persons is to be selected for participation in the study
survey. Also, a probability sample of sites and days is to be selected
for the purpose of obtaining high-volume air samples. Selective sampling
is to be used to collect samples of tap water, house dust, and soil
because probability sampling for these data was deemed impractical.
Note that the specific methods proposed for measuring environmental
related factors differ somewhat among the various types of data being
sought. These differences reflect several considerations, such as the
extent to which surrogate variables reflect the factors of interest,
the measurability of factors, the variability of factor measurements,
the quality control of data collection, and the suitability of data
collecting techniques under actual survey conditions. However, the
planned methodology stresses probability sampling techniques wherever
possible in order to facilitate valid statistical analyses and to
increase the degree of control over data collection. Field enumerators
will follow explicit, nonjudgmental procedures throughout. These
procedures will range, as outlined in the following sections, from
obtaining small selective samples of relatively homogenous factors, such
as tap water at a particular residence or school, to obtaining large
stratified random samples from a highly variable item, such as air
quality in a smelter community.
Specifically, the survey will result in the selection of a stratified
probability sample of persons who reside at various distances downwind
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from nonferrous smelters in selected communities. Approximately 240
persons, aged 35 and under, will be selected at varying distances from
the emission source in each of six smelter communities (a selective
sample of study sites was identified by the Project Officer on the
basis of prior investigation). Additionally, 80 residents aged 60 and
older will be selected in each of three of these communities. Blood,
urine, and scalp hair samples will be obtained and analyzed for these
persons and will comprise the basis for estimating community uptake
coefficients of lead, zinc, arsenic, copper, manganese, and cadmium. To
estimate the exposure levels of the downwind residents to these six
elements, residence data and samples of soil, household dust, and tap
water will be obtained at each of the six communities selected for
study. To estimate levels of atmospheric exposure, high-volume air
samples will be obtained at random locations throughout the target area
and at random points in time. The number of dust and tap water samples
will be equivalent to the number of households that have individuals in
the sample; that is, less than or equal to 1,680, the total number of
individuals to be selected. Additionally, we anticipate that a minimum
of 90 high-volume air samples will be taken at each smelter site, a
total of approximately 540 (90 x 6) air samples for the study. One soil
sample will be collected at each pre-schooler play area, school playground,
and high-volume air sampling site.
Prior to the studies in the six sample communities, a pretest, or
pilot survey, will be conducted at Corpus Christi, Texas. The method-
ology will be identical to that planned for the survey sites except that
a smaller sample of persons will be selected to participate. Approximately
two persons per age/sex cohort will be selected from each geographic stratum
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resulting in a total of approximately 128 (2x8x8) individuals. The
survey design for air sampling will also be equivalent to that planned
for the main study sites except that the period of time sampled will be
reduced from 20 to 10 days—that is, aooroximately 45 high-volume air
samples will be collected during the pretest.
Each study site (community) will be visited prior to the survey in
order to ascertain the appropriate delineation of target (high-risk)
population and to develop sampling materials. The actual sampling plan
will be developed individually to suit the particular circumstances of
the community, such as availability of mapping materials, prevailing
atmospheric patterns, geographic topography, type and location of the
smelter and other major emission sources, and population densities.
Tentatively, we expect to obtain a balanced sample of five individuals
from each cohort from each of approximately eight distance strata (40
persons in each cohort). These strata will generally increase in size
(land area) as the distance from the stack emission increases, in order
to optimize the sample design according to the usual pattern of particular
fallout.
Although the actual number of high-volume air samples will ultimately
depend upon the site circumstances, the number of air samples per stratum
will range from approximately 2 obtained on each of 3 days to 3 obtained
on each of 7 days. The number of observations will increase as the
distance from the stack increases. The number of electric hookups
needed to accommodate the air samplers at each of the study sites is
expected to range from 8 to 18 depending upon the number of strata used
for sampling at the particular site.
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Often,, studies of environmental quality present emphasis and
analyses that are based on purposefully selected samples of population
and environmental factors. Such findings are highly susceptible to
biases and often are not valid. In contrast, the methodology presented
in the present study stresses random probability sampling techniques
which will facilitate valid statistical analysis.
The following sections address specific components of the survey
design including target population, construction of the sampling frame,
sample selection techniques, sample size, and the estimation precision.
1.3 Target Population
The target population consists of the relatively high-risk human
population that resides "downwind" of lead, zinc, and copper smelters in
selected U.S. smelter communities. Specifically, American Smelting and
Refining Company (zinc), Corpus Christi, Texas, will be used as a pilot
test; the six study smelters consist of:
(1) St. John Mineral Corporation (lead), Herculaneum, Missouri;
(2) Missouri Lead Operating Company, Bixby, Missouri;
(3) Anaconda Company (copper), Anaconda, Montana;
(4) Phelps Dodge Corporation (copper), Ajo, Arizona;
(5) National Zinc Company, Bartlesville, Oklahoma; and
(6) New Jersey Zinc Company, Palmerton, Pennsylvania.
In appendix 1.1, the sites are characterized according to population,
migration, and age characteristics. Other neighboring communities, some
of which are listed in appendix 1.1, may also be included in the target
populations.
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Delineation of the target population will be based largely on pre-
vailing wind patterns. Wind roses (see appendix 1.2) have been developed
for all test sites. These diagrams depict the relative frequency of
wind velocity and direction. At Anaconda, for example, westerly winds
prevail 85 percent of the time—largely at 7 to 21 miles per hour. The
target population for Anaconda, therefore, would ideally comprise all
persons (with exceptions noted below) residing in a fan-shaped area to
the east of the smelter.
The population in these communities is additionally restricted to
the relatively young (preschool, school age, and age 20 to 35), and to
the relatively old (age 60 and older) that have not had occupational
exposure at the community smelter. The exact delineation of this
population will differ by site depending on local circumstances such as
those alluded to in the previous section. Presurvey site visits are
being anticipated for the purpose of gaining the pertinent local infor-
mation needed to construct a sample frame (see section 1.3).
Several aspects of the study present somewhat unique sampling
problems. For example, most smelter communities are relatively small
(population 1,000 to 5,000) and show net outmigration during the past
decade. In this stereotype community, relatively few of the older male
residents will not have had occupational exposure, and relatively few of
the 20 to 35 age group will remain in the community. The minimum size
for each stratum will be imposed by the expected number in the popula-
tion of the most scarce cohort, usually the preschool group. The approximate
stratification guidelines presented in figure 1.1, therefore, will necessarily
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to
I
o
&
0 0.3 0.7 1.1 1.6
2.2
3.0 5.0
km from emission source
Fig. 1.1. Preliminary distance-stratification for a target population based upon Zn and Cd content of
topsoil according to Miesch and Huffman [Ref. 1.1] in East Helena, Montana.
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differ by site. Obviously, sampling from such populations can guarantee
adequate cohort representation over the range of distances only to the
extent that these cohorts are contained in that population. In other
words, we anticipate, depending on the community, that virtually all of
the families residing near the stack will need to be screened in order
to obtain adequate information about uptake of some of the cohort groups
in that area. Figure 1.1 reveals that the area near the smelter stack,
represented by the steep portion of the curve, contains a highly variable
particulate content.
The curve presented in figure 1.1 was developed on the basis of
results from several prior studies [Refs. 1.1, 1.2, 1.3]. These works
reveal that the particulate dropout rates for varying distances from the
smelter stack follow a somewhat similar pattern for several of the
elements to be investigated in the study. Distance-fallout data were
compared for zinc, cadmium, lead, and arsenic on the basis of air samples,
surface soil samples, and blood samples. Surface soil samples reflect
the fallout rates and the atmospheric mobility of lead [Ref. 1.4]. The
general shape of this curve is useful in describing relatively homogeneous
strata, which contain approximately equal variances in each exposure
level. Equally spaced distance readings on the vertical axis, therefore,
identify distance strata for which equal-size samples of persons will
yield approximately equal reliability for each stratum estimate.
It is noteworthy that stratum 8 in figure 1.1 (from 5 to 8 kilometers
downwind of the smelter) is generally considered to be beyond the range
of atmospheric transport and, therefore, will serve to some extent as a
control group with minimal exposure. More accurately, however, the
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mobility of individuals in the area can be expected to result in some
exposure for most individuals living in the community, thus precluding
selection of a true control group from a smelter community.
1.4 The Sampling Frame
The first requirement for a probability sampling of any nature is
the establishment of a frame. A frame is a collection of sampling units
that may be unambiguously defined and identified. A list of persons,
families, or houses might be a sufficient frame for certain types of
samples. For the planned survey, one must assume that a complete list
of the target population will not be available and will be costly to
develop. Therefore, an area sampling frame will be developed. Such a
frame will result in a probability sample; that is, all persons in a yet
unspecified target population will have a known, nonzero probability of
being selected for the study. The method and materials used to obtain a
stratified area sample will vary by site. As shown in appendix 1.1, the
sites to be' studied are generally characterized by such small populations
that Census of Population data are not sufficiently detailed to use as a
sampling frame.
Corpus Christi, the one exception to this characterization, is a
tracted area for which the Census material constitutes a suitable base
for constructing an area frame. The frame construction for Corpus
Christi will involve the following tasks:
1. Obtain the pertinent Census materials; these are already
available at RTI and include 16 sheets of enumeration district/
block maps and block statistics (on magnetic tape);
2. Obtain county highway maps showing roads and other boundaries
useful for constructing area segments outside the urban area
and also showing locations of dwelling units outside the urban
area;
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3. Obtain pertinent stratification information from local sources,
such as health departments and weather services;
4. Delineate target area and strata boundaries;
5. Select for each stratum an enumeration district (ED) with
probability proportional to the 1970 population for the ED in
which the first sample segment will be located (a sample
segment will comprise a cluster of from 6 to 14 households);
6. Continue task 5 using with-replacement sampling until a
sufficient number of segments have been assigned to yield the
requisite cohort samples; the procedure of tasks 5 and 6 will
be repeated within each sample ED to identify specific sample
segments and their survey sequence.
The process of developing the sampling frame for less populated
areas encompasses the same tasks except that aerial photography and
street maps will be used to delineate the primary sampling units (PSUs).
To facilitate the selection of sample segments, the sample PSUs will be
cruised and subsegmented and households will be listed according to
methodology developed'at RTI [Ref. 1.5].
The information that is expected to be pertinent for stratifying
the target population may include several factors as noted earlier in
section 1.1. Additionally, each stratum should be sufficiently large to
yield the requisite sample. The minimum size stratum for each site can
be anticipated by viewing the smallest cohort proportion and making
allowances for possible nonresponse in occupational exposure. Using
Ajo, Arizona as an example, approximately 7 percent of the population is
male and 60 or older. According to the 1970 Census, 71 (5/.07) persons
will be needed to produce the requisite sample of five in this cohort if
all participate, if none have had occupational exposure, and if all have
lived in Ajo for at least a year. Therefore, the 71 persons plus
additional to account for possible nonresponse and occupational exposure
suggests that the minimum stratum size may be approximately 125. What
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actually constitutes a reasonable allowance for these sample losses,
however, will be ascertained from local sources and site experience.
This minimum stratum size, the relatively small site populations, and
the increasing stratum areas as the distance from the source increases
suggests that fewer than 8 strata will be feasible for some sites. The
actual number of strata used will depend on several factors including
what constitutes the downwind population.
1.5 Sample Selection Techniques
1.5.1 Survey Participants
The major considerations outlined in this section involve the need
to obtain randomized samples from an adequate representation over a wide
range of distances from smelters for 6 to 8 cohort groups. To accomplish
this objective, the downwind population in each "distance stratum" will
be partitioned, as described in section 1.3, into small segments such as
city blocks. Instructions to data collection field staff will contain
the following information:
A list of segments to be surveyed and the order of visiting
these segments;
- Maps showing segment locations and specific boundaries;
- A form on which a tally will be maintained for each cohort
group for each stratum;
- A form for recording a count of all eligible persons in those
segments visited, which of them were asked to participate, and
which did participate.
The field enumerator will continue to visit segments in the pre-
designed order in each stratum until either the cohort samples (5 in
each cohort group) are filled or until all households in the stratum
have been either contacted or verified as not containing any of the
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eligible individuals still needed. Except for eligible individuals that
do not cooperate, this technique will result in a probability sample of
the target populations that will facilitate valid inferences and analyses
of the data. The use of cash incentives is expected to hold the nonresponse
and hence the departure from a probability sample to a minimum level.
In a similar study, the voluntary response rate without the use of
incentives was 80 percent [Ref. 1.6].
1.5.2 Air Sampling
The placement of the air-sample locations will coincide with the
first segments selected in each stratum for the sample of individuals.
Also, for each air-sample location, a list of days during which the 24-
hour samples are to be obtained will be provided to the field enumerators.
This list of days comprises a probability sample of time periods throughout
the survey period. From 4 to 6 air-samplers will be operating virtually
throughout the survey period, and the requisite number of electric
hook-ups is expected to range from 8 to 18 for each smelter site depending
on the number of strata. Constraints on the allocation require that no
more than 2 strata are designated for monitoring on a particular day,
and that no stratum will be assigned more than 3 monitors on any single
day. The procedure is as follows:
1. Randomly select 3 days from the first 19 days of the survey
period without replacement and assign these to stratum 1—two
locations proximate to the first two segments (household
sampling units) will be monitored on each of these 3 days;
2. Repeat the procedure of number 1 for stratum 2;
3. Repeat the procedure for the remaining strata except that
days already assigned twice are ineligible, and the number of
days to be assigned to each stratum increases for strata that
are more distant from the smelter.
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1.5.3 Sampling for Soil Contamination
Composite samples of surface soil are to be collected in play areas
of all study children. Appproximately 80 (or less to the extent that
some families may have more than one child in the study) of these soil
samples will be obtained from residential play areas for each smelter
site, and one composite sample will be taken from each school yard where
study children attend.
Variation in the soil content of study elements throughout the play
areas, both for different locations and times, is expected to be small
relative to variation in the air samples. For this reason, and because
random sampling appears impractical, a selective composite sample will
be relied upon to measure element exposure from soil in the play area.
The enumerators will first establish the boundaries of the most commonly
used play area and will then select from 3 to 5 surface soil samples
from scattered points in the play area. These samples, which will be
obtained concurrently with the interview, will comprise the composite
sample for that play area.
1.5.4 Sampling Tap Water-
A sample of tap water will be obtained during the interview at the
residence of each study participant. The tap water sample will be
obtained from the kitchen tap or other source commonly used for drinking
and cooking (a single pass after the water has been allowed to run for a
few seconds). Random sampling at different locations and times was not
proposed for this measure of exposure, because it should be relatively
homogeneous within a household, and because what little improvement in
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data that might result from a suitable randomization of this measure
does not appear to justify the accompanying increase in respondent and
interviewer burden.
1.5.5 Quality Control
Analytical errors—that is, errors in the lab analyses—can constitute
a serious problem [Ref. 1.4]. Several methods for controlling these
errors are described more fully in the data collection and lab analysis
section of this work plan, but one aspect of the quality control is
described briefly here because it relates to sample randomization. To
the extent possible, the sample data will be stored in the lab and
analyzed in random groups rather than in batch groups as they are sent
in from the field in order that analysis error can be identified as
error rather than as factor effect. Also, the forms used for tallying
eligibles in the sample segments will identify 10 percent of the eligibles
as quality-control individuals. Two samples of blood and hair will be
obtained for each of these individuals and two samples of tap water and
dust will be taken at their dwelling. Also, two soil samples will be
taken for 10 percent of the sample preschool children that are designated
for quality control. The purpose of these quality control observations
is to measure the possible influence of sample acquisition, packaging,
shipping, and lab analysis. Additionally, 10 percent of the sample
individuals will be reinterviewed at a later date to verify the infor-
mation obtained on the survey questionnaire; the identity of these
persons will be unknown to the initial interviewer.
1.6 Sample Sizes and Sampling Error
The sampling errors and sample sizes are presented here in two
sections, for individuals and for high-volume air samples.
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1.6.1 Allocation of the Sample of Individuals
If estimates of population totals or averages are sought, the optimum
sample allocation in stratified sampling is a function of stratum vari-
ances, costs, and stratum sizes, according to the following equation:
= n(NhV /ch )7 1 \V /ch
where IL = the optimum sample size for stratum h for an overall sample
of size n; N, = the number of elements in stratum h of the population;
S, = the standard deviation of stratum h; and C, = the cost of sampling
from stratum h.
To meet the objectives of this study, however, accurate estimates
are needed of mean exposure at various distances from the emission
source. The N, , therefore, are dropped from equation 1. Also, C. in
the proposed study will be approximately constant for all strata. The
optimum n. can then be obtained by using equation 1 and the fact that
the S, are also approximately equal (see figure 1.1):
n = n S, / E S,
s h h
= n/L ;
= 40/8
= 5
where L is the number of strata (8 or less), n is the number of individuals
per cohort (40), and other notation is as defined for equation 1. The
desired sample allocation of the 1,680 sample persons is described in
table 1.1, although, as noted earlier, the actual stratum sizes may differ
among smelter sites.
1-15 12-17-76
-------
Table 1.1. Tentative sample allocation for individuals*
at the study sites .
Number of
Geographic
Site
Lead (1)
Lead (2)
Zinc (1)
Zinc (2)
Copper (1)
Copper (2)
Preschool
Male Female
5
5
5
5
5
5
5
5
5
5
5
5
Individuals by Cohort Group in Each Stratum
School Age
Male Female
5
5
5
5
5
5
5
5
5
5
• 5
5
20-35 Years
Male Female
5
5
5
5
5
5
5
5
5
5
5
5
60 Yrs
Male
5
0
5
0
5
0
& Older
Female
5
0
5
0
5
0
*Assuming, tentatively, eight strata as depicted in figure 1.1: 0.0 - 0.29 km,
0.3 - 0.69 km, 0.7 - 1.09 km, 1.1 - 1.59 km, 1.6 - 2.19 km, 2.2 - 2.99 km,
3.0 - 4.99 km, and 5.0 - 7.99 km.
1-16
12-17-76
-------
1.6.2 High-Volume Air Samples
The high-volume air samples are needed to estimate exposure levels
at varying distances from the emission source, at varying distances from
the transit line of the downwind pattern (corresponds to primary wind
direction), and at varying wind velocity and direction.
All air samples will be collected by the Chemistry and Life Sciences
Division of RTI. These high-volume samples will be collected over 24
hours on fiberglass filters.
Two sampling questions need to be answered about the high-volume
air survey:
1. How many sampling points are needed in each stratum?
2. How many locations should be observed during a sample day?
Several 24-hour readings are needed in each stratum in order to measure
the variation over time [Ref. 1.2] as well as the need to measure the
influence on exposure of different wind velocities and directions. The
sample size and allocation is presented in table 1.2, but it will be
altered to suit the individual site circumstances. Methodology for
estimates of sample size and allocation is described in appendix 1.2.
The per-site sample size totals 87 location-days. This size sample is
expected to produce a coefficient variation for element content of
atmosphere of 0.20 or less at the stratum level.
1-17 12-17-76
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Table 1.2. Tentative sample allocation for air samples*.
Type of Observation
Locations (A)
Days (B)
24-hour samples (A x B)
Ratio, days/locations
Sl
2
3
6
1.5
Number
S2
2
3
6
1.5
of Observations,
S3
2
4
8
2.0
S4
2
4
.8
2.0
S5
2
5
10
2.5
S±, in
S6
2
5
10
2.5
Each
S7
3
6
18
2.0
Stratum
S8
3
7
21
2.3
Total
18
-
87
-
*Based on data presented in appendix 1.2 [Ref. 1.2].
1-18
12-17-76
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APPENDIX 1.1
POPULATION CHARACTERISTICS OF SURVEY SITES
1-19 12-17-76
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Table 1.1.1. Selected population characteristics of survey sites.*
Smelter Neighboring
D 1 3.L&
town towns
Arizona Ajo
Rowood
Missouri Bixby
Bass
Buick
Viburnum
Herculaneum
Festus
Crystal City
Horine
i Povely
o
Montana Anaconda
Gregson
Warmsprings
Oklahoma Bartlesville
Dewey
Tuxedo Park
Pennsylvania Palmerton
Texas Corpus Christi
(pretest site)
Population
number
5,881
<1,000
-
520
1,885
7,530
3,898
517
9,771
29,683
3,958
5,620
204,525
Net migration .
i Q^n ge 8rouPs> percent
percent ' 1-5 6-17 20-35 60+
-16.6 12 25 19 14
-18.9 10 22 18 19
6.4 10 20 20 17
-5.4 9 17 20 22
22.0 11 26 19 12
IsJ
I
M
•-J
I
*Based on the 1970 Census of Population.
-------
APPENDIX 1.-2
SAMPLE SIZES FOR AIR SAMPLING
1-21 12-17-76
-------
The requisite sample sizes and allocations are based tentatively
on data presented in table 1.2.1 [Ref. 1.2]. These allocations will
ultimately reflect also the specific smelter-site characteristics,
which will be obtained from site visits.
The variances (based on table 1.2.1 data) equal 891 and 305 for
strata 6 and 8, respectively. Sample sizes of 10 and 23 for these
two strata will yield estimates with less than a 20 percent coefficient
of variation (CV). If a regression estimator proves effective, say with
a correlation coefficient (R .123...p) of 0.8, then the CV would be
approximately 12 percent.
Table 1.2.1. Lead content of air, yg/cu m.*
Day
1
2
3
4
Stratum
(2.2
13.0
84.0
18.0
-
6; 2 locations
-3.0 km)
30.0
68.0
66.0
- .
Stratum
(5.0
1.3
15.0
9.6
24.0
8; 3
- 8.0
7.6
36.0
3.2
60.0
locations
km)
4.2
25.0
4.2
29.0
*Based on reference 1.2.
2 - 2
The variances were calculated according to: S = £ (X.. - x) /(nm-1)
where
X.. = Pb readings for day i and location j with i ranging from
1 to n and j ranging from 1 to m.
1-22
12-17-76
-------
The coefficients of variation are calculated according to:
C = S / x /nm
e .
where
Se = S /1-R .12...p and the other terms are as defined above.
y
Also, the following ratio of standard deviations for each stratum
suggests that the sample ratio for day/locations should be approximately
2.2:
mn/m = S /S
where
S and S are the standard deviations"for days and locations,
D Li
respectively.
1-23 12-17-76
-------
APPENDIX 1.3
WIND ROSES FOR SMELTER SITES
1-24 12-17-76
-------
7.1
5.^
5.0
i Z^ ^
'. A«ta / X v •.
/:/»
K//^r
^T ^'
, v ^
•:• '.;°. ci ' c o. i fs
1-25
12-17-76
c."\L:;-or>NiA oof/.PUTsa rn
-------
3-5
1 j - '3
PEK-C1NT OCCURRENC
i,.
7 - M
• M-i »•:-
1-26
12-17-76
-------
OCCURRENCE
1-27
12-17-76
;>••"ij;*--' V-'VV' •^•"~v« ^u'-''*"•••- •
r;^=*^V;. r>r-V.-l": : v*•"'• v
-------
PI !i:K--!jLL'vri-:-nrK-ujLfiM! I:M. HU .
7.-3
7.1
_^ -"• ,1 f j f -C ^ 1 ^
\E:K-c;r.Ni OCCURRENCE
0.15
1-28
12-17-76
-------
/\
3.CJ
S
*•• ^ i '"• r • O O 1 °
u • u '* U • y J J • I *.
'E;R.-Cf:NT OCCURRENCE.
1-29
12-17-76
-------
APPENDIX 1.4
RESUMES OF RTI PROJECT STAFF
1-30 12-17-76
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JAMES R. CHROMY, Senior Statistician and Director,
Sampling Research and Design Center
Professional Experience
1966 to date. Research Triangle Institute, Research Triangle Park,
North Carolina 27709.
1976 - date: Director, Sampling Research and Design Center.
Responsible for coordinating research program in sampling statistics
and for coordinating sampling and other statistical support for a
wide variety of projects being conducted throughout the Institute.
1972 - 1975: Manager, Sampling Department and Senior Statistician,
Statistics Research Division. Responsible for the development of survey
designs and sampling techniques for a wide variety of projects in which
data are collected by means of sample surveys. Supervised a permanent
staff of thirteen professional statisticians, nine support personnel
and many additional temporary support staff at peak periods.
1968 - 1971: Head, Sampling Section and Senior Statistician,
Statistics Research Division. Developed sample designs for the
National Assessment of Educational Progress in 1969 and 1970. This
task included both the selection of 9-year-olds, 13-year-olds, and
17-year-old students in-school by means of a school frame and 17-year-
olds and young adults (ages 26-35), out-of-school through an area frame.
> Was responsible for the design of samples selected for other studies.
1966 - 1968: Statistician, Statistics Research Division. Develop-
ment of optimal sample designs in terms of minimum cost and maximum
precision. Assisted in the development of computer micro-simulation
population models.
1962 - 1965. Statistical Reporting Service, USDA, Lincoln, Nebraska.
Agricultural Statistician. Assisted in field office operations of agricul-
tural .area surveys and objective yield estimates. Conducted monthly
cattle-on-feed mail surveys and nonresponse interview surveys.
Education
B.S., Technical Agricultural Economics, University of Nebraska, Lincoln,
Nebraska, 1964.
M.E.S., Experimental Statistics, North Carolina State University, Raleigh,
North Carolina, 1966.
Ph.D., Statistics, North Carolina State University, 1974.
Professional Activities
Alpha Zeta
American Association for Public Opinion Research
American Statistical Association
Biometric Society
Gamma Sigma Delta
International Association of Survey Statisticians
Phi Kappa Phi
1-31 12-17-76
-------
JAMES R. CHROMY (Continued)
Selected Publications
Chromy, J. R. and Hendricks, W. A. [1967]. Further Investigations of
Sampling Plans for Estimating NASO Budget Requirements. Project SU-284
Final Report, Research Triangle Institute.
Chromy, J. R. [1967]. Matrices of Transitional Probabilities for a
Demographic Simulation Model. Working Paper No. 7 developed for the
Demographic Micro-Simulation Model Project. Research Triangle Institute'.
Chromy, J. R. [1968]. A Generalization of the- Matrix of Probabilities
Approach for Population Micro-Simulation. Working Paper No. 19 developed
for the Demographic Micro-Simulation Project. Research Triangle Institute.
Chromy, J. R. [1968]. Methods for Assigning Ages in the Initial Population.
Working Paper No. 25 developed for the Demographic Micro-Simulation Project.
Research Triangle Institute.
Chromy, J. R. and Horvitz, D. G. [1970]. "Appendix C: Structure of
Sampling and Weighting," Report 1, 1969-1970 Science; National Results
and Illustration of Group Comparisons. Washington, D.C.: Government
Printing Office.
Chromy, J. R., Moore, R. P., and Clemmer, Anne [1972]. "Design Effects
in the National Assessment of Educational Progress Survey," Proceedings,
Social Statistics Section, American Statistical Association, pp. 48-52.
Chromy, J. R. (Editor) [1973]. A Study of the SES and STOC Stratification
for NAEP Samples. Project 25U-796-6 Final Report, Research Triangle
Institute.
Moore, R. P., Chromy, J. R., and Rogers, W. T. [1974]. National Assess-
ment's Approach to Sampling - Year 02. National Assessment of Educa-
tional Progress, Denver, Colorado.
Chromy, J. R. [1974]. Pairwise Probabilities in Probability Non-replacement
Sampling. Ph.D. dissertation, North Carolina State University, Raleigh, N.C.
Chromy, J. R. and Horvitz, D. G. [1974]. "The Use of Monetary Incentives
in National Assessment Household Surveys." Proceedings, Social Statistics
Section, American Statistical Association, pp. 171-179.
Piper, Lanny L. and Chromy, J. R. [1975]. "Design Effects for Alphabetic
Cluster Samples." Proceedings, Social Statistics Section, American
Statistical Association.
