Document 6BwOjr8bLrD763V7ZKqmXByY9
FROIM: 366-3951
/ TO:
RONALD D. SNEE
Engineering Department Louviers 5(185
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E. I. Z Po n t Z O NO u r s & CV n y & W t o n, DO V V O 19898
ENGINEERING DEPARTMENT LOUVIERS BUILDING
February 14, 1984
Project Officer for Lead Environmental Criteria and Assessment Office U. S. EPA MD-52 Research Triangle Park, NC 27711
In accordance with 48FR43724 and 48FR56639, E. I. du Pont de Nemours and Company herewith submits comments on External Review Draft No. 1, Air Quality Criteria for Lead, Docket No. ECAO-CD-81-2.
John M. Pierrard Environmental Manager Chemicals and Pigments Department
Charles G. Pfeifer Consultant Statistician Engineering Department
Ronald 0. Snee Consultant Supervisor Engineering Department
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DOCUMENT REVIEW FORM
Title/Draft
Air Quality Criteria for Lead (External Review Draft #1)
Return to:
Project Officer for Lead Environmental Criteria and
Assessment Office, D.S. SPA MD-52 Research Triangle Park, NC 27711
Coinmen ter /Organizat ion/Address *
Chapter No./Title
John M. Pierrard E. I. du Pont de Nemours and Co., Inc. Wilmington, DE 19898
Chapter 11. Assessment of Lead Exposures and Absorption in Human Populations
RECOMMENDATIONS
(1) Acceptable as is
D (2) Acceptable alter minor revision
B (3) Acceptable after major revision (4} Not acceptable
If you have checked cither 3 or A, please specifically state reason(s) in the comments space below.
fh. Raviewer's Signature
Date
Additional Contributors to Document Review (Name and Affiliation)
Prof. Richard L. Anderson Statistical Consultant Lexington, KY 40502
Charles G. Pfeifer Ronald D. Snee E. I, du Pont de Nemours and Co., Inc. Wilmington, DE 19898
General Comments (use extra pages if needed, tut please be concise)
These comments relate to the treatment of the NHANES II blood lead results and the associated report of the Time Trend Analysis Review Group, and the Billick analysis of blood lead screening data. We are convinced that major changes in the criteria document are required to accurately portray the meanings of these studies. Du Pont has conducted comprehensive separate analyses of the studies and is submitting, as part of this document review, the reports, "Analysis of Reported Blood Lead Level Declines During NHANES II and Their Relationship To The Survey Design and Gasoline Lead Exposure" and "Analysis of a Study by The Department of Housing and Urban Development on Blood Lead Levels of Children in New York City". We are further submitting the report "Comments on January, 1984 Draft of Du Font's Analysis of Blood Lead Level Declines", by Dr. R, L, Anderson, Professor of Statistics in the Statistics Department and Assistant to the Dean for Statistical Services, College of Agriculture, University of Kentucky, and former President of the American Statistical Association.
*If comments being submitted on behalf of another organization, include that information.
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General Comments (Continued)
As noted in our report on the NHANES II blood lead study, we believe that the report of the Time Trend Analysis Review Group leaves the misleading impression that the reported 5-6 ug/dl blood lead decrease actually occurred, whereas our analysis, making use of statistical techniques and site location data beyond those in the analyses reviewed by the Group, shows that up to 70 percent of the reported decline in blood lead levels is explainable by survey demographics.
Our analysis of the NHANES II data and our review of the CDC, NCHS and EPA analyses lead to the further conclusions that (1) the analyses reported by CDC, et al, which formed the basis for the Group review, are flawed by technical error and their conclusions are misleading, (2) national gasoline lead use is an inappropriate measure of gasoline lead exposure; site specific gasoline lead use is more appropriate, (3) when site specific gasoline lead is used as the exposure measure, gasoline lead use accounts for only 0.25 to 0.75 yg/dl of the reported blood lead decline, and (4) factors in addition to differential site demographics and gasoline lead exposure are responsible for some of the reported blood lead decline.
As noted in his review. Prof. Anderson concurs with our findings on the technical errors in the analyses of CDC, et al, as well as the superiority of our analytic approach. The January, 1984 draft of our report, reviewed by Prof. Anderson, contained the identical technical substance as the edited version submitted as part of this review.
For these reasons, we strongly recommend that the Review Group make appro priate amendments to their report after review of our analyses, and that the Criteria Document also be appropriately amended.
Based on Du Pont Vs. analysis of the New York City blood lead study, we conclude that neither HUD's gasoline lead data nor the New York City blood lead data are adequate to determine a meaningful blood lead-gasoline lead relationship. As detailed in our report, we maintain that EPA's reliance on the HUD study is improper because (!) HUD used the wrong data to represent gasoline lead use in New York City, (2) the HUD blood lead data are seriously flawed by sampling irregularities, procedure changes and data handling inconsistencies, (3) HUD'S treatment of the blood lead data suffers from serious deficiencies which further contribute to the already formidable difficulties in proper inter pretation, (4) HUD's blood lead-gasoline lead relationship is unreliable.
Accordingly, we recommend that the Criteria Document be appropriately amended to more accurately reflect the significant limitations of the Billick studies.
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COMMENTS ON JANUARY 1984 DRAFT OF DUPONT'S ANALYSIS OF BLOOD LEAD LEVEL DECLINES
R. L. Anderson*
1. Model (1) in Section IIIA is better than that presumably used by CDC/EPA, because it includes between site effects of the within site X-Variables.
2. The use of a two stage procedure is approved because the between-site X and Z values are orthogonal to the within-site X variables. If we have an X'% matrix As follows:
Xw' Xw X"-Zw
This two-stage procedure avoids the necessity of using a more complicated weight matrix. The latter would be needed in a single-stage analysis because a two-stage sampling plan involves both within and between site variance components. It is quite possible that the use of between site regression coefficients as well as within site regression coefficients will reduce the size of the trend decline in blood lead levels.
Statistical Consultant, 33119 Braemer Dr., Lexington, Ky. 40502. February 10, 1984
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2/
3. When we now append a vector, say T, for the linear trend to the W-part of the above matrix, we note that (X^ T) and (Z^ .T) will not be null. It appears from the
discussion of the CSMB -procedure that T was not adjusted for Xw and Zw ; if .so, the CSMB - procedure probably will produce a biased estimate of the linear time trend of blood lead levels.
On the other hand, the unbiased estimate of this linear time trend by adjusting for T and T (as I presume was done in the CDC/EPA procedure) may not provide an unbiased estimate of the change in blood lead level per unit time. In a multiple regression model with a number of X's and T,
EY = ZB X + V = Vl iii
btT'
b^ represents the predicted change in Y when X. is increased by one unit, provided the other X's remain fixed. Unfortunately in the blood lead problem, if we change T by one unit,.many of the X's will change; hence, an unbiased effect of a unit change in time probably is not bfc.
There is no known statistical technique to handle the last problem, but I would examine the X, Z and T vectors to see if it is possible to obtain sets for which the row elements of the (X(Z) vectors are nearly alike. Determine the population weight and the value of bfc for each set. Then weight the bfc's by the population weights. This weighted average b^. should have less bias than the over-all b^; however, its variance might be increased so much that its mean square error is not improved. This is a problem which should have been understood before the survey design was selected. I believe it would have been possible to select a survey design which would have minimized the bias in b as an estimator of the true time trend in blood lead level.
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h. An important aspect of this investigation should be an attempt to explain the decline in blood lead levels over time by one or more causitive variables. Time is an innocent surrogate for unidentified causitive variables. One such possible causitive variable is the amount of gas lead explosure. I would hope that something better could be used than site exposure based on National Gas Pb. Hie site specific variable suggested by the Dupont investigators appears to be more useful. I would like to see how much of the decline in blood lead level can be attributed to this site specific gas lead variable, when the proper adjustment mentioned above for T is used. One computational procedure is to determine the value of b. after adjustment for gas lead as well as the other site variables.
