p.1 

OAR Box 1131 

Prepped by Ollie Stewart 

Document Number: 

119)11-1-397 

Docket Number: 

A-83-22 

Printed 4/21/2008 2:34:12 PM Sheet 119 of 162 
P.2 

#-»i3rjr-*»7 

THE EFFBCTS OP CUMULATIVE HA D EXPOSURE ON PREGNANCY OUTCOME 

.AND CHXXDftOOD DSVBtOPMOlT DOaiNO TttS FIRST FOUH YEA88 

1 

ULU 

Mtf ' 3 1992 

EPA AiR DOCKET 

Graham Vimpani, MO PhD1 

Pater Baghurst MSc Phtf 

Anthony J McMiehaal MD PhD3 

Evelyn Robertson MD4 

Nail Wigg MP 

Russell Roberta M Clin Psych6 

Running headt Port Plria Cohort Study 

Preaanted afrt 

Advances in Lead Research: laplioetions for Environmental Health 

Conference 

National institute of Environmental Health Sciences 

Research Triangle Park 

North Carolina 

January 9-11, 1989 

Address for correspondence; 

Dr Graham Vimpani, 

Department of Paediatrics, 

Flinders Medical Centre* 

Bedford Park. 

South Australia. 5042 

Phone (618) 275 9911 Fax (618) 27S 9450 

1 Department of Paediatrics, Plindars Medical Centre, 

Bedford Park, South Australia 

Division of Human Nutrition, Commonwealth Scientific 

and Industrial Research Organisation, Adelaide, louth 

Australia 

Department of community Medicine, University of 

Adelaide, louth Australia 

Department of Chemical Pathology, Adelaide Children's 

Hospital, North Adelaide, louth Australia 

Health Programs, Child Adolescent and Family Health 

Service, Adelaide, South Australia 

Research Clinical Psyoholeglat, Child Adolescent and 

Family Haalth Service, Adelaide, South Auatralia 

20'39« d S33N3I0S -ISHOD i.2121 68 . 9 Nbf 
P.3 

J«N 04 '#9 09;J7 f^lnefcRS nti»*wH». 6i d «iiJ'*»J 

ABSTRACT 

The Port Pirie cohort study is a long-ttrm follow-up study of tht relationship 

between cumulative lead expoaure, pregnancy outcome, and childhood nsurodevel* 

opment, Of 723 pregnancies followed to birth, 601 and 548 children were available for Study St ages 2 and 4 years respectively, 

There was a statistically significant doae-dcpendent relationship between 

antenatal blood lead concentrations and the risk of preterm delivery. Plscental tissues in lste fetal deethe end preterm aeiiveriee had higher eoncentratlons of lead than in uncomplicated pregnancies, 

Blood lead concentrations sntenatally, at delivery and postnetally at 6, IS 

and 24 aenths of age «•!'* i>«gnllv«ly correlated with mental development at two 

years. When multiple covariatas, including maternal IQ and HOME acore were 

included in a multiple regression model an inverse relationship (p-0.07) 

between PbB end mental development at 2 yeara wee evident suggesting that « 

child with a PbB of 30ug/dl at 6 montha of age would have a deficit of 

approximately 3X on the Bayley MDI relative to a child with PbB of 10 ug/dl, 

The PbB at each age, particularly at ages 2 and 3 years and the integrated 

postnatal average PbB wars rslatsd to mental abilities as assessed by the 

McCarthy Scales at age four years. Multiple regression analyses incorporating 

a range of social, obststrle snd neonatal faetors indicated that subjects with 

an average postnstsl PbB of 30 ug/dl had a general cognitive score 7.2 points 

lower (93% confidence limits 0,3 -13,2; mean score 107.1) than those with an 

average concentration of 10 ug/dl. No threshold dose for an offset was 

evident. ~ 

It la concluded that postnatal PbB la inversely related to cognitive development in children, although one oust bs circumspect in making causal Inferences 

from studies of this rslstlonshlp because of the difficulties in defining and 

controlling confounding effects. 