March 1976
1-32 12-17-76
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LANNY L. PIPER, Statistician
Professional Experience
1972 to date. Research Triangle Institute, Research Triangle Park,
North Carolina 27709. Statistician, Sampling Research and Design
Center. Design and analyze survey samples.
Education
B.S., Mathematics, Miami University, Oxford, Ohio, 1970.
M.S., Statistics, North Carolina State University, Raleigh, North
Carolina, 1972 (National Science Foundation Fellowship)
Professional Activities
American Statistical Association, member.
Selected Publications
Chromy, J. R. and Piper, L. L. [1973]. A Survey of High School Seniors
to Determine Responses to the Job Skills Sampling Questionnaire.
Project 25U-814 Final Report, Research Triangle Institute.
Mason, R. E. and Piper, L. [1973]. Technical Report Children's
Television Workshop Surveys 1972-1973. Project 25U-683, Research
Triangle Institute.
Piper, Lanny L. and Chromy, James R. [1975]. Design Effects for
Alphabetic Cluster Samples. Presented at the 1975 Annual Meetings
of the American Statistical Association.
April 1976
1-33 12-17-76
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STEPHEN R. WILLIAiMS, Senior Statistician
Professional Experience
1975 to date. Research Triangle Institute, Research Triangle Park,
North Carolina 27709. Senior Statistician, Sampling Research and
Design Center. Involvement in the sample design and analysis for a
variety of studies. Project or sampling leader in several large-
scale dental surveys. .
1970 - 1975. Southern Research Institute, Birmingham, Alabama 35205.
Senior statistician, Economic Research and, Planning Section. Project
leader on a study to design and assist in the implementation of a
statewide information system for health planning. Project leader on
numerous health studies in the areas of epidemiology, ambulatory-
health care, health-facilities planning, information systems, and the
characterization of hospital inpatients and their care. Statistics
instructor at the University of Alabama. Econometrician and bio-
statistician support on numerous and varied studies in the social
sciences field.
1960 - 1970. United States Department of Agriculture. Survey
statistician and mathematical statistician in the Research and Develop-
ment Branch. Primary responsibilities in nationwide surveys involving
area- and multiple-frame and other types of probability sampling.
Mathematics instructor at Rollins College, Winter Park, Florida.
Education
B.S., Economics, University of Wyoming, Laramie, Wyoming, 1958.
M.S., Economics, University of Wyoming, Laramie, Wyoming, 1959.
M.S. coursework requirements in Statistics, Iowa State University,
Ames, Iowa, 1963.
Completed additional courses in Statistics at George Washington
University and University of Florida, 1963-1967.
Presently pursuing Ph.D., Biostatistics, University of Alabama,
Birmingham, Alabama.
Selected Publications
Williams, S. R. [1971]. "Forecasting Florida Citrus Production,
Methodology and Development." U.S. Department of Agriculture .
Bulletin.
Williams, S. R. and Schaffer, S. [1971]. Selected Population, and
Housing Characteristics From a Sample Survey of Households in Greene
County, Alabama. Project Final Report, Southern Research Institute.
1-34 12-17-76
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STEPHEN R. WILLIAMS (Continued)
Williams, S. R., Tropper, P., and Schaffer, S. [1972].- A Local-Area
Information Generation System for Transportation, Housing, and
General Urban Development. Project Final Report, Southern Research
Institute.
Williams, S. R. [1974]. Ambulatory Health Care; Survey and Fore-
casting Methodology. Project Final Report, Southern Research Institute.
Williams, S. R. and Nash, E. [1974]. Factors Associated with the
Incidence of Congenital Anomolies; A Localized Investigation.
Project Report, Southern Research Institute.
Williams, S. R. and Schaffer, S. [1975]. "Health Information Systems,"
Southern Research Institute Bulletin, pp. 12-17.
Williams, S. R. and Folsom, R. E. [1976]. Bias Resulting From School
Nonresponse; Methodology and Findings. Project Report, Research
Triangle Institute.
April 1976
1-35 12-17-76
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APPENDIX 1.5
REFERENCES
1-36 12-17-76
-------
REFERENCES
1.1. Miesch and Huffman, Abundance and distribution of lead, zinc3
cadmiwn, and arsenic in soils in Helena Valley3 Montana. Area
Environmental Pollution Study (EPA Office of Air Programs
Publication No. AP-91), p. 65.
1.2. Dusan Djurie1, et al., Environmental contamination by lead from
a mine and smelter. Archives of Environmental Health, Vol. 23,
pp. 275-279, October 1971.
1.3. Oyanguren, H. and E. Perez, Archives of Environmental Health,
Vol. 13, p. 185, 1966.
1.4. J. L. Seeley et al., Determination of lead in soil. Applied
Spectroscopy, Vol. 26, No. 4, pp. 456-460, 1972.
1.5. Research Triangle Institute, Field Sampling Manual. Research
Triangle Park, North Carolina: Research Triangle Institute,
1976.
1.6. Hammer, D. I., et al., American Journal of Epidemiology,
Vol. 93, p. 84, 1971.
1-37 12-17-76
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2.0 Field Operations
2.1 On-Site Project Operations (At RTI)
2.1.1 Project Staff
2.1.1.1 Overall Supervision
Field operations will be under the general supervision of James D.
Bates, Director of the Survey Operations Center (SOC) in the Statistical
Sciences Group (SSG) of the Research Triangle Institute (RTI), and
Thomas G. Virag, Senior Survey Specialist within SOC. All SSG activities
for this research effort will be coordinated under the general supervision
of Dr. W. Kenneth Poole, Director of the Statistical Methodology and
Analysis Center (SMAC). The RTI and project administrative structures are
presented graphically in figures 2.1 and 2.2, respectively.
2.1.1.2 Survey Director
Benjamin S. H. Harris, III, Health Survey Specialist within SOC
will serve as Survey Director, assisted by survey assistant Martha L.
Smith and other survey specialists and survey assistants as required.
Working in close coordination with representatives of SMAC, the Sampling
Research and Design Center (SRDC - see section 1.0), and the Chemistry and
Life Sciences Group (CLSG - see section 3.0), the Survey Director will be
responsible for supervising the Field Operations, including the following
tasks:
. Training RTI project staff in study'objectives and data collection
procedures;
Public relations at the performance sites;
2-1 12-17-76
-------
Treasurer
W. H. Perkins, Jr.
Office of Accounting
R. S. McLean
Corporate V. P.
S. C. Ashton
Office of Research
Contracts
J. C. Ragan
N>
I
Chemistry and Life Sciences
Vice President
M. E. Wall
Social Sciences
Vice President
W. C. Eckerman
Statistical Sciences
Vice President
D. G. Horvitz
Energy, Engineering, and
Environmental Sciences
Vice President
J. J. B. Worth
Center for
the Study of
Social Behavior
... .
A D'"*tor
A- M- Uuze
Fig. 2.1. Research Triangle Institute administrative structure.
-------
M. E. Wall
Program Director
UNC
C. M. Shy
Epidemiologist
Porgram Advisor
Research Assistant
CLSG
R. W. Handy
Chemist
Program Advisor
J. Kearney
SSG
W. K. Poole
Senior Biostatistician
Program Advisor
i
CO
Laboratory
Assistants
SRDC
SOC
SMAC-CAC
J. Chromy
S. Williams
L. Piper
L. Bressler
D. Bates T-
T. Virag L.
B. Harris
M. Smith
Field Operations Personnel
Survey Specialists
Survey Assistants
Survey Clerks
Independent Subcontractors
Hartwell
Bressler
to
Fig. 2.2. Project administrative structure.
-------
Recruitment and briefing of independent subcontractors;
Pretest of data collection instruments and procedures;
Receipt control, verification, and entry of data; and
Quality control procedures relevant to the foregoing tasks.
2.1.1.3 Site Administrator(s)
Data collection, coordination and validation at the performance sites
will be conducted by a CLSG professional acting as Site Administrator (SA)
and independent subcontractors, with overall supervision by the RTI Survey
Director and backup administrative assistance available from RTI's national
staff of Field Supervisors (see below). The SA will be responsible for
overall coordination and quality control of data collection at each performance
site; for the collection of all air and general soil samples (see below);
and for coordination and shipment of data from the performance site to
RTI. The SA will remain at the site' for the duration of data, collection;
the same SA at the very least will oversee such activities at sites represent-
ing the same type smelter. At the present time, RTI anticipates that
J. Kearney will be one SA, with backup from Project Leader Handy and Survey
Director Harris (see Figure 2.2).
2.1.1.4 Data Receipt Control, Scan-Edit, and Direct Entry
Data receipt control, scan-edit, and entry at RTI will be under the
general supervision of Mildred C. Pennington. Throughout planning for
and conduct of receipt control, scan-edit and entry, Survey Assistant
Smith will be assigned to the project to provide overall supervision of
these tasks. Experienced survey clerks will check in survey instruments,
perform the scan-editing, maintain manual logs, and refer problem cases
to the Survey Assistant or Survey Director for resolution. Direct data entry
2-4 . 12-17-76
-------
will also be conducted under the supervision of Survey Assistant Smith,
with overall guidance from the Survey Director as needed.
Resumes of individuals named in the preceding paragraphs will be
found in appendices 2.1 and 3.1.
2.1.1.5 Training Manual
A training manual will be developed by RTI for use in training RTI
project staff arid briefing independent subcontractors. This manual will
address study objectives; data collection instruments; detailed rationale
and procedures for collecting environmental and biological samples;
coding and editing instructions for all survey instruments; instructions
for administration, coordination, and quality control of all field operations;
and discussions of anticipated problems. A tentative outline for this
training manual appears in appendix 2*2.
2.1.1.6 Training Session(s)
Before data collection begins at the first performance site, RTI
will conduct an intensive one week training session for RTI project staff,
in particular the prospective SA(s) who will be responsible for coordination
of data collection activities at the performance sites, and staff who will
be responsible for data receipt control and entry at RTI. The training
session agenda will in general resemble the training manual outline in
appendix 2.2 and will address study objectives; data collection instruments;
rationale and detailed procedures for collecting environmental and biological
samples; instructions for administration, coordination, and quality control
of all field operations; coding and editing instructions for all survey
instruments; and discussions of anticipated problems. Since data collection
2-5 12-17-76
-------
at the performance sites will be carried out consecutively and will therefore
cover several months, and since some activities will begin immediately
while others will follow in sequence, additional briefing sessions may be
required as refreshers or as special problems arise.
These training sessions will be conducted by the Survey Director,
Project Leader, and other appropriate personnel assisted by RTI project
consultant experts in. epidemiology, biochemistry, and community health
sciences: Dr. Stephen H. Gehlbach, Assistant Professor of Community Health
Sciences at Duke University, Adjunct Assistant Professor of Epidemiology
in the University of North Carolina (UNC) School of Public Health, and
Director of Research for the Family Medicine Program at Duke University
[Ref. 2.1]; Dr. Carl M. Shy, Director, UNC Institute of Environmental
Studies; and Dr. Boyd R. Switzer, Assistant Professor of Nutrition, UNC
•
School of Public Health". Resumes of these consultants will be found in
appendix 2.1.
2-6 12-17-76
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2.1.2 Data Receipt Control and Entry
2.1.2.1 Receipt Control
Data will be received at RTI/SOC from three sources: the independent
subcontractors at the performance site, the SA at the performance site, and
RTI/CLSG. From the independent subcontractors, RTI/SOC will receive
copies of each day's Household Screening Questionnaires (HSQ's) and Logs (HSL's)
and each week's Production, Time and Expense Reports. From the SA, RTI/SOC
will receive Participant Consent Forms (PCF's) and Study Questionnaires (SQ's).
From RTI/CLSG, RTI/SOC will receive results of chemical analyses. Examples
of questionnaires appear in appendix 2.3.
Each completed survey instrument will be checked in by identification
(ID) number by project personnel on the day received; at the same time,
the document will be assigned to a batch for control purposes. Completed
*
survey instruments will be maintained in batches while they are in RTI's
custody.
2.1.2.2 Visual Scan-Edit
Following check-in and receipt acknowledgement, each document will
be scan-edited on an item-for-item basis to detect omissions, incon-
sistencies, and/or illogical or incompatible entries. Specifically, this
review is designed to verify:
That the executor understood and followed the question sequences
and intent correctly and that entries seem reasonable and
consistent;
That any sampling or skip sequences were correctly followed
and that no applicable items were omitted; and
2-7 12-17-76
-------
That each instrument is properly identified and that all items
required for verification of the individual's work x^ere
completed.
2.1.2.3 Direct Data Entry
Following scan-edit and error resolution by telephone or other action
(see below), complete survey instruments will be coded by use of communications
terminals permitting direct data entry operations. Direct data entry means
simply that programmable terminals with keyboards and cathode ray tube
display screens are used instead of manual coding and keypunch. A programmed
format specifically designed for the survey instrument appears on the display
screen. As the terminal operator looks at the hard-copy documents, she
keys the responses into the terminal. The keyed data then appear instantaneously
on the display screen. The data are recorded on magnetic tape cassettes for
transmission to a computer facility. Hence, the direct data entry process
accomplishes in one step what previously has taken two steps. In addition,
time savings are substantial because of quality control opportunities
cited below.
2.1.2.4 Quality Control
RTI will use three types of quality control in processing the survey
data: a check of the survey data at the source; at the data entry point,
since the data will be entered through programmable terminals; and the
traditional concept of verification through re-keying.
. Reinterview; As a quality check of the interview process, RTI plans
to reinterview by mail, telephone, or personal visit, approximately ten
percent of the population for whom completed questionnaires are obtained.
2-8 12-17-76
-------
This procedure will actually permit a two-fold verification: that the
interview was conducted, and that responses are consistent.
. Visual Scan-Edit: Should a completed survey instrument fail the
visual edit check, two procedures will be implemented. First, an attempt
will be made to resolve the problem by telephone from RTI/SOC to the site of
instrument completion. Second, should the problem be critical enough to
necessitate further action, the document will be transmitted to the appropriate
person with specific instructions for resolution.
. Direct Data Entry; Programmable terminals, referred to in numerous
articles as intelligent terminals, have proven to be very effective devices
for converting data to machine-readable form. These devices allow editing at
the point of data entry in a manner that was previously unavailable. Error
rates drop because operators can easily correct keystroke errors which are
normally left for the verifier when keypunches are used. Even if the operator
must go back to a previous field to make a correction, no already keyed data
are lost. As the data are entered, the terminal checks the data for proper
range or invalid punches, and if an error is detected, locks the keyboard.
If necessary, the editing supervisor or survey assistant can aid the
data entry clerk in resolving the error.
The basic philosophy associated with direct data entry is to provide
a device that allows the operator to make easy corrections of keystroke
errors and to detect at data entry time any errors that may be corrected
by review of the hard copy instrument. Beyond these checks, it is desirable
to have a minimum of ten percent verification by re-keying to insure that
the data are converted to machine-readable form with a very low error rate.
2-9 12-17-76
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Should an error rate of more than one percent per operator be discovered
through re-keying, 100 percent verification of that operator's work will
be carried out. The Survey Director will be provided regular reports of
the results of direct data entry quality control procedures.
2-10 12-17-76
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2.1.3 Confidentiality of Project Data
There are two basic areas where there should be concern about maintaining
data confidentiality: source documents (survey instruments/questionnaires)
and data tape files. RTI recognizes the need to maintain these project
documents under strict controls to insure confidentiality and record integrity.
Storage for hard-copy source documents (HSQ, PCF, and SQ) shall be in
a secure, well-ventilated, vault-like room in the basement of the Ragland
building on the RTI central campus at Research Triangle Park, North Carolina.
The room has about 600 square feet of floor space and has both wall and
free-standing shelving. Access is by one locked door, with controlled,
i.e., signed for, entry only on authority of one of the project staff
in charge of receipt control and coding operations, Survey Director
Harris or Survey Assistant Smith. Materials will be stored here, with
such working amounts as are necessary being removed, signed for by record
identification, and worked on in a secure space under supervision. Materials
will be received in the mail on a daily flow basis and, insofar as possible,
be dealt with on a flow basis, with real-time receipt control records
being maintained for all processing steps. Overnight storage of processing
batches will be in a locked and secure work space. When processing has
been completed, all source documents will be filed in an ordered, accessible
manner. During all stages of processing and storage, project personnel
will control access to and removal and replacement of survey instruments
from specified working and storage areas.
2-11 12-17-76
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Data tape files will be maintained on a strict need-to-know basis
throughout the extent of the project; at no time will these files be
readily accessible except under specific authority of a senior professional
working on the project. However, only the PCF will provide a link between
the various ID numbers and a specific participant's name, and the PCF
will never be converted to machine-readable form - that is, the data tape
files will never contain participant's names or addresses, and the PCF
will be destroyed when the study is concluded.
2-12 12-17-76
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2.1.4 Protection of Human Subjects Certification
The Department of Health, Education and Welfare has determined
that RTI should operate under the special assurance provisions of the
Protection of Human Rights regulations. Upon notification, the
Institute's Committee on Human Rights is prepared to review the data
collection forms and protocol for this study. The membership of the
Institute's Committee on Human Rights consists of:
Dr. J. N. Brown
Dr. W. C. Eckerman
Dr. D. G. Horvitz
Dr. M. E. Wall
Mr. S. C. Ashton
Mr. R. L. Weborn
2-13 . 12-17-76
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2.2 Off-Site Project Operations (At Smelter Locations)
2.2.1 Performance Sites
2.2.1.1 Selection
The Project Officer has specified the following smelter locations
as performance sites for this research effort:
Ajo, Arizona;
Anaconda, Montana;
Bartlesville, Oklahoma;
. Bixby, Missouri;
Herculaneum, Missouri; and
Palmerton, Pennsylvania,
2 I/
not necessarily in that order (see section 2.4 - Schedules for Field Operations)vi—
2.2.1.2 Public Relations
RTI plans to establish communication with certain agencies/organizations
at/regarding each performance site. These agencies/organizations will-
include but not necessarily be limited to the following:
. Various federal agency representatives, including regional
EPA representatives and tne Center for Disease Control (CDC): These
agencies have had various interests and contacts in/with environmental
studies of smelter communities, including a recent CDC study [Ref. 2.2];
such contacts/experience may prove useful to this research effort.
. State and local health agency representatives; These agencies
may also have had various levels of interest and experience regarding
2.1/
—i— A decision has been made that Bartlesville, Oklahoma, will not be the
first performance site; in addition, RTI will perform a pretest at one
additional smelter location, probably Corpus Christi, Texas - see
appendix 2.4.
2-14 12-17-76
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environmental/health studies of smelter communities; such interest/
experience is expressed in correspondence such as that reproduced as
appendix 2.5 and may prove useful to this research effort. RTI will
contact appropriate representatives of these agencies in an attempt to
secure their cooperation, assistance, endorsement and participation.
In particular, RTI hopes that the assistance of these agencies might be
enlisted in securing qualified field staff and sites for training field
staff and central data collection (see below). During initial contact
with appropriate agencies, RTI hopes to make arrangements for the follow-
up of participants for whom study data collected indicate medical attention,
and participants will be informed of such arrangements (see below).
. Local education authorities; RTI will contact appropriate
representatives of these agencies in an attempt to secure their cooperation,
assistance, participation, and endorsement. The cooperation of appro-
priate education authorities is considered essential since it will be
necessary to collect soil samples in each school-yard where study children
participants attend. In addition, schools are potential sites for training
field staff and central data collection.
. Smelter representatives; RTI anticipates meeting with represen-
tatives of the smelter industry and individual smelter firms in an
attempt to secure their cooperation. The role chosen by the smelters
may have a significant impact on the cooperation of potential partic-
ipants in the smelter communities.
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. Other; In addition to the agencies listed in the preceding
paragraphs, RTI plans early meetings/discussions/investigations regarding
other elements in the smelter communities related to the logistics of
this research effort, including local electric utilities regarding power
drops for air sampling devices; transportation alternatives for independent
subcontractors, participants, and in particular the shipment of study
materials to and from RTI; hotels/motels for training and accommodation
of field staff; and municipal agencies such as the police department to
inform them of study activities.
2.2.1.3 News Releases
Once the various levels of public relations have been completed,
and the positions and levels of participation of the various agencies
have been determined, RTI plans a series of news releases, approved by
the Project Officer, through the appropriate federal, State, or local
agency to inform the public -of the study's objectives and activities
in an attempt to improve cooperation by potential study participants.
RTI anticipates involvement of local and area newspapers, radio, and
television in this publicity campaign utilizing news releases and public
service announcements which would explain succinctly the reasons for
and potential benefits of the study, such as the dangers of heavy metal
absorption. This publicity campaign will probably start at each performance
site approximately two weeks before data collection is to begin.
2-16 12-17-76
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2.2.2 Independent Subcontractors
2.2.2.1 Recruitment
While at the smelter location to contact appropriate federal, state
and/or lopal agencies related to the study, RTI will initiate recruit-
ment of field staff/independent, subcontractors to participate in the
actual study data collection. RTI plans to retain two or three types of
staff who will work as independent subcontractors to perform data collection
in the field coordinated by the SA:
. Field Interviewers (FI's) who would be responsible for contacting
and screening households, completing questionnaires, and collecting dust
and water samples and some soil samples.
. Medical personnel such as Registered Nurses or medical technicians
to obtain the blood samples and collect the urine samples; and perhaps
. Barbers to collect the scalp hair samples with a minimum of
burden to the participant (see below).
With regard to recruiting the field staff at each location, RTI
anticipates three potential sources:
. RTI listings; RTI has been conducting national surveys for
over 16 years and has conducted other studies involving surveys in various
parts of the nation. As a result, a current list is available of some
2,500 persons who have served RTI on one or more projects or have indicated
their availability. This list will serve as the starting point in securing
qualified individuals. Many of the persons on this list have at least
some health-related training and/or experience. For example, figures
2-17 12-17-76
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2.3 through 2.7 present graphically the number of interviewers from the
current RTI listing living in counties within a reasonable distance of the
performance sites in Arizona, Missouri, Montana, Oklahoma, and Pennsylvania,
respectively. That is not to say that all of these individuals would be
available or suitable for this research effort (see below).
. State and local agency contacts; RTI hopes that some qualified
field personnel might be retained through the assistance of State and local
agencies, particularly health agencies (see appendix 2.5). RTI may offer
such agencies an active role in the collection of biological samples from
household survey participants by subcontracting that aspect of the data/
sample collection to such agencies, by engaging agency personnel to work
for RTI during their off time, or by assisting RTI in retaining qualified
individuals to serve as independent subcontractors.
Newspaper advertisements; In areas where the RTI listings
and/or State and local agency contacts are inadequate, appropriate
advertisements will be placed in local or area newspapers.
. Interviews; Once potential field staff have been located,
they will be screened and interviewed by RTI staff, most likely the Survey
Director and/or the SA or a Field Supervisor (FS-see below), in order to
determine their qualifications and availability for this research effort.
At each site, RTI anticipates retaining at a minimum three FI's and two
medical staff members; an additional FI will most likely be retained at
each of the three sites where individuals over 60 years of age will be
2-18 12-17-76
•\
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9 -C.V - -
'*" ,'' V'> O* '.', C N -' v
/v"','.'':;:{'';-, »y^.^.'^^ayy.?
LEGEND
® Places ol 100.000 or more inhabitants
• Places ol 50.000 to 100.000 inhabitants
O Places of 25,000 to 50.000 inhabitants outside SMSA's
Standard Metropolitan
Statistical Areas (SMSA's)
SANH CRUJ
Fig 2.3. Location and number of interviewers from the current RTI listing
living in counties within a reasonable distance of the Ajo, Arizona,
performance site [Source: Ref. 2.3, p. 972].
2-19
12-17-76
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NJ
I
NJ
LEGEND
Places of 100.000 at more inhabitants
Places ol 50.000 lo 100.SoO .nhaoitants
Places ol 25.000 to 50.000 inhabitants outside SMSA's
t-| Standard Metropolitan
Statistical Areas iSMSA's)
Fig. 2.4. Location and number of interviewers from the current RTI listing living in counties
within a reasonable distance of the Bixby and Herculaneum, Missouri, performance sites
[Source: Ref. 2.3, p. 995].
-------
10
M
-vj
,, MISSOUL* - I P°WELL
'" '•/ OMttSOUl"
SCALE
O IO 2O 3O 4O SO MILES
LEGEND
• Places of 50,000 to 100,000 inhabitants
O Places of 25.000 to 50.000 inhabitants outside SMSA's
Standard Metropolitan
Statistical Areas (SMSA's)
Fig. 2.5. Location and number of interviewers from the current RTI listing living in
counties within a reasonable distance of the Anaconda, Montana, performance site
[Source: Ref. 2.3, p. 996].
-------
10
I
to
NJ
OKLAHOMA CITY
CANADIAN ^ OKLAHOMA
OKIAHOM.A ciry
LEGEND
® Places of 100.000 or more inhabitants
• Places of 50,000 to 100,000 inhabitants
O Places of 25,000 (o 50,000 inhabitants outside SMSA's
Standard Metropolitan
Statistical Areas (SMSA's)
to
I
I-1
-j
»-j
0\
SCALC
0 10 2O 3O «O SO MILES
Fig. 2.6. Location and number of interviewers from the current RTI listing living in counties
within a reasonable distance of the Ba'rtlesville, Oklahoma, performance site
[Source: Ref. 2.3, p. 1006].
-------
BINGHAMTON
NJ
U>
ro
I
,o.,« < .SCRAN TON
\2
DfADiNC / PHILADELPHIA V"
•BETHLEHEM EASTON
LEGEND
(•) Places ot 100.000 or more inhabitants
• Places ol 50.000 to 100.000 inhabitants
D CenKal cities ol SMSA's with fewer than bO.OOO inhabitants
O Places ol 25.000 to 50.000 inhabitants outside SMSA's
I Standard Metropolitan
Statistical Areas (SMSA's)
O _ IO iO 30 « SO MILCS
Fig. 2.7. Location and number of interviewers from the current RTI listing living in counties
within a reasonable distance of the Palmerton, Pennsylvania, performance site
[Source: Ref. 2.3, p. 1008].
-------
surveyed, so that data collection can be completed at each site in
approximately one month (see below). In addition, RTI is considering
retaining the services of a barber at each site to assist with the
collection of the scalp hair sample (see below).
. Qualifications: Potential FI's should ideally be known to
and/or recommended by RTI, various State or local agencies, and/or
similar organizations; present evidence of relevant survey, environmental,
and/or health-related experience; live within a reasonable distance of the
performance site; have an automobile available; be available to work irregular
hours and/or weekends; and be physically capable of carrying the survey
equipment and materials. The medical independent subcontractors should
ideally meet the above criteria, and be currently employed in some area
requiring acquisition of blood samples. The barber(s) should ideally
present evidence of training, experience, and quality performance; live
within a reasonable distance of the performance site; have an automobile
available; and be available to work irregular hours and/or weekends.
In certain areas, such as Arizona, RTI anticipates that independent sub-
contractors will most likely have to be bilingual - that is, speak English
and Spanish.
2.2.2.2 Training
After the independent subcontractors have been recruited and before
data collection activities begin, RTI will conduct two-day briefing sessions
at each performance site to acquaint the independent subcontractors with
study objectives; survey instruments; rationale and detailed procedures
for collecting environmental and biological samples; administrative and
quality control considerations; and anticipated problems, in order to
2-24 12-17-76
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increase the relevance and quality of the data collected. The training
session agenda will follow closely the outline and content of the training
manual, a tentative outline of which is presented in appendix 2.2.
The training sessions will be conducted by the Survey Director,
RTI Senior Chemists, and consultants, and will be attended by the RTI
professional SA and the independent subcontractors. During the training
sessions, the independent subcontractors will be carefully instructed in
all aspects of the field work. Considerable emphasis will be placed
on the objectives and significance of the study and the nature of the
data collection. Practice interviews will be conducted to insure that each
FI becomes thoroughly familiar with household screening and interviewing
techniques and use of the survey instruments. If it becomes apparent that
any independent subcontractor needs additional training, such instruction
will be provided before the field work assignment is given.
