United States
Environmental Pn
Agency
                                8-83 028aF
                               '986
Research and Development
Air Quality
Criteria for Lead
Volume  I of IV

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                           EPA-600/8-83/028aF
                                       June 1986
Air Quality Criteria for Lead
          Volume I of IV
      U.S. ENVIRONMENTAL PROTECTION AGENCY
         Office of Research and Development
     Office of Health and Environmental Assessment
      Environmental Criteria and Assessment Office
         Research Triangle Park, NC 27711

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                                   NOTICE

     Mention  of  trade  names  or  commercial   products  does  not  constitute
endorsement or recommendation for use.
                                       n

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                                  ABSTRACT

     The document evaluates  and  assesses  scientific information on the health
and welfare effects associated with exposure to various concentrations of lead
in ambient air.   The  literature  through 1985 has been reviewed thoroughly for
information relevant  to air  quality  criteria,  although  the  document  is  not
intended as  a complete  and  detailed review  of all  literature  pertaining to
lead.  An  attempt has  been  made to  identify the major  discrepancies  in our
current knowledge and understanding of the effects of these pollutants.
     Although  this document  is  principally  concerned  with  the  health  and
welfare effects of  lead, other scientific data are presented and evaluated in
order to provide  a better understanding of this pollutant in the environment.
To this  end,  the  document includes chapters  that discuss the  chemistry and
physics  of  the  pollutant;   analytical  techniques;   sources,  and  types  of
emissions;  environmental  concentrations  and  exposure  levels;  atmospheric
chemistry  and dispersion  modeling; effects  on vegetation;  and  respiratory,
physiological, toxicological,  clinical, and  epidemiological  aspects  of human
exposure.

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                                           CONTENTS
                                                                                          Page
VOLUME I
  Chapter 1.  Executive Summary and Conclusions 	    1-1

VOLUME II
  Chapter 2.   Introduction 	    2-1
  Chapter 3.   Chemical and Physical Properties	    3-1
  Chapter 4.   Sampling and Analytical Methods for Environmental Lead 	    4-1
  Chapter 5.   Sources and Emissions 	    5-1
  Chapter 6.   Transport and Transformation 	:	    6-1
  Chapter 7.   Environmental Concentrations and Potential Pathways to Human Exposure ..    7-1
  Chapter 8.   Effects of Lead on Ecosystems 	    8-1

VOLUME III
  Chapter 9.   Quantitative Evaluation of Lead and Biochemical Indices of Lead
               Exposure in Physiological Media 	    9-1
  Chapter 10.  Metabolism of Lead 	   10-1
  Chapter 11.  Assessment of Lead Exposures and Absorption in Human Populations 	   11-1

Volume IV
  Chapter 12.  Biological Effects of Lead Exposure 	   12-1
  Chapter 13.  Evaluation of Human Health Risk Associated with Exposure to Lead
               and Its Compounds 	   13~1
                                              iv

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                                       TABLE OF CONTENTS
                                           CHAPTER 1
                               EXECUTIVE SUMMARY AND CONCLUSIONS
LIST OF FIGURES 	        ix
LIST OF TABLES 	        xi
LIST OF ABBREVIATIONS 	       xii
MEASUREMENT ABBREVIATIONS 	        xv
GLOSSARY VOLUME II 	       xvi
GLOSSARY VOLUME III 	       xix
GLOSSARY VOLUME IV	        xx
AUTHORS AND CONTRIBUTORS 	      xxi i
CLEAN AIR SCIENTIFIC ADVISORY COMMITTEE 	     xxi 11
PROJECT TEAM 	       XXV

 1.  EXECUTIVE SUMMARY AND CONCLUSIONS 	      1-1
     1.1  INTRODUCTION 	      1-1
     1.2  ORGANIZATION OF DOCUMENT 	      1-2
     1.3  CHEMICAL AND PHYSICAL PROPERTIES OF LEAD 	      1-3
     1.4  SAMPLING AND ANALYTICAL METHODS FOR ENVIRONMENTAL LEAD 	      1-5
          1.4.1  Sampling Techniques 	      1-6
          1.4.2  Analytical Procedures 	      1-9
     1.5  SOURCES AND EMISSIONS 	      1-11
     1.6  TRANSPORT AND TRANSFORMATION 	      1-19
          1.6.1  Atmospheric Transport 	      1-19
          1.6.2  Deposition 	      1-24
          1.6.3  Transformation 	      1-28
     1.7  ENVIRONMENTAL CONCENTRATIONS AND POTENTIAL PATHWAYS
          TO HUMAN EXPOSURE 	      1-32
          1.7.1  Lead in Air	      1-32
          1.7.2  Lead in Soil and Dust	      1-35
          1.7.3  Lead in Food 	      1-36
          1.7.4  Lead in Water 	      1-37
          1.7.5  Baseline Exposures to Lead 	      1-38
          1.7.6  Additional Exposures 	      1-42
                 Urban atmospheres 	      1-42
                 Houses with interior lead paint 	      1-44
                 Family gardens 	      1-44
                 Houses with lead plumbing 	      1-44
                 Residences near smelters and refineries 	      1-45
                 Occupational exposures 	      1-45
                 Secondary occupational exposure 	      1-46
                 Special habits or activities 	      1-46
          1.7.7  Summary 	      1-47
     1.8  EFFECTS OF LEAD ON ECOSYSTEMS 	      1-50
          1.8.1  Effects on Plants 	      1-53
          1.8.2  Effects of Microorganisms 	      1-56
          1.8.3  Effects on Animals 	      1-57
          1.8.4  Effects on Ecosystems 	      1-59