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Table 1 

Assessment Instruments being used at 7 years 

Wechsler Intelligence Scale for Children - Revised (WISC-R) 

British Ability Scales: Word Reeding Test 

Mathematics Tsst 

Visual motor integration test (Beery) 

Auditory Verbal Learning test (Rev) 

Flnger-localieatlon teat (Gaffen) 

Auditory Reaction tine 

Dichotic listening tssks (Geffen) 

Audlologlcal screening 

Connor's Psrent end Tsschsrs Rating Scales 

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in 

Teal*. 2 

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Men lead concentratioem (ug/g dry tissue) 

together with 93X coafldafic* Uadta, 

la cord* aad placamtal tissuee of differeot pregnancy 

U) 

o 

z 

Cord Placeotal ana Placeatal body 

Wormsl 22 1.42 (0.87-2.32) 0.78 (0.61-1.00) 0.48 (0.38-0.61) 

Premature rupture 18 1.91 (0.94-3.88) 0.72 (0.55-0.95) 0.41 (0.32-0.53) 

of 

o 

in Late fetal deaths 6-9 1.18 (6) 2.73 (6) 0.76 (9) 

(0.24-5.77) (0.69-10.8) (0.44-1.30) 

Preterm birthe 23 2.47 (1.31-4.03) 1.24 (0.91-1.67) 0.66 (0.49-0.90) 
JAN 6 "89 12:08 UCHSL SCIENCES PAGE.06 

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9d 
P.7 

Tabli 10 Mean MSCA Scores at age 4 years by quartile of blood lead 

concentration (at each blood sampling time) 

Blood 

lead 

quart 

•ile 

l(low) 

2 

3 

4(high) 

l(low) 

2 

3 

4(high) 

l(low) 

2 

3 

4(high) 

l(low) 

2 

3 

4(hlgh) 

I (low) 

2 

3 

4(high) 

(No.) 

Antenatal 

avenge 

6.1 

8.6 

10.5 

14.3 

108.8 

109.4 

106.7 

104.3 

58.4 

57.9 

56.5 

55.2 

48.2 

49.4 

48.0 

47.3 

54.4 

54.4 

53.9 

52.5 

(534) 

Time of blood sampling 

DcUv- Umbll. 

«y 

5.6 

8.3 

11.0 

16.2 

109.5 

108.8 

106.1 

104.2 

58.0 

57.9 

56.2 

55.3 

49.1 

49.5 

47.7 

46.9 

54.9 

53.9 

53.9 

52.4 

cord 

6 

mot. 

Mean Blood 

4.3 

7.3 

9.9 

14.9 

8.4 

12.5 

16.9 

24.4 

13 

mot, 

a 

years 

Lead fug/dn 

12.0 

18.5 

24.4 

34.9 

13.3 

18.7 

24.4 

33.7 

Qoneral_Co«iiitlYfi_Index 

108.6 111.2 110.1 

109.3 107.4 109.9 

104.7 105.9 105.4 

106.3 104.1 103.6 

112.4 

109.4 

104.6 

102.3 

3 

yean 

11.9 

17.5 

22.5 

30.2 

112.0 

109.0 

105.7 

102.0 

PMceptutUPerformanee Score 

57.7 

57.7 

55.2 

57.1 

49.3 

48.6 

47.7 

47.2 

54.5 

54.3 

52.9 

53.2 

(479) (474) 

59.2 

57.0 

55.8 

55.6 

58.5 

58.5 

56.1 

54.6 

59.5 

58.3 

55.7 

54.1 

Memory, Score 

49.8 

47.6 

48.0 

47.2 

49.2 

49.4 

47.1 

47.1 

50.9 

49.0 

47.3 

45.6 

Moor-Scan 

55.6 

53.6 

53.4 

52.9 

(526) 

55.2 

54.0 

53.5 

52.8 

(527) 

55.6 

55.4 

51.9 

52.2 

(534) 

59.0 

58.3 

56.7 

53.6 

51.1 

48.3 

47.3 

45.9 

55.9 

54.2 

53.7 

51.5 

(525) 

4 

years 

Integrated 

post-natal* 

9.8 

14.7 

19.0 

26.2 

111.1 

109.2 

103.6 

104.7 

58.8 

58.7 

54.9 

55.2 

50.7 

48.3 

46.8 

47.0 

t 

55.0 

55.0 

52.0 

52,7 

(530) 

12.4 

17.6 

21.7 

28.1 

112.6 

108.3 

104.0 

103.0 

59.7 

58.1 

55.6 

54.1 

50.2 

48.1 

46.9 

46.3 

56.0 

54.3 

52.1 

52.8 

(463) 

* This Is the Integrated postnatal avenge blood lead concentration concentration. 