5. I would also suggest that we analyze gas lead in the same way as blood lead (i.e., gas lead as the dependent variable, y); then perhaps we should consider a canonical correlation between the two regressions. In other words one essentially has three regressions:
E(blood lead) = 6^^ +B^T; E(gas lead) = SsiXi + 8 tT E(blood lead) - BE(gas lead). I am not an expert in multivariable analysis, but it appears we have here two random variables (amount of blood lead and amount of gas lead), with a large number of non-random causitive variables plus T, the surrogate for other un named causitive variables. Perhaps there is a better procedure to analyze such data than using multiple regression. I feel that the CDC/EPA report dodges the many important aspects of this problem. I sympathize with anyone who attempts
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to analyze data based on a poor survey design. I cannot understand why there
were not some revisits to the same sites and if possible to the same respondents.
I thought that the use of overlapping samples was almost obligatory for detecting time
trends
(see the work of Kulldorff, among others).
6. In this respect, I was asked to comment on the need to consider the survey design in 'the analysis. I realize that many of my colleagues would advocate such, but I doubt that the improvement in estimates would even Compensate for the added variability induced by the use of estimated weights; for this reason, I applaud the two-step procedure by the Dupont statisticians.
7. Finally, it appears that even with the use of the amount of gas lead in the analysis, there may remain a large unexplained downward trend in blood lead levels, I suggest that the model include a(0,1) dummy variable for before and after the late 1979 regulation. I would also attempt to discover if there were some other variables which might explain some of the extremely high and low blood lead site values (Figure 1, 2. and 3 in Section III).
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DOCUMENT REVIEW FORM
Title/Draft Air Quality Criteria for Lead (External Review Draft #1)
Commenter/Organization/Address *
Ronald D. Snee Charles 6. Pfeifer E. I. du Pont de Nemours and Co., Inc. Wilmington, DE 19898
Return to:
Project Officer for Lead Environmental Criteria and
Assessment Office, U.S. EPA MD-52 Research Triangle Park, NC 27711
Chapter No./Title
Chapter 11. Assessment of Lead Exposures and Absorption in Human Populations
RECOMMENDATIONS
D 0} Acceptable as is
(2) Acceptable after minor revision 0 (3) Acceptable after major revision
(4) Not acceptable
II you have checked either 3 or 4, please specifically state reason(s) in the comments spece below.
Additional Contributors to Document Review (Name end Affiliation)
^v^^sS^nature '
Date
General Comments (use extra pages if needed, but please be concise)
1. Refer to end of Section 11.3.5, page 31,
Reference to analytical variability and associated impact on misclassif lo cations is important. This discussion needs to be extended to other studies as well. In our comments of January 31, 1983 to David Weil on the December 15, 1982 draft of Chapter 11, we offered a table (Table B.l, page 31) comparing variance components for six studies. We regard such a table and improved discussion of analytical and person-to-person variance components as essential to the Criteria Document. Attached is a copy of this table.
*I comments being submitted on behalf of another organization, include that information.
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General Comments (Continued) 2. Refer to Table 11-62
Reference is made to Snee, R. D.; Pfeifer, C. (1983) regarding a statistical test that detected no differences among blood lead-air lead slopes over many studies for adult males, adult females and children. This reference is based on our comments of January 31, 1983 to David Weil on the December 15, 1982 draft of Chapter li. However, in spite of this conclusion. Table 11-62 presents a summary of blood lead-air lead slopes for several studies without putting these slopes in context according to our result. Further, the Roels, et al (1980), and Yankel, et al (1980), are inappropriate for inclusion here because of their inherent problems. 3. Omission Charles G. Pfeifer should be included as a member of the Scientific Peer Review Panel and contributor to Chapter 11.
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- 31 -
TABLE 61 VARIABILITY SUMMARIES OF BLOOD LEAD VALUES
Study
geometric Standard Deviation
TTJ "" (2)
PT Number of
Overall Analytical Person-to-Person Subjects Populations
NHANES II
1.365(4)
Azar, et al (1975)
1.354(6) 1.301(?)
Yankel, et al (1977) 1,293(7)
Tepper and Levin (1975)
1,304(6) 1.313(7)
McLaughlin, et al (1973)
1.531(6)
Johnson, et al (1976) 1.549(6)
1.155(5) 1.227(6)
1.155(9) 1.268(6)
1.493(6)
1.476(6)
1.317 1.250(6) 1.180(8)
1,237 1.127(6) 1,143(8) 1.156(6)
1,222(6)
149 880 1935 217 241
5 7 11 23 6
22 (1) GSD overall * exp (aa + a*; )^2]
(2) GSD analytical - exp (oa)
(3) GSD person-to-person - exp (at)
(4) Computed by Du Pont (see November 12, 1982 letter to Dr. Weil regarding comments on Chapter 11)
(5) Computed from NHANES II blind QC data by Annest, et al
(6) From Lucas (1981)
(7) Pooled from GSD's presented In December 15, 1982 Criteria Document Draft of Chapter 11
(8) Estimated from (6) and (7)
(9) Value obtained from NHANES II and used as a conservative approximation to evaluate the person-to-person component.
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ANALYSIS OF REPORTED BLOOD LEAD LEVEL DECLINES DURING NHANES II AND THEIR RELATIONSHIP TO THE SURVEY DESIGN AND GASOLINE LEAD EXPOSURE
by Charles G. Pfeifer Engineering Department
John-M, Pierrard Chemicals and Pigments Department
Ronald D, Snee Engineering Department
February 14, 1984 E. I. du Pont de Nemours and Company, Inc*
Wilmington, Delaware 19898
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- S2-III -
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02/26/76 07/25/76 12/22/76 05/21/77 10/18/77 03/17/78 08/14/78 01/11/79 06/10/79 11/07/79 04/05/80
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DUP050031113
0
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DUP050031115
APPENDIX 4 Corrected Site Blood Lead Means Versus
Mean Examination Date Based on Between Site Analyses With
Survey Demographic Terms Only Adjustment Sets 1, 1W, and 2
TEH 0530204
DUP050031116
TIME PLOTS OF CORRECTED <BJ SITE MEAN BLOOD LEADS (CORRECTED VALUES FROM MODEL " 1 " )
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DUP050031117
NOTE:
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DUP050031118
Corrected Site Mean Blood Lead (CSMB)
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DUP050031119
APPENDIX 5
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TEH 0530208
DUP050031120
Between Site Model A Untransformed Gas. Lead Exp. Dep. Var.: Adj. Set 2W
1 3 !3 1 SATUROAY, NOVEMBER 1 9 , 1 9 8 3t GCUR75
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DUP050031144
APPENDIX 6 Regression Summaries of Corrected Site
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DUP050031145
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DUP050031147
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DUP050031150
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TEH 0530239
DUP050031151
Corrected Site Mean Blood Lead
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1 3 !3 1 SATURDAY, NOVEMBER 1 9 , 1983t GCUR75
COMPLETE RECORDS FOR BLOOD PB, VARIABLES 1 - 6 , 2 2 - 3 0 , OAYS_PB, LEAO_WT,
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TEH 0530241
DUP050031153
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DUP050031154
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DUP050031155
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DUP050031156
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DUP050031157
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DUP050031158
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TEH 0530247
DUP050031159
Corrected Site Mean Blood Lead Between Site Model G Transformed Gas. Lead Exp. Based on Adj. Set 2W
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DUP050031160
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TEH 0530249
DUP050031161
B'SSi!;; ..43S
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TEH 0530080
DUP050030993
Table IV-2 (Pg. 2 of 2) Site Specific Gasoline Lead
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TEH 0530081
DUP050030994
- IV--9 -
assumed that the association between gasoline sales and population holds at the county level as well. Accordingly, county gasoline lead use was estimated (refer to Eq. 1} as the product of state gasoline lead use and the ratio of 1975 county populations to 1975 state population. To account for differences in the areas of the sites, and the consequent different exposures even if tne same mass of gasoline lead were used, the county lead use value was divided by the land area of each site.