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                           TABLE OF CONTENTS (continued).

                                                                                     Page

1.9  QUANTITATIVE EVALUATION OF LEAD AND BIOCHEMICAL INDICES OF LEAD
     EXPOSURE IN PHYSIOLOGICAL MEDIA 	      1-61
     1.9.1  Determinations of Lead in Biological Media	      1-62
            Measurements of lead in blood 	      1-63
            Lead i n pi asma 	      1-63
            Lead in teeth 	      1-63
            Lead in hair	      1-64
            Lead i n uri ne 	      1-64
            Lead in other tissues 	      1-64
            Quality assurance procedures in lead analyses  	      1-64
     1.9,2  Determination of Biochemical Indices of Lead Exposure in
            Biological Media 	     1-65
            Determination of Erythrocyte Porphyrin (Free Erythrocyte
            Protoporphyrin,  Zinc Protoporphyrin) 	     1-65
            Measurement of Urinary Coproporphyrin 	     1-66
            Measurement of Delta-Aminolevulinic Acid Dehydrase Activity 	     1-67
            Measurement of Delta-Aminolevulinic Acid in Urine and
            Other Media 	     1-67
            Measurement of Pyrimidine-S'-Nucleotidase Activity 	     1-68
            Measurement of Plasma 1,25-dihydroxyvitamin D  	     1-68
1.10 METABOLISM OF LEAD 	     1-69
     1.10.1 Lead Absorption in Humans and Animals 	     1-69
            Respiratory absorption of lead 	     1*69
            Gastrointestinal  absorption of lead 	     1-70
            Percutaneous absorption of lead 	     1-71
            Transplacental transfer of 1ead 	     1-71
     1.10.2 Distribution of Lead in Humans and Animals 	     1-71
            Lead in Blood 	     1"71
            Lead Levels i n Ti ssues 	     1-72
                     Soft tissues 	     1-72
                     Mineralizing tissue 	     1-73
                     Chelatable lead 	     1-74
                     Animal  studies 	     1-74
     1.10.3 Lead Excretion and Retention in Humans and Animals 	     1-75
            Human studies 	     1-75
            Animal  studies 	     1-76
     1.10.4 Interactions of  Lead with Essential  Metals and Other Factors 	     1-76
            Human studies 	     1-76
            Animal  studies 	     1-76
     1.10.5 Interrelationships of Lead Exposure with Exposure Indicators
            and Tissue Lead  Burdens 	     1-77
            Temporal  charactersitics of internal indicators of lead exposure —     1-78
            Biological aspects of external  exposure/internal  indicator
            relationships 	     1-78
            Internal  indicator/tissue lead relationships 	     1-78
     1.10.6 Metabolism of Lead Alkyls 	     1-79
            Absorption of lead alkyls in humans and animals 	     1-79
            Biotransformation and tissue distribution of lead alkyls 	     1-80
            Excretion of lead alkyls 	     1-80
                                         VI

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                           TABLE OF CONTENTS (continued).