<L. T_.|3 5 u ^ 5 y^zsY ut^r^e - erf /lAP& ^sr/^ 

VMV.W^ COVA U**L <U~ S M-vwi^ < 

* • > 

)0^ ^ 

i0-39bd S33N3IDS ISHOn 60:2 1 68 . 9 Ntff 
P.8 

-^n T T - ;-^ftf^nf-' " 

».i6 li 

Table 9 

Heen McCarthy Scale aeoree by sex and place of reeldence 

MCSA Scale 

Verbal Parcep- Quant. Memory Motor 

perform 

fid 

•alt 

Boys 

(N - 236) 

Girls 

(N - 281) 

Pise* of residence! 

Port Pirie 

(N • 410) 

Others 

(H • 127) 

32.9 55.6 50,2 47.5 52.7 105,7 

54.1 58.0 50.7 48.6 54.7 108.3 

53.0 56.7 50.3 47.8 53.5 106.3 

54.8 58.2 51.3 49.5 54.7 110.2 

All 

(N - 537) 

SE 

53.5 56.9 50.5 46.2 53.8 107.1 

0.4 0.4 0.4 0,4 0.4 0.7 

80'39«d S3DN3IDS "ISHDO 60:21 68. 9 Ntff 
Table 8 

Partial linear regression coefficients for each blood lead measure 

with and without maternal XQ aad HOME acore In the mode? 

(One tailed significance teats) 

Blood lead 

maasurs 

Average antenatal 

Delivery 

Cord 

6 months 

13 months 

24 months 

Xntsgrated 

peetnetal 

Regression coefficients 

(change in MDI per unit change la blood lead [ug/dl1) 

Ignoring maternal Controlling for 

maternal XQ 

-0.26 -0.21 

40.19 40.27 

40.05 40.07 

-0.24 (p-0.01) -0.24 (p-0.01) 

-0.09 -0.06 

-0.16 -0.12 

-0,26 (p.0.03) -0.22 (p-0.05) 

Controlling for 

maternal IQ aad 

BOMB score 

-0.07 

40.23 

40.10 

-0.16 (p-0.07) 

-0.03 

-0.05 

-0.12 (p-0.19) 

* The model contains the 13 eoeloeconoelci demographic, naonatlal and 

behavioural factors shown in Table 6. 

\H1 IttQL- scofQ. 

rJ^i'^ 

* » * 1*^ ' 

eft ipy\ o ^ 

60'39Wd S33N3I3S ISHDH 01 :2l 68. 9 NUf 
P.10 

»• . 2a/3i 

Table 7 

Beyley MDI by maternal intelligence score (VAIS) 

Maternal VAIS Kumber 

<80 

81-90 

91-100 

>100 

refused or 

unavallabls 

All mothere 

50 

117 

145 

94 

163 

592 

Bayley MDI 

98.3 

106.7 

111.1 

114.0 

108.1 

109.3 

SB 

2.7 

1.4 

1.3 

1.6 

1.0 

0.6 

PI! " ^Hr l qqr)N3T~.s -tRr-nn PIT :?.\ fifl . 9 NHT 
P.11 

j.. . ..,.,• tartars with BayUy MDI 

Factor 

Sododemognphie factor*: 

Maternal tge (yean): 

<2t 

22-29 

*30 

Pather'i iscondary education (yean); 

unknown 

S3 

> 3 

Mother's r wndary education (yean); 

$ 3 

>3 

Father*! workplace: 

office 

non-office 

Motber'i workplace: 

away from home 

home 

Parental relationship: 

living together 

living apart 

Motber'i antenatal surital itatue: 

single, widowed, divorced 

married or defacto 

Quid's Una nnk: 

flfst born 

Moood born 

nbssquent 

Neonatal Pastors: 

Neonatal oxygen use at birth: 

required 

not required 

Aegar aeon at 3 nlnutes: 

S t 

9 or 10 

Neonatal jaundice: 

present 

absent 

Use Tor gestational age: 

small 

appropriate 

large 

Behaviounl factor. 