Inspection of Table IV--2 reveals that the two largest gasoline lead exposure values were associated with New York City sampling sites (Sites ID's 19 and 51). This is not unexpected because New York State represents an exception to the strong relationship between gasoline sales and population. Because of the influence of the New York'City area. New York State has much lower gasoline consumption than its population would imply. The nine county New York Standard Metropolitan Statistical Area (NYSMSA) had 1970 population of 11,571,883 persons and gasoline consumption of 1,964,179 thousand gallons [19]. For the same year, New York State population was 18,236,951, and gasoline consumption was 5,506,910 thousand gallons. Thus, 1970 per capita gasoline consumption in the NYSMSA (170 gallons/year) was only 32 percent of that in the non-SMSA portion of the state (532 gallons/year). This pattern is ascribed to congestion and the availability of common carrier commuter facilities in the NYSMSA.
As a result of this exception, these two New York City sites were excluded from all analyses reported in Section V. Further, no gasoline lead data were available from Hawaii and, consequently, Honolulu (Site ID 2) was also excluded from these analyses. In order to achieve fair comparisons between results given in Section III which did not consider exposure to gasoline lead, and those in Section V which did, these three sites were excluded from analyses in Section III as well.
TEH 0530082
DUP050030995
- IV-10 -
IV.8 Comparing National and Site-Specific Measures of Gasoline Lead Exposure
Figure IV-1 is a time plot of quarterly national gasoline lead exposure during the survey period. Here quarterly national lead use (billions of grams) has been divided by U.S. square miles (3,540,023) to express exposure in the same units as the site-specific measure. The plot shows a dramatic, nearly linear, decline in gasoline lead use during the NHANES II survey period. The cor relation coefficient, based on 17 quarterly values starting with 1Q76, is -.79.
Quarterly values of site gasoline lead exposure using (1) were computed for each site throughout the survey period. This was done to determine if the relationship between site gasoline lead exposure and time conformed to the pattern exhibited by the national lead use. These data are provided for each site and quarter in Table IV-3, along with the national values. Correlation coefficients and plots, similar to Figure IV-1, were developed for each site (although the plots are not shown here). Figure IV-2 summarizes these relationships in a histogram of the 51 correlation coefficients corresponding to all sites except New York City and Honolulu. These coefficients are large and negative, and range between -.97 and -.47. Uniformly, the individual site time trends conform to that observed nationally (r-.79).
Each NHANES II site was sampled once during a short time frame within the "1 survey period, roughly about six weeks. A time plot of the site specific
measure is shown in Figure IV-3 where site average GCUR75 is plotted against site average examination date (Days__Pb). The plot reveals only a slight downward trend (r-,10). By taking logarithms, the highly skewed nature of the GCUR75 values is symmetrized. Figure IV--4 is a plot of these logarithms (base 10) versus time. Again, a slight downward trend is present (r=-,17). These figures and correlation coefficients suggest that exposure to gasoline ] lead, as encountered by the survey site itinerary, is not nearly as strongly declining as the four year lead exposure trends based on either national or individual site lead use. : J4
TEH 0530083
DUP050030996
0.000014 + N0V75 FEB76 HAT76 AUS76 NOV76 FEB77 HAT77 AUG77 N0V77 FEB78 MAT78 AUG78 N0V78 FEB79 HAT79 AU679 N0V79 FEBSD HAT80
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TEH 0530084
DUP050030997
Table IV-3
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DUP050030998
Table IV-3 (Pq. 2 of 3)
Quarterly Site and National Gasoline Lead Use
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DUP050030999
Table IV-3 (Pg. 3 of 3)
Quarterly Site and National Gasoline Lead Use
SITE CAS LEAD EXPOSURE (X 10,0001
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TEH 0530087
DUP050031000
ffiSSSSS
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Figure IV-2
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Gasoline Lead Exposure at the NHANES 11 Survey Sites '
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DUP050031001
Figure IV-3 Site Specific Gasoline Lead
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DUP050031002
Figure IV-4
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DUP050031003
- IV--18 -
This observation on the influence of site itinerary is conceptually illustrated in Figure IV--5. The solid lines indicate the strong downward trend in gasoline lead use at the sites during the survey period. The points on these lines show the exposure at the time the site was sampled. The collection of such points, summarized by the dotted line, portrays the exposure encountered by the site itinerary.
The slight trend in Site specific gasoline lead exposure raises suspicion that this variable is not well correlated with blood lead, since blood lead levels dramatically declined during the survey period (see Figure IW). However, a plot of site mean blood lead versus log site gasoline lead exposure (Figure IV--6) demonstrates a fairly strong relationship (r=.49). Thus, the site specific exposure appears to be sensitive enough to detect an expected relationship between blood lead and gasoline lead. In fact, in the analyses reported in Section V, this variable was flagged as significant (p^.05) when adjusting for demographic effects.
Values of GCUR75 vary by a factor of 400. tittle reliabledata is available on the range of exposures to be expected. In the study by Azar, et al [20] where individuals studied for olood lead wore personal air monitors, air lead concentrations varied by a factor of 46. Thus, it may be expected that variation in exposures in a sample as diverse as NHANES II would be even greater. It is common to represent a density measure in regression models by its logarithm due to the typical skewed nature of such data. As the analyses in Section V confirm, there is little difference in the estimated contributions of gasoline lead exposure to the reported blood lead decline when using GCUR75 or log^0GCUR75.
TEH 0530091
DUP050031004
Figure IV-5 Conceptual Illustration of Exposure at Individual Sites
Versus Exposure Encountered by Survey Itinerary
TEH 0530092
DUP050031005
Figure IV-6 Site Mean Blood Lead Vs. Site Specific
Gasoline Lead Exposure
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TEH 0530093
DUP050031006
- IV-21 -
An aspect of the site-specific measure that could result in a time-related bias is the between-site variation in site area (square miles)* Counties or groups of counties are defined by political boundaries rather than natural boundaries. Consequently, if these areas tended to decrease in size according to site itinerary,, there would be a tendency to dampen the true site-specific exposure time trend. Figure IV--7 is a plot of site areas versus site average examination date. No strong trend is apparent. The correlation coefficient is -.20 and this is exaggerated negatively by the influential site near the beginning of the survey.
Another way to investigate a potential time bias in the site-specific exposure is to relate county lead use versus site average examination date. County lead use is state lead use proportioned by the fraction of the state's population living in counties representing a survey site (see Eq. 1). County lead use divided by county size gives the site specific measure. The time correlation coefficient for county lead use is -.13. Consequently, variation in county size appears to have little Impact on the exposure-time trend relationship.
Inherent in the site specific measure of gasoline lead exposure is Specification error due to a nonuniform distribution of gasoline lead within a sampling site. A measure of gasoline lead exposure that accounts for variation within sites would help to alleviate this limitation. Unfortunately, on the basis of available data, it is impossible to derive an exposure measure to account variation between individuals within sites. At best, one might investigate an exposure measure accounting for variation between subsites within sites.
It is expected, though, that the specification error associated with the site specific exposure measure is of much less severity than that resulting from use of national gasoline lead exposure, where all individuals in the U.S., regardless of location, are assumed to have the same exposure to gasoline lead in a calendar quarter.