2.2.2.3 On-Site Consultants
As a contingency, RTI plans to enlist the services of physician
consultants on-site to serve as points of contact for the field staff in
the event that any problems or questions are encountered in the data
collection process, particularly in regard to the acquisition of biological
samples. For example, the existence of certain disease entities such
as bleeding tendencies may preclude the acquisition of a blood sample
from a given participant.
2-25 12-17-76
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2.2.3 Household Data Collection
2.2.3.1 Screening
Once RTI/SRDC has designated the data collection areas/grids within
each performance site related to distance downwind from the smelter;
data collection instruments and forms have been approved by the Office
of Management and Budget (OMB); and the field staff have been retained
and trained, household data collection will begin.
FI's will be primarily assigned to specific areas or grids within
the smelter community; this procedure should facilitate the FI's familiarity
with and recognition within that area or grid. During the first day
of household contact, which will hopefully follow immediately the training
session, the Survey Director and SA will accompany the FI's to assist
them with their first household contacts.
Data will be collected by door-to-door interview. Each residence
unit encountered in each data collection grid will be visited in sequence.
Within each residence unit so encountered, households will be screened
to determine those containing eligible individuals - that is, those
(1) with no direct occupational exposure to the smelter within the preceding
12 months, (2) who have lived within the smelter study area for at least
the preceding 12 months, and (3) who fall within one of the four study
age groups: pre-schopl 1-5 years or 12-72 months of age, school age
6-18 years of age, and adults 20-35 years of age (with an option to age
40), and in three sites 60 years of age or greater. Such eligibility
will be determined by the FI as part of the household data collection
process. A residence unit within the data collection grid may contain
2-26 12-17-76
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more than one household containing an eligible study participant. Similarly,
such a household may contain more than one eligible study participant.
Each eligible person in those residence units will be invited to participate
in the study until the required number and distribution of participants
is obtained.
At the time of first household contact, the FI will introduce himself
as a representative of RTI and EPA; present his study identification and
(hopefully) copies of letters from appropriate federal, State and local
agencies; and explain the nature and purpose of the study. The FI will
maintain a log record of residence units and households visited and screened
on a Household Screening Log (HSL - see appendix 2.3). Screening of the
household to determine whether or not it contains eligible individuals
will be determined by administration of the HSQ (see appendix 2.3). RTI
anticipates a certain number of nonrespondentsj or households which cannot
be screened; nonpartioipants or refusals; and •ineligibles, or households
which contain no eligible respondents. If an eligible person refuses to
participate in the study, the refusal and the reason(s) therefore will
be noted on the HSL. Visits to screen potential households or to enlist
participants will be limited to three. Where required, the HSQ will be
available in more than one language - for example, English and Spanish
for Arizona.
2.2.3.2 Participant Consent Form
When an eligible person within a household agrees to participate,
the precise location of the residence unit will be noted on a map at
the time of the enlistment, so that the distance of the residence unit
2-27 12-17-76
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from the smelter can be accurately calculated. In addition, the
individual will be required to sign a Participant Consent Form
(PCF - see appendix 2.3) in order to participate in the study.
The PCF will introduce the study; explain its objectives,
sponsorship (the relationship and roles of RTI and EPA), and re-
quirements of and risks, burdens, and benefits to participants; and
stress that participation is completely voluntary and that all data
collected will be kept confidential. The PCF will hopefully contain
•
an indication of the support and/or involvement of the smelter firm
and appropriate State and local agencies; the names and telephone
numbers of appropriate authorities so that participants may obtain
additional information if desired; and inform the participants of
arrangements with these agencies for appropriate follow-up of any
study participants for whom study data collected indicate a need
for medical attention. The PCF will be signed by the participant
or, in the case of persons under age 18, the parent or other responsible
guardian, and will contain an agreement to provide the necessary in-
formation and samples, including a specific release and arrangements
(appointed time and place) to draw blood. Participants may freely
withdraw from the study at any time; however, in order to encourage
participation RTI will offer an incentive of ten dollars to each
participant to be paid after the blood sample is obtained. Again,
confidentiality of data will be stressed, including steps taken to
disassociate the name of the participant from the data once collected;
2-28 12-17-76
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for example, the PCF is the only data collection instrument which will
bear the name of the participant and allow its association to study identi-
fication numbers, but will be maintained in hard copy only and stored
in a restricted area, as indicated in a previous section. To emphasize
this disassociation, for example, the incentive will be paid in cash
rather than by check or money order, although the participant or his/her
guardian will initial a receipt indicating that the incentive was received.
The PCF will make two copies, one for the head of the household and one
for the participant or his/her guardian; the original will be attached
to the questionnaire until it is received at RTI and verified. Where
required, the PCF will be available in more than one language - for example,
English and Spanish for Arizona.
2.2.3.3 Study Questionnaire
The Study Questionnaire (SQ - see appendix 2.3) is divided into four
parts, Part A related to the household and which will be completed only
once for each household containing at least one participant, Part B
related to the individual participant. Part C providing information on
the interviewer and respondent, and Part D indicating whether or not
corresponding and duplicate environmental and biological samples were
obtained and the date, time, and place of acquisition of such samples.
Participants will be identified by a unique study number used to correlate
and cross-identify the questionnaires and samples (see below) by way
of pre-printed self-adhesive labels. Where required, the SQ will be
available in more than one language - for example, English and Spanish
for Arizona.
Household information includes questions related to family socioeconomic
2-29 12-17-76
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status (occupations, educational levels), and questions related to food
sources and preparation. Information on individual participants includes
demographic characteristics such as age, sex, race, marital status,
occupation, and educational level; residence information; health informa-
tion such as current health status and history of exposure to heavy
metals, including questions related to symptoms of clinical and sub-
.clinical toxicity; personal characteristics such as exposure to cigarettes
and various drugs and sundries, and average number of hours spent outside
each day; and dietary information such as exposure to food stuffs high
in heavy metal content [Ref. 2.4] and history of pica, the ingestion of
non-food substances such as paint, clay, and plaster. In addition, for
children participants, information will be collected on location of play
area(s) and school(s) attended.
2.2.3.4 Sample Collection
The specific methods proposed by RTI for measuring environment-
related factors differ somewhat among the various types of exposure.
These differences reflect several considerations such as the extent to
which surrogate variables reflect the factors of interest, the measur-
ability of factors, the variability of factor measurements, the quality
control of data collection, and suitability of data collection techniques
under actual survey conditions. The proposed methodology stresses random
sampling techniques wherever possible to facilitate valid statistical
analyses and to increase the degree of control over data collection;
FI's will follow explicit, nonjudgmental procedures throughout. These
2-30 12-17-76
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procedures will range, as described in appendix 2.6, from obtaining small
selective samples of relatively homogeneous items, such as tap water
at a particular residence, to obtaining large stratified random samples
for a highly variable item, such as air quality in a smelter community.
As indicated in preceding sections, data collection will be divided
among the various field staff. The collection of environmental samples
will be divided between the SA and the FI. The SA will be responsible for
collecting air and general soil samples such as soil samples from each
school yard where study children participants attend; RTI anticipates that
more than one school age child participant may attend the same school.
The FI will be responsible for the selection and screening of residence
units, households, and eligible participants; acquisition of the PCF
and administration of the SQ; collection of dust and tap water samples for
each participating household, and soil samples from the appropriate play
area for each pre-school child participant; explanation of the procedure
for collecting the urine sample; and arrangements for the participant to
go to a central location for acquisition of the biological samples and
disbursement of the incentive. At that central location, the urine and
blood samples will be collected by the medical independent subcontractor;
the hematocrit will be determined by the medical independent subcontractor;
and the scalp hair sample will be obtained, perhaps by a barber.
For each household containing a study participant, samples of housedust
and tap water will be collected, and the precise location of the residence
noted on a map so that the distance of the residence unit from the smelter
2-31 12-17-76
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can be accurately calculated. For each study participant, RTI shall endeavor
to obtain a completed PCF and SQ, and samples of blood, urine, and scalp
hair; in addition, soil samples will be collected from the appropriate
play area for each pre-school child participant and from each school yard
2 2/
where study children participants attend.—1—
2.2.3.5 Quality Control
Two aspects of quality control will directly involve the participating
households and individuals - duplicate samples and reintervieu. For
households/participants for whom duplicate samples are to be collected*
the purpose and procedures for collecting the duplicate samples (see below)
will be explained. Each person completing an HSQ or an SQ will be informed
that they may be selected for reinterview.
2 2/
—i— In addition to the environmental and biological samples specified in
Exhibit A: Scope of Work for this contract, the Project Officer has asked
RTI to consider two additional measurements, paint and dietary lead, which
might increase the significance of data collected in this research effort.
Since these measurements are not part of the Scope of Work, procedural and
cost considerations are presented in a separate document.
2-32 12-17-76
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2.2.4 Central Data Collection
As indicated in preceding sections and paragraphs, RTI plans to
arrange for the collection of biological samples at a central location
which would be manned by at least one medical staff member and perhaps
a barber for four hours in. the evening Monday through Friday and 9 a.m.
to 5 p.m. on Saturdays. Participants would come to this location to
deposit their urine samples and permit the collection of blood and scalp
hair samples. In addition, hematocrits will be—performed at this
location. In the event that a participant does not have transportation
to the location, RTI will be prepared to provide transportation. In
the event that the participant's physical condition makes travel impractical,
such as an elderly, disabled, or otherwise infirm person, the medical
staff member may have to go to the home in order to obtain the necessary
samples. Ideally, the biological samples will be collected the day after
the participant is enlisted or during the day on Saturday.
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2.2.5 Site Administrator's Responsibilities
At each performance site, the SA will have three areas of responsibility:
(1) general supervision and coordination of field operations; (2) collection
of air and soil samples; and (3) data management, handling, and shipment.
2.2.5.1 Coordination of Field Operations; Data Management
. As indicated in preceding sections, an RTI professional will serve
'as SA and as such be responsible for the coordination and quality control
of data collection; these individuals will remain at each site for the
duration of data collection at that site, and at the very least the same
individual will oversee such activities at sites representing the same
-type smelter. The SA will work in close communication with the Survey
Director and other professionals at the RTI central facility at Research
Triangle Park, North Carolina, in order to coordinate and supervise immediate
field operations at each performance site. The SA will have to coordinate
his own project activities with those of the independent subcontractors
to ensure that various project activities proceed as effectively and efficiently
as possible with regard to both time and cost. The SA will also serve as
a trouble-shooter.
Among the field operations which the SA will have to coordinate
are:
Obtaining household mapping information, copies of HSLs, HSQs,
and administrative forms, and soil, tap water, and housedust samples from
the FI's;
2-34 12-17-76
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Scheduling and transportation of participants to the central
data collection facility for collection of biological samples, including
delivery of the completed PCF and SQ to the central data collection facility;
and
. Retrieval of the completed PCFs, "SQs and biological samples
from the central data collection facility.
2.2.5.2 Sample Collection
As intimated and discussed in preceding sections and appendix 2.6,
the SA will be responsible for collecting random air samples in the
smelter community, and composite soil samples from the smelter community
at large as well as from each school yard where study children participants
attend.
2.2.5.3 Data Storage, Packaging and Shipment
With regard to survey instruments, the SA will only be responsible
for shipping the completed PCFs and SQ's to RTI/SOC, although he will
receive copies of HSLs, HSQs, and various administrative forms from the
appropriate independent subcontractors for review and reference as needed.
All samples will be chilled to 0°-5°C (not frozen) after collection
and will be shipped in this condition via Federal Express.
High density polyethylene containers (120 ml) will be used for tap
water, urine and soil samples. Different types of caps are being investi-
*
gated to provide a leak-proof seal, without contamination. Shipment by
Federal Express eliminates the possibility of sample contamination due
to pressure gradients in transit. Plastic containers will be shipped in
styrofoam blocks in which depressions are cut to exactly hold each container.
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RTI experience with such shippers has resulted in no container damage
and a minimum of sample temperature change during transit.
Zip-Loc plastic containers will be used for air, scalp hair
and dust samples. Provisions will be made to insure a tight seal
to prevent sample loss and contamination. The plastic bags will
be shipped in a styrofoam-lined box.
Blood samples will be shipped to RTI in specially designed 8-tube
Vacutainer shippers. As with other samples, blood samples will be
chilled (not frozen) in order to reduce losses due to hemolysis and
volatilization.
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2.2.6 Quality Control
2.2.6.1 Training
In order to standardize the quality of data collection techniques
and procedures from the outset, a training manual will be developed by
RTI for use in training RTI project staff and briefing field interviewers.
This manual will address study objectives; data collection instruments;
detailed rationale and procedures for collecting environmental and
biological samples; instructions for administration, coordination, and
quality control of all field operations; instructions for data receipt
control, scan-edit, and entry; and discussions of anticipated problems
(see appendix 2.2). In addition, RTI will conduct training sessions for
RTI project staff and independent subcontractors which will address study
objectives and procedures in order to increase the quality and relevance
of data collected. One major objective of the training activities will be
to provide explicit, nonjudgmental procedures for the field staff to follow.
2.2.6.2 Supervision
The RTI Survey Director will supervise and coordinate the field
operations, providing flexibility of coverage should additional pro-
fessional level effort be required at any time during the data
collection period. The SA will remain at the performance site until '
data collection is completed, and the same SA will be used at least
for sites of the same smelter type. RTI plans to enlist the services
of physician consultants on-site to serve as points of contact for the
2-37 12-17-76
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field staff in the event that any medical problems or questions are
encountered in the data collection process, particularly in regard to
the acquisition of blood samples.
The Institute has a field operations staff of Field Supervisors (FSs)
located at key points across the country who have coordinated the work
of field data collection staffs for a variety-of projects and will be
available to assist with supervision and/or coordination of data collec-
tion for this project if required. These area supervisors are currently
based in or near the following major metropolitan areas: Boston, New
York, Washington, Atlanta, Pittsburgh, Detroit, Chicago, St. Louis,
Houston, Los Angeles, and San Francisco. At the very least, the appropriate
FSs will be made aware of project activities and provided a copy of the
training manual; depending upon time and cost considerations, the appropriate
FS may be invited to attend the training session at the performance site.
In order to facilitate supervision, both RTI/SOC and the SA will re-
ceive copies of the HSLs, HSQs and various administrative forms completed
by independent subcontractors which will provide an opportunity to monitor
the production and activity of the field staff.
As indicated in preceding sections, the Survey Director and SA will
accompany the independent subcontractors during the first day of data
collection at each performance site; the SA will be encouraged to meet
frequently with independent subcontractors to review study progress and
problems; and survey instruments will be edited upon receipt at RTI/SOC.
2.2.6.3 Sample Collection
Each sample will be properly labeled as it is collected. Each individual
sample will be treated the same as all other samples of that particular
type.
2-38 12-17-76
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2.2.6.4 Duplicate Sample Collection
As a check on the quality or precision of collecting certain
of the biological and environmental samples, RTI plans to collect
duplicate soil, housedust, tap water, blood, and scalp hair samples
(the last two from adult participants only) from ten percent of the
sample sources, using the same technique and as nearly as possible
the same sites as the original sample (see appendix 2.6).
2.2.6.5 Reinterview
As a quality check of the interview process, RTI plans to re-
interview by mail, telephone, or personal visit approximately ten
percent of the population for whom completed questionnaires are obtained.
This procedure will permit a two-fold verification - that the interview
indeed took place and that responses are consistent.
2-39 12-17-76
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2.2.7 Respondent/Participant Burden
The only anticipated risk to participants will involve the acquisition
of the blood sample, and the biwden will consist of the time to respond
to the questionnaire(s); the time and inconvenience of allowing the FI
into the household to collect the household environmental samples; and
the time, inconvenience and perhaps minor discomfort of providing the biological
samples (see below). In order to complete household data collection,
approximately two hours of time may be required of each participant, including
travel and the collection of all relevant samples.
To offset this burden, RTI will offer the incentive of ten dollars
per participant and an opportunity to obtain some health measurements, such
as the hematocrit and the various analyses for metal burden. Potential
participants will be informed of the potential dangers of heavy metal
absorption and benefits to be gained in the early discovery of heavy metal
absorption in the participants and their communities. Participants will
be informed of arrangements with appropriate area agencies for the follow-
up of study participants for whom study data indicate medical attention.
2-40 12-17-76
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2.3 Anticipated Problems
RTI has identified the following potential problem areas which may have
a significant impact on project'time, cost or validity.
»
2.3.1 Smelter Resistance
RTI has assumed that the smelter industry will provide at the very
least a promise of verbal cooperation or passive resistance. In the event
that the smelter takes a position of active resistance, project performance
at a given site might be seriously jeopardized, since most of the performance
sites are relatively small communities whose economy is significantly influenced
by the smelter.
2.3.2 Recruiting Independent Subcontractors
Since the six performance sites were not specified prior to the signing
of the contract, RTI predicated field operations costs on the assumption that
independent subcontractors could be retained at, or within a reasonable
distance of., the smelter community performance site. Should RTI be unable
to find independent subcontractors at, or within a reasonable distance of,
the performance site, they will have to be brought into the performance
site from more distant points at an additional expense for travel and
subsistence.
2.3.3 Nonparticipants
-As indicated in preceding sections, RTI anticipates a certain number of
nohrespondents, nonparticipants, and ineligibles. However, in some of these
small smelter communities, these various categories of nonparticipants may
significantly reduce the number of data sets available for analysis. Through
callbacks and the incentive, RTI hopes to keep nonrespondents and non-
2-41 12-17-76
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participants at a minimum, but eligibility is determined by established criteria.
In some of these small smelter communities, for example, the number of
adult men without direct occupational exposure may be small.
2.3.4 Incomplete Data Sets
Even though an individual may agree to participate in the study and
sign a PCF, a complete set of questionnaires and samples for that individual
may not be obtained for a variety of reasons such as baldness, inability
or refusal to provide a scalp hair sample or a urine sample, or refusal
to provide a blood sample. RTI has anticipated some of the potential
problems in obtaining complete data sets and made appropriate provisions,
such as offering an incentive to be paid only after collection of the
blood sample; transportation to and from the central data collection
facility; and arranging for the medical independent subcontractors to visit
the participant at home to collect the biological samples. Nonetheless,
participation in this survey is voluntary and the small size of most of these
smelter communities limits the number of eligible volunteers. Therefore,
RTI will accept as a minimum data set a blood sample and completed HSQ,
PCF, and SQ.
2.3.5 Missing Data
Since various data elements must be shipped to RTI from the performance
site via Federal Express and/or mail, the possibility exists for those data '
elements to be lost or damaged so as to not be useable. In the past, RTI
has had little problem with regular first class mail, but. is consider-
ing using registered mail in this study.
2-42 12-17-76
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2.4 Schedules for Field Operations
2.4.1 Time Schedule
Figure 2.8 presents graphically a time schedule for the field
operations, including preparations, data collection in the field, and
data processing. In Figure 2.8, tasks at RTI are as follow:
Task 1 - Preparation of work plan and data collection instruments;
Task 2 - Review and revision(s) of work plan and data collection
instruments;
Task 3 - Preparation of training manual;
Task 4 - Training session;
Task 5 - Data receipt control, edit and direct entry;
Task 6 - Reinterview; and
Task 7 - Preparation of final report.
For each performance site, Phase I refers to public relations,
recruitment of independent subcontractors, and publicity; Phase II
refers to training; and Phase III refers to data collection. This
time table is predicated on approval of study protocol and data
collection instruments by EPA and OMB early in 1977. In order to
minimize interviewer and participant burden, RTI anticipates that
field operations at each site would be conducted during temperate
weather; some studies have indicated that weather plays a significant
role in project efficiency and participation. [Ref. 2.5]
At this point in time, RTI anticipates that the performance
sites would be studied in the following order:
Pretest - Corpus Christi, Texas;
Performance site 1 - Anaconda, Montana;
2 - Palmerton, Pennsylvania;
3 - Herculanuem, Missouri;
2-43 12-17-76
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SITE
RTI
ACTIVITY
TASKI
TASK
o
TASK 4
TASK
S551
TASK 7
PRETEST
PERFORMANCE
SITE I
to
I
n.. i «• i
^*W*
TIME
FRAME
N
0
1976
J
1977
M
M
S
ON
0
1977
M
1978
Fig. 2.8. Field operations time table.
-------
4 - Bartlesville, Oklahoma;
5 - .Bixby, Missouri; and
6 - Ajo, Arizona.
It is further anticipated that the elderly age group will be studied
at Herculanuem, Bartlesville, and Ajo.
2-45 12-17-76
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2.4.2 Cost Schedule
Figure 2.9 presents graphically cumulative estimated cost
(exclusive of fee) and labor hours by month for the field operations.
These cost and labor hour projections are based on Figure 2.8 and
predicated on the same assumptions.
2-46 12-17-76
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APPENDIX 2.1
RESUMES OF RTI PROJECT STAFF AND CONSULTANTS
2-48 12-17-76
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JAMES D. BATES, Director, Survey Operations Center
Professional Experience
1963 to date. Research Triangle Institute, Research Triangle Park, North
Carolina 27709.
1976 to date: Director, Survey Operations Center.
1972-1976: Manager, Survey Methodology and Operations Department.
1971-1972: Senior Economist, Center for the Study of Social Behavior.
1968-1971: Head, Economics Section in Social Statistics Group.
1965-1968: Economist in Sampling Group of Statistics Research Division.
1963-1965: Statistics Research Division contract with U.S. Agency for
International Development on project as Survey Statistician. Rural
Economic Surveys, Federal Office of Statistics, Nigeria, West Africa.
1961-1963. Florida Citrus Commission, Department of Agricultural Economics,
University of Florida, Gainesville, Florida. Assistant Marketing Research
Economist.
Education
B.S., Agricultural Economics, University of Florida, 1958.
M.S., Agricultural Economics, University of Florida, 1963.
Completed course work toward Ph.D. in Economics at North Carolina State
University.
Professional Activities
American Economic Association, member.
American Farm Economic Association, member.
Phi Kappa Phi.
Gamma Sigma Delta.
Alpha Zeta.
Publications and Reports
"Behaviorial Characteristics of Customers Shopping for Fresh Oranges,"
(with S.W. Williams and M.R. Godwin) Florida Citrus Commission, in
cooperation with the University of Florida Department of Agricultural
Economics, Agricultural Experiment Station and the Marketing Economic
Division of ERS, USDA, Pub. S.C.C.-E.R.D. 65-8, May 1965.
A Study of Job Vacancies and Manpower in Durham County, James D. Bates,
Statistics Research Division, Research Triangle Institute, July 1966.
A Study of Financial Assistance to Child Care Institutions by the State
~of North Carolina, James D. Bates and James A. Street. Statistics Research
Division, Research Triangle Institute, March 1967.
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Operating Costs in Homes for the Aged and Nursing Homes in North Carolina,
D.A. King and J.D. Bates, Statistics Research Division, Research Triangle
Institute, March 1967.
An Intensive Investigation of the Problems Associated with Young Men who
are Mentally Unqualified for Military Service. A.M. Huq, T.H. Jerdee,
J.D. Bates and Don Jackson, Research Triangle Institute, May 1967.
An Index of Economic Status of Individual Rural Families. J.D. Bates,
J.V. Rachal and L. Gould, Research Triangle Institute, January 1971.
Alcohol Safety Action Program, Annual Report, J.R. Miller, B.A. Moser,
S. Trustman and J.D. Bates, March 1972.
Drug Usage and Arrest Charges, William C. Eckerman, James D. Bates, J. Valley
Rachal, and W. Kenneth Poole, December 30, 1971.
North Carolina Survey on Aging, J.D. Bates and D.W. Jackson, March 9, 1972.
An Operational Consumption Measure of Economic Status; With Applicability
to United States Rural Families, J.D. Bates, J.V. Rachal, W.K. Poole and
R.P. Moore, October 1972.
A Description of Field Procedures and Data Processing for the Household
Survey for New Towns, J.D. Bates, and D.W. Jackson, November 30, 1973.
A Review of USAID Projects in Four Major Livestock Producing States in
Nigeria: An Assessment of Range Management, J.D. Bates, G. Howze, F.A.
Abercrombie, and H. Van Blake, May 1975.
3/76
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CURRICULUM VITAE
STEPHEN HUNTER GKHL3.ACH
Born; January 14, 1942, in Mo line, Illinois
Education; Academic; Received A.B. degree, Harvard College 1964.
Graduated from Case Western Reserve School of
Medicine (1963)
Internship and Residency; Mixed medical-pediatric internship
at the Royal Victoria Hospital in
- » ._ Montreal, Quebec
One year residency in pediatrics
. . -• • at Childrens1 Hospital Medical Center
in Boston
• •.>,' ' • - :
!,.-./' One year residency in pediatrics at
^•; • . . .,Duke Medical Center
Military Service: Served tvo years in U. S. Public Health Service assigned to
the North Carolina State Board of Health as Field Epidemiologist
working primarily in the field of general- communicable disease j~.
control .
« ..•:-. •• . N
Licensure; North Carolina, December, 1971 •• . : '
Publications; (coauthor); "Haeraolytic Anaenia in Infectious Mononucleosis Due
Inapparent Congenital Spherocytosis," Scand. J. Haernat.,
"*'••••. '7: 141-L44, 1970.
« (coauthor); '"Clinical Reactions Following Rubella Vaccination,"
JAMA. 220; 1569-1572, 1972.
•-. . . (coauthor): "Coccicioidomycosis," Arch. Int. Med., 131: 254-255,
1973.'
(coauthor): "Spread of Disease by Fecal-Oral Route in Day
. ' Nurseries,"' HSMHA Health Reports, 83: 320-322, 1973.
2-51 -. 12-17-76
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PUBLICATIONS: Gehlbach, S., Cooper, B., "Haemolytic Anaemia in Infectious
Mononucleosis Due Inapparent Congenital Spherocytosis,"
Scand. J. Kaemat., 7: 141-144, 1970.
Grand, M., Wyll, S., Gehlbach, S., "Clinical Reactions Following
Rubella Vaccination," JAMA, 220: 1569-1572, 1972.
Gehlbach, S., Hamilton, J., Conant, N., "Coccidioidomycosis,"'
Arch. Int. Med., 131: 254-255, 1973.
Gehlbach, S., MacCormack, J., Drake, B., Thompson, W., "Spread of
Disease by Fecal-Oral Route in Day Nurseries," HSMHA Health Reports,
88: 320-322, 1973.
Gehlbach, S., Williams, W., Woodall, J., Freeman, J., "Pesticides
and Human Health - An Epidemiologic Approach'," Health Service
Reports, 89: 274-277, 1974.
Gehlbach, S., Williams, W., Perry, L., Woodall, J., "Green Tobacco
Sickness - Ann Illness of Tobacco Harvesters," JAMA, 229: 1880-
1883, 1974.
Roe, C., Schonberger, L., Gehlbach, S., et. al.: "Enzymatic
Alterations in Separate Outbreaks of Reye's Syndrome:
Prognostic Implications", presented to the Reye's Syndrome
-..Conference, Columbus, Ohio, October, 1974.
Gehlbach, S., Williams, W.: "Pesticide Containers.: Their
Contribution to Poisoning," Arch. Env. Health, 30: 49-50, 1975.
.Landrigan, P.J., Gehlbach, S.H., Rosenblum, B.F., etc."Epidemic
lead absorption near an ore smelter, N.E.J.M. 292: 123-219,
1975. •
Roe, C. R., Schonberger, L.B., Gehlbach, S.H., Wies, L.A. and
Sidbury, J.B., "Enzymatic alterations in Reye's syndrome:
Prognostic implications", Pediat. 55: 119-126, 1975.
Gehlbach, S.H., Gutman, L.T., Wilfert, C.M., Brumley, G.W.,
and Katz. S.L. "Recurrence of skin disease in a nursery:
Ineffectually of hexachlorophene bathing", Pediat. 55:
422-424, 1975.
Gehlbach, S.H., Williams, W.A., et.al.: "Nicotine absorption
by workers harvesting green tobacco", Lancet 1: 478-480, 1975.