Mouthing activity at IS momhi: 

„ frequent 

Inunnedliu 

never 

*•• / a.. mm 

chiMrt* MtvnMDt SE 

104 

377 

109 

74 

ISO 

271 

216 

289 

147 

438 

231 

349 

537 

32 

59 

331 

274 

199 

122 

173 

411 

132 

448 

220 

366 

33 

489 

36 

241 

306 

42 

I0S-7 

110-2 

109-8 

991 

108-9 

112-3 

108-0 

111-0 

111*8 

1086 

Ul-9 

107*6 

110-2 

100-0 

101-2 

llfrl 

109-9 

169*1 

108*1 

106*7 

110*3 

105*2 

U0-4 

108*7 

109-7 

101-2 

109*6 

ltl-6 

107-9 

1100 

111*7 

1-S 

0*8 

1-3 

1*7 

1-0 

0-9 

0-8 

0-9 

W 

0*7 

1-0 

0*6 

04 

2-1 

2-0 

0*7 

1-0 

1-0 

13 

1*0 

0-6 

1*3 

0-7 

M 

0-6 

2-9 

6-7 

20 

0-9 

04 

28 

t I -39bd S30N3IDS 18HDn 01 :2l 68. 9 NWf 
et • •SPf R *>.12'3Z 1 

w 

a 

a. 

in 

u 

z 

u 

to 

Table 5 

of Bayley MDI with Wood lead history 

itratiom Integrated 

PBB 

(ug/dl) 

Pereietently high* 

Intermediate' 

Paraiatantly low* 

51 

4S1 

62 

29.9 

18.4 

10.0 

MDI 

102.2 1.6 

109.7 0.6 

112.2 1.6 

01 

I 

o 

3 

w 

at 

m 

to 

z 

a 

v 

• PbB conceatrationa la the higheat quartile of PbB distribution On all 

three poataatal aamplinga (6, 15 and 24 montha). 

' All except high aad low group 

+ PbB eoaeeatratloae la lowest quartile on all three occasions 
TTpir^' (TTirn^' 

JM3 

W< Ob 

Table 4 

Correlations between blood lead eonceatretlene at 

auccessivs sgss and Bayley developmental indices at 24 months 

Pearson correlation 

coefficient 

Blood aaaple MDI PDI No. 

Maternalt 14-20 weeka gestation 

after 20 weeks gestation 

average antepartum 

at delivery 

Childt umbilical cord 

6 months 

15 months 

24 nonths 

integrated postnatal average 

-0.06 

-0.08* 

-0.11* 

-0.03 

4.04 

-0.12* 

-0.12* 

-0.181 

-0.151 

-O.05 

-0.02 

-0.06 

-0.02 

-0.04 

4.07 

-0.02 

-0.02 

-0.01 

509 

560 

566 

524 

520 

575 

579. 

586 

494 

* <0.05 # <0.01 

EI -39b d S3DN3I0S -.SHOD I I-.21 68 . 9 Nbf 
feaampmj^B^'ammmmmai •*•• mm-^sm ICBIOC * m i-»-•-*»••• P . » 32 

Table 3 

<x 

a. 

Perccntagea 

daaalfled 

relative, riska of 

to maternal blood 

at delivery 

delivery 

ooncentretlc 

UI 

o 

z 

o 

if) 

m 

i o 

3 

Blood lead 

(«s/di) 

< 8 

B - 11 

11 -14 . 

>14 

X of p*'v-lm« 

birth* 

1.7 

3.4 

A.7 

3.8 

Ctiadv 

Imlmtiv* rink 

1.0 

2.0 

2.7 

3.4 

adjusted* 

Relative rlmk 

1.0 

2.1 

3.0 

4.4 

* Adjuated for mother'a age, gravidity, aoelal atatua, occupation and 

smoking bebite by multiple logiatlc regreeelon) 

CO 

CD 

10 

• *:- . 

M 
P.15 

rTWT--rwTnr " 

• '.--# x: 

Tabic 12 Estimated Coefficients ot Log Blood Lmmd Conoontretlon from Simple and 

Multiple Regression Analyses of MSCA Scores at the Age of Pour Years.* 

Biooo SAMH.1 OINBKAL COGNITIVE Ihota 

OMFUa MaTiAL 

PiacirruAk-PuraaMANci 

SCALB 

IIMPLB PASTIAL 

MtMoay SCALB 

UMPta PASTUL 

eottfeliiii ±SE (t VQIU ' 

Antcnoti! (average) 

Delivery 

Cord 

6 Mo 

15 Mo 

24 Mo 

36 Mo 

48 Mo 

Integrated postnatal 

average 

-15.1*4.7 

(0.001) 

-10.4*39 

(0.008) 

-6.1*3.4 

(0.08) 

-13.1*3.8 

«0.001) 

-14.3*3.8 

(<0.00l) 

-23.8*4.3 

(<0.001) 

-23.1*4.3 

«0.001) 

-20.1*4.1 

(<0.00l) 