TEH 0530094
DUP050031007
Figure IV-7
Site County Areas Versus Examination Date
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TEH 0530095
DUP050031008
f
V. Effect of Exposure to Gasoline Lead on Reported Blood Lead Decline
In this section the results of analyses accounting for exposure to gasoline lead are presented, the modelling approach is that described in Section III..A where a between-site analysis is performed on the set of adjusted site blood lead means obtained from the within-site analysis. The only difference is that the between-site models incorporate, In addition to survey demo graphics, one or more terms (2-type covariates) for gasoline lead exposure.
Based on the regression results three methods are investigated for estimating the amount of the blood lead decline ascribable to exposure to gasoline lead. The first compares the residual blood lead trend before and after removing the effects of gasoline lead exposure. The second uses the estimated blood lead/ gasoline lead coefficients to estimate the decline for the survey sites over the four year period, and the third uses the blood lead-time coefficient.
The collective results of these analyses suggest that site specific exposure to gasoline lead accounts for less than 1.0 ug/dl of the blood lead decline. The key results are presented in Tables 5, 6, 12, 13, 15 and 19,
V.A Results of the Between-Slte Analyses
i The four sets of adjusted site mean blood leads, based on results of within-site analyses on models 1, 1W, 2 and 2W (see Appendix 1), are used as the dependent variables in the between-site analyses that follow. The only change from the between-site models shown in Table II1--6 is the inclusion of one or more Z-type covariates reflecting current or lagged exposure to gasoline lead at each survey site.
The key feature of the measure of gasoline lead exposure used is that it attempts to reflect the exposure of the sampled individuals at each site at the time the site was visited during NHANES II. This is essential since it was shown in Section IV that the gasoline lead exposure time trend, reflecting site itinerary during NHANES II, corresponds neither to the national gasoline lead use trend nor the lead use trend at any single site over the entire survey period. u
TEH 0530096
DUP050031009
- V-2 The four gasoline lead exposure variables considered were current site exposure (GCUR75), thirty day lagged exposure (GLAG75), forty-five day lagged exposure (GLAG275), and sixty day lagged exposure (GLAG375). The lagged measures were constructed analogous to that described in Section IV for GCUR75. The values for each record correspond to the date preceding the examination date according to the lag interval (ie, 30, 45 or 60 days). The individual measures were averaged within sites and the site averages used in the between-site analyses. Table V-l presents a listing of these site averages. A variety of between-site models were investigated for Adjustments Sets 1, 1W, 2 and 2W. These between-site models, involving gasoline lead exposure terms, will be referred to by letters A-K. Table V-2 indicates the gasoline lead exposure terms included in each model. Two variations of each between-site model were investigated - one where the gasoline lead exposure measures are considered in untransformed form and one where each was transformed to log^g units.
TEH 0530097
DUP050031010
Table V-1
Site Averages of Current and Lagged Site Specific Gasoline Lead Exposure
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TEH 0530098
DUP050031011
Table V-1 (Pg. 2 of 2)
Site Averages of Current and Lagged Site Specific Gasoline Lead Exposure
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TEH 0530099
DUP050031012
- v-s -
Table V-2
Gasoline lead Exposure Terras Included in Between-Site Models
Between Site Model A B
C 0 E F
G H I J K
No Lag GCUR75
X
X X X
X X
term
30 Day lag 45 Day Lag
GLAG75
GLAG275
X X
X X
XX X XX XX
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X
X X X
Table V-3 presents highlights of the weighted least squares regression summaries on between- site models A-K, where the weights were the reciprocals of the adjusted blood lead site mean variances. For reference , the results of between-site analyses based only on personal, residence, and itinerary survey demographics are included. Inclusion of one or more terms for gasoline lead exposure increased the adjusted R -value from .01 to .07,
Although in most analysis categories it is difficult to justify a best model
p
based on adjusted R-values, model A was marginally the best in all cases when gasoline lead exposure was untransformed and model G was marginally the best in all cases when gasoline lead exposure was transformed. The overall
2
best predictive models on the basis of the maximum R -adjusted criterion were models G, F, E based on Adjustment Sets 2 and 2W. These models include GCUR75 with each of the other lagged gasoline lead terms. Appendix 5 provides
TEH 0530100
DUP050031013
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TEH 0530102
DUP050031015
II
- V-8
the detailed regression summaries for models A, E, F and G based on all adjustment sets and transformed and untransformed gasoline lead exposure terms. For Models A-D where a single gasoline lead exposure term (centered about overall mean) is included, the maximum variance inflation factor (VIF) is 10 or less and usually associated with the urban term. For the other models with more than orte gasoline lead exposure term, the VIF's are considerably higher and, as expected, always associated with the exposure Iw terms. The VIF's among the gasoline lead exposure terms in Models H, I, J and K are exceedingly large and generally have marginally poorer predictive ability than models E, F and G. The VIF's associated with survey demographic terms remain relatively small (ie, less than 11) for all models.
For models using untransformed gasoline lead exposure, one site data record (Washington, D.C.) suggested marginal influence (according to Cook's 0 criterion) on the estimated model coefficients at the fifth-percentile F-distribution value of .60. However, in the case of the models using the transformed gasoline lead exposure, no influential site records were noted.
Table V-4 presents a summary of the regression coefficients for models A and G based on Adjustment Set 2W. The corresponding coefficients from the analysis without gasoline lead exposure terms (see Table VII--6) are included in order to assess the impact of gasoline lead exposure on survey demographic effects.
From Table V-4 it; is seen that the terms reflecting exposure to gasoline lead were flagged as significant (p<.05) in the presence of between-site survey demographic factors. In general, for models A-K the gasoline lead exposure terms were significant at or near the .05 level in all models where one exposure term (log transformed or not) was present or where log^Q GCUR75 and one other log transformed lag term were present. It should be noted, however, that when two or more highly correlated gasoline lead exposure terms are present (refer to maximum VIF's in Table V--3) the coefficients will be driven away from zero in opposite directions. For example,for model G the lagged coefficient is -1.70 suggesting, by itself, thatthe higher the lagged gasoline leadexposure, the lower the expected blood lead level. This
I
TEH 0530103
DUP050031016
- V-9 -
Table V-4 Coefficients Compared in Analyses of Adjustment Set
With and Without Gasoline Lead Exposure
Model Terms
Without Gas Pb Exposure
Coeff.
t-value
With Gas Pb Exposure
Model A
Mode l G
Coeff.
t--value Coeff.
t-value
Black
,34*
2.00
,20
1.16
.12
.73
Male
41
,78
.52
1.04
.35
.73
Child
.54
1.65 ,24
.71 ,14
,41
Teen
1.09
1,78
1.34*
2,24
1,06
1.80
Income
,53*
2.43
.52*
2.47
.45
2.21*
Bl_MA
8.59*
2.08 7.39
1.85
4,97
1.25
BL_CH
-.30
-.23
>16
.12 .85
.67
BL_TN
-1-26
-.41
-.62
-.21 -1.73
-.60
BL_IN
1.74*
1,34
1,73
1.39
1.78
1.50
MA_CH
-11.49
-2.16
-9.86
-1.91 -6.39
-1.23
MAJ'N
2,28
.16 4.77
,35 7.91
.61
MA_IN Si CHJN
-.43 .50
-.12 ,21
-.46 -.46
-.14 -.20
-.30 -.69
-.09 -.31
TN_IN
-2.35
-.49
-.91
-.19
1.34
.29
Urban
.22* 2.61 .08 .76 .03 .32
CC
-.17
-1,59
-.14
-1.25
-.08
-.78
Winter
-.12
-1.83
-.14*
-2.19
-.13
-2.14*
Spring
.04
.61 .01
.15 -.09
-1.21
Summer
.06
1.05
.06
1.02
-.03
-.43
South
-.09
-1.05
-.07
-.93
-.07
-.90
West
.09
1,27
.15
2.02
,09
1.27
Northeast
.10
1.71
.07
1.29
,03
.61
Lead Wt
9.7(xl0"-7)
.14
27.5(xl0"7) -.41 24.2(xlO-7) -.38
1og10 GCUR75 log1Q GLAG375
.12* 2.11 1.82
2.25*
-1.70
-2.11*
| flagged as significant at P. 05
TEH 0530104
DUP050031017
- V-10 -
interpretation is: clearly implausible. It is well known that the individual coefficients among highly correlated terns provide little useful information. At best, the impact of the fitted exposure coefficients may be evaluated as a set.