Gehlbach, S.H., and Williams, W.A.: "Epidemiology of pesticide
poisonings in North Carolina", (Abstract) Pediat. Res., 4:
297, 1975.
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BENJAMIN S. H. HARRIS, III, Health Survey Specialist
Professional Experience
1964 to Date. Research Triangle Institute, Research Triangle Park, North
Carolina 27709.
1974 - date: Health Survey Specialist, Survey Methodology and
Operations Department, Statistics Research Division. Currently
Project Leader of a follow-back study of children who received
diagnostic doses of radioactive iodine over the period 1946-1960.
Also involved in a national survey of the incidence, prevalence, and
costs of traumatic injury to the central nervous system; a study of
the outcomes of alternative modes of treating prostatic carcinoma;
and a national registry of chronic intermittent dialysis patients.
Major contributor to the evaluation of the Mecklenburg County, North
Carolina, Alcohol Safety Action Project; and monitored grant review
committees for the National Institute on Alcohol Abuse and Alcoholism
(NIAAA).
1971 - 1974: Medical Science Analyst, Center for Health Studies.
Project Leader of a study of diagnosis and determination of disability
in alcoholism; the preparation of a directory of State and local
alcoholism services; and a pilot follow-back study of patients treated
for tuberculosis in the North Carolina Sanitorium system by pneumothorax
and pneumoperitoneum with fluoroscopy during the period 1930-1950.
Supervised survey of Medicare procedures used by physicians in selected
metropolitan areas; major contributor to a study involving the collec-
tion and analysis of data relating to civilian techniques in inter-
national development assistance, and a survey of attitudes and capabilities
of major hospitals in North Carolina regarding the handling of patients
involved in radioactive accidents. Coordinated site visits to alcoholism
treatment centers sponsored by NIAAA and prepared a summary and evalua-
tion of the site visit process, assisted with the Third Annual Alcoholism
Conference of NIAAA, and involved in medical evaluation of the supple-
mental food program for Women, Infants, and Children. Assisted in the
preparation of new contract proposals related to health services, and
served as a consultant to the Craven County (N.C.) Health Department
in the preparation of a proposal to the North Carolina Regional Medical
Program.
1966 - 1971: Health Services Analyst, Operations Research and
Economics Division. Principal Investigator on studies of hospital
utilization in the last year of life and the economic costs of kidney
disease; major contributor to study of the post nuclear attack pre-
vention and control of communicable respiratory diseases; supervised
survey of drug usage among arrestees for serious crimes in selected
metropolitan areas; research on the economic costs of alcoholism and
excessive fertility.
1964 - 1966: Biologist, Natural Products Laboratory. Responsible
for biological assays and pharmacologic evaluation of synthetic and
naturally-occurring toxic agents, the immediate operation of the
Institute's animal colony, coordinating the Laboratory's bio-assay
program, and assisting in the preparation of new contract proposals
in bio-medical areas.
2-53 12-17-76
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1961 to 1964. Duke University Medical Center, Durham, North Carolina 27710.
Research Assistant, Department of Psychiatry, Division of Electroencephalography
(EEC). Research activities included portable EEC, the EEC in various types
of epilepsy, guides for teaching EEC, neurophysiologic changes in the brain
of the cat after administration of hallucinogens, and changes in electrical
activity resulting from drowsiness and psychopharmacologic agents; prepara-
tion of Keysort data cards for classification and condensation of EEC's;
and recording EEC's in operating rooms during neurosurgical procedures.
During this time also served as junior staff psychiatrist, John Umstead
(State mental) Hospital, Butner, North Carolina.
Education
B.A., Zoology, Duke University, Durham, North Carolina, 1960.
Graduate work in medicine, Duke University School of Medicine, 1960-1965.
Course in Operations Research, Georgia Institute of Technology, Atlanta,
Georgia, 1968.
San Diego Summer School of Alcohol Studies, University of California, San
Diego, 1972.
Honors
President, Pre-med scholastic honorary society, Duke University, 1959-60.
NIMH student research stipends, summers of 1961 and 1963.
Who's Who in North Carolina, 1973.
Selected Publications
"Experience with Portable Electroencephalography in a General Hospital."
Electroencephalography and Clinical Neurophysiology, 1963, 15:1047
(Abstract of paper presented to Southern EEC Society, Durham, N.C.,
November 17, 1962).
"Psychiatric Problems in Children with Frontal, Central and Temporal Lobe
Epilepsy." Southern Medical Journal. 1966, 59:49-53, coauthor.
"Murine Toxicity of Cochliobolus carbonum." Applied Microbiology, 1968,
16(11):1710-1722, coauthor.
"Interictal Focal or Lateralized Discharges Occurring in the Electroencepha-
lograms of Patients Suffering From Centrencephalic Epilepsy." Confinia
Neurologica, 1968, 30:368-374, coauthor.
The Economic Cost of Kidney Disease and Related Diseases of the Urinary
System (PHS Pub. No. 1940). Washington, D.C.: U.S. Government Printing
Office, 1970.
"Estimation of a Potential Hemodialysis Population." Medical Care, 1970,
8(3):209-220, coauthor.
"The Number and Cost of Medicines Prescribed for the Treatment of Patients
with Selected Diseases." Inquiry. 1970, 7(3):38-50.
Postattack Communicable Respiratory Diseases. Research Triangle Park, N.C.:
Research Triangle Institute, 1970, coauthor.
Care in Hospitals and Institutions During the Last Year of Life by Cause of
Death: United States, 1962-1965 Deaths. Washington, D.C.: U.S. Depart-
ment of Commerce, National Technical Information Service, 1972 (NTIS
Accession No. PB-208-639).
Military Civic Action Final Report, Volume I: Evaluation of Civilian Tech-
niques in International Development Assistance. Research Triangle Park,
N.C.: Research Triangle Institute, 1972.
2-54 12-17-76
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Medical Facilities - Control of Radioactive Materials in North Carolina
Transportation Accidents (RM-24U-754). Research Triangle Park, N.C.:
Research Triangle Institute, 1973.
"Alcohol Abuse: An Overview." Adit: Approaches to Drug Abuse and Youth,
1973, 2(1):1-2,11-15.
Mecklenburg Alcohol Safety Action Project; An Analysis of Ultimate
Performance Measures to Determine Total Project Impact. Research
Triangle Park, N.C.: Research Triangle Institute, 1974.
"Edgar Allan Poe on Sullivan's Island." Accepted for publication in 1975
in the South Carolina Magazine.
January 1975
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MILDRED C. PENNINGTON, Research Assistant II
Professional Experience
1973 to date. Research Triangle Institute, Statistics Research Division,
Research Triangle Park, North Carolina 27709. Research Assistant to the
manager and supervisor of the clerical staff of the Survey Methodology and
Operations Department.
1942-1973. United States Department of Agriculture
1961-1973: United States Department of Agriculture, Statistical
Reporting Service and the North Carolina Department of Agriculture,
Division of Agricultural Statistics, Raleigh, North Carolina. Sta-
tistical Assistant to the statistician and supervisor to the clerical
staff of the Input and Collection unit.
1942-1961: United States Department of Agriculture, Standards and
Research Division, Statistical Research Laboratory, Institute of
Statistics, North Carolina State University, Raleigh, North Carolina.
Act as assistant to the statistician and supervisor to the clerical
staff of the Survey Operation Group.
Education
Needham Broughton High School, Raleigh, North Carolina 1935
Attend one week course on Supervision and Group Performance, Atlanta,
Regional Training Center, Atlanta, Georgia, 1971
Professional Activities
Association for Coordination Interagency Statistics, North Carolina State
Departments, 1971-1972; member.
February 1973
2-56 12-17-76
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CURRICULUM VITAE
Carl M. Shy
I. Born: October 23, 1931 - Milwaukee, Wisconsin
Married: June 6, 1959
Wife: Eve Carol (nee Rudich)
Children: Leslie (3/26/60)
Rosalie (4/2/62)
Ann (6/4/65)
II. Pre-Medical Education: 1. A.B. St. Louis University,.1956
Major in Philosophy and Economics
2. St. Louis and Marquette Universities, 1956-57
Graduate Studies in Philosophy and Economics
III. Medical Education:
Year
1.' 1958-1962
.Location
Marquette University
School of Medicine
2. 1960 (Summer) Marquette University
School of Medicine
3. 1962-1963
4. 1963-1964
'5. 1964-1965
6. 1965-1967
University of Michigan
University of Michigan
Medical Center
University of Michigan
School of Public Health
University of Michigan
School of Public Health
Appointment and D-2nres
Medical Student, M.D.
received June 1962
Student Fellowship
(2 months) in Physiology
Intern (Straight Medicine)
Resident I in Internal
Medicine •
Student in Department of
Epidemiology: M.P.H.
Received May 1965
Student in Department of
Epidemiology: Dr.P.H.
Received April 1967
IV. Post-Doctoral Public Health, Medical and Academic Experience:
Year Location Appointment
1.. 1967-1971
U.S. Public Health Service
National Air Pollution
Control Administration.
(Now tho Environmental
Protection Acj-nncy)
Durham, North Carolina •
Epidemiologist and Chief,
Epidemiology Branch,
Division of Health Efff:C<
Research
2-57
12-17-76
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-2-
2. 1971-1972
3. 9/72-12/73
4. 1968-1973
5. 1969-Present
6. 1970-Present
7. 197.1-Present
8. 1968-Present
1971-Present
9. 1/74-Present
Environmental Protection
Agency, Office of Research
and Monitoring, Division
of Health Effects Research,
Research Triangle Park,
North Carolina
Environmental Protection
Agency, Office of Research
and Monitoring, National
Environmental Research
Center, Research Triangle
Park, North Carolina
University of North
Carolina
Department of Epidemiology
Duke University
Deputy Director
Division of Health
Effects Research
Director, Human Studies
Laboratory (Final Civil
Service Grade was GS-16)
Adjunct Assistant Professor
Assistant Clinical Professor
of Epidemiology (Part-time-
Appointment)
Journal of Chronic Diseases Editorial Consultant
Wake County Hospital
State of Ohio
State of North Carolina
University of North Carolina
Staff Member, Medical Night
Clinic (General Pediatric
and Internal Medicine
Practice)
Medical Li censure
Medical Li censure
Director, Institute of
Environmental Studies
Lecturer, Department of
Epidemiology, School of
Public Health
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12-17-76
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-3-
V. Membership in Scientific Organizations:
1. Alpha Omega Alpha National Honorary Medical Fraternity
2. Delta Omega National Honorary Public Health Society
3. American Association for the Advancement of Science
4. Society for Epidemiologic Research
5. American Public Health Association
6. North Carolina Lung Association, Advisory Committee on Air
Pollution
2~59 12-17-76
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-4-
VI. Publications:
1. Shy, C.M. and Meade, R.C.: The hippuric acid radio isotope renogra;n,
Harquotte Msd. Rev. 26:139-147, 1951.
2. Shy, C.M.: Diagnostic procedures for determining hypertension of renal
origin. Marquette Msd. Rev. 26:194-199, 1961.
3. Meade, R.C. and Shy, C.M.: The evaluation of individual kidney function
using radioiodohippurate sodium. J. Urol. 86:163-170, 1961.
4. Shy, C.M.: A comparison of psychoanalytic and philosophical thought.
Marquette Med. Rev. 27:61-67, 1962.
5. Shy, C.M.: Of Man and Machines (Student Editorial). Marquette Had. Rev
*
6. Associate editor of Vol. 27, No. 3 (March 1962) issue of Marquette Med.
Rev.
7. Shy, C.M.: The pituitary-thyroid relationship in Graves' disease.
Marquette Med. Rev. 27:162-166, 1962. .
8. Shy, C.M.: The determinants of the one-second forced expiratory volurna,
as a measure of chronic obstructive lung disease, in a.total population stud;
Doctoral dissertation submitted and accepted in partial fulfillment of the
requirements for the degree of Doctor of Public Health, April 1957. Dissert;
is available in microfilm form from University Microfilms, Ann Arbor, Michig-
9: Shy, C.M., Creason, J.P., Pearlman, M.E., McClai'n, K.E., Benson, F.B. anc
Young, M.M. The Chattanooga School Children Study: Effects of Community
•Exposure to Nitrogen Dioxide. 1. Methods, Description of Pollutant Exposure
and Results of Ventilatory Function Testing. J. Air Pollution Control Assoc.
20:539-545, August 1970.
10. Shy, C.M., Creason, J.P., Pearlman, M.E., McClain, K.E., Benson, F.B. anc
Young, M.M. The Chattanooga School Children Study: Effects of Community
Exposure to Nitrogen Dioxide. 2. Incidence of Acute Respiratory Illness.
J. Air Pollution Control Assoc. 20:582-588, September 1970.
11. Shy, C.M.: Health Effects. Chapter in National Emissions Standards
Study, A Report to Congress, 1970.
12. Cohen, A.A., Shy, C.M.,"Benson, F.B., Riggan, W.R. and Ncv/ill, V.A.: Air
Pollution Episodes: Guides for Health Departments and Physicians. HSMHA Meal
Reports, June 1971.
13. Hammer, D.I., Finklea, J.F., Hendricks, R.H., Shy, C.M. and Morton, R.O.I-:
Ha-ir Trace Motal Levels and Environmental Exposure. t\mnr. J. Epic!. 93:84-92,
February 1971.
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14. Pearl man, M.E., Pinkie?., J.F., Shy, C.M., VanBruggen, J.B. and fiewill,
V.A.: Chronic Oxidant Exposure and Epidemic Influenza. Environmental
Research, June 1971.
15. Pearlman, M.E., Finklea, J.F., Creason, J.P., Shy, C.M., Young, M.D.
and Morton, R.J.M.: Nitrogen Dioxide and Lov/er Respiratory Illness, Pediatri
47(2), February 1971.
16. Shy, C.M.: Environmental Epidemiology. Chapter in Environmental Hancibo'
for .International Students. University of North Carolina, (In Press), 1972.
17. Hammer, D.I., Finklea, J.F., Hendricks, R.H., Hinners, T.A., Riggan, W.B
and Shy, C.M.: Trace Metals in Human Hair as a Simple Epidemiologic Monitor
of Environmental Exposure. Trace Substance in Environmental Health, Vol. 5,
1972.
f
18. Cohen, A.A., Bromberg, S., Buechley, R.W., Heiderscheit, L.T. and Shy,
C.M.: Asthma and Air Pollution from a Coal-Fueled Power Plant. Arnsr. J.
Public Health 62:1181-1188, September 1972.
. , *
19, Mauser, T.R. and Shy, C.M. Position Paper: NO Measurement. Environ. S<
and Techno!. 6:890-894, October 1972. . .
20. Shy, C.M., Hasselblad, V., Heiderscheit, L.T. and Cohen, A.A.: Environs
Factors in Bronchial Asthma. Published in Environmental Factors in Respiratt
Disease, 1972.
.21. Love, G.J., Shy, C.M., Calafiore, D.C., Benson, F.B. and Finklea, J.F.:
The Strategy for Determining the Effects of Environmental Pollution on Human
Health. Environ. Letters 3(1):13-20, 1972.
22. Pinkerton, C., Creason, J.P., Shy, C.M., Hammer, D.I., Bueckley} R.W. anc
Murthy, G.K.: Cadmium Content of Milk and Cardiovascular Disease Mortality.
Trace Substances in Environ. Health, Vol. 5, 1972.
23. Riggan, W.B., Hammer, D.I., Finklea, J.F., Hasselblad, V., Sharp, C.R.,
Burton, R.M. and Shy, C.M.: CHESS - A Community Health and Environmental
Surveillance System. Published in Proceedings of Sixth Berkeley Symposium or
Mathematical Statistics and Probability, Vol. VI, Effects of Pollution on
Health, University of California Press, 1972.
24. Finklea, J'.F., Cranmer, M.F., Hammer, D.I., McCabe, L.F., fiewill, V.A.
and Shy, C.M.: Health Intelligence for Environmental Protection: A Demandir
Challenge. Published in Proceedings of the Sixth Berkeley Symposium on Moth?
tical Statistics and Probability, Vol. VI, Effects of Pollution on Health,
University of California Press, 1972.
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25. Pearlman, M.E., Finklea, J.F., Creason, J.P., Shy,•C.M., Young, M.M.
and Morton, R.J.M.: Nitrogen Dioxide and Lower Respiratory Illness.
Published in October 18, 1971 issue of Modern Medicine. (Abstract)
26. Shy, C.H.: Referee for Article "Air Pollution: A Major Public Health
Problem" by Ayres, Evans and Buehler. Published as CRC Critical Reviev/ in
Clinical Laboratory Sciences, January 1972.
27. Shy, C.M., Hasselblad, V., Burton, R.M., Nelson, C.J. and Cohen, A.A.:
Effects of Air Pollution on Ventilatory Function of U.S. School Children:
Results of Studies in Cincinnati, Chattanooga and New York. Arch. Environ.
Health 27:124-128, September 1973.
28. Nelson, C.J., Shy, C.M., English, T., Sharp, C.R., Andleman, R., Truppi,
L. and VanBruggen, J.: Family Surveys of Irritation Symptoms During Acute Air
Pollution Exposures: 1970 Summer and 1971 Spring Studies. 0. Air Poll. Ccntr.
Assoc. 23:81-86, February 1973.
29. Shy, C.M. and J.F. Finklea. Air Pollution Affects Coraiunity Health.
Environ. Sc. and Techn. 7:204-208, March 1973.
30. Shy, C.M., J.F. Finklea, D.C. Calafiore, F.B. Benson, V.'.C. Nelson and
V.A. Newill. A Program of Community-Health Surveillance Studies (CHESS).
.Published in Determination of Air Quality - Proceedings of the ACS
Symposium on Determination of Air Quality, p. 41-48, Plenum Press,
Mew York-London, 1972.
31. Shy, C.M., C.J. Nelson, F.B. Benson, R.S. Chapman, VJ.B. Riggan and V.A.
Newill. Ventilatory Function in School Children: 1967-1958 Testing in
Cincinnati Neighborhoods. Published in Health Consequences of Sulfur Oxides:
A Report from CHESS 1970-1971. In press.
32. Shy, C.M., V. Hasselblad, J.F. Finklea, R.M. Burton, M. Pravda, R.S.
Chapman, and A.A. Cohen. Ventilatory Function in School Children 1970-1971
Testing.in New York Communities. Published in Health Consequences of Sulfur
Oxides: A Report from CHESS 1970-1971. In Press.
33. Shy, C.M., W.B. Riggan, W..C. Nelson, R.C. Dickerson, F.B. Benson, J!F.
Finklea, A. Colucci, D.I. Hammer, and V.A. Newill. An Overview of CHESS.
Published in Health Consequences of Sulfur Oxides: A Report from CHESS
1970-1971. In press. . .
34. Finklea, J.F., C.M. Shy, G.J. Love, C.G. Hayes, VI.C. Nelson, R.S. Chapman
and D.E. House: Health Consequences of Sulfur Oxides: Summary and
Conclusions Based Upon CHESS Studies of 1970-1971. Published in Health
Consequences of Sulfur Oxides: A Report from CHESS 1970-1971. In press.
35. Shy, C.M.: Transportation and Health. In Proceedings of the 'Consiecticut
Conference on Transportation, Connecticut Lung Association, 1973, In pr-:-5S.
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VII. In-House Technical Reports and Inter-Agency Experience in Federal
•Government:
1. Shy, C.M.» Hairier, D.I., Goldberg, H.E., Newill, V.A. and
Nelson, W.C. Health Hazards of Environmental Lead. (To be
submitted for publication.) Revised March, 1972.
2. Love, G.J., Shy, C.M., Calafiore, D.C., Benson, F.B. and
Finklea, J.F. The Strategy for Determining the Effects of .
Environmental Pollution on Human Health.
3. Member of combined EPA-DHEW Environmental Health Task Force to
prepare a report to Congress entitled "Human Health and Environ-
mental Pollution." April-May, 1971, published in 118 Congressional
- Record S. 4169, March 17, 1972.
4. Staff member in preparation of Air Quality Criteria documents for
nitrogen oxides, carbon monoxide and photochemical oxidants.
March-September, 1970.
5. Member of EPA Health Planning Task Force to identify EPA health
• research needs in relation to legislative mandates and agency
directives, and to plan a consolidated EPA health research pro-
gram: July - November, 1971.
6. Member of EPA Task Force to revise existing air quality criteria
for sulfur oxides: May-July, 1972.
7. Assistant to Dr. Vaun Newill, Chief, Health Effects Branch, EPA
Headquarters in developing submission to the President's New
...-;.. Technology Initiatives Program, Washington, D. C., November -
December 1971. Submission was accepted and funded for FY •
. 1973-1977. .- .
.•
8. Member of Federal Inter-Agency Ad Hoc Committee on Classification
of Toxic Substances: November 1972 - present (December 1972).
9. Co-Chairman with Dr. David Rail for Project "Biological and Genetic
Effects of Pollution" as part of the US/USSR Environmental
Agreement, November 1972 - Present.
10. Submission of contract proposal "Environmental and Familial Determinants
of Respiratory Disease in Adolescents" for National Heart and Lung
' Institute, March 7-April 7, 1972; Shy, Chapman, House and DeSantis.
11. Finklea, J.F., M. J. Cranmer, D. I. Hammer, L. J. McCabe, and C. H.
Shy.- Health Intelligence for Environmental Protection: A Demanding
Challenge. . . .
12. Love, G. J., C. R. Sharp, J. F. Finklea, C. M. Shy and J. Knelson.
Atmospheric Levels of Air Pollution Producing Significant Harm,
June 13, 1972.
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-8-
13. Shy, C. M. Health Effects of Various Ambient Air Concentrations
of Lead. EPA Position Paper Developed at Request of Director,
National Environmental Research Center, RTF, N.C., October 12,
1971.
14. Shy, C. M. Health Research and Air Quality Criteria. Chapter
Written for Revision of Air Quality Criteria for Sulfur Oxides,
June 1972 (Unpublished).
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VIII. Papers Presented at Scientific and Other Public Meetings
1. The Cincinnati School Children Study. The effects of air pollution
on ventilatory performance of elementary school children. Presented
at the annual meeting of the Society for Epidenn'ologic Research,
Washington, D.C., May, 1968.
2. The determinants of the one second forced expiratory volume in an
epldemlologic study of a total community (Tecumseh, Michigan).
• Presented at the annual meeting of the American Public Health As-
sociation, Detroit, Michigan, November, 1963.
3. The Cincinnati and Chattanooga School Children Air Pollution Studies.
• . Presented at the meeting of the U.S.-Japan Cooperative Science
Group, Boston, Massachusetts, February, 1969.
4. An epidemiologic study of the effects of nitrogen dioxide exposure
on a population. Presented at the annual meeting of the Tennessee
Public Health Association, Nashville, Tennessee, October, 1959. '
5. [a) A National Health Effects Surveillance Network.
G>1 Atr Pollution and Asthma.
(c] Air Pollution and Acute Respiratory Disease.
(dj Cigarette Smoking and Epidemic Influenza. Papers presented
at the Arizona Chest Disease Symposium, Tucson, Arizona,
March, 20-22, 1970.
6. Monitoring the Health Effects of Air Pollution Control. Presented
at the Southeastern Industrial Health Conference, Gatlinburg,
. Tennessee, October 1, 1970.
7. Health Hazards of Automobile Emissions. Presented at the Mid-
Atlantic sectional meeting of the Air Pollution Control Association,
Harrisburg, Pennsylvania, October 8, 1970.
8. The Chattanooga School Children Study. Effect of Atmospheric Nitro-
gen Dioxide Exposure on the Incidence of Acute Respiratory Disease.
Presented at the 98th annual meeting of the American Public Health
Association, Houston, Texas, October 26, 1970.
9. Air Pollution and Acute Respiratory Disease. Presented at the Third
Annual New York State Conference on Air Pollution, Albany, New York,
October 29, 1970.
10. Shy, C.H. Health Hazards of Proposed Fossil Fueled Power Plant in
Astoria, Queens, New York. Citizens for Clean Air, New York, Mew
York, October, 1970.
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IL Shy, C.M. Repeat of-above. New York City CoM-.fr.on Council Hearings.
New York, New York, December, 1970.
12. Shy, C.M. Health Hazards of Carbon Monoxide. West Virginia
State Medical Society Annual Meeting, Charleston, West Virginia,
January 30, 1971..
13. Shy, C.M. Asthma and Air Pollution. West Virginia State Medical
Society Annual Meeting, Charleston, West Virginia, January 31, 1971.
14. Shy, C.M. Community Health and Environmental Surveillance S-tudies.
Colloquim for Foreign Scientist-Visitors, Duke University, January
16, 1971.
15. Shy, C.M. Briefing on Mercury, Cadmium and Lead as Hazardous
Substances. Presented to National Air Quality Criteria Advisory
Committee, Rockville, Maryland, March 18, 1971. '
•
16. Say, C.M. A Program of Co~nr.ur.fty Health and Environmental
Surveillance Studies (CHESS). Presented at the annual meeting
.of the American Chemical Society, Los Angeles, April, 1971.
17. Shy, C.M., Hammer, D.I., Hendricks, R.H., Hinners, T. and
Finklea, J.F. Hair as an Epidemiologic Tool to Quantitate
Trace Element Body Burdens. Presented at the Fifth Annual
Conference on Trace Substances and Health, Columbia, Missouri,
June, 1971.
i
18. Ftnfxlea, J.F., Cranmer, M.F., Hammer, D.I., McCabe, L.J., Nevrill,
V.A, and Shy, C.M. Health Intelligence for Environmental Protection:
A Demanding Challenge. Presented at the Sixth Berkeley Symposium
on Mathematical Statistics and Probability, Berkeley, California,
.July 19, 1971.
19. Burton, R., Norn's, C., Shy, C.M., Benson, F.B. and Heiderscheit, L.
A Community Survey of Cigarette Smoking and Alveolar Carbon Monoxide.
Presented at the 99th annual American Public Health Association,
Minneapolis, Minnesota, October 11-15, 1971.
20. Shy, C.M., Hasselblad, V., Burton, R.M., Cohen, A.A., Pravda, M.
and Deutscher, S. Is Air Pollution in New York City Associated
With Decreased'Ventilatory Function in Children. Presented at the
99th annual American Public Health Association, Minneapolis,
Minnesota, October 11-15, 1971.
21. Shy, C.M. Chairman, Symposium on Epidemioloqic Methods to Maasure
Biologic Response to Environmental Pollution. Annual fleeting of
Society for Epidemic logic P.esearch, Atlanta, Georgia, May, 1971.
22. Shy, C.M. Asthma and Air-Pollution. Presented at annual seating
of Southeastern Allergy Association, Asiieville, M.C., October, 1971.
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23. Shy, C.M. and associates. Effect of Atmospheric Particulate
Matter and Sulfur Dioxide on Yen til a tory Performance of
Children. Presented at annual ir.eeting of American College
of Chest Physicians, Philadelphia, Pa., October, 1971.
24. Shy, C.M. Health Effects of Motor Vehicle Emissions. Presented
at annual Southeastern Industrial Health Conference, Gatlinburg,
Tennessee, November, 1971.
25. Shy, C.M. Evaluation of Health Hazards of Fuels and Fuel Additives.
Presented at Annual Public Hearing on Long Range Medical Aspects of
Air Pollution, Rutgers Medical School, Piscatav/ay, New Jersey,
March, 1972. . • . ' .
26. Report on Health Consequences of Sulfur Oxides: A Report from
CHESS 1970-71 to the National Air Quality Criteria Advisory
Committee, Washington, D. C., November 16, 1972.
27. Presentation at the. EPA Research Seminar for Federal Agencies,
Washington, 0. C., -iovefnbar 20, 1972.
28. Chairman, Workshop on Multiple Factors in Disease at the New York
Academy of Sciences International Symposium on Pulmonary Reactions .
to Organic Dusts, New York, November 8, 1972.