-28.9*5.3 

(<0.00t) 

-1.8*5,7 

(0.75) 

-0.4*4.5 

(0.93) 

3.3±4.| 

(0.42) 

-8.3*4.4 

(0.05) 

-3;3*4.8 

(0.46) 

-11.1*3.4 

(0.04) 

-13.1*5.6 

(0.02) 

-5.5*5.1 

(0.29) 

-13.0*7,3 

(0.04) 

-9.5*2.7 

«0.001) 

-5.1*2.3 

(0.03) 

-3.0*2.0 

(0.13) 

-7.8*2.2 

(<0.001) 

-8.2*2.2 

«0.001) 

-13.3*13 

(<0.001) 

-13.6*2.3 

«0.001) 

-11.2*2.4 

(<0.00l) 

-13.1*3.2 

«0.00l) 

-4.1*3.3 

(0.22) 

0.2*2.7 

(0.95) 

1.6*2.4 

(0.50) 

-4.8*2.5 

(0.06) 

-3.2*2.8 

(0.26) 

-6.2*3.2 

(0.03) 

-7.7*3.3 

(0.02) 

-4.0*3.0 

(0.18) 

-8.3*4.1 

(0.03) 

-4.8*2.7 

(0.07) 

-4.9*2.2 

(0.03) 

-3.0*2.0 

(0.12) 

-4.9*2.2 

(0.03) 

-5,3*2.2 

(0.01) 

-13.4*2.4 

(<0.001) 

-12.7*2.4 

(<0.001) 

•*• 10.3*2.3 

(<0.00l) 

-13.3*3.1 

(<0.001) 

2.0*3.3 

(0.54) 

-0.4*2.6 

(0.89) 

2.6*2.4 

(0.27) 

-2.4*2.5 

(0.34) 

-0.5*2.7 

(0.87) 

-7.3*3.1 

(0.02) 

-7.2*3,2 

(0.27) 

-4.1*3.0 

(0.17) 

-7.9*4.2 

(0.06) 

*Tbe pettlel legrmton eeefnclcntt are from analyse* incorporating all the eovarlates la Table 2. The P values arc for 

aateismenti of the two»alded hypotheam that the estimates are wot aers. 

^ e~ U I Li^ e ,~ Meoi leJ - TUs ~ <* - " ^ 

&S<> r <*w. 

SI '39b d S3DN3I0S ISHDn 21 '21 68 . 9 Nttf 
P.16 

Birth fc- 4 <eerd A maternal) - placenta 

0^1 » 4 gt wed .amp.asx,^ , a , j , « t 

79 80 81 82 83 84 88 88 87 88 88 

YEAR 

Piiur e 1 The Port Pirie Cohort Data CoNeetlon 8oheo\jle. 

£vA ***** Vx-a-Aj 

Sjjt 

0 * ^ 1 » 

^ ,V1) 

91 '39bd S33N3IDS 18HDn 3t :3I 68. 9 Ndf 
P.17 

231 

22 

€ 21h 

OS 

r 201 

| 19 

! § 18 

& 

*o o o 

17 

16 

3

 161-

14 

13 h 

i •»•.•..• . •« • 

8 1 

15 24 38 

age (months) 

48 60 

Figure 11 

Coonetplc mean blood lead concentration (wgydi) A(td 93 

i)5rcent confidence Intervals, by sex and age. 

JAN 5 '89 isiao et e 1739450 - • ««.-- ~. 

il-39bd S30N3ID9 ISHDH 21:21 68. 9 Nttf 
P.18 

••-. -ir-Tii-'TT^wrff" 

/.*. Oi- 'Oi* OV'tt <wt'«M.iv. rM.t<Ur«. t l c -•-•>-••*• • . J -

G> 

0) 

120 n 

110 -

100-

9 0 -

8 0 -

2

70 

McCarthy Scale; -•> Verbal 

Quantitative 

Percep-Perf 

Cognitive (QCI) 

Memory 

Motor 

8 0 -

5 0 -

40 

10 20 30 

Blood lead concentration 

—r40 

Figure 111 

81 '39ttd S30N3IDS "ISHOn El :2t 68. 9 Nbf 
I PI 

fit 

coefl = -15S) 

I U l 

. ChangefciPbB j 

Blood lead concentration frig/dl) 

z 

O) 

ro 1 

ID 

ro 

co 

c 

o 

in 

in 

o 

z 

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in 

TJ 

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Figwre i v