The other aspect of the results in Table V-4 to be noted is the comparison of survey demographic coefficients. Following the analysis presented in Section III, inclusion of the single gasoline lead exposure term changed the t-value by more than one unit only for Urban; inclusion of two exposure terms resulted in a one unit t-value change for Black, Child, Urban, Spring and Northeast. Comparing coefficients between Models A and 6, t-values for Spring and Summer changed by more than one unit.
The VIF for logjQGCUR75 is 7.50 in Model A which implies 86.7 percent of the variation in log10GCUR75 can be explained by variation in survey demographics. For Model G, the VIF for log2gGLAG375 is 1734 which implies over 99.9 percent of its variation can be explained by survey demographics and log^0GCUR75. From this perspective it is doubtful that additional information can be gained by including, in general, more than one term for gasoline lead exposure.
V.B Estimation of Blood Lead Decline Attributable to Site Specific Gasoline
Lead Exposure, .
________________ .
In this section,, three approaches to estimating the contribution of exposure to gasoline lead are examined, The first compares residual trends from between-site models with and without gasoline lead exposure terms. The second employs the regression coefficient of gasoline lead. Tne third uses a time coefficient adjusted for survey demographics and gasoline lead exposure.
TEH 0530105
DUP050031018
V.B.l Comparison of Residual Blood Lead Time Trends
Following the same basic approach as described in Section III.D, residuals from between-site Models A-K (based on adjusted site blood lead means from within-site analyses and transformed and untransformed terms for gasoline lead exposure) were regressed on site mean examination date. This residual blood lead time trend is the trend that remains after the effects of survey demographics (P, R, and I terms) and gasoline lead exposure have been removed. Comparing this time trend to the one obtained when only effects of survey demographics were removed provides a way to isolate the contribution of gasoline lead exposure to the reported blood lead decline.
Table V-5 provides a summary of these results for all models and situations evaluated. The residual decline Ug/dl) is estimated by computing the difference between the predicted residual blood lead at the mean examination date of all venous blood lead examinees at the first site sampled (Day 16.46 after survey began) and the last site sampled (Day 1452.93) in NHANES II. The contribution of exposure to gasoline lead is then estimated by comparing residual blood lead declines from Models A-K with that associated with a model only accounting for survey demographics. Df the 88 analyses performed, estimates of the contribution of gasoline lead exposure ranged from .11 to .67 vg/dl. Models 6, F and E, based on Adjustment Sets 2 and 2W, were identified in the previous section as giving the highest adjusted R -values. The contribution estimates from these analyses were all .52 ug/dl, which reflects approximately 10 percent of the reported blood lead decline.
TEH 0530106
DUP050031019
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TEH 0530107
DUP050031020
- V--13 -
The analyses of Models A-K are not conditional analyses where terms for gasoline lead exposure were fit after the survey demographic terms. Rather, residual blood lead time trends were evaluated from two separate least squares analyses where all terms were simultaneously fitted each time. Because of this, it is felt that this is a viable and fair approach to isolating the contribution of gasoline lead exposure to the reported blood lead decline. All of the residual blood lead declines (.93-1.51 ug/dl) from Models A-K were significantly (p<:.05) greater than zero. Therefore, the individual coef ficients of model terms will be biased to the extent that they are correlated with unaccounted for causes of the remaining trend. However, it is felt that the approach here, which computes the gasoline lead contribution by differencing, diminishes the impact of biasing in the individual regression coefficients.
A single term for time (Days_Pb) was included in the residual regressions from Models A-K. Although this may not be the best model to estimate the blood lead decline in all analyses performed, for purposes here and in view of the data limitations!, this seems to be more than adequate. Figures V-l and V-2 j are plots of the corrected (residuals plus overall mean) site means versus site mean examination date for Model G based on Adjustment Sets 1W and 2W, respectively. These plots typify the general linear behavior present in all analyses. The details of the regressions of corrected site mean blood leads on time are presented in Appendix 6 from Models A, E, F and G based on Adjustment Set 2W. According to Cook's D criterion, no sites were identified as influential in these analyses.
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TEH 0530108
DUP050031021
Figure V-l Corrected Site Blood Lead Means
from Between Site Model A Based on Adjustment Set 1W
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TEH 0530109
DUP050031022
Figure V-2 Corrected Site Blood Lead Means
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DUP050031023
- V--16 -
One last set of between-site analyses were performed to evaluate the contribution to the blood lead decline of gasoline lead exposure by comparing the trend present in the adjusted site mean blood leads with the residual trend based on a model accounting for effects of current exposure to gasoline lead (and lead weight) but not in the presence of survey demographics. These, analyses are summarized in Table V-6 and follow the format and interpretation of the entries in Table V-5. The estimated contributions range between .27 and .75. ug/dl. Interestingly, even when ignoring effects of survey demographics, the single term for exposure to gasoline lead is estimated to contribute only slightly more to the blood lead decline than when survey demographics are accounted for.
V.B.2 Use of Blood Lead/Gasoline Lead Regression Coefficients
In each of the analyses with Models A-K, regression coefficients associated with gasoline lead exposure terms were estimated. In this section these coefficients are used to estimate the blood lead decline during NHANES II attributable to gasoline lead exposure. In order to do this a reliable measure of gasoline lead exposure at the beginning and end of NHANES II is needed. Since the blood lead-gasoline lead coefficients were based on 61 of the 64 survey sites, the contribution of gasoline lead exposure should be evaluated based on the change in gasoline lead exposure during the survey that collectively occurred for these 61 survey sites.
V.B.2.a. Description of Computations
Three computational methods were investigated to evaluate the collective change in exposure to gasoline lead at the survey sites. Basic to the computations was either a state or national gasoline lead use value associated with the beginning and ending quarters of NHANES II. These lead use values were then converted to gasoline lead exposure measures analogous to GCUR75, GLAG75, GLAG275 and GLAG375,
TEH 0530111
DUP050031024
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TEH 0530112
DUP050031025
- V--18 -
Gasoline lead use values were linearly interpolated from quarterly values (associated with midpoint of the quarter) to arrive at a lead use figure associated with no lag, 30-day lag, 45-day lag and 60-day lag. The quarterly values are given by site in Table IV--3. Table V-7 provides a summary of these times in terms of NHANES II study day and date. As before the blood lead decline attributable to gasoline lead exposure will be evaluated between the mean examination dates of the first (Day 16) and last (Day 1453) sites sampled in the survey.
Table V-7
Summary of Reference Dates for Evaluating Changes in Gasoline Lead Exposure for the Survey Sites
Start of NHANES II Day Date
End of NHANES II Day Date
No lag 30-Day Lag 45-Day Lag 60-Day Lag
16
3/7/76 1453
2/11/80
-14
2/6/76 1423
1/12/80
-29
1/22/76 1408
12/28/79
-44
1/7/76 1393
12/13/79
A gasoline lead use value was computed for each of the 61 survey sites associated with each of the eight dates above. These values are given in Table V-8 using the notation GS, GF, GSL30, GFL30, GSL45, GFL45, GSL60, GFL60, where "S" refers to start and "F" to final, with the lag time appended. Additional information by site on county population, state population, and county area that is used in the gasoline lead exposure calculations is contained in Table IV-2.