29. Shy, C. M., et al. Effects of Air Pollution on Ventilatory Function
'' of U. S. School Children: Results of Studies in Cincinnati, Chattanc
and New York. Presented at the American Medical Association, Air
Pollution Medical Research Conference, Chicago, Illinois, October
2-3, 1972.
30. Shy, C. M. Health Consequences of Environmental Deterioration.
Presented at the Conference on the Environment, Chapel Hill, North
Carolina, December 1, 1972.
31. Shy, C. M. Testimony at Court Hearing, Tampa, Florida, April 26,
1972, Regarding Health Effects of S09 and Particulate Emissions.
4 • C* '
32. Shy, C.M. Air Pollution and Its Relation to Respiratory Disease
(CHESS).. Presented at the Scientific Session, Association of
Pediatric Pulmonary Centers, American Academy of Pediatrics, New
York, N. Y., October 14, 1972. .
33. Shy, C.M. Reported Results of the CHESS Program at Regional Meeting
of the Council on Environmental Quality, Public and Occupational
Health.of the American Medical Association, Washington, D.C.,
December 1, 1972; and v.-ith Dr. Finklea summarized EPA's health
research program to the same AMA Ccuncil, December 9, 1972.
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34. Shy, C.M. Adverse Health Effects of Transformed Products of S0?
Emissions - Resulted from CHESS Program. Presented at Weather and
Air Pollution Committee Session, American Academy of Allergy,
Washington, D. C., February 9, 1973.
35. Shy, C.M. Additional Analysis of 7-City Lead Study. Presented to
EPA's Hazardous Materials Advisory Committee, Washington, 0. C.,
February 26, 1973.
36. Shy, C.M. Air Pollution Epidemiology. Presented to Sophomore Medice
Students, Duke University Medical Center, .Durham, N. C., February 27.,
1973.
37. Shy, C.M. Briefing on CHESS Program for Science Newswriters, Washir.r
D. C., March 2, 1973. . . "
38. Shy, C.M. Effects of Low Levels of Oxi.dants and NC> Upon Humans.
•Presented at CRC Automotive Air Pollution Symposium, Washington, D. C
March 8, 1973.
39. Shy, C.M. Health Intelligence for Air Quality Standards. Presented
Meeting of the President's Air Quality Advisory Board, St. Louis, Mat,
27, 1973. . .
40. Shy, C.M. Assessing Environmental Health Effects in Populations.
Presented at Annual Meeting of N. C. Tuberculosis and Respiratory
Disease Association, Wrightsville Beach, N. C., April 13, 1973.
41. Shy, C.M. Health Effects of Environmental Contaminants. Presented
at Annual Meeting of the American Industrial Health Conference, Denvr
Colorado, April 17, 1973.
42. Shy, C.M. Transportation and Health, Presented at the Connecticut
Conference on Transportation, Hartford, Connecticut, May 16, 1973.
*s\
43. Shy, C.M. Human Health Effects of Nitrogen Dioxide Exposure: A
Review. Presented at the National Academy of Science, National
Research Council Conference on Health Effects of Air Pollutants,
October 4, 1973.
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IX. Awards and Honors
Superior Service Medal, U.S. Public Health Service, June 1971
Quality Increase (GS 14/2 to 14/3} February, 1970
Delta Omega National Honorary Public Health- Society, May 1955
Scientific Writing Award, Marquette Medical Review, June 1952
Alpha Omega Alpha National Honorary Medical Fraternity, June 1961
Second Place, Gram!ing Memorial Student Medical Essay, September 1960
2-69 12-17-76
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MARTHA LILLIAN SMITH, Survey Assistant
Professional Experience:
1973 to Date. Research Triangle Institute, Statistics Research Division
Research Triangle Park, North Carolina.
Survey Assistant on New Towns Study, National Longitudinal
Study of High School Class of 1972, Supervisor of
Microfilming Department, Survey Assistant on a Thyroid
Neoplasm Study and Study of Head and Spinal Cord Injury.
1972 to 1973. Resident Counselor, Smith College, Northampton, Mass.
Assisted Dr. Betty Spear, Chairman, University of Mass.,
Department of Women's P. E. in Developing a historical
research project for a national convention of the
American Association of Health P. E. and Recreation. ~~
President, graduate class.
1965 to 1972. Western Guilford High School, Greensboro, North Carolina,
Teacher of health, P. E., and mathematics. Coached varsity
track and field, basketball and golf. Chairman of boys
and girls P. E. Department. Chaired department's self study
for Southern Assoc. of Accredtion. Supervisor of student
teachers. Advisory Committee on Girls Athletics of the
N. C. High School Athletic Association.
1964 to 1965. Union Pines High School, Cameron, North Carolina. Teacher
of health, P. E., and government. Coached varsity and
junior varsity basketball.
Summer.
1962 to 1963. General counselor, Camp Lakeside, Hendersonville, North
Carolina.
Director of the girls camp, Camp Lakeside, Hendersonville,
North Carolina.
Head tennis counselor, Camp Ton-A-Wanda, Hendersonville,
North Carolina.
1966 & 1970. Director of programming and counseling, Camp Mountain Lake,
Hendersonville, North Carolina.
1971 & 1972. Trip director, Tripp Lake Camp, Poland Maine.
2-70 12-17-76
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Education
1957 to 1960. Diploma - Central Davidson High School, Lexington,
North Carolina.
1960 to 1964. B. S. May, 1964 - Appalachian State University, Boone,
North Carolina
" Major: Health and Physical Education
Minor: History
1958 to 1969. Graduate Work - University of North Carolina, Greensboro,
North Carolina.
Major: Physical Education
1972 to 1973. M. S. May, 1973 - Smith College, Northampton,
Massachusetts
Major: Physical Education
Thesis Topic: Survey on Women's Athletics in
Massachusetts
Contributing Work
Risk of Thyroid Neoplasms after Receiving Diagnostic Doses of
Radioactive Iodine During Childhood. Monthly Technical Progress
Reports, Research Triangle Park, N. C.: Research Triangle Institute,
September, 1974 to November, 1976. (co-author)
Followup of Patients Receiving Diagnostic Doses of 131 Iodine
During Childhood-Summary Report; Pilot Study. Research Triangle
Park, N. C.: Research Triangle Institute, February, 1975.
(co-author)
Publications
A Study of Interscholastic Athletics in the Springfield, Massachusetts
Educational Region. Martha L. Smith, Masters Thesis, Smith College,
Northampton, Massachusetts, May, 1973.
11/76
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12-17-76
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Name; Boyd Ray Switzer, Ph.D. Sex; Male Birth Date; October 3, 1943
Title; Assistant Professor in Department of Nutrition, School of Public Health
and Assistant Professor in Department of Biochemistry and Nutrition,
School of Medicine.
Social Security No; 229-60-0083 Place of Birth; Harrisonburg, Virginia
Martial Status; Janie J. Switzer, wife. No. of Children; 2
Education
Degree and
Institution Discipline Year Conferred
Bridgewater College Chemistry B.A. (cum laude)
Bridgewater, Virginia 1965
University of North Carolina Biochemistry Ph.D. 1971
Chapel Hill, North Carolina _
Professional Experience
June to September 1964 National Science Foundation Undergraduate Research
Participant, University of Tennessee, Knoxville,
Tennessee. This work resulted in a publication in
J. Am. Chem. Soc. 87:4477, 1965.
Sept. 1965-Sept. 1968 National Institutes of Health (NIH) Research Trainee.
University of North Carolina at Chapel Hill.
Sept. 1968-Aug. 1970 NIH Predoctoral Fellow. University of North Carolina
at Chapel Hill.
Aug. 1970-April 1971 Postdoctoral Research Assistant. University of North
Carolina at Chapel Hill.
April 1971-Sept. 1971 NIH Postdoctoral Fellow. University of North Carolina
at Chapel Hill.
Sept. 1971-July, 1972 NIH Postdoctoral Fellow. University of Southern Cali-
fornia, Los Angeles, California.
July 1972-Present Assistant Professor, Department of Nutrition.
Dec., 1972-Present Assistant Professor, Joint Appointee in the Department
of Biochemistry and Nutrition.
Membership in Organizations
American Chemical Society
American Association for the Advancement of Science
The Lambda Society at Bridgewater College
2-72 12-17-76
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Major Research Activities
Study of Collagen Biosynthesis in Human Skin Fibroblasts in Tissue Culture.
June 1966 to August 1970.
Ornithine Transcarbamylase: Mode of Fluoride Inhibition. Aug. 1970 to July
1972.
Nutritional Evaluation of the Focus on Optimal Development (F.O.O.D.) Project
in Durham Public Schools (biochemical component). May to June 1973.
Diet-Hormone Interaction with Emphasis on the Role of Insulin and Glucagon
(collaborative study with Dr. J.C. Edozien). July 1972 to present.
Medical Evaluation of the Special Supplemental Food Program for Women, Infants
and Children (WIC). Director of Biochemistry Laboratory. July 1973 to present.
Presentations
Annual Meeting of the American Society of Biological Chemists, San Francisco,
California, June 16, 1971.
Annual Meeting of the Tissue Culture Association, Lake Placid, New York, June 7,
1971.
Annual Meeting of the North Carolina Academy of Sciences, Wilmington, North
Carolina, May 3, 1969.
Annual Meeting of the Federation of American Societies for Experimental Biology,
Atlantic City, April 9, 1974.
Teaching Experience
The University of North Carolina 1972-present.•
1. NUTR 200, Cell Biology (lecture) and NUTR 201 Cell Biology Laboratory
taught jointly with Dr. John J.B. Anderson.
2. NUTR 202, Nutritional Biochemistry taught jointly with Dr. J.C. Edozien
and Dr. John J.B. Anderson.
3. Faculty member of 1973 Summer Program in Health Sciences sponsored by
North Carolina Health Manpower Development Program.
4. BIOC 8, Biochemistry for Dental Hygiene Students, taught jointly by
several faculty members.
5. BIOC 226, Biochemical Regulations, taught jointly by several faculty
members.
Research advisor for 1 or 2 students and have not directed any masters or
doctoral dissertation research previously.
2-73
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Special Assignments
Self-study Report of the Department of Nutrition, 1972.
Self-study Report of the School of Public Health, 1972.
Task Force Report for the Research and Development Board of the North Carolina
Public Health Association, March to August 1973.
Member of the Vitamin A Panel of the Institute of Nutrition, Jan. 1973 to
present.
Chairman of Doctoral Advisory Committee in the Department of Nutrition, 1974
to present.
Chairman of M.P.H. Comprehensive Examination Committee in the Department of
Nutrition, October 1974 to present.
Chairman of the Fellowship and Traineeship Committee, School of Public Health,
1974-75.
Member of the Safety Committee, School of Public Health, 1974-75.
Member of the Board of Scientific Directors, Institute of Nutrition, Feb. 1975
to present.
2-74 12-17-76
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Boyd Ray Switzer, Ph.D.
BIBLIOGRAPHY
1.• Bowman, N.S., Rice, D.E., and Switzer, B.R. Magnetic Nonequivalence in
Derivative of a-Hydroxy Acids. J. Am. Chem. Soc. 89:4477, 1965.
2. Switzer, B.R., Waters, M.D., and Summer, G.K. Studies on Regulation of
Alkaline Phosphatase Activity and Collagen Biosynthesis in Human Skin
Fibroblasts (abstract). Fed. Proc. 28:901. 1969.
3. Switzer, B.R., Summer, G.K., and Waters, M.D. Protein Biosynthesis in
Mammaliam Cell Cultures (abstract). J. Elisha Mitchell Society 85:115,
1969.
4. Switzer, B.R. and Summer, G.K. Improved Method for Hydroxyproline Analysis
in Tissue Hydrolysates. Anal. Biochem. 39:487, 1971.
5. Switzer, B.R. and Summer, G.K. A Modified Fluorometric Micromethods for
DNA. Clin. Chim.__Acta. 32:203, 1971.
6. Switzer, B.R. Studies on Collagen Biosynthesis in Human Skin Fibroblasts.
Dissertation, 1971.
7. Switzer, B.R. and Summer, G.K. Effect of Ascorbate and Medium Change on
Human Fibroblasts in Culture (abstract). In Vitro 6:383, 1971.
8. Switzer, B.R. and Summer, G.K. Studies on Collagen Biosynthesis in Human
Skin Fibroblasts (abstract). Fed. Proc. 30:1195, 1971.
9. Switzer, B.R. and Summer, G.K. Collagen Synthesis in Human Skin Fibro-
-blasts. Effect of Ascorbate, ot-Ketoglutarate and Ferrous Ion on Proline
Hydroxylation. J. Nutrition 102:721, 1972.
10. ~Switzer, B.R. and Summer, G.K. Inhibition of Collagen Synthesis by ct,a'-
Dipyridyl in Human Skin Fibroblasts in Culture. In Vitro 9:160, 1973.
11. Waters, M.D., Summer, G.K., Switzer, B.R., Moore, R.D. and Heitkamp, D.H.
Alkaline Phosphatase Activation and Collagen Synthesis in Human Skin
Fibroblasts in Culture. Exptl. Cell Res. 80:170, 1973.
12. Switzer, B.R., Zand, T., Niehaus, N.J., and Edozien, J.C. Effect of Diet
on Fasting Plasma Immunoreactive Insulin (abstract). Fed. Proc. 33:669,
1974.
13. Edozien, J.C., Niehaus, N.J. and Switzer, B.R. Effect of Diet on Fasting
Plasma Catecholamines in Rat (abstract). Fed. Proc. 34:881, 1975.
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THOMAS G. VIRAG, SR., Senior Survey Specialist
Professional Experience
1969 to date. Research Triangle Institute, Research Triangle Park, North
Carolina 27709. Senior Survey Specialist in the Survey Operations Center
of the Statistical Sciences Group. Planning, organizing, and supervising
the collection and analysis of survey data for a variety of research projects.
Participation in a list of selected Research Triangle Institute projects is
shown below.
1975 - 1976: National Study to Determine the Incidence, Prevalence, and
Costs of Head and Spinal Cord Injuries — Project Leader for a large
data collection effort involving approximately 300 hospitals yielding
9,000 medical record abstractions, 3,000 patient tracing cases, and
1,000 personal health cost interviews using a field staff of 52 site
administrators.
1975 - 1976: Follow-Back Study of Children Receiving Diagnostic Doses
of Radioactive Iodine Over the Period 1946 - 1960 — Provided management
support for the project involving data collection efforts in approximately
10 medical centers in the United States; approximately 1,500 medical record
abstractions were completed with subsequent tracing operations conducted
with the identified patient population.
1975 - 1976: Evaluation of Hospital Discharge Survey — Provide manage-
ment support for project activity of survey specialists to review current
design of the Hospital Discharge Survey (HDS) to develop and test alternative
data collection procedures, and to offer recommendations for the continua-
tion of the HDS.
1974 - 1975: National Survey to Evaluate the Organization of Fire Service
Delivery — Project Leader for data collection effort involving mail,
telephone, and in-person survey techniques. Questionnaires administered
to fire chiefs, city managers, and building inspectors approximately 1,300,
400, and 500 completed questionnaires respectively. In-person interviews
completed with a staff of approximately 50 field interviewers.
1974 - 1975: Pilot Study to Establish Protocol for the Conduct of the
National Study to Determine Incidence, Prevalence, and Costs of Head and
Spinal Cord Injuries — Project Leader for a large-scale pilot study in
eight geographic areas to test data collection methodology to design a
cost-effective and feasible protocol for a national study. Involved
contacting office-based physicians, hospitals, nursing homes, and other
providers of health care/treatment to test data collection procedures
utilizing a field staff of 23 individuals.
1973 - 1974: Senior Survey Specialist, National Assessment of Educational
Progress Administration Department, Statistics Research Division. Field
Director for Out-of-School Assessment. Responsible for nationwide field
staff of 13 full-time supervisors and over 100 part-time interviewers.
Develop and conduct training programs for field staff; formulate all
field procedures; and coordinate data check-in and Verification, assess-
ment scheduling, and budgeting.
2-76 12-17-76
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1970 - 1973: Survey Specialist, Survey Group of Statistics Research
Division. Southeast Regional Supervisor, Northeast Regional Supervisor,
and Eastern United States Field Coordinator. As a Regional Supervisor,
responsible for supervising District Supervisors, each responsible for
completing the assessment in one to three states. Hiring, training, and
maintaining a field staff to work with the schools involved, etc. As Field
Coordinator, responsible for two Regional Supervisors and their staff of 15
District Supervisors.
1971 - 1972: Survey Specialist, Survey Group of Statistics Research
Division. Survey of Practicing Physicians at six sites across the United
States. Served as Field Director and was responsible for pretesting sur-
vey questionnaire, assisted in questionnaire development, prepared training
materials, trained and supervised the data collection at one of the sites.
1966 to 1969. California Area Schools, California, Pennsylvania. Teacher-
principal, supervising student teachers, and directing pilot school research
study in the area of modern mathematics.
1964 to 1966. Gateway Union Schools, Monroeville, Pennsylvania. Teacher,
self-contained classroom.
Education
B.S., Education, California State College, California, Pennsylvania, 1964.
M.S., Education, California State College, California, Pennsylvania, 1969.
Professional Activities
National Education Association, 1964 - 1967.
Selected Publications
"A Study to Determine Factors Physicians Take Into Consideration in Deciding
Whether to Accept Assignment, Billing Arrangements Physicians Make to Cope with
the Deductible and Co-Insurance Features of Reimbursement, and the Nature of
These Billing Practices—Volume I: Study Design and Pilot Survey," J.T. Wakeley,
W.C. Eckerman, R.E. Mason, and T.G. Virag, August, 1972.
"Working Paper No. 1—Pilot Study Protocol for the Head and Spinal Cord Injury
Project," W.D. Kalsbeek, T.G. Virag, K.D. Nash, and J. Lessler, Research
Triangle Institute, January, 1975.
"Qut-of-School Field Operations and Data Collection Activities—National
Assessment of Educational Progress for the Period of January 1, 1974 -
September 30, 1974," W.K. Grogan and T.G. Virag, Research Triangle Institute,
July, 1975.
"Evaluating the Organization of Service Delivery: Fire—Final Report Data
Collection Operations," T.G. Virag, Research Triangle Institute, September, 1975.
March, 1976
2-77 12-17-76
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APPENDIX 2.2
TENTATIVE TRAINING MANUAL OUTLINE
2-78 12-17-76
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1.0 Introduction
1.1 Research Triangle Institute (RTI)
1.2 Environmental Protection Agency
1.3 Background: Related and Previous Studies
1.4 Study Objectives
1.5 RTI Project Staff and Structure
1.6 Project Timetable
2.0 Preparations for Field Operations
2.1 Involvement of Other Agencies
2.2 News Releases
3.0 Overview of Field Operations
3.1 Introduction and Purpose
3.2 Sampling Considerations
3.3 Survey Instruments
3.4 Household Data Collection
3.5 Confidentiality
3.6 Quality Control
3.7 Supplies Required for Conduct of Field Work
3.8 Disposition of Supplies
4.0 Household Contact and Data Collection
4.1 Preparation
4.2 Screening
4.2.1 Assignment of Field Staff
4.2.2 Sampling Considerations
4.2.3 Explaining the Study ..
2-79 12-17-76
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4.2.4 Household Screening Questionnaire
4.2.5 Household Eligibility
4.2.6 Household Screening Log
4.2.7 Problems
4.2.7.1 Nonrespondents
4.2.7.2 Nonparticipants
4.2.7.3 Ineligibles
4.3 Household Data Collection
4.3.1 Participant Consent Form
4.3.2 Study Questionnaire
4.3.3 Sample Collection
4.3.3.1 Household
Soil (Pre-school age only)
. Tap Water
House Dust
4.3.3.2 Individual
. Urine
Scalp Hair
. Blood
4.3.4 Incentive
4.,3.5 Liaison with Central Data Collection Facility
4.3.6 Quality Control
4.3.6.1 Labels
4.3.6.2 Duplicate Samples
4.3.6.3 Reinterview
2-80 12-17-76
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4.3.7 Problems
4.3.7.1 Refusals
4.3.7.2 Incomplete Data Sets
4.3.7.3 Transportation for Participants to Central
Data Collection Facility
4.4 Survey Instruments: Administration
4.4.1 Household Screening Questionnaire
4.4.2 Participant Consent Form
4.4.3 Study Questionnaire
4.4.3.1 Household Information
4.4.3.2 Individual Information
4.4.3.3 Interviewer/Respondent Information
4.4.3.4 Sample Information
4.5 Sample Collection Methodology
4.5.1 Soil
4.5.2 Tap Water
4.5.3 House Dust
4.5.4 Urine
4.5.5 Scalp Hair
4.5.6 Blood
4.6 Central Data Collection
4.6.1 Overview
4.6.2 Scalp Hair Sample
4.6.3 Blood Sample
4.6.4 Hematocrit
4.6.5 Urine Sample
4.6.6 Quality Control: Duplicate Samples
4.6.7 Problems
2-81 12-17-76
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4.6.7.1 Incomplete Data Sets
4.6.7.2 Adverse Participant Reaction
4.7 Work Schedule
5.0 Administrative Procedures
•
5.1 Reporting
5.1.1 Household Screening Log
5.1.2 Production, Time and Expense Reporting
5.2 Contacts
5.2.1 RTI Staff
5.2.2 Site Administrator
5.2.3 Central Data Collection Facility
5.2.4 Local Consultants and Agencies
5.3 Special Problems
6.0 Data Receipt Control and Entry (RTI Staff and Site
Administrator(s) Only)
6.1 Survey Instruments
6.1.1 Household Screening Questionnaire
6.1.1.1 Receipt
6.1.1.2 Batching
6.1.1.3 Scan-Edit
6.1.1.4 Direct Data Entry
6.1.2 Household Screening Log
6.1.2.1 Receipt
6.1.2.2 Batching
6.1.2.3 Scan-Edit
6.1.2.4 Direct Data Entry
2-82 12-17-76
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6.1.3 Participant Consent Form
6.1.3.1 Receipt
6.1.3.2 Batching
6.1.3.3 Scan-Edit
6.1.4 Study Questionnaire
6.1.4.1 Receipt
6.1.4.2 Batching
6.1.4.3 Scan-Edit
6.1.4.4 Direct Data Entry
6.2 Results of Chemical Analysis
6.2.1 Receipt
6.2.2 Batching
6.2.3 Scan-Edit
6.2.4 Direct Data Entry
6.3 Quality Control
6.3.1 Scan-Edit
6.3.1.1 Visual
6.3.1.2 Direct Data Entry
6.3.2 Re-keying
6.3.3 Reinterview
6.3.3.1 Household Screening Questionnaire
6.3.3.2 Study Questionnaire
2-83 12-17-76
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7.0 Site Administrator Responsibilities (RTI Staff and
Site Administrator(s) Only)
7.1 Coordination of Field Operations
7.1.1 Training Sessions
7.1.2 Local Agencies
7.1.3 Independent Subcontractors
7.1.4 On-Site Consultants
7.1.5 Field Supervisors
7.1.6 Central Data Collection Facility
7.2 Sample Collection
7.2.1 Air
7.2.2 Soil
7.3 Data Management and Shipment
7.3.1 Survey Instruments
7.3.1.1 Household Screening Questionnaires
7.3.1.2 Household Screening Logs
7.3.1.3 Participant Consent Forms
7.3.1.4 Study Questionnaires
7.3.1.5 Independent Subcontractors' Production, Time
and Expense Reports
7.3.2 Environmental Samples
7.3.2.1 Air
7.3.2.2 Soil
7.3.2.3 Tap Water
7.3.2.4 Housedust
2-84 12-17-76
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7.3.3 Biological Samples
7.3 .'3.1 Urine
7.3.3.2 Scalp Hair
7.3.3.3 Blood
7.4 Special Problems
APPENDIX: Glossary of Terms
2-85 12-17-76
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APPENDIX 2.3
SURVEY INSTRUMENTS
2-86 12-17-76
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RESEARCH TRIANGLE INSTITUTE
OMB No.
Approval Expires
STUDY OF HUMAN TISSUE HEAVY METAL BURDEN IN
NON-FERROUS SMELTER COMMUNITIES
HOUSEHOLD SCREENING LOG
Site Number
Segment Number
Interviewer Number
Date
Day of Week
(Month)
(Day) (Year)
Household
Number
Street Address
Eligible
Household
Member(s)
Yes
No
Member(s)
Agree (s) to
Participate
Yes-
No
Number
of
Participants
•
•
Reason (s) for Nonparticipation, Nonresponse, or
Ineligibility
-------
QMS NO.
Approval ExpirtS
RESEARCH TRIANGLE INSTITUTE
STUDY OF HUMAN TISSUE HEAVY METAL BURDEN IN
NON-FERROUS SMELTER COMMUNITIES
NOTICE: All information recorded on this doeumtnt which would permit identification of en individual will be held in
nrict confidence, will be toed only by penora engaged in or for the purposes rated for this nudy. end will not be
disclosed or released to other persons or used for eny other purpose without the consent of the individual.
HOUSEHOLD SCREENING QUESTIONNAIRE
I. Site Number | | 2. Segment Number | - | | 3. Interviewer Number
4. Household Number | | | | 5. Date [ | | ~ | | | ~ | | |
IMonthl (Deri lYarl
B. What is the exact address of this residence?
(Street Number and Namel
(Aoermetn Number!
(Off) (Stetel
7. a. Do you have a telephone? | 1 ! Yes IGo to Question 7bl \ * I No (Go to Question 7cl
b. If yes. what is the number?
(Zip Code)
cm-cm-mo:
(Ana Codal
c. If no. what is the number of the nearest telephone? I I I I ~ [ | | | ~ I I I I I
(Ant Code)
\ 1 I Do not know
B. How many persons reside at this address? | [ |
9. For each person in your household, including yourself, pleese indicate the age. tairthdata, sex, length of residence at this address
and in this community, occupation, and relationship to you. beginning with the oldest and proceeding to the youngest:
Household
Member
Number
01
02
03
04
05
06
07
08
09
10
Age
(Years)
Birthdete
onth
Day
Year
Sax
Length of Residence
At this
Address
Un
ts
MP.
orY
In th
Commu
Units
s
nlty
M,0.
crY
Occupation*!)
During Past
12 Month!
Relationship
to
Respondent
Participant
Number
10. a. Has anyone in your household worked at the smelter at any time during the past 12 months?
| ' I Yes (Go to Question tOb) \ a [ No | 3 I Oo not know
b. If yes, indicate relationship to respondent.
and household member number(s) from question 9
If it is apparent that the household contains no persons eligible to participate in this study, thank the respondent and
proceed to the next household. However, if persons in the household appear to be eligible to participate in this study.
continue to question 11.
11. Would you participate in a health nudy as a paid volunteer? ( 1 > Yes 2 j No
12. In your opinion, would other members of your household participate in a health survey as a paid volunteer?
| 1 | Yes. all | 2 | Yes, some | 3 | No I e \ Do not know
-------
OMB No.
Approval Expires
RESEARCH TRIANGLE INSTITUTE
STUDY OF HUMAN TISSUE HEAVY METAL BURDEN IN
NON-FERROUS SMELTER COMMUNITIES
PARTICIPANT CONSENT FORM
I understand that the Research Triangle Institute is engaged in a study of heavy metal (arsenic, cadmium, copper, lead,
manganese, and zinc) absorption by persons living in communities near non-ferrous smelters. I understand that this survey is being
conducted because increased amounts of heavy metal absorption have recently been discovered among persons living near smelters in
the United States, particularly in young children. I understand that the survey is being conducted in order to measure the health
effect(s), if any, of heavy metal absorption by persons living in communities near non-ferrous smelters, and is limited to the purpose
stated. I further understand that the survey is being conducted under the auspices of the United States Environmental Protection
Agency in cooperation with the Center for Disease Control of the United States Public Health Service and the
(State and local health departments) :
I do hereby freely consent to participate in this study of heavy metal absorption and understand that my participation will
consist of providing answers to a questionnaire related to heavy metal exposure and the following environmental and biological
samples: (1) a four ounce sample of cold tap water from a source commonly used for drinking and cooking, (2) a sample of
housedust from a small area (0.25m3) on the surface of the living room floor using a small vacuum device, (3) a small (approximately
four ounces) early morning urine sample, (4) a small sample of scalp hair, and (5) a small (approximately 10 cc) blood sample to be
taken from an arm vein. I understand that a four ounce composite sample of surface soil will be taken from the play area(s) of each
pre-school child participant and that in some small children the blood sample may be obtained from a finger or heel. I understand
that an agent of the Research Triangle Institute will administer the questionnaire in my home and at the same time collect the tap
water, housedust, and soil samples. I further understand that I am to deliver my urine specimen to
(Address of designated central data collection facility)
on (Day of week) , (Date) at (Time) a.m./p.m.
where an agent of the Research Triangle Institute will obtain the scalp hair and blood samples and where I will receive an incentive of
ten dollars for my full participation in this study. I understand that a small number of households and individuals will be selected for
the collection of duplicate soil, tap water, housedust, scalp hair, and blood samples and reinterview, but that such selection would
not entitle me to further compensation.
I understand that a report of my test results will be sent to the State and local health authorities. In addition, I would/
would not like a copy of this report sent to my family physician, Dr".
Address: ;
If important facts about my personal health should be found in the course of the study, I will be provided that information, and I
also would/would not like a copy of that information sent to my personal physician. I understand, however, that my name will not
otherwise be voluntarily disclosed, that all information collected in this study will be compiled into a general summary which will be
strictly confidential, and that my name will not be referred to in any way when compiling and evaluating the results of the study.
I understand that participation in this study may result in no direct benefits to me, other than those described herein, and that I
am free to withdraw from this study at any time. It has been explained to me that there are no significant risks to me from
participation in this study. I further understand that while participating in the study I will be free to ask any questions concerning
the study; if I have any further questions about the project, I know that I am free to contact
(Local health department representative) telephone number or
(State health department representative) telephone number
or Mr. Benjamin S. H. Harris, III, Survey Operations Center, Research Triangle Institute, Research Triangle Park, North Carolina
. 27709, telephone number 919-549-8311, extension 2700.
Participant's Name (Print)
Date ,
~T~—:. ' ' , ' ~~—, Participant Number
(Month) (Day) (Year)
Site Number Segment Number Household Number
Signatures:
Witness:
Participant
Parent, guardian, or other Interviewer Number
legal representative of
participant*
'If the participant is a minor (under 18 years of age), this consent form must be signed by the parent or legal guardian.
-------
OMB No.
Approval Expires
STUDY OF HUMAN TISSUE HEAVY METAL BURDEN IN
NON-FERROUS SMELTER COMMUNITIES
Sponsored by:
Health Effects Research Laboratory
Environmental Protection Agency
Research Triangle Park, North Carolina 27711
Conducted by:
Research Triangle Institute
P.O.Box 12194
Research Triangle Park, North Carolina 27709
QUESTIONNAIRE
THE RESEARCH TRIANGLE INSTITUTE OF RESEARCH TRIANGLE PARK, NORTH CAROLINA
IS UNDERTAKING A RESEARCH STUDY FOR THE U.S. ENVIRONMENTAL PROTECTION
AGENCY OF THE HEALTH EFFECTS, IF ANY, OF HEAVY METAL ABSORPTION BY PERSONS
LIVING IN COMMUNITIES NEAR NON-FERROUS SMELTERS. WE WILL BE ASKING SEVERAL
QUESTIONS ABOUT YOU AND YOUR FAMILY. YOUR COOPERATION, ALTHOUGH ENTIRELY
VOLUNTARY, IS ESSENTIAL TO ASSURE THE SUCCESS OF THIS STUDY.
IMPORTANT
ALL INFORMATION RECORDED ON THIS DOCUMENT WHICH WOULD PERMIT
IDENTIFICATION OF AN INDIVIDUAL WILL BE HELD STRICTLY CONFIDENTIAL, WILL BE
USED ONLY BY.PERSONS ENGAGED IN OR FOR THE PURPOSES OF THIS RESEARCH STUDY,
AND WILL NOT BE DISCLOSED OR RELEASED TO OTHER PERSONS OR BE USED FOR ANY
OTHER PURPOSE.
Study Number
Site Number
Segment Number
Household Number
Participant Number
-------
A. HOUSEHOLD INFORMATION
1. For each person in your household, including yourself, please indicate age and educational level, beginning with the oldest and
proceeding to the youngest (enter responses in matrix below):
Household
Member
Number
01
02
03
04
05
06
07
08
09
10
Age
(Years)
Educa-
tional
Level
(Years)
Currently
Employed at
Smelter
1 = Yes 2 = No
Normally
Spend Day
at Home
1 = Yes 2 = No
Excess Metal Absorption
Screened
Diagnosed
Partici-
pant
Number
2. Does anyone in your household currently work at the smelter? (Enter responses in matrix above.)
3. Which members of your household normally spend their day at home? (Enter responses in matrix above.)
4. Has anyone in your household ever been screened for excess heavy metal absorption?
Yes
No
3 Do not know (Enter response in matrix above.)
5. Has any member of your household ever been diagnosed as having excess heavy metal absorption?
1 Yes
No
3 Do not know (Enter response in matrix above.)
6. Male head of household:
a. Household member number:
b. Occupation
c. Highest educational level completed:
| 1 | 8th grade or less [ 4 | College - incomplete
7 Technical school beyond high school
2 High school - incomplete
College graduate
3 High school graduate
7. Female head of household:
a. Household member number:
6 Graduate school
8 Do not know
9 Other (Specify)
b. Occupation
c. Highest educational level completed:
8th grade or less
College - incomplete
2 High school - incomplete 5 College graduate
3 High school graduate
Graduate school
Technical school beyond high school
8 Do not know
9 Other (Specify)
-2-
-------
8. What is the approximate age of your house?
Years
1 Do not know
9. What type of structure is your house? (51 percent or more of exterior surface.)
I 7 I Wood frame
Solid brick, concrete, or rock
Brick or rock veneer
Asbestos
Aluminum siding
8 Do not know
3 Stucco
6 Composition siding
10. Is there evidence of flaking paint present in the home?
Yes
9 Other (Specify)
No
11. Are paint chips present in the soil surrounding the home? II Yes
No
Do not know
12. Do you cool your home with any of the following appliances? (Check all that apply.)
Central air conditioning
Window fan(s)
None of these
2 Window air conditioner(s)
3 Evaporative cooler(s)
5 Ceiling exhaust fan(s) 8 Do not know
6 Circulating fan(s)
9 Other (Specify)
13. Are any of the following articles used in storing, preparing, and/or serving food in your household? (Check all that apply.)
Unglazed pottery (home-made or craft)
1
None of these
Glazed pottery (home-made or craft)
Do not know
3 Hand-painted flatware
14. Does your household grow any of its own food in a home garden? | 1 | Yes | 2 | No
15. Where does your household obtain fresh fruit and/or vegetables? (Specify)
16. What is the primary source of your water for drinking?
I 1 | Bottled water
Tap - community well 5 Tap - cistern
3 I Do not know
2 I Tap - municipal supply 4 Tap - private well
17. What is the primary source of your water for cooking?
6 Do not know
7 Other (Specify)
Bottled water
2 Tap - municipal supply
Tap - community well
Tap - private well
Tap - cistern
6 Do not know
Other (Specify)
18. Has anyone in your family ever been treated for:
No Yes Relationship to respondent and/or household member number:
I 1
a. Seizures?
b. Hyperactivity?
c. Mental retardation?
I.
1
1
2
2
2
(Specify)
(Specify)
(Specify)
-3-
-------
B. PARTICIPANT INFORMATION
IF THE PARTICIPANT IS UNDER 18 YEARS OF AGE, THIS SECTION OF THE QUESTIONNAIRE MAY HAVE
TO BE ADMINISTERED IN WHOLE OR IN PART TO THE PARENT OR GUARDIAN, AND MUST BE
ADMINISTERED IN THAT PERSON'S PRESENCE. IF THE PARTICIPANT SUFFERS FROM A SPEECH OR
HEARING DEFICIT, THIS SECTION OF THE QUESTIONNAIRE MAY HAVE TO BE ADMINISTERED TO THE
SPOUSE OR ANOTHER SPOKESMAN-SEE SECTION C.
First, I would like to ask some general questions about you/the participant.
1. Sex (by observation):
Male 2 Female
2. Race (by observation):
3 American Indian
6 Unknown
White
Asiatic
Other
(Specify).
Black
Spanish
surname
3. What was your/the participant's age in years at last birthday?
Years
4. What is your/the participant's birth date?
(Month) (Day) (Year)
5. What is your/the participant's approximate weight in
pounds?
6. What is your/the participant's marital status?
1
Married 2 Never married 3 Widowed
Divorced 5 Separated
6 Other (Specify).
Next, I would like to ask some questions about your/the participant's education.
7. Are you/is the participant in school now?
Yes (Go to question 8)
No (Go to question J1)
8. What type of school do you/does the
participant attend?
1
Nursery school or kindergarten (Go to question 10)
Elementary school
Junior high school
Senior high school
(Go to question 9)
9. What grade are you/is the participant in?
10. What is the address of the school?—
(Continue)
(Street)
11. Highest educational level completed:
None
8th grade or less
High school - incomplete
High school graduate
College - incomplete
College graduate
Junior college
College
Graduate school
Technical school
Other
(Specify)
(Go to question 12)
(Go to question 12)
(City)
Graduate school
8 Technical school beyond high school
Other (Specify)
-------
Next, I would like to ask some questions about your/the participant's occupation and residence.
12. Are you/is the participant presently employed in any capacity?
Yes (Go to question 14)
No (Co to question 13)
13. If not presently employed, which of the following best describes your/the participant's status?
1 Housewife 4 Unemployed
(Go to question 20)
Student 5 Retired (Go to question 15)
Child (Go to question 23)
Disabled
14. If presently employed, which of the following best describes your/the participant's status?
3 Employed part-time
Self-employed
Employed full-time
15. What is/was your/the participant's usual occupation? (Specify)
16. Are you/is the participant presently employed in this occupation?
Yes
2 No
17. If yes to above question, how many years have you/has the participant been employed in that occupation?
If no to above question, how many years were you/was the participant employed in that occupation?
18. If you are/the participant is presently employed, what is the nature of the company for which you/the participant worlds)?
(Specify) '.
19. How long have you/has the participant been employed by your/the participant's present employer?
Units
Months
Years
20. How many times have you/has the participant changed occupations during the past 5 years?
21. Does your/the participant's occupation usually take-you/the participant away from home?
22. Have you/has the participant worked at a smelter at any time during the past 12 months?
Yes
No
Yes (STOP!)
No (Continue)
23. Have you/has the participant ever worked at or lived within 2 miles of:
Worked at
Yes No
1
1
a. Paper/wood industry
b. Smelting industries
c. Glass manufacturing plant ll
d. Pesticide manufacturing plant [ 1 |
Lived near
Yes No
2
1
1
e. Mining area
1
Hours
24. How many hours of the day, on the average, do you/does the participant normally spend away from home?
25. How many hours of the day, on the average, do you/does the participant normally spend more than 2 miles from home?
Years (If less than 1 year, STOP!
Hours
26. How many years have you/has the participant lived in this city or town?
27. How long have you /has the participant lived at this address?
Units
Days
2
Months
3
Years
28. How many times have you/has the participant changed living quarters during the last 5 years?
-5-
-------
Next, I would like to ask some questions regarding your/the participant's personal habits.
29. What is the natural color of your/the participant's scalp hair?
0
Brown
Black
Red
Blonde
Gray
Bald
Other (Specify)
30. How many times per week, on the average, do you/does the participant shampoo your/the participant's hair?
31. Which of the following hair care products do you/does the participant use? (Check all that apply and specify the most frequently
Brand Brand
used brand.)
Washing (Shampoo or soap)
Setting .lotion
Artificial coloring
5 Permanent
Last application date (Month) (Day)
(Year)
Hair spray
32. Do you/does the participant use any foot powder or toenail polishes?
If yes, specify brand(s)
Yes
No
33. Do you/does the participant drink? (Check all that apply and indicate amount.)
How much/week?
j_)J Beer
2 Wine
None of these
Other alcoholic beverage (Specify)
3 Liquor
34. Have you/has the participant ever smoked as many as 5 packs of cigarettes—that is, as many as 100 cigarettes during your/the
participant's entire life?
1
Yes (Co to question 35)
No (Go to question 39)
35. Do you/does the participant now smoke cigarettes?
Yes
No
36. How old were you/was the participant when you/the participant first started smoking?
Years
37. If you/the participant no longer smoke(s), how old were you/was the participant when you/the participant last gave up smoking?
Years
38. On the average, how many cigarettes do (did) you/does (did) the participant smoke per day?
Less than '/» pack (1-5 cigarettes)
2 About V4 pack (6-14 cigarettes)
About 1 '/> packs (26-34 cigarettes)
5 About 2 packs (35 or more cigarettes)
About 1 pack (15-25 cigarettes)
39. What is the average number of hours that you/the participant spend(s) out of doors each day?
Hours
40. Do you/does the participant ever eat non-food substances such as paint, clay, dirt, or plaster? 1 Yes
2 No
-------
41. (For children participants only) Where does the participant play most frequently? (Check one.)
At home indoors
At home outdoors
0
On the same block indoors | 5 | On a different block indoors
On the same block outdoors 6 On a different block outdoors
Other (Specify)
Next, I would like to ask some questions regarding your/the participant's health.
42. What do you consider the current status of your/the participant's health?
1 Excellent 2
Good 3 F
43. Are you/is the participant currently taking any
0 None
1 Tranquilizer
2 Sedative
44. Do you/does the participar
a. . Loss of appetite
b. Weight loss
c. Fatigue
d. Nausea and/or
vomiting
e. Diarrhea
f. Abdominal pain
g. Sore throat
3
4
5
Analgesic
Hormone
Oral contracep
air I 4 [ Poor
prescription medication(s) on a regular daily basis? (Check all that apply.)
6 Antibiotics (Specify)
7 Oth°r (SpTify)
t suffer from any of the following symptoms?
If yes, specify If yes, specify
Yes No how long Yes No how long
1
I
1
1
1
1
1
2
[7]
2
2
0
s
I 2 I
h. Cough | 1 |
i. Changes in skin pigmentation | 1 j |
j. White lines across fingernails Mil
k. Pins and needles, numbness or -
I Weakness or wasting of the
muscles of the limbs
r» •
m. ram or soreness of the ™
mouth, nose, or eyes 1
2
2 I
2 |
2
2
2
Next, I would like to ask some questions regarding your/the participant's diet.
45. Which meal(s) do you/does the participant usually eat at home? (Check all that apply.)
I 1 I Breakfast | 2 | Lunch | 3 [ Dinner
46. When you do not/the participant does not eat at home, where do you /does the participant eat? (Check all that apply.)
School
1
Meal prepared at home but eaten elsewhere
3 Work
Restaurant
5 Other (Specify)
47. Are you/is the participant presently following any of the following dietary regimens? (Check all that apply.)
0
Formula/prepared baby foods
2 Bland food ulcer diet
Diabetic diet
Reducing diet
Organic foods
Vegetarian
None of these
Other (Specify)
•7-
-------
48. On the average, how often do you/does the participant eat the following foods? (Check the appropriate box.)
Foodstuff
a. Shellfish
b. Fish
c. Liver
d. Kidney
e. Hamburger
f. Eggs
g. Milk
Canned Foods:
h. Tomatoes
i. Beans
j. Peas
k. Peaches
0)
u
c
o
CD
S CD
o §
:> a
1
CO
flj
c
o
o "5
A CD
< §
2
$
0)
..
3 CD
< CN
3
CO
o
XI O
< E
4
CD
S
c
a
W C
3 o
5
S
z
6
Foodstuff
Baby Foods:
I. Oranqe juice
m. Apple juice
n. Applesauce
o. Peaches
p. Spinach
q. Mixed vegetables
r. Beef
«
c
o
a
*•* -X
£ S
I5
«£ CO
1
S
c
o
^
0 "^
^ 0)
< S
2
>
>
?,
c
O «!
*J ^
0 9
3 s
-------
COMMENTS
-9-
-------
^BE
D. SAMPLE INFORMATION
For each . sample collected for a given household or
individual, attach the appropriate label to the appropriate
container before collecting the sample. Complete section D
below when appropriate.
'
e/j
ta
a
Q
<:
— =-
§
^
m
: 1_
CO
I
I
D
D
Study Number
1. Site Number
2. Segment Number
3. Household Number
4. Participant Number
5.
6.
7.
8.
9.
10.
Type of
Sample
Soil
Tap Water
Source:
House Dust
Scalp Hair
Blood
Urine
Original Sample
Collected
Yes
1
1
1
1
1
1
No
2
2
2
2
2
2
If Collected. Date
Month
Day
Year
If Not Collected,
Reason
Interviewer
Number
Duplicate Sample
Selected
Yes
1
1
1
1
1
"V "V
£x
No
2
2
2
2
2
xx
XX
Collected
Yes
1
1
1
1
1
1
No
2
2
2
2
2
2
If Collected, Date
Month
Day
Year
If Not Collected,
Reason
11. Hematocrit
(Month) (Day) (Year)
% Date
COMMENTS:
12. Urine Protein
Interviewer Number
-10-
-------
APPENDIX 2.4
PRETEST CONSIDERATIONS
2-100 12-17-76
-------
PRETEST CONSIDERATIONS
In order to test and standardize the data collection instruments
and procedures, RTI will conduct a Pretest of this Work Plan in a limited
number of households at a non-ferrous smelter site not selected for the
main study effort, most likely Corpus Christi, Texas, with the approval
of the Project Officer. The Pretest will be conducted by the RTI project
staff and consultants with at least some on-site assistance by independent
subcontractors. The Pretest will simulate the main study as closely as
possible and will therefore follow the Work Plan as closely as possible,
including sampling, field operations, and chemical analysis. If no
major problems are encountered with the Work Plan such that modifications
are minimal or unnecessary, then the data from the Pretest would provide
at least some limited data on a seventh non-ferrous smelter community.
If problems are encountered which require modifications of the data
collection instruments or procedures before proceeding with the main
data collection effort, some of the data collected in the Pretest may
still be useful (other than as a justification for the modification),
depending upon the nature of the problem and/or the required modification.
The decision in favor of Corpus Christi (over Hayden, Arizona) has been
based on a number of considerations related to the logistics of executing
the study protocol at a site for the first time, in particular the
availability and costs of, and problems and staff burden associated
with, various ancillary and support services including:
1. Attitude of the smelter; Both of the smelter firms with
operations at Hayden are involved in various litigations, although
only the Asarco plant at Hayden is specifically involved in such
litigation. In addition, there is information that the smelter
2-101 12-17-76
-------
industry may undertake an epidemiological study at Hayden.
2. Attitude of federal, State, and local agencies: RTI would
prefer a Pretest site where the appropriate federal, State and local
agencies would be interested, perhaps experienced, and hopefully could
be actively involved, in such a study. At a meeting at Phoenix,
Arizona, on November 23, 1976, RTI was encouraged by support expressed
by the Arizona Department of Health Services and the University of
Arizona College of Medicine; however, the primary focus of that meet-
ing was Ajo.
3. Availability of independent subcontractors; The Pretest
will attempt to simulate the main study as closely as possible, except
on a smaller scale, and will therefore follow the Work Plan as closely
as possible, including involvement of independent subcontractors. Fig-
ures A-2.4.1 and A-2.4.2 present graphically the number of inter-
viewers from the current RTI listings living in counties within a
reasonable distance of the sites in Texas and Arizona respectively,
which were under consideration for the Pretest. That is not to say,
however, that all of those individuals would be available or suitable
for this research effort. For example, RTI has two other major survey
research efforts planned for the Phoenix area in early 1977 which
would deplete the number of available interviewers in Maricopa county
during that time. More important, however, is the distance which the
interviewers must travel to reach the site and the cost and burden
associated with that travel.
2-102 12-17-76
-------
O
U>
I
H1
•~1
0\
...... ],.„«> ! ,.„.,. I M.,lo, I .... 1"%,
LUBBOCK
V«)ltfl(XI I •€.!•»
l.o^•t I
• IM. .MOl
WICHITA FALLS
O««VM| K>.M»
MIDLAND
• 41 tM, 1 «G***D . *K«tll
blC
,. .4- - [--
~»J ,«4
ABILENE
SHERMAN DENISON
TEXARKANA
IfXAtXANA
,"• • I *«lwtlOH fC«*MOMA|W>7 ,1 * *-Vj»ljONGV««
L "•» I ~ Y- • -f—VI VYU« IJH^—-«
1 \ «nno I *».«to*l \ 1 -X i iTVI FR I
FORT WORTH 1 -^ . ^( >"''"* .".*oi«i
^u ; _ I I 3-x^" '\ i.«'-« >' / M "••*"° V- " "I \ 1 l x
u.m-\ s\ «».• .""""* Vo....^y'\«>>oui '\ ,~^, >_^-;. V°"""v. \J'v *"* )
"" /• SAN ANGELO <»"""'~"\ ..'......^WACO V.,.(i \ *£U) -— X ^ v\V' \
\ °./
Wn |..Jlr-""M V"U_ ',- (BEAUMONT-
'"^ySatcpM-iiONV^T PORT ARTHUR
< -.o. j ....,^--r-- |^ \^T>< lM^»;5?__L..M-,:f .\J;"^;.^:.\ORANGE
•• p— -p •'- -|- -I / A^^^X^v^Vr^I^
^^ i ' CAW AMTnrjtnt •*.'*" 'i y*-0*"'11/ ....i.\ ^ \ —, \Sjr'—c....»\'o»
LtGfND
<•'' Hlacti ol 100 000 01 man .nlubitjnu
• PlMcs 01 bO.OOO 10 100000 mhibitinlt
Q Cenliil cilm ol SMS*'t oilh lc«« lh
-------
LEGEND
® Places ol 100.000 01 more mhaBitanls
• Placet ol 50.000 to 100.000 mnabitants
O Places of 25.000 to 50.000 inhabitants outside SMSA's
Standard Metropolitan
Statistical Areas (SMSA's)
Fig. A-2.4.2. Location and number of interviewers from the current RTI
listing living in counties within a reasonable distance of
the Hayden, Arizona, potential Pretest site [Source: Ref.
2.3, p. 972].
2-104
12-17-76
-------
4. Nature of the Site; RTI would prefer a community large
enough to permit some flexibility in the event of a large number of
nonparticipants, and so that the logistics of implementing the field
operations for the first time would not be too involved. Both of the
Pretest sites under consideration would present a bilingual popula-
tion. However, Hayden and Winkelman, Arizona, which together-make up
the Hayden smelter community, have a combined population of less than
2,000, have extremely limited transportation and medical facilities,
and are approximately two hours driving one way from the nearest
transportation facilities and sources of supplies and support services.
5. Cost; Since the performance sites for the main study
were not known when the proposal was written, one of the smelter
communities in the St. Louis area was considered as a Pretest site for
the purpose of estimating Pretest cost. Several of the considerations
cited in preceding paragraphs will have some impact on cost, particularly
the availability of independent subcontractors within a reasonable dis-
tance of the site, the magnitude of the Pretest, and the site itself.
For example, round trip tourist air fare Raleigh to Corpus Christi is
$230, and Raleigh to Tucson is $308 (plus ground transportation to
Hayden).
Some of these same considerations entered into the choice of the
three performance sites where elderly persons will be studied, in that
RTI will need a larger population base and additional independent sub-
contractors. The outcome of the Pretest may have some impact on RTI's
time and cost projections.
2-105 12-17-76
-------
APPENDIX 2.5
RELEVANT CORRESPONDENCE
2-106 12-17-76
-------
OTHO H WHITENIECK. O.DS.. •oestDe'»
ROBERT 0. McCULLOUGH. O.O.. v.ce P
THOMAS OONICA. M.O., secneT-.v
GLEN (.. BERKENB1LE. M.O.
WALLACE BVRO. M.O.
ARNOLD HELVEY
EUGENE A. OWENS. MO.
». A. TATE- TAYLOR
HAROLD A. TOAZ
Vc
R. LEROY CARPENTER. M.D.. M.P.H.
Nortneast 10th Street & Stonewall
Post Office Box 53551
Oklahoma City, Oklahoma 73105
September 17, 1976
Carl Hayes, Ph.D.
Air Pollution Control Division
Research Triangle Park,
North Carolina 27711
Dear Dr. Hayes: " .
I' very much appreciate talking with you about the studies on the
Heavy Metal Absorption conducted in Bartlesville in the Spring of
1975. I had previously discussed the findings with Dr. Phillip
Landrigan at the Center for Disease Control.
I feel much more comfortable with your assurance that the final
report when released to the public will be modified. I expressed
to you our anxiety about some of the language in the preliminary
report and I am pleased that you are planning to modify this
language to indicate that the levels obtained in the children in
the Bartlesville survey are not of sufficient magnitude to warrant
immediate and concentrated reappraisal.
I am pleased that the EPA plans to conduct follow-up studies in
some of the towns to further delineate the epidemiological
significance of the levels found in the children. I would
strongly urge that Bartlesville, Oklahoma be selected as one of
the towns for further study. As we discussed on the telephone
Bartlesville was the first town to be studied and you and I both
realize that some of the technical aspects of the study were some-
what less than satisfactory especially in the areas of specimen
collection and in the methodology of sampling. I would like to
suggest that this is one very good reason for going back to
Bartlesville with a follow-up study. In addition I would like
to emphasize that some of the highest levels of cadmium and lead
were found in children in Bartlesville and feel that this finding
would be an important factor in selecting Bartlesville as one of
the towns for further study.
2-107
12-17-76
-------
Carl Hayes, Ph.D. 2 September 17, 1976
Although I am unable at this time to commit the resources of the
State Health Department's Epidemiology Program to assist in further
follow-up studies I can assure you of our interest and we would be
happy to evaluate the extent of the follow-up studies and the
degree to which we. could participate. Bartlesville is located in
a county that does not have a local health department and for this
reason the Epidemiology Program at the State Department of Health
would assist in any further investigation of this problem.
At the present time we are not taking any action on the preliminary
report which you forwarded some three weeks ago . I indicated to
you that we felt that it would be important before the final report
is released to the public that a meeting be arranged between the
management of the National Zinc Company in Bartlesville and the
local physicians in Bartlesville and representatives .of the State
Department of Health. We do not plan to ask for this meeting until
such time as we receive the final draft copy of the report.
«
Sincerely yours,
Armond H. Start, M.D.
Director, Division of
Communicable Disease
AHS/mls
2-108 12-17-76
-------
APPENDIX 2.6
SAMPLE COLLECTION METHODOLOGY
2-109 12-17-76
-------
SAMPLE COLLECTION METHODOLOGY
A. General Considerations
The specific methods proposed by RTI for measuring environment-related
factors differ somewhat among the various types of exposure. These differences
reflect several considerations such as the extent to which surrogate
variables reflect the factors of interest, the measurability of factors,
the variability of factor measurements, the quality control of data collection,
and suitability of data collection techniques under actual survey conditions.
The proposed methodology stresses random sampling techniques wherever
possible to facilitate valid statistical analyses and to increase the degree
of control over data collection; Field Interviewers (FI's) will follow explicit,
nonjudgmental procedures throughout. These procedures will range, as described
in subsequent sections, from obtaining small selective samples of relatively
homogeneous items, such as tap water at a particular residence, to obtaining
large stratified random samples for a highly variable item, such as air quality
in a smelter community.
Sample collection will be divided among the various field staff. The
collection of environmental samples will be divided between the Site
Administrator (SA) and the FI. The SA will be responsible for collecting
air and general soil samples such as soil samples from each school yard
where study children participants attend; the FI will be responsible
for the collection of dust and tap water samples for each participating
household, and soil samples from the appropriate residential play area
•
for each pre-school child participant. The collection of biological samples
2-110 12-17-76
-------
will be divided between the independent subcontractors. The FI will be
responsible for the explanation of the procedure for collecting the urine
sample, and arrangements for the participant to go to a central location
for collection of the biological samples; at that central location, the
urine and blood samples will be collected by the medical independent sub-
contractor, the hematocrit will be determined by the medical independent
subcontractor, and the scalp hair sample will be obtained, perhaps by a
barber.