TEH 0530113
DUP050031026
Table V-8 Current and Lagged Gasoline Lead Use
At Each Survey Site At Beginning and End of Survey
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TEH 0530114
DUP050031027
Table V-8 (Pg. 2 of 2)
Current and Lagged Gasoline Lead Use at Each Survey Site at
Beginning and End of Survey
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TEH 0530115
DUP050031028
- V--21 -
The first computational method, referred to as Method 1, evaluates gasoline lead exposure analogous to the method of evaluating GCUR75 for an individual except the individual components are replaced by averages based on the 61 survey sites. The simplified formula, where the summations extend over the 61 sites used, follows:
S(Stat.e Gas Pb Use at time t)^ 2(County Pop, 75}^ 2($tate Pop. 75).. s(County Areas) .
i1
This formula was evaluated using a state gasoline lead use at each time t shown in Table V-7. See Table V-9 for a summary of these evaluations.
The second computational method, referred to as Method 2, evaluates a gasoline lead exposure by averaging the exposure densities of the individual sites. The formula is
^ (State; Gas Pb Use at time t). (County Pop. 75), S --------------------------------------- --------2---------- -------,-----------J- 161 i=l (State Pop. 75)^ (County Areas).
This formula was also evaluated for each of the eight times and these values are given in Table V-9,
The third computational method, referred to as Method 3, evaluates NHANES 11 survey site exposure to gasoline lead by proportioning national gasoline lead use at time t on the basis of the fraction of the U.S. population represented by the population of the sampled'counties. The formula is
(Nat, Gas Pb Use at time t) ^(County Pop. 75)^ (U.S. Pop. 75) X (County Areas)i
TEH 0530116
DUP050031029
- V--22 -
National gasoline lead use was evaluated by linear interpolation between quarterly values that included each of the eight dates (Table V--7)* The relevant national quarterly values and associated dates are listed below.
Date Nat. Gas. Pb Use (gr)
11/15/75 2/15/75 5/15/76 11/15/76 2/15/76
38,332,862,660 34,270,161,240 41,421,017,370 25,147,533,040 17,842,296,150
The other values used in Method 3 are 213,030,000 for 1975 U.5. population, 46,714,564 for 1975 total county population of 61 sites, and 72394 mi2 for
total county area of 61 sites. The evaluations for the eight dates are shown in Table V-9.
Table V-9
Total Gasoline Lead Exposure Values for 61 Survey Sites For Three Computational Methods
Start No Lag 30-Day Lag 45-Day Lag 60-Day Lag
Method 1
.000107344 .000103705 .000105391 .000107077
Method 2
.000150624 .000145220 .000148588 .000151956
Method 3
,000108860 .000105024 .000107052 .000109081
End No Lag 30-Day Lag 45-Day Lag 60-Day Lag
,0000542747 .0000604188 .0000634909 .0000665630
.0000789113 .0000890318 .0000940920 .0000991523
.000055018 .000062313 .000065961 .000069608
TEH 0530117
DUP050031030
- V-23 -
The v.alues presented in Table V-9 may be used to compute the change in exposure at 61 sites during the four-year NHANES II survey. This change then is multiplied by the respective regression coefficients, from models where gasoline lead exposure was untransformed, to get a blood lead contribution from each exposure term. The contributions of each exposure term then are summed to evaluate the total blood lead decline attributable to the gasoline lead exposure terms used in that particular model.
For models where the gasoline lead exposure terms appear in log1Q form, the values appearing in Table V-9 need to be appropriately altered. For Methods 1 and 3, the logarithm of the values in Table V-9 was computed from which the difference between log exposures was applied to the regression coefficients. For Method 2, however, the computational formula was altered by averaging the 1 logarithm of the quantity in braces. These values at the eight exposure times are given below in Table V-10.
Table V-10
Total Log Gasoline Lead Exposure Values for 61 Survey Sites Method 2
Start
End
No Lag
-4.2670
-4,5493
30-Day Lag
-4.2840
-4.4953
45-Day Lag
-4.2743
-4.4714
sis
60-Day Lag
-4.2649
-4.4484
For Adjustment Sets 2 and 2W, the dependent variable is on a natural log scale. The exposure regression coefficients, therefore, signify change in ln(blood lead) per change in exposure. Multiplying the regression coefficients by the change in exposure provides an estimated change in ln(blood lead). However, what is desired is the change in blood lead and this cannot be obtained by exponentiation of the change in ln(blood lead). The change in blood lead (ABlood Pb) is easily shown to be given by the expression
j ABlood Pb * Bs(l-exp(-bA{Exposure))
TEH 0530118
DUP050031031
- V-24 where B$ is the predicted site mean blood lead value at the first mean examination date (Day 16,46 of survey) from a regression of Adjustment Set 2 or 2W on site mean examination date. Further, b is the gasoline lead exposure regression coefficient and ^Exposure reflects the change in exposure to gasoline lead. The values used for 8$ are 16,184 ug/dl for Adjustment Set 2 and 16.087 ug/dl for Adjustment Set 2W. V.B.2.b. Discussion of Results It was noted in Section V.B.l that between-site Model A provided the highest adjusted Revalues among models where the gasoline lead exposure terms were untransformed and Models G, F, and E were best among models where the gasoline lead exposure terms were log-transformed. Gasoline lead exposure contributions to the reported blood lead decline based on regression coefficients for Models A, E, F and G and each of the computational methods were evaluated. The gasoline lead exposure regression coefficients are given in Table V-l.l for these models, based on Adjusted Sets 1, 1W, 2 and 2W. The estimated contributions by gasoline lead exposure to the reported blood lead decline during NHANES II are summarized in Table V--12. The results associated with Adjustment Sets 2 and 2W were exponentiated so all contribution estimates are in terms of ug/dl.
TEH 0530119
DUP050031032
Coefficients of Gasoline Lead Exposure Terms
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TEH 0530120
DUP050031033
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TEH 0530121
DUP050031034
- V--27
The results displayed in Table V-ll, which are based on regression coefficients of gasoline lead exposure terms, lack the consistency of the results reported in Table V-5, which are based on a comparison of residual trends. The estimated contribution to the reported blood lead drop for Model A ranges between .24 and .52 ug/dl, somewhat comparable to the Model A results in Table V-5 where the drop was from .14 to .35 yg/dl. However, the results for Models E, F and G are substantially different from those in Table V-5.
A closer inspection of the results in Table V-12for Models E, F and G reveals why these values are erroneous. In computing the estimated blood lead decline, contributions from each gasoline lead exposure term are evaluated separately and summed. For example, the change in blood lead associated with changes in each exposure term may be written
ABlood Pb a A(Exposure) + b A(lag Exposure)
where a and b are the estimated regression coefficients associated with the respective exposure terms. For the situation here the b~coefficient is negative (see Table V-ll) for Models E, F and G because of the high correlation between the two exposure terms (see VlF's in Table V-3 for these models). Further, both coefficients are driven away from zero although their sum is close to the regression coefficient based on a model with a single exposure term. The result of this is an expression for evaluating ABlood Pb which is inadmissible since the true coefficient for the lagged exposure must be nonnegative; otherwise, an increase in a(Lag Exposure) serves to reduce ABlood Pb.
To show this anomaly another way, note that the change in current exposure (GCUR75) is greater than the change in any of the lagged exposures (to see this compute exposure changes based on the data in Tables V-9 and V--10.). This is true for untransformed or transformed exposures regardless of exposure calculation method. This results in an upper bound on ABlood Pb as follows:
ABlood Pb < (a+b) A(Exposure).