For each household containing a study participant, samples of housedust
and tap water will be collected. For each study participant, RTI shall
endeavor to obtain samples of blood, urine, and scalp hair; soil samples
will be collected from the appropriate play area for each pre-school child
participant and from each school yard where study children participants
attend.— In addition, air and soil samples will be collected for the
overall smelter community.
— In addition to the environmental and biological samples specified in
Exhibit A: Scope of Work for this contract, the Project Officer has asked
RTI to consider two additional measurements, paint and dietary lead, which
might increase the significance of data collected in this research effort.
Since these measurements are not part of the Scope of Work, procedural and
cost considerations are presented in a separate document.
2-111 12-17-76
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B» Environmental Samples
1. Air
Twenty four hour air particulate samples will be collected by the SA
using high-volume sampling units (Fisher Scientific, Cat. No. 1-037-40) on
pre-washed Tape A 8" x 10" glass fiber filters (Fisher Scientific, Cat. No.
9-730-68).
The high-volume air samples will be obtained at random points, which
are coincidental with a subsample of the random blocks (segments) containing
sample individuals. This matching is not intended to provide matched
observations between individuals and air samples, but rather to expedite the
selection of a random point sample that is dispersed throughout the target
population and that is representative of the area over time. These samples
will be taken at random points in time concurrently with the other data
collection activities at each performance site. At any point in time during
the survey period, approximately five high-volume units will be operating
at the site being investigated.
The SA will be provided with a list of sample days numbering from
approximately 1 to 19. The randomization process will involve assigning,
for example, three numbers from 1-19, selected at random and without replace-
ment, and subject to the constraint that each day is assigned at most to
three strata at each site. The constraint will facilitate maximum utilization
of the high-volume air sampling equipment. The following partial table
represents a hypothetical example of such a randomized list:
2-112 12-17-76
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Stratum Days on which a high-volume air sample is to be
taken (day 1 = first day of survey at site)
Sx 8, 12, 17
S2 2, 8, 15
Sg 2, 3, 9, 10, 12, 14, 19
According to this schedule, two and three air samples (see table A-2.6.1)
would be taken in strata S_ and S0, respectively, on the second day of the
/ o
survey, and so on until approximately 87 operation sets are taken at that
site (see figure A-2.6.1). Table A-2.6.2 presents the type of format which
might be used to describe the survey and lab results for one of the study
elements, such as lead.
The sampling units will be placed at locations prescribed by the
stratum-day sampling scheme shown in figure A-2.6.1. Power drops will be used
as required.
3
The initial air flow, approximately 1.7 m /min. , and the final flow
will be accurately read from the pressure gauge and related to total sample
volume by the following expression [Ref.2.6]:
V = air volume samples (m )
Q. = initial air flow (m /min)
3
Q = final air flow (m /min)
T = sampling time (min.)
2-113 12-17-76
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Table A-2.6.1. Tentative sample allocation for air samples.*
Type of Observation
liumber of Observations in Each Stratum, Si
S2
S4
S6
SB
Locations per day
Days
Ratio, days/locations
22222233
'3 34 4 5 5 6 7
1.5 1.5 2,0 2.0 2.5 2.5 2.0 2.3
Based on the following data from Djuric [2]:
Day
Stratum 6; 2 locations
(2.2 - 3.0 km)
Stratum 8; 3 locations
(5.0 - 8.0 km)
1
2
3
4
13.0
84.0
18.0
___^_
30.0
68.0
66.0
^,
1.3
15.0
9.6
24.0
7.6
36.0
3.2
60.0
4.2
25.0
4.2
29.0
21
with approximate estimates of variance: sr - - r-
o nm— L
2 2
= 891; and s0 " 697
o
suggesting a total sample size, nm, needed for a 20 percent c.v.: rim,8* (.. ) =• 9
a ratio;
s, days
nn8 = 20
suggests that sample size ratio days/locations should be
s,. locat.
o
approximately 2.2
2 1 n _ - 2
where s, = —r I (x.-x) and (nm), is total sample size in stratum h.
6 n-1 i n
2-114 '
12-17-76
-------
to
M
G
I
•-J
Fig. A-2.6.1. Geographic and temporal placement of high-volume air samples: a partial hypothetical example
depicting only the first two days of the survey.
-------
CT.
N)
*-4
0\
Table A-2.6.2. Exemplary format for presenting survey and laboratory results for study element: lead.
N)
i
Observation
number
1
2
3
Pb reading,
mg . per
cubic meter
4.2
36.0
60.0
Distance
from source,
km
2.5
1.2
1.3
Direction from
source, degrees
from transect
. 0.4
-5.2
-10.1
Wind
velocity,
km/hr
35.1
20.4
2.4
Wind
direction,
degrees from
transect
-10.5
-10.4
-5.3
Ground
level
temp . ,
°C
32.1
34.5
35.1
Upper
atmosphere
temp . ,
°C
30.0
33.1
40.0
87
7.8
5.0
35.6
2.4
-2.1
38.1
34.0
-------
Wind direction, wind speed and extent of precipitation will be noted
for each sampling day.
Although each sampler will be calibrated at RTI, the air flow calibration
data will be validated at the site with an EPA audit device.
After the collection period, the filter will be removed-from the sampler,
folded so that only surfaces with collected particulates are in contact and
placed in a tightly secured plastic Zip-Loc bag for shipment to RTI.
2-117 12-17-76
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2. Soil
The basic sampling protocol will call for the collection of single
composite samples of surface soil at air sampling sites, from the residential
play areas of pre-school age study children participants, and from the school
yard(s) where study children participants attend. Approximately 80 (or
less to the extent that some families may have more than one study child
participant) of these soil samples will be obtained from residential play
areas, one for each pre-school age child participant; one composite sample
will come from each school yard where study children attend and from each
air sampling location.
Variation in the soil content of study elements throughout the sample
collection areas, both.for different locations and time, is expected to be
small relative to variation in the air samples. A small composite sample,
therefore, will be relied upon to measure element exposure from soil in play
areas. The boundaries of the most commonly used play area will be established
and 3-5 surface soil samples collected from random points in the play area
using a random number table. These samples will comprise the composite
sample for that play area.
Samples will be taken from the top 2.0 cm of soil with a plastic scoop,
and collected in appropriately labeled four ounce plastic bottles for shipment
to RTI.
12-17-76
-------
3. House Dust
A sample of settled dust will be collected for each household by the
FI using a vacuuming technique after that of Solomon and Hartford [Ref. 2.7].
A single sample will be taken from the floor in the central area of the living
room, away from the walls. The sampling area will be delineated and standardized
using a 0.5 x 0.5 m Lucite template placed on the surface, thereby allowing
results to be reported on an area basis as well as on a weight basis. In
2
taking each dust sample, one pass will be made of the 0.25 m area with a
special vacuum holder utilizing a special nylon filter holder, a glass fiber
paper insert, and a portable pump as the vacuum source. The vacuumed dust
will be trapped in the upper chamber of the nylon holder; the used filter
and dust gathered will then be placed in appropriately labeled, tighfely
secured Zip-Loc bags for shipment to RTI. Disposable plastic gloves will be
worn when handling dust samples.
Random sampling at different locations and time is not proposed for
this measure of exposure, because the sample should be relatively homogeneous
within a household, and because what little improvement in data that might
result from a suitable randomization does not seem to justify the accompanying
increase in participant and interviewer burden.
2-119 12-17-76
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• 4. Tap Water
At each household, the FI will collect a sample of cold tap water in
a four ounce plastic bottle, from the kitchen tap or other source commonly
used for drinking and cooking, in a single pass after the water has been
allowed to run for ten seconds. Time will be measured using a stop watch.
Random sampling at different locations and time is not proposed for this
measure of exposure, because the sample should be relatively homogeneous
within a household, and because what little improvement in data that might
result from a suitable randomization does not seem to justify the accompanying
increase in participant and interviewer burden.
2-120 12-17-76
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C. Biological Samples
1. Urine
At the time that the participant is enlisted, arrangements will be made
for the collection of a urine sample in a four ounce plastic bottle. . A twenty-
four hour urine sample would be considered ideal, but is considered impractical
to collect from children, and adults who work away from home. The interviewer
will leave the appropriately labeled specimen bottle with the participant,
explaining that the participant is to collect a urine specimen from the first
micturation on the morning that the participant is to have the blood sample
drawn; the urine specimen will then have to be refrigerated by the participant
until it is delivered to the central data collection facility. In the event that
a participant arrives at the central data collection facility without a
urine specimen, an attempt will be made to obtain one at that time, with
appropriate labeling and notation; if the morning urine sample was collected
but left at home, arrangements will be attempted to send the FI to the
participant's home to retrieve the urine sample. Where RTI provides participant
transportation to the central data collection facility, this last step
may be avoided. In some instances, RTI may ultimately have two urine samples
for some participants. The central data collection facility must have toilet
facilities.
If children participants are not toilet-trained, special procedures
may have to be implemented in order to obtain a urine specimen. RTI is
considering testing commercial disposable absorbent diapers for this purpose
in the Pretest. The mother would be provided one or two such commercial
disposable absorbent diapers and an appropriately labeled Zip-Loc bag,
2-121 12-17-76
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with instructions to place the disposable diaper next soiled by urine
only in the Zip-Loc bag for delivery to the central data collection facility
with interim refrigeration as required.
RTI is considering a qualitative test for proteinuria using a dipstick
procedure.
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2. Scalp Hair
From each study participant from whom the collection of such a
sample is feasible, a full-length sample of scalp hair of sufficient
quantity for chemical analysis will be obtained using scissors or shears.
Although the amount of scalp hair available from the participant will
ultimately determine the size of the scalp hair sample, a concerted
effort .will be made to collect as large a sample as possible from each
participant up to the minimum amount needed for chemical analysis.
To facilitate the collection of an adequate scalp hair sample,
and to reduce the resultant trauma to the participant, RTI is considering
two methods of obtaining the scalp hair sample: (1) to allow the partici-
pant or some member of the participant's family to collect the sample
under the supervision of the independent subcontractor, and/or (2) to
have a barber collect the scalp hair samples. Scalp hair samples will
be collected at the central data collection facility using disposable
plastic gloves, and placed in appropriately and individually labeled
Zip-Loc plastic bags; the scalp hair sample will be completely enclosed
within the plastic bag which will be locked carefully and returned to
KTI for analysis.
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3. Blood
An attempt will be made to collect a blood sample from each
participant from a brachial vein by venipuncture using a heavy metal-free
10 ml. Vacutainer tube containing liquid EDTA as an anticoagulant. Prior
to venipuncture, blood flow in the selected arm will be restricted using
a tourniquet; the venipuncture site will be prepared by cleansing with an
individually wrapped sterile alcohol swab. Venipuncture will be accomplished
by a disposable 20 G x 1 1/2 inch Vacutainer needle contained in a reusable
Vacutainer holder. After collection of the blood sample, the Vacutainer
tube will be appropriately labeled and then inverted several times to
insure mixture with the anticoagulant; the venipuncture site will again be
cleansed with an individually wrapped sterile alcohol swab, pressure applied
to retard hematoma formation, and a sterile adhesive bandage applied.
Where venipuncture by Vacutainer presents problems, as in the very
young, obese, or elderly, alternatives may have to be employed at the
discretion of the individual collecting the sample. In some instances,
venipuncture may still be accomplished using a disposable needle and
syringe with immediate transfer of the blood sample to a heavy metal-free
10 ml. Vacutainer tube containing liquid EDTA as an anticoagulant.
The syringe would permit gradual and variable withdrawal of blood and
be therefore less likely to collapse the vein. The preparation of the
venipuncture site and the handling of the sample would be identical
to that described in the preceding paragraph.
In the case of children participants, blood samples (0.5 ml.) may
have to be drawn via finger (children over two years of age) or heel
(children less than two years of age) stick using long point microlances
2-124 12-17-76
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and heparinized capillary tubes. The method of drawing blood samples by
finger or heel involves several steps. After the child is secure or even
before, his hand or foot must be cleansed of all noticeable dirt, grime
and anything else, such as food stains, with a cotton swab. After that,
the finger tip (usually the index finger) or heel to be stuck is selected
and held. The finger or heel is then washed with 0.1 molar hydrochloric
acid on a sterile gauze pad; the finger or heel is wiped vigorously to
mobilize surface heavy metal contaminants thus rendering the puncture site
relatively free of heavy metal contamination. The finger or heel is then
wiped with a dry gauze pad. Next, the finger or heel is wiped with an
individually wrapped sterile alcohol swab. After this, the finger or
heel is massaged by applying gentle pressure towards the puncture site,
thereby pushing the blood up toward the puncture site. When the puncture
site appears somewhat red and engorged with blood, the site is punctured
with an individually packaged long point microlance. The first drop of
blood thus elicited is wiped away with an individually wrapped dry sterile
gauze pad. The free-flowing blood is then collected with a gentle milking
motion into two or preferably three heparinized capillary blood collection tubes
of approximately 280 microliters in volume to within one inch of their top
end. During the blood collection procedure, care should be taken to see
that the tip of the capillary tube is held right on the point of puncture
and the blood collected there so that the blood does not run down the finger
or heel and then into the tube, thereby opening possibilities of contamination.
The tube fills itself through capillary action; when each tube is full,
the blood collector places each tube on a clean level surface. When blood
sample collection is completed for a particular child (see hematocrit section
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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.
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4. Hematocrit Determination
Hematocrit will be determined at the performance site by the
microhematocrit method using a microhematocrit centrifuge. Hematocrit
values will be read with a reader and recorded on the appropriate Study
Questionnaire (SQ-see appendix 2.3).
In the case of Vacutainer blood samples, two microhematocrit
tubes will be filled three-fourths full from the blood in the Vacutainer
tube and one end of each hematocrit tube will be sealed with putty. The
microhematocrit tubes will then be centrifuged, the percentage of packed
red cells read on a hematocrit reader, and the value recorded on the SQ.
The stopper will be replaced in the Vacutainer tube which will then be
refrigerated for shipment to RTI for analysis.
In the case of the finger or heel stick, the procedure will
be the same as that in the preceding paragraph except that only one micro-
hematocrit tube will be filled per participant, directly from the puncture
site.
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D. Quality Control
Each sample will properly labeled as it is collected. Each individual
sample will be treated the same as all other samples of that particular
type.
As a check on the quality or precision of the procedures and techniques
for collecting certain of the biological and environmental samples, RTI
plans to collect duplicate soil, housedust, tap water, blood, and scalp hair
samples (the last two from adult participants only) from ten percent of the
sample sources, using the same technique and as nearly as possible the same
site(s) as the original sample.
The duplicate soil samples will be collected from the same area as the
original using the same collection" procedures. The duplicate housedust
sample will be taken from a floor area immediately adjacent to the site of
the original sample using the same collection procedures. The duplicate
tap water sample will be taken from the same water source as the original
sample using the same collection procedure. The duplicate scalp hair sample
will be taken using the same collection procedure in an amount equal to the
original sample (where possible). The duplicate blood sample will be taken
from the same venipuncture using the same collection procedure as the original
sample by changing Vacutainer tubes. The duplicate samples will be taken
by the same person as the original sample and at the same approximate time.
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APPENDIX 2.7
REFERENCES
2-129 12-17-76
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REFERENCES
2.1. Landrigan, P. J., et al., Epidemic lead absorption near an ore smelter:
the role of partioulate lead. New England Journal of Medicine,
Vol. 292, No. 3, pp. 123-129, January 1975.
2.2. Center for Disease Control, Protocol: nationwide survey of children
living near primary non-ferrous metal smelters.
2.3. U. S. Department of Commerce, Social and Economic Statistics Admin-
istration, Bureau of the Census. County and City Data Book, 1972;
Statistical Abstract Supplement. Washington, D. C.: U. S. Government
Printing Office, 1973.
2.4. Bureau of Foods, Compliance Program Evaluation, FY 1974 Heavy Metals
in Foods Survey (7320.130, Chemical Contaminants Project), June 19, 1975.
2.5. Hall, W. G., and L. T. Slovic, U. S. Department of Commerce, National
Bureau of Standards. Survey Manual for Estimating the Incidence of
Lead Paint in Housing (NBS Technical Note 921). Washington, D. C.:
U. S. Government Printing Office, 1976.
2.6. Federal Register, Vol. 36, p. 8192, 1971.
2.7. Solomon, R. L., and J. W. Hartford, Lead and cadmium in dust and soils
in a small urban community. Environmental Science and Technology,
Vol. 10, No. 8, pp. 773-777, August 1976.
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3.0 Physical Methods of Analysis
This section describes the sample preparation procedures which will
be carried out on the blood, urine, scalp hair, tap water, dust, air
particulate, and soil collected at the smelter sites. These materials
will be analyzed for As, Cd, Cu, Mn, Pb and Zn by atomic absorption
spectrophotometry.
A spark source semiquantitative scan will be obtained on two bio-
logical samples from each age-sex group by Commercial Testing and
Engineering, Golden, Colorado. This corresponds to a total of 252
samples from the six smelter sites which will be analyzed in this manner.
Free erythrocyte protoporphyrin (FEP) content will be determined in
each blood sample to establish extent of chronic exposure to lead. A
microspectrofluorometric procedure will be employed. Since only a
partial overnight urine sample will be taken, a measure of excreted
creatinine will be used to estimate 24-hour urinary volume. In this
manner, amounts of metals excreted over, a 24-hour period may be cal-
culated. Creatinine will be assayed by a spectrophotometric procedure.
Quality control will play a prominent role in all routine analytical
operations. Both internal and external reference materials will be used
to insure continuing analytical accuracy. All calibration procedures
will be carried out by the method of standard additions.
3.1 Atomic Absorption Analysis
All atomic absorption analysis will be carried out on a Perkin-
Elmer Model 403 Atomic Absorption Spectrophotometer using an HGA-2000
Graphite Furnace with deuterium arc background correction. Absorption
peaks will be recorded with a Perkin-Elmer Recorder Model 056. Sample
injection will be accomplished with an Eppendorf pipet.
3-1 12-17-76
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All glassware used in sample preparation will be soaked overnight
in 1% HNCL, rinsed well with deionized water and dried. Precleaned
volumetric pipets will be used for reagent and sample deliveries. All
HNCL solutions will be prepared from analytical reagent grade material
and deionized water.
Sample preparation procedures are described below for each matrix.
3.1.1 Biological Samples
Samples in this category include blood, urine and scalp hair speci-
mens collected from the study participants.
3.1.1.1 Blood
Blood samples will be diluted with 0.5% HNCL and analyzed directly
for the metals of interest. Results will be reported as weight of
metal/100 ml blood.
3.1.1.2 Urine
Urine samples will be diluted with 0.5% HNCL and analyzed directly
for the metals of interest'. Results will be reported as weight of
metal/ml urine and weight of metal/estimated 24 hr urinary volume.
WC
v = —°-
24e C
u
C = creatinine coefficient (mg/kg)
C = 18 (females)
c
C - 23 (males)
c
C = creatinine concentration in urine (mg/ml) (see Section 3.4)
V2, = estimated 24 hr urinary volume (ml)
W = body weight (kg)
M = M V0.
u 24e
M = weight of metal in estimated 24 hr urinary volume
3-2 12-17-76
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M = metal concentration (mg/ml)
M = M WC /C
u c u
3.1.1.3 Scalp Hair
Scalp hair samples will be cut into approximately 1 cm sections
with stainless steel scissors and rinsed with a 1:1 methanol:ether
mixture. The hair material will be washed with a 10% Prell (liquid)
solution, rinsed well with deionized water and dried at 105°C. A 100 mg
(approximately) portion of the washed hair collection will be weighed
and digested at 85° with a 1:1 HNO» mixture. The concentrate will be
diluted with deionized water and analyzed directly for the metals of
interest. Results will be reported as weight of metal/gm hair.
3.1.2 Household Samples
The samples included in this category are tap water and dust col-
lected at the homes of the study participants.
3.1.2.1 Tap Water
Fifty microliters of concentrated HNO, will be added to 10 ml of
tap water and the solution analyzed directly for the metals of interest.
Results will be reported as weight of metal/liter tap water.
3.1.2.2 Dust [Ref. 3.1]
Dust samples will be removed from the 23 mm glass fiber filter and
screened on a 30 mesh ASTM sieve. The samples will be weighed and
digested at 85° with 1:1 HNO-. Deionized water will be added to a
reference volume, filtered and the filtrate analyzed directly for the
metals of interest. Results will be reported as weight of metal/gm
dust.
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3.1.3 Environmental Samples
Samples in this category include air particulate samples collected
according to the sample design described in Section 1.4.2. and soil
samples taken at the air sampling locations, from the play area of pre-
schoolers and the school yard of school-age subjects.
3.1.3.1 Air Particulates
Air particulate samples will be eluted from a 2.0 x 20.3 cm strip
of the glass fiber filtering media with 5% HNCL in an ultrasonic bath.
The filter will be removed and the acid mixture heated at 85°. The
concentrate will be diluted to a reference volume with deionized water,
filtered and analyzed directly for the metals of interest. Results will
3
be reported as weight of metal/m air (see Appendix 2.6, B.I for calcu-
lation of air sample volume).
3.1.3.2 Soil [Ref. 3.2]
The soil sample will be screened on a 10 mesh ASTM sieve and dried
at 105°C. A weighed soil sample will be slurried in a minimum volume of
deionized water and digested with concentrated HNO_ at approximately
100°C. To the cooled mixture will be added 30% H^ and the heating
continued with intermittent swirling. The cooled digestate will be
filtered, diluted to a reference volume with deionized water and analyzed
directly for the metals of interest.
3.2 Spark Source Mass Spectrometric Analysis
Two samples of each biological type from every age-sex group and
smelter site (total 252) will be submitted for spark source mass spec-
trometric analysis. A semiquantitative scan will be obtained by the
Instrumental Analysis Division of Commercial Testing and Engineering
Company, Golden, Colorado. The analysis will be run on an Associated
Electrical Industries (AEI) Model MS7 instrument.
3-4 12-17-76
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3.3 Free Erythrocyte Protoporphyrin (FEP) Analysis
A fluorometric method based on the procedure reported by S. Granick
et al. [Ref. 3.3] will be used to determine FEP. The method requires
only 2 microliters of whole blood. The ethyl acetate-acetic acid extraction
and the free porphyrin separation with aqueous HC1 will be carried out
in the cuvette and the fluorescence of the lower porphyrin layer measured
directly. The excitation monochromator will be set at 400 nm and a scan
obtained with the emission monochromator at 500-700 nm (fluorescence
emission maxima occur at 608 and 658 nm with a relative intensity ratio
of 2.08). Standard solutions of authentic porphyrins will be used for
calibration purposes.
Approximately 90% of the total free erythrocyte porphyrin content
is protoporphyrin. However, correction will be made for the presence of
small amounts of uroporphyrin and coporphyrin. The presence of these
compounds will result in a lower 608 nm/658 nm peak intensity ratio.
This assay will detect FEP levels as low as 4.5 yg/100 ml whole
blood.
A Hitachi Perkin-Elmer Model MPF-2A Fluorescence Spectrophotometer
will be used for the FEP analysis.
3.4 Urinary Creatinine Analysis [Ref. 3.4]
One ml of urine will be diluted to 100 ml with deionized water.
Four ml of this solution will be mixed with 2 ml of an alkaline picrate
reagent. Twenty minutes later the optical density will be read at 520
nm. A blank and standard solution (1.0 mg/ml) will be prepared and
processed in the same manner. The creatinine concentration will be
calculated in the following way:
, n . Optical Density (sample) x 100
mg creatinine/ml urine = r - „.—r—-—*-~—,r .',
& Optical Density (st'd)
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A Parkin-Elmer Model 402 UV-Visible Spectrophotometer will be used
for this analysis.
3.5 Quality Control and Analytical Protocol
3.5.1 Instrument Calibration
At the start of each analytical run, the atomic absorption spec-
trophotometer will be calibrated for the element to be analyzed for,
using standard solutions containing known quantities of metal in the
appropriate control matrix material. Pooled collections of blood,
urine, scalp hair, tap water, dust and soil, shown to have minimal or
nonelevated metal concentrations, will serve as baseline matrix mate-
rial. In each case the actual metal concentration will be determined by
the method of standard additions. Potential control soil samples will
be obtained at a distant upwind location from the smelter in an attempt
to simulate soil type.
Air particulate calibration solutions will be prepared by spiking
glass fiber filter sections with known amounts of the metals of interest.
In the case of scalp hair, dust, soil and air particulate calibra-
tions, the standard additions will be done prior to sample workup.
These calibration solutions will serve as internal reference mate-
rials as described below.
Calculation of analytical curves and determination of unknown
sample concentrations will be carried out on a programmable calculator.
3.5.2 Limits of Detection
Detection limit (DL) will be defined as that amount of metal which
will give a net signal two standard deviation units greater than the
mean blank signal. This corresponds to that amount measurable at a
3~6 12-17-76
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precision level of 50% RSD. An analysis giving a net signal less than
two blank standard deviation units will be reported as not detected (ND).
3.5.3 Routine Analytical Protocol .
After the instrument has been calibrated for a specific metal in a
particular collection matrix, an analytical run (60-80 samples) will be
initiated by a team of two analysts. Duplicate sample injections will
be made on all samples. Depending on the total furnace program time, 20
to 30 samples will be processed per hour. The analysts will alternate
between sample injection and data calculation; the metal concentration
of each sample will be determined immediately after analysis. Matrices
which vary widely in metal levels (air particulates, soil, dust) may
exhibit concentrations outside of the linear working range. These
samples will be set aside, suitably diluted and analyzed as a group
against appropriate calibration standards.
3.5.4 Analytical Priorities
First priority will be given to the biological samples (urine,
blood and scalp hair). Included in this category are the blood FEP and
urinary creatinine assays. Tap water samples will be analyzed next.
Dust, soil and air particulate analysis will be performed as soon as the
others have been completed.
3.5.5 Quality Control Procedures
The quality control measures incorporated in the routine analytical
protocol will serve two major functions: to maintain constant instrument
performance and determine analytical precision and accuracy.
3.5.5.1 Instrument Performance
Instrument performance will be monitored by determining the signal
response of a reference material after approximately every 15 samples.
3-7 12-17-76
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These evaluations will be carried out with an original calibration
solution (internal reference) or, when available, an external reference
material with a metal concentration known to the analyst. These proce-
dures are not intended to assess precision or absolute accuracy but to
establish the validity of the original calibration data. If the reference
sample signal has changed by more than +10-15% or +2 standard deviation
units, appropriate measures will be taken before continuing the analytical
run (e.g., changing the graphite tube, balancing the D~ arc-light source
intensities, recalibrating).
3.5.5.2 Accuracy and Precision
Accuracy will be assessed by analysis of external reference materials
approximately every 20 samples. This procedure will be carried out
blind. The reference materials will be coded and processed in the same
manner as field samples. External reference materials available for
this purpose are listed below:
• Blood (CDC) - Pb and FEP;
• Tap water (EPA/Cincinnati) - all metals;
• Air particulates (EPA/RTP) - As and Pb, others as they become
available.
Precision will be assessed by analysis of duplicate samples (see
Section 2.2.6.4). These materials will be coded at the smelter site; their
identity as a duplicate will be unknown to the analyst. Samples which
will be evaluated in this manner are listed below:
• Blood (10%) participants over age 18 only,
• Scalp hair (10%) participants over age 18 only,
• Tap water (10%),
3~8 12-17-76
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• Dust (10%), and
• Soil (10%).
3.5.5.3 Interlaboratory Comparison
An interlaboratory comparison study will be initiated. Samples to
be identified by the EPA Project Officer will be split for independent
analysis.
3.5.6 Calibration of High Volume Air Samplers
All high volume air samplers will be calibrated against a top
loading Orifice Calibration Unit Model 330 (Sierra Instruments, Inc.,
St. Paul, Minnesota). This device has been calibrated against a primary
standard, positive displacement Rwots Meter by the Environmental Protection
Agency, Research Triangle Park, North Carolina (EPA/RTP). The calibration
data are presented in Figure 3.1.
Each high volume sampler will be equipped with a pressure gauge for
monitoring air flow across the 8" x 10" glass fiber filter. To calibrate
the pressure gauge readout in terms of air flow, a long term air sampling
experiment will be carried put with each high volume unit. As the
resistance to air flow increases, periodic measurements of the pressure
drop across the orifice will be made with a water manometer and related
to the corresponding pressure gauge reading. With this calibration
data, the gauge on each sampler may be directly converted to standard
cubic meters air flow per'minute across the filter medium. Alternatively,
two or three filters will be placed on the sampler to simulate resistance
to air flow.
Sampler calibration will be checked at the site with an EPA audit
device.
After use at a smelter site, brushes on the air samplers will be
changed and the unit recalibrated.
3-9 12-17-76
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•vj
>cr>
A2 C.oocH
0.00019
Fig. 3.1. Calibration of\SierrI°Instrument Orifice, Model 330.
-------
3.6 Determination of Total Particulate Solids in Air
Subsequent to filter prewashing with 5% HNO , each filter will be
tared, inspected for imperfections and handled in a manner consistent
with the procedures described in the Federal Register [Ref. 3.5]. Each
filter will be stamped with an identification number and placed in a
Zip-Loc bag for transport to the site. On return to RTI, the filters
will be weighed as described [Ref. 3.5] and the net weight reported as
3
amount of total particulates/m air.
3.7 Personnel
All chemical analysis will be carried out at RTI and will be under
the direction of Dr. Robert W. Handy, Senior Chemist in the Chemistry
and Life Sciences Group (CLSG). Dr. Monroe E. Wall, CLSG Director and
RTI Vice President, will provide overall coordination for all phases of
this program.
Assisting Dr. Handy will be chemical professionals Gail T. Hess,
David F. Natchske, Karen Robbins and technician Carolyn Foust. Mrs.
Hess will direct and evaluate the routine quality control measures
during daily analytical runs.
Resumes of these individuals will be found in appendix 3.1.
3.8 References
3.1. Solomon, R. L., and J. W. Hartford, Environmental Science and
Technology, Vol. 10, p. 777, 1976.
3.2. Krishnamurty, K. V., E. Shpirt, and M. M. Reddy, Atomic Absorption
Newsletter, Vol. 15, p. 68, 1976.
3-11 12-17-76
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3.3. Granick, S., et al., Procedings of the National Academy of
Science. Vol. 69, p. 2381, 1972.
3.4. Hanok, A., Manual for Laboratory Clinical Chemistry. Los Altos,
California: Geron-X, Inc., 1969, pp. 147-151.
3.5. Federal Register, Vol. 36, p. 8192, 1971.
3_12 12-17-76
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APPENDIX 3.1
RESUMES OF RTI PROJECT STAFF
3-13 12^17-76
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ROBERT W. HANDY, Senior Chemist
Professional Experience
1975 to date. Senior Chemist, Chemistry and Life Sciences Division,
Research Triangle Institute, Research Triangle Park, North Carolina.
Development of trace metal analysis techniques by atomic absorption
spectrometry and general analytical methodology. Monitoring gas and
aerosol levels in environmental chamber studies using instrumental
and wet chemical methods. Analysis of environmental and biological
materials for trace metals by atomic absorption spectrometry. Isola-
tion, identification and quantitation of drug metabolites from various
biological fluids using radiochemical tracers, gas and liquid chro-
matographic techniques.
1965 to 1975. Chemist, Chemistry and Life Sciences Division, Research
Triangle Institute, Research Triangle Park, North Carolina. Synthesis
of substituted cinnamylidene malononitriles; research in modified
steroid synthesis and drug metabolism.
1954 to 1964. Research Chemist, Kay-Fries Chemicals Co., Inc., West
Haverstraw, New York. Synthesis and bench-scale process development
of fine organic intermediates; orthoesters, pyrimidines and miscel-
laneous polyfunctional compounds.
Education
B.S., Chemistry, Brown University, Providence, Rhode Island, 1954.
M.S., Organic Chemistry, Stevens Institute of Technology, Hoboken,
New Jersey, 1964.
Ph.D., Medicinal Chemistry, University of North Carolina, Chapel Hill,
North Carolina, 1971.
Professional Societies
American Chemical Society
Selected Publications
"Reactions of some 4-Piperidones with Olefin-forming Phosphorus
Reagents," M.S. Thesis (1964).
"The Synthesis of Some l-(g-Diethylatninoethyl)-2-(p-ethoxybenzyl)-
5-substituted Benzimadazoles," F. I. Carroll, R. W. Handy, J. A.
Kepler and Joan A. Gratz, J. Heterocyclic Chem., 4^ 262 (1967).
"Metabolism of Antifertility Steroid IV - The Synthesis of 6-Chloro-
17-hydroxypregna-4,6-diene-3,20-dione-4-^C-acetate (Chlormadinone
Acetate)," K. H. Palmer, R. W. Handy and M. E. Wall, J. Labelled
Compounds, 7_, 16 (1971).
"The Total Synthesis of 7 (8 -»• llo) Aboestrogens. Delination of the
Role of Steric Effects in the Biochemistry of Steroids," C. G. Pitt
and R. W. Handy, Tetrahedron, 27, 527 (1971).
3-14 12-17-76
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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
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DAVID F. NATSCHKE, Chemist
Professional Experience
September 1976 to date. Research Triangle Institute, Research
Triangle Park, North Carolina 27709. Chemist, Chemistry and Life
Sciences Division. Analyze biological and environmental samples by
atomic absorption. Methods development.
June 1974 - July 1975. Phelps-Dodge Corp., Morenci, Arizona.
Assistant Chemist. Analysis of a variety of samples by classical
methods. Some programming.
September 1972 - May 1973. New Mexico Bureau of Mines, Socorro,
New Mexico. Student Analyst. Analyzed samples by atomic absorption
and classical methods.
Education
Military Electronics School, 1966-1967.
B.S., Chemistry, New Mexico Institute of Mining & Technology,
Socorro, New Mexico, 1974.
Graduate School in Chemistry, University of North Carolina,
Chapel Hill, N.C., 1975-1976.
Professional Activities
American Chemical Society, member.
ACS Undergraduate Award in Analytical Chemistry, 1974.
October 1976
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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
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KAREN W. ROBBINS
Education
B.A., Chemistry, University of North Carolina, Chapel Hill,
• North Carolina, 1974
Computer Science, .Durham Technical Institute, 1975
Experience
1976 to present. Research Triangle Institute. Chemist.
Materials experience in preparation of piezoelectric films
and optical coatings. Analysis of basic oxide furnace
materials and. .processes.
1973 to 1974. Pathology Laboratory, University o£ North
Carolina at Chapel Hill. Research assistant on various
pathology problems.
3-18 12-17-76
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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.
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4.2 Data Analysis
RTI will use the TUCC IBM 370/165 computer facility for its data
analysis. The data will be stored on 9-track tapes written at 1000 bpi
with an OS standard label.
In its analysis, RTI will examine the following relationships:
(a) the relationship between environmental levels of the trace
metals of interest (i.e., levels of metals in air, water, soil
and dust samples), the distance from the smelter, wind speed,
and wind direction; and
(b) the relationship between tissue levels of the trace metals
(i.e., levels in hair, blood and urine), environmental levels,
and sociodemographic variables (e.g., age, sex).
As is now envisioned, the principal statistical techniques that will
be used to examine these relationships are the analysis of variance,
multiple regression and stepwise regression. In addition, it may also
be worthwhile to examine some multivariate techniques (i.e., techniques
which consider the above relationships for more than one trace metal at
a time).
4.2.1 Analysis of Environmental Levels
In particular, for the relationships in (a) above, the following type of
model will be analyzed for each trace metal being studied:
Y.jk(M) = u + D. + S. + Wk + eijk (1)
where
Y.-t(M) = concentration of metal M in either air, water, soil, or dust
samples for the i distance, j wind speed,
and k wind direction,
u = mean metal M level,
4-2 12-17-76
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D. = i distance effect
S. = j wind speed effect,
W, = k wind direction effect, and
e. ., = random error.
ijk
In the above model, the independent variables (distance from smelter,
wind speed, wind direction) have been categorized and indexed by i, j,
and k, respectively. This allows for a general type of relationship
between the levels of the metals and the independent variables rather
than imposing a functional relationship as does regression. With this
model, one may use the technique of analysis of variance to test for the
effects of different distances from the smelter, differences in wind
speed, and also differences in wind direction. These correspond to
tests of equality of the D., the S., and the W, , respectively.
i J fc
As required by the subject Request for Proposal (RFP), the analyses of
the environmental levels, whether they be air, water, dust, or soil,
will be done separately for each site. If differences between sites are'
also of interest, this may be investigated by including a site variable,
L, , in model (1) to produce
Yhijk(M) ' u + Lh + Di + Sj + Wk + ehijk . (2)
Site differences.may then be tested by testing the equality of the L,
and the differences may be exhibited by displaying the adjusted site
means from model (2).
4.2.2 Analysis of Tissue Levels
For the relationships in (b) above, the analysis will again be done by
site and in this case will also be done by broad age categories, since
soil samples are taken only for school and preschool children. In
4"3 12-17-76
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particular, the following type of model will be analyzed for each trace
metal:
Y..k(M) - u + A. + S. H- BlXlk + B2X2k
+ B,X,. + B.X.. + B.X.. + e. .. (3)
3 3k 4 4k 5 5k ijk
where
Y..*(M) = concentration of metal M in either blood, hair or
urine samples for the k individual in the i age
, .th
group and j sex group;
u = mean metal M level;
A. = age effect for the i age group;
S. = sex effect for the j sex group;
B,, ...,B,. = regression coefficients to be estimated;
X,k,...,X_k = corresponding concentration of metal M in the air,
water, soil, and dust samples, respectively,
for the k individual; and
e. ., = random error.
IJK
The above model will permit the examination of the effect of age and sex
as well as environmental levels on metal M tissue levels. A similar
model may also be used to examine the effects of distance and wind
direction on metal M tissue levels. In model (3), testing for age and
sex effects corresponds to testing the equality of the A. and S. while
testing for the relationship between tissue levels and environmental
levels corresponds to testing the nullness of B..,...,Bc. When the
parameters in model (3) have been estimated, the resulting fitted equation
may serve as a predictive model for the reference population.
In order to help determine the form of model (3) for the various
metals, it may be worthwhile to employ the technique of stepwise regression.
4-4 12-17-76
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This technique can be used to give insight into the relative strengths
of the various demographic, environmental and meteorological variables
in predicting tissue levels in humans. In essence, this technique selects
those variables (in a stepwise manner) which best predict the dependent
variable of interest (i.e., tissue levels).
In addition to using the various statistical models given above,
other techniques which will be employed to examine the relationships of
interest include: computing correlations between pairs of variables;
examining scatter plots of tissue levels versus the demographic, environ-
mental, and meteorological variables; and computing means of the demo-
graphic, environmental, and meteorological variables for various cate-
gories of tissue levels and then plotting these means. .
4.3 Potential Problems
4.3.1 Missing Observations
' Because of the nature of the data being collected for the present
study, there undoubtedly will be a large number of missing observations.
These missing observations may consist of all or only selected observations
from a sample individual (e.g., the individual refuses to give any data
at all or he gives all the data desired except a urine sample). In
order to carry out the analyses described in section 4.2, it will.be
necessary to determine how these missing observations are to be handled,
keeping in mind that the easiest solution of only analyzing individuals
with complete observations is probably unsatisfactory because too many
individuals with partial observations would have to be discarded.
The specific techniques to be used for handling missing observations
will be determined during the analysis, and will depend upon several
considerations. Some of the pertinent considerations include the
following:
4-5 12-17-76
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The reason for the missing observation,
The type of measurement (e.g., tissue level) for which the
observation is missing,
- The type of analysis or estimate for which the missing obser-
vation is needed,
The number of missing observations for that measurement,
The minimum measurable level if the observation is missing
because it is less than that level, and
The information available from that and other individuals that
may facilitate the estimation of the missing observation.
The methodology decided upon will be made available for Project Officer
review and will be fully documented in the final report. The following
methodologies will be among those considered.
If relatively few observations are approximately "randomly" missing
for a particular measurement, cohort means will probably be substituted
for the value and the degrees of freedom will be appropriately modified.
If relatively few observations are missing because they are below a
x»
i
measurable minimum, the range midpoint of this observation, —j, may be
substituted for the missing value, particularly if the range is small
(i.e., if [0,xl] is small where x' is the smallest measurable value for
X.). However, if the number or range of unmeasurable observations is
large, a more refined technique may be used. Under this condition,
methodology for the estimation of distributional location and scale
parameters under the situation of singly censored samples, would be
appropriate for the initial analysis. In Sarhan and Greenberg [Ref. 4.2],
order statistics are used to obtain unbiased best linear estimates of
4-6 12-17-76
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location and scale parameters from samples of size 20 or smaller and
unbiased "nearly best" linear estimates from larger samples in which
single censoring occurs. Once the distributional parameters are estimated,
it will then be possible to substitute values for the unmeasurable
observations based upon the estimated distribution.
9
In running the regression analyses described in section 4.2, one
may encounter either missing dependent (Y) or missing independent (X)
variables. To handle this problem, one might use a model in which an
indicator variable reflects the missing independent variables and "two-
stage" estimation models [Ref. 4.3] are used to predict missing dependent
variables. The two-stage method is used in SAS [Ref. 4.4], one of the
software systems utilized by RTI. The method uses a least squares
solution to obtain parameter estimates from the available observations,
and then uses estimates of missing values from this preliminary model in
place of the missing values—the analysis can then be conducted as if
the data were complete except for -changes in degrees of freedom. However,
if information is known about the range of the dependent variable, i.e.,
that 0 £ y.. £ y! where y! is the minimum detectable level for Y., then
the two-stage estimation alone would ignore this useful bit of informa-
tion. Therefore, the two-stage estimation (estimating missing data.on
the basis of complete observation vectors) would be used to set values
when they fall below the minimum measurable level, but only if these
estimated values were within the known range [0,y!]. Thus, the following
inputed value would be used for a missing y..:
^ ^
y.., if 0 ^ y. . < .y'.
0, if y± * 0
y! otherwise
4-7 12-17-76
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where
y*. is the imputed value for the missing y.. value,
/N
y.. is the first-stage estimate of the missing y ., and
y! is the minimum detectable level of Y..
The indicator variable model suggested above for accommodating
missing X variables in regression analysis might be of the following
type:
y.. = I.(QQ + 6^] + (l-I.j)e2 + e.j (4)
where
y. is an observed dependent variable for individual j,
I. is an indicator variable (0,1) according to whether the X obser-
vation is present or missing because it is below measurability,
6, are parameters to be estimated, and
e. is a stochastic error term.
4.3.2 Trace Metal Intake Due to Diet
At the present time, it is anticipated -that environmental levels of
air, water, soil, and dust will be sampled to determine human exposure
to the trace metals of interest. However, it is well known that diet is
also an important contributor of trace metal to an individual. For
example, EPA personnel have indicated that the proportion due to diet of
the total lead absorbed by individuals may be"as high as .66. In
addition, the amount of lead in various diets may vary by several
orders of magnitude. Accordingly, it may be quite important to the
success of the present study to obtain some measure of the amount of
trace metals in the diets of the sample individuals. Procedures which
have been suggested for obtaining diet trace metal levels include:
4-8
12-17-76
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(i) feces samples,
(ii) analyzing duplicate diets from sample individuals,
(iii) adding questions about diet to the individual's question-
naire, and
(iv) analyzing area grocery store food samples.
At the present time, EPA and RTI personnel are investigating these
procedures to determine if one or more of them should be incorporated
into the present study. Accordingly, it may be appropriate to field
test these procedures to determine their accuracy and feasibility.
4.4 Personnel
The analysis of the data for the current project will be under the
direction of Senior Statistician Dr. Kenneth Poole who is the manager of
RTI's Statistical Methodology and Analysis Center (SMAC). Working with
Dr. Poole in analyzing the data will be Senior Statistician Dr. Tyler
Hartwell who is also a member of SMAC. In addition, Programmer Ms.
Lois Bressler from the Computer Applications Center (CAC) will assist
Drs. Poole and Hartwell with the data processing.
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APPENDIX 4.1
RESUMES OF RTI PROJECT STAFF
4-10 12-17-76
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W. KENNETH TOOLE, Head, Statistical Methodology Department
Professional Experience
1967 to date. Research Triangle Institute, Research Triangle Park, North
Carolina, 27709. Statistician, Statistics Research Division. Consults
in matters.relating to the theory and application of stochastic processes.
Does applied research in reliability, regression analysis and estimation.
Education
B.S., Mathematics, Austin Peay State University, Clarksville, Tennessee,
1961.
M.P.H., Biostatistics, University of North Carolina, Chapel Hill, North
Carolina, 1963.
Ph.D., Statistics, University of North Carolina, Chapel Hill, North
Carolina, 1968.
Held a one-year traineeship at Vanderbilt University during 1961-1962.
Attended a. six-week summer session on Biostatistics at Stanford University,
1962.
Professional Activities
American Statistical Association, member.
Institute of Mathematical Statistics, member.
Selected Publications
"Particle Size Distribution and Hopper Flow Rates," with E. D. Sumner,
Journal of the Pharmaceutical Sciences, Vol. 55, No. 12, December 1966.
"Water Absorptive Properties of Selected Solids in a Lipophilic Base I,"
with E. D. Sumner, D. N. Entrekin, and A. F. Ike, Journal of the
Pharmaceutical Sciences, Vol. 58, No. 1, January 1969.
"Some Aspects of Linear Prediction in Stationary Time Series," Institute
of Statistics Mimeo Series, No. 566, University of North Carolina,
Chapel Hill, North Carolina, 1968.
"An Investigation of Certain Physical and Mechanical Properties of Wood-
Plastic Combination," with Eric Ellwood, Robert Gilmore, and James A.
Merrill. ORO-638, Isotopes-Industrial Technology, Division of Technical
Information, United States Atomic Energy Commission.
"Fertility Measures Based on Birth Interval Data." Theoretical Popula-
tion Biology, Vol. 4, No. 3, pp. 357-387, September 1973.
"Some Methodological Issues in Cohort Analysis of Archival Data," with
K. 0. Mason, H. H. Winsborough, and William M. Mason, American Socio-
logical Review, Vol. 38, pp. 242-258, April 1973.
"Estimating the Effect of Unwanted Fertility of a Post-Parturn Re-
cruitment Strategy," with J. R. Udry. American Journal of Public Health,
Vol. 64, No. 7, pp. 696-699, July 1974.
4-11
12-17-76
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"The Estimation of Examiner Error and the True Transition Probabilities
for Teeth or Surfaces in Dental Clinical Trials," with B. V. Shah and
A. C. Clayton. Archives of Oral Biology, Vol. 18, pp. 1291-1302, 1973.
"Estimation of the Distribution Function of A Continuous Type Random
Variable Through Randomized Response," Journal of the American Sta-
tistical Association, Vol. 69, No. 348, December 1974.
"An Index of The Economic Welfare of Rural Families," Frances M.
Magrabi, Jean L. Pennock, W. Kenneth Poole and J. Valley Rachal.
Journal of Consumer Research, Vol. 2, #3, pp. 178-187, December 1975.
"Diphenylhydantoin and Phenobarbital Concentration In Saliva and Plasma
of Man Measured by Radioimmunoassay," C. E. Cook, Ellen Amerson,
W. Kenneth Poole, Philip Lesserr -and Lorcan O'Tauma. Clinical Phar-
macology and Therapeutics, Vol. 18, //6, pp. 742-747, December 1975.
"A Computer Program for Multiple Decrement Life Table Analyses" with
P. C. Cooley, to appear in Computer Programs in Biomedicine.
9/76
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TYLER D. HARTWELL, Senior Statistician
Professional Experience
1964 to date. Research Triangle Institute, Research Triangle Park,
North Carolina, 27709. Statistician, Statistical Methodology and
Analysis Center. The work has involved the application of statistical
methods to a wide variety of research areas. Considerable experience
in using statistical computer packages to analyze laboratory and sur-
vey data. Research areas have included: analysis of the impact on
environmental variables of nuclear power plants, estimation of the
incidence and prevalence of head and spinal cord injuries, analysis
of survey instruments and procedures designed to measure English
language proficiency, use of ridge regression in copper smelter gas
blending for' control of sulfur dioxide, investigation of the role of
leadership in preventing drug abuse in the army, evaluation of
training methods designed to help army leaders reduce social problems
in their units, investigation of the relationships between drugs and
crime, projecting the supply of nursing manpower, evaluating sampling
techniques as related to a national assessment of education, simulat-
ing hospital utilization, projecting U. S. manpower requirements for
short-term general hospitals, method comparison of N0_ air-monitoring
instruments, investigation of the relationships between atmospheric
oxidant and various pollutant and meteorological variables, time
series analysis of non-stationary rocket vibration data, design of
chemical experiments, and estimating tolerance limits from censored
samples.
1962 to 1964. North Carolina State University, Raleigh, North Carolina.
Graduate work in the Department of Experimental Statistics.
1961 to 1962. Autonetics, a Division of North American Aviation,
Downey, California, Mathematical Analysis Group. The work included
systems reliability, data analysis and developing computer programs.
Education
B.S., Mathematics, University of Michigan, Ann Arbor, Michigan, 1961.
M.E.S., Statistics, North Carolina State University, Raleigh, North
Carolina, 1964.
P.h.D., Statistics, North Carolina State Universtiy, Raleigh, North
Caroina, 1971.
Professional Activities
American Statistical Association, member.
Biometric Society, member.
Phi Eta Sigma
Phi Kappa Phi
Selected Publications
"Expected Mean Squares for Nested Classifications," with D. W. Gaylor,
Biometrics. Vol. 25, pp. 427-430, 1969.
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"Simulation of Hospital Utilization," with D. G. Horvitz and
J. R. Batts, Proceedings of the American Statistical Association,
Social Statistics Section, pp. 129-138, 1970.
"Estimating Variance Components for Txvo-Way Disproportionate Data
with Missing Cells by the Method of Unweighted Means," with
D. W. Gaylor, Journal of the American Statistical Association,
Vol. 68, pp. 379-383, 1973.
"Compariability of Nine Methods for Moitoring NO- in Ambient Air,"
with C. A. Clayton, Environmental Monitoring Series, EPA-650/4-74-012,
1974.
"Head and Spinal Cord Injury: A Pilot Study of Morbidity Survey
Procedures," with W. D. Kalsbeek, submitted to American Journal
of Public Health. 1976.
"Estimating Morbidity Trends by Means of a Source Panel Design," with
W. D. Kalsbeek. Paper presented at 104th Annual Meeting of the
American Public Health Association, Miami Beach, Florida, October,
1976.
"Investigation of the Role of Multihearth Roaster Operations in
Copper Smelter Gas Blended Schemes for Control of SO ," with
B. H. Carpenter and K. J. C. Smith, submitted to Environmental Science
and Technology, 1976..
"Preliminary Analysis of Nonradiological Environmental Data at the
Zion Nuclear Power Plant," Research Triangle Institute, Research
Triangle Park, North Carolina, 1976.
"Design, Data Collection and Analysis of a Field Test of Instru-
ments and Procedures to Measure English Language Proficiency,"
Research Triangle Institute, Research Triangle Park, North Carolina,
1976.
"Examining the Properties of Qualified Observer Opacity Readings
Averaged Over Intervals of Less Than Six Minutes," Research-Triangle
Institute, Research Triangle Park, North Carolina, 1976.
"An Experimental Evaluation of Three Training Methods Designed to
Help Company Level Army Leaders Reduce the Incidence of Social
Problems in Their Units," Research Triangle Institute, Research
Triangle Park, North Carolina, 1975.
"The Role of Company Level Leadership in Preventing Drug Abuse in
the Army," Research Triangle Institute, Research Triangle Park,
North Carolina, 1974.
"Review of Methods of Estimating Number of Narcotic Addicts,"
Research Triangle Institute, Research Triangle Park, North Carolina
1975.
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"Trends in Registered Nurse Supply," Research Triangle Institute,
Research Triangle Park, North Carolina, 1975.
"Relationship of Criminal Behavior and Drug Abuse: Phase I: The
Identification, Evaluation, and Possible Utilization of Available
Data Sets," Research Triangle Institute, Research Triangle Park,
North Carolina, 1975.
"Examination of the Relationships Between Atmospheric Oxidant and
Various Pollutant and Meteorological Variables," Research Triangle
Institute, Research Triangle Park, North Carolina, 1975.
"Investigation of Motion Control and Fiber Lab Instrument Performance
in Determining the Characteristics of Cotton Samples," Research Triangle
Institute, Research Triangle Park, North Carolina, 1972.
"Evaluation of Sampling Plans which Determine the Characteristics of
a Bale of Cotton," Research Triangle Institute, Research Triangle
Park, North Carolina, 1972.
"Effects of Nitrogen Oxide Levels on Health Characterisitcs of Persons
in Chattanooga, Tennessee," Research Triangle Institute, Research
Triangle Park, North Carolina, 1973.
"Ten. Year Projections of U.S. Manpower Requirements for Short-Term
General Hospitals in Five Personnel Categories, Research Triangle
Institute, Research Triangle Park, North Carolina, 1973.
"Estimation of Annual Ingestion of Strontium-90 from Two Diets in
Selected Segments of the U.S. Population," Research triangle Institute,
Research Triangle Park, North Carolina, 1966.
"Advanced Studies of Stochastic Processes: Power Spectral Analysis
in Non-Stationary Models," Research Triangle Institute, Research
Triangle Park, North Carolina, 1967.
"Methodology for Assessing the Harzards of Electromagnetic Radiation
to Ordinance: Statistical Tolerance Limit Calculations With and
Without Censoring of the Data," Research Triangle Institute, Research
Triangle Park, North Carolina, 1968.
10/76
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LOIS D. BRESSLER, Programmer
Professional Experience
1969 to date. Research Triangle Institute, Research Triangle Park, North
Carolina 27709. Programmer, Computer Applications Center. IBM 370/165 OS,
FORTRAN, and statistical package programs.
1967-1969. General Telephone Company of the Southeast, Durham North Carolina.
Programmer and systems programmer. IBM 360/30 and 40 DOS, PL/I and Assembler
Language, billing applications and systems programming.
Education
B.A., Mathematics, University of North Carolina, Asheville, North Carolina,
1966.
Graduate work in linguistics and computer science, University of North Carolina,
Chapel Hill, North Carolina, 1970-1972.
Selected Publications
Improved Exposure Measurements. S. B. White, C. A. Clayton and L. D. Bressler.
Prepared for U.S. Department of Transportation, National Highway Traffic '
Safety Administration, Washington, D.C., September 1975.
North Carolina Educational Policy Plans for the 1970's. Alvin M. Cruze,
Stephen A. Johnston and Lois A. Bressler. Prepared for North Carolina
Department of Administration, Raleigh, N.C., April 1974.
January 1976
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APPENDIX 4.2
REFERENCES
4-17 12-17-76
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REFERENCES
4.1. Triangle Universities Computation Center (TUCC), Memorandum:
TUCC Security Features (General Information Series Document
No. GI-066-1). Research Triangle Park, North Carolina: TUCC,
February 1976.
4.2. Sarhan and Greenberg, Contributions to Order Statistics. New
York: John Wiley & Sons, Inc., 1962.
4.3. Cochran, W. G. and G. M. Cox, Experimental Designs. New York:
John Wiley & Sons, Inc., 1962.
4.4. Service, J., A User's Guide to the Statistical Analysis System
(SAS). Raleigh: North Carolina State University, 1972.
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