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- V-28 -
Thus, applying the change in current exposure to the sum of the coefficients provides an upper bound to the contribution to the reported blood lead decline due to exposure to gasoline lead. For comparison purposes, these results are shown in Table V-13. Note these conservative estimates are all well below the corresponding values for Models E, F and G in Table V-12. The range of upper bound estimates is .23 to .56 ug/dl. The corresponding range based on the comparison of residual trend results in Table V-5 for the models is .32 to .85 ug/dl. The agreement is now remarkably similar.
Table V-13
Upper Bounds to Estimated Contributions to Reported Blood Lead Decline by Gasoline Lead Exposure
Based on Between-
Method 1
Method 2
Method 3
Adj BPb Site
No Log
No Log No
Log
Set
Model
Transform Transform Transform Transform Transform Transform
1E F G
.26 .47 ,35 .45 .25 .48 .33 .44 .24 .49 .32 ,45
.26 .49 .25 .48 .24 .49
1W E F G
.25 .48 .34 .44 .24 .47 .33 .43
.23 .49 ,31 .45
,26 .48 .25 .47 .23 .49
2E F
G
.25 .54 .34 .50 .24 .53 .33 .49
.23 .54 .31 .50
.25 .54 .25 .53
,23 .54
2W E
F G
.25 .55 .34 .51
.24 .54 .33 .50 .23 .56 ,31 ,52
.25 .55 .25 .54 .23 .56
Results based on ridge regression estimates for Model G are discussed in Section VI.B.2. The estimated contributions due to gasoline lead exposure are smaller than those presented in Table V-13.
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- V-29 -
One further set of analyses was done using the regression coefficient of GCUR75 from models which excluded the between-site effects of survey demographics. These coefficients, along with those previously reported for Model A (Table V-13), are summarized in Table V-14. Note that the gasoline lead exposure (GCUR75) coefficients, with one exception, are larger when between-site survey demographics are not accounted for. This is not surprising since certain demographic factors and gasoline lead exposures have been shown to be related to time and blood lead. Consequently, the gasoline lead exposure coefficient attempts to account for aTl_ time related changes due to survey demographics, gasoline lead exposure, and other time-related causes.
The estimated contributions to the blood lead decline are given in Table V--15 based on the blood lead/gasoline lead exposure slope for models not accounting for between-site survey effects. These values which are conservative show a range of contribution estimates from .29 to .59 vg/dl.
Table V-14
Coefficients of Gasoline Lead Exposure Terms From Betweer-Site Models Not Accounting for Survey Demographics
Based on
Adj BPb Set
Between-
Site Model
Gasoline Lead Expose Not Transformed Log Transformed
1 Model A
4513.4
No Survey Dem
5486.0
1.6044 1.5523
1W Model A
4479.5
No Survey Dem*
5463.5
1.6124 1.7422
2 Model A No Survey Dem
274.9 383.1
.1109 .1143
2W Model A No Survey Dem*
279.4 375.4
.1170 .1270
Except Lead Wt
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- V-30 Table V--15
Estimated Contributions to Reported Blood Lead Decline by Gasoline Lead Exposure
Effects of Between-Site Survey Demographics Excluded
Computational
Based on
Method
Adj BPb Set
. Method 1
1 1W
2 2W
Method 2
1 1W 2
2W
Method 3
1 LW
2 2W
V.B.3 Use of "Time11 Coefficient
Form of Exposure Term No Transform Log Transform
.29 .46 .29 .52 .32 .54 .32 .59
.39 .44 .39 ,49 .44 .51 .43 ,57
.30 .46 .29 .52 .33 .54 .32 .59
Analyses were performed on Between-Site Models A and G with a time term (Days__Pb) added to estimate the time coefficient adjusted for survey demographics and gasoline lead exposure. These analyses are similar to the ones discussed in Section III.E.2 except that now terms for gasoline lead exposure are included.
Ostensibly* such a time coefficient could be used to quantify the contribution to the reported blood lead decline not due to survey demographics and gasoline lead exposure* However, it was noted in Sections I.B and III.E.2 that this does not occur. This time coefficient will capture all the linear time components associated with all other model terms not themselves corrected for time.
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- V--31 -
The results of the analyses with time are included for completeness. They illustrate the above fact on the interpretation of the time coefficient as well as present additional Insight into the relationships among survey demographics, gasoline lead exposure and time.
Table V-16 presents the regression summaries from these analyses for Model A (results for Model G were similar). As was noted in reference to the analogous
Table V-16
Between-Site Regression Results of Model A with Time Term
No Transform Root MSE n2
rV
N
Error Degrees of Freedom
Max VIF
Max Cook's D GCUR75 Coefficient
Time Coefficient
Time VIF
1 2.57
.79 61 36
JDdbttU un nujuvumsnv oci 1W 2 2.61 2.91 .78 .80
61 61
35 36
2W 2.93
.80 61 35
6.91 .75
2192,7 -.00373* 3,74
7.87 .70
2227.4 -.00373* 3.75
6.91 .44
99.59 -.000281* 3.74
7.87 ,40-
108.5 -.000283* 3.75
LogioTransform Root MSE oZ
kV
N
Error Degrees of Freedom
Max VIF
Max Cook's D Log1QGCUR75
Coefficient Time Coefficient
Time VIF
COo
2.51
61 36
10.45 .21
1.118*
-.00386* 3.47
Flagged as significant at p<_.05
2.54 .79
61 35
10.80 .19
1.188*
2.78 .82
61 36
10.45 .19 .0752*
-.00388* 3.49
-.000283* 3.47
2.78 ,82
61 35
10,80 ,15 .0856*
-.000287* 3.49
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{iiiiaiM i:
- V-32 -
summaries in Table III-10, inclusion of a time term greatly improved the prediction precision. Residual regressions against time from these analyses demonstrated no time-related effects remained. The variance inflation factors (VIF) associated with time indicate over 70 percent of the variation in time & is explainable by survey demographics and gasoline lead exposure.
Table V-17 summarizes these estimated blood lead declines for the variations of Model A analyses, using the time coefficient adjusted for survey demographics and gasoline lead exposure. It is seen that these declines are comparable to the declines associated with the adjusted site mean blood leads (see Table III-8). Consequently, these results illustrate that the time coefficient, even though adjusted for survey demographics and gasoline lead exposure, accounts for time-related effects of both survey demographics and gasoline lead exposure.
Table V-17
Estimated Blood Lead Decline (pg/dT) Based on Time Regression Coefficient
Exposure Term for Gasoline Lead
Model A Results Based on Adjustment Set 1 1W 2 2W
a Untransformed
5.36
5.36
5.38
5.37
T ransformed
5,54
5.57
5.41
5.44
The impact on the regression coefficients of Model A results before and after,
including a time term, is shown in Table V-18. As was concluded from a
$gfj
w similar comparison shown in Table III--12, the addition of a time term changes
m many (10 to be exact) of the t-values of the survey demographic effects by at least one. The corresponding impact on the gasoline lead coefficient is more
clearly identified by comparing these values in Table V-16 with those in
ffi Table V--1.1 for Model A,. Here it is seen that the gasoline lead coefficient is
substantially reduced after inclusion of a time term - by a factor of more
than two in most cases. Refer to Section V.D for further discussion on the
relevance of this observation.
t ''j
f
.&J
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m' >
M - V-33 -
Table V-18
Coefficients Compared from Between-Site Model A Results With and Without Time Using Adjustment Set 2W
Without "Time" Coefficient t-value
With "Time" Coefficient t-va.iue
t-values differing by at least
Black Male Child teen Income Bl_MA BL_CH BL_TN BL_IN MA_CH MA_jN MA_IN CH IN T N_IN Urban CC Winter Spring Summer South West Northeast
lead_Wt GCUR75 1og10GCU.R75 Days_Pb
.20 .52 .24 1.34* .52* 7,39 .16 -.62 1.73 -9.86 4.77 -.46 -.46 -.91 .08 -.14 -.14* .01 .06 -.07 .15 .07
1,16 1.04
.71 2,24 2,47 1.85
.12 -.21 1.39 -1.91
.35 -.14 -.20 -.19
.76 -1.25 -2.19
.15 1,02 -.93 2.02 1.29
27.5(xl0"7) -.41
.12* 2.11
,41* ,06 -.27 .76 -.11 3.16 .98 -1,12 -1.10 -6.76 -8.81 -2.52 -1.70 1.58
3,48 .17
-1,15 1,90 -.67 1.18 1.15 -.57
-1.21 -1.99
-.97 -1.13 -1.12
.51
-.06 -.03 -.11*
-.02 -.12*
.10* .06
-.78 -.44 -.25 -.47 -.47 -2.31 2.06 1.56
49.1(xl0-7
.086*
2.34
-.000287* -7.00
CM
r~i
i H
1
COM
t
X X X X X X
X
X X
Flagged as significant at p.05
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- V--34 -
V.C Estimation of Blood Lead Decline Attributable to National Gasoline Lead Use
The unsuitability of national gasoline lead use as an exposure correlate to NHANES II blood lead data was demonstrated in Section IV. There it was shown tnat the gasoline lead exposure trend, as encountered by the survey site itinerary, is considerably different from the trend in national gasoline lead use during the survey period. Consequently, the fact that national gasoline lead use does not account for site-to-site variation in exposure limits the suitability of this exposure correlate.
It may be argued that some global measure exposure needs to be incorporated in order to account for such factors as import of lead contaminated food inside, or personal travelling outside, a geographic location. To this extent, incorporation of national gasoline lead use in between-site models with survey demographics should provide upper bound estimates of the real contribution of gasoline lead exposure.
Between-site analyses were performed based on survey demographic terms and national gasoline lead use. The national gasoline lead use values were taken from [3]. Table V-19 presents a summary of the residual blood lead time declines and portions of reported blood lead declines attributable to national gasoline lead use. These summaries were obtained in the same manner as those in Table V-5. The results show that national gasoline lead use contributes between .78 and 1.12 ug/dl to the reported blood lead decline. The upper bound estimates are approximately twice those when using the site specific gasoline lead exposure correlate.
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TEH 0530130
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V.O Summary
A variety of analyses and approaches are reported herein which address the contribution of gasoline lead exposure to the reported 5-6 vg/dl blood lead decline during NHANES II. Collectively and consistently, these analyses suggest that, while gasoline lead exposure is significantly associated with blood lead levels, its contribution to the decline is only between .25 and .75 ug/dl. The results based on the best explanatory models, where the natural logarithm of blood lead was used as the dependent variable and site specific gasoline lead exposure (ie, densities) were expressed in terms of base 10 logarithms, was about .50 vg/dl, This value is remarkably consistent with that obtained by multiplying the (crudely) estimated air lead decline during NHANES II of ,32 ug/m^ [8] with the widely agreed blood-1ead/air-lead slope range of 1-2 m3/dl [9],
The measure of exposure to gasoline lead used in these analyses (except for Section V.C) reflects exposure at each survey site at the time that site was sampled. This aspect is of considerable importance since it was determined that the gasoline lead exposure time trend corresponding to survey itinerary differs considerably from the four-year trends seen nationally or, for that matter, at any of the individual survey sites. Naturally, no index based on state or local lead use, population and area can be expected to accurately reflect individual exposures. To do this, personal monitoring data would be required which clearly is unavailable. Consequently, some specification error in exposure will be present which would have the effect of underestimating these regression Coefficients,
Summarizing in more detail, three approaches were investigated for estimating the contribution of gasoline lead exposure. In the first, the difference between residual time declines was made based on models with and without gasoline lead exposure terms. Effects of four exposure terms were investigated - one reflecting current exposure and the others reflecting 30, 45 and 60-day lagged exposures - in eleven between-site models. Each model
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- V--37 -
was analyzed using adjusted site mean blood lead sets from within-site analyses 1, 1W, 2 and 2W. Exposure terms were expressed in untransformed and log transformed form .in each analysis variation. The best predictive models were those containing just the current exposure term or the current with one other lagged term. The estimated contribution due to gasoline lead exposure ranged from .11 to .67 jig/dl, with .52 ug/dl being the value associated with the preferred models. A further between-site analysis was performed where survey demographic effects were excluded. By comparing the residual decline m with the decline of the adjusted blood lead site means, the contribution of gasoline lead exposure was found to be between ,27 and .75 ug/dl depending on analysis variation. These results may be considered conservative in that survey demographics were not addressed.
The second approach used the gasoline lead exposure regression coefficients to evaluate the blood lead decline by multiplying them by the change in exposure. The exposure change was computed to reflect the four-year change that occurred at all survey sites, regardless of when each was visited by the survey caravans. Three different computational methods were used to reflect collective survey site exposure changes and all gave comparable results. Based on a model which incorporated current gasoline lead exposure, the estimated contributions ranged from .24 to .55 ug/dl. The estimated contributions based on models which included more than one term for exposure proved to give inadmissible results, resulting from negative coefficients due to high correlations among exposure terms. Admissible upper bounds for contributions based on these models ranged from .23 to .56 ug/dl. A contribution was also estimated based on the coefficient from the between-site analysis where no survey demographics were included. These values ranged between .29 and ,59 ug/dl.
It was noted in Section V.B.3 that inclusion of a time term in models with a term for gasoline lead exposure reduced the gasoline lead exposure coefficient by a factor of two. This smaller coefficient is the correct least squares estimate because it is adjusted for all other terms in the model (see, for example [11]) including time. However, the second approach used the larger I\ ij
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iJ
DUP050031045
- V-38 -
(biased) coefficient to estimate the gasoline lead contribution to the reported blood lead decline. The conservative value used would, in some sense, compensate for the effect of specification error on the regression coefficient noted above.
The third approach was based on use of the regression coefficient for "time" in models with terms for survey demographics and gasoline lead exposure. It has been noted that this approach is incorrect for estimating the portion of the reported blood lead trend not due to either survey demographics or exposure to gasoline lead.
Based on the results in Table V-5, it appears highly likely that causes other than survey demographics and gasoline lead exposure were responsible for Some of the reported decline. This unexplained decline was significantly different from zero and ranged between .96 and 1.61 yg/dl depending on model and analysis. Likely candidates accounting for the unexplained decline include improved sample handling and collection during the survey, improved quality control, and other sources of lead exposure. Unfortunately, even marginally satisfactory data are not available on any of these candidates except improved quality control. Blind control sample results, available only after the first eleven months of the survey, provided a hint of a downward bias - at best, explaining only a portion of the unexplained decline.
Although it wa;$ concluded in Section III that national gasoline lead use is an unsuitable correlate to NHANES II blood lead data, its contribution to the reported blood lead decline was estimated between .78 and 1.12 ug/dl. These estimates are approximately twice that obtained when using the site specific measure of gasoline lead exposure and probably reflect an upper bound to the true effect of gasoline lead use.
Accurately and precisely estimating the true blood lead decline due to exposure to gasoline lead is not possible from these data due to inherent confounding among factor effects. It may be argued that a portion of the time related survey effects such as black, urban and income representation, actually incorporate some component of gasoline lead exposure, as well as
TEH 0530133
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