                                                                                     Page

1.11 ASSESSMENT OF LEAD EXPOSURES AND ABSORPTION IN HUMAN POPULATIONS 	     1-80
     1.11.1 Levels of Lead and Demographic Covariates
            in U.S.  Populations 	     1-81
     1.11.2 Time Trends in Blood Lead Levels Since 1970 	     1-85
            Studies in the United States 	     1-85
            European Studies 	     1-87
     1.11.3 Gasoline lead as an Important Determinant of Trends in Blood Lead
            Levels 	     1-87
     1.11.4 Blood Lead versus Inhaled Air Lead Relationships 	     1-95
     1.11.5 Studies Relating Dietary Lead Exposures (Including Water) to
            Blood Lead 	     1-102
     1.11.6 Studies Relating Lead in Soil and Dust to Blood Lead 	     1-103
     1.11.7 Additional Exposures 	     1-104
1.12 BIOLOGICAL EFFECTS OF LEAD EXPOSURE 	     1-105
     1.12.1 Introduction 	     1-105
     1.12.2 Subcellular Effects of Lead 	     1-105
     1.12.3 Effects of Lead on Heme Biosynthesis, Erythropoiesis, and
            Erythrocyte Physiology in Humans and Animals 	     1-108
     1.12.4 Neurotoxic Effects of Lead 	     1-116
            Internal Lead Levels at Which Neurotoxic Effects Occur 	     1-116
            The Question of Irreversibility 	     1-118
            Early Development and the Susceptibility to Neural Damage 	     1-118
            Utility of Animal Studies in Drawing Parallels to the Human
            Condition 	     1-119
     1.12.5 Effects of Lead on the Kidney 	     1-121
     1.12.6 Effects of Lead on Reproduction and Development 	     1-122
     1.12.7 Genotoxic and Carcinogenic Effects of Lead 	     1-124
     1.12.8 Effects of Lead on the Immune System 	     1-124
     1.12.9 Effects of Lead on Other Organ Systems 	     1-125
1.13 EVALUATION OF HUMAN HEALTH RISKS ASSOCIATED WITH EXPOSURE TO LEAD AND
     ITS COMPOUNDS 	     1-125
     1.13.1 Introduction 	     1-125
     1.13.2 Exposure Aspects:  Levels of Lead in Various Media of Relevance to
            Human Exposure 	     1-126
            Ambient Air Lead Levels 	     1-126
            Levels of Lead in Dust 	     1-127
            Levels of Lead in Food	     1-127
            Lead Levels in Drinking Water	     1-129
            Lead in Other Media 	     1-129
            Cumulative Lead Intake From Various Sources 	     1-129
     1.13.3 Lead Metabolism:  Key Issues for Human Health Risk Evaluation 	     1-130
            Differential Internal Lead Exposure Within Population Groups 	     1-130
            Indices of Internal Lead Exposure and Their Relationship to
            External Lead Levels and Tissue Burdens/Effects 	     1-132
            Proportional Contributions of Lead  in Various Media  to Blood
            Lead in Human Populations 	     1-136
     1.13.4 Biological Effects of Lead Relevant to the General Human Population .     1-138
            Criteria for Defining Adverse Health Effects  	     1-139
            Dose-Effect Relationships for Human Adults  	    1-140
            Dose-Effect Relationships for Children  	    1-142


                                         vii

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                           TABLE OF CONTENTS (continued).
     1.13.5 Dose-Response Relationships for Lead Effects in Human Populations ...     1-150
     1.13.6 Populations at Risk	     1-154
            Children as a Population at Risk	     1-154
            Pregnant Women and the Conceptus as a Population at Risk 	     1-155
            Description of the U.S.  Population in Relation to Potential
            Middle-Aged White Males (aged 40-59) as a Population at Risk 	     1-156
            Lead Exposure Risk	     1-157
     1.13.7 Summary and Conclusions 	     1-158
1.14 REFERENCES 	     1-161

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                                        LIST OF FIGURES


:igure                                                                                   Page

 1-1   Metal  compl exes  of  1 ead  	    1-4
 1-2   Softness  parameters of metals  	    1-5
 1-3   Pathways  of lead exposure  from the  environment to man, main compartments
       involved  in partitioning of internal body  burden of absorbed/retained
       lead,  and main routes of lead  excretion	    1-12
 1-4   Chronological  record of  the relative increase of lead  in snow strata,
         pond and lake  sediments,  marine sediments, and tree  rings.  The data
         are  expressed  as  a ratio  of  the latest year of the record and should
         not  be  interpreted to  extend back in time to natural or uncontaminated
         levels  of lead concentration 	    1-14
 1-5   The global lead  production  has changed historically in response to
         major economic and political events.   Increases in lead production
         (note log scale)  correspond  approximately to historical increases
         in lead emissions shown  in Figure 1-4	    1-15
 1-6   Locations of major  lead  operations  in the  United States  	    1-18
 1-7   Trend  in  lead content of U.S.  gasolines, 1975-1984	    1-20
 1-8   Lead consumed in gasoline  and  ambient  lead concentrations,  1975-1984  	    1-21
 1-9   Profile of lead  concentrations in the central northeast  Pacific.  Values
         below 1000 m are  an order magnitude lower than reported by Tatsumoto  and
         Patterson (1963)  and  Chow and Patterson  (1966) 	    1-25
 1-10  Lead concentration  profile in  snow  strata  of northern  Greenland  	    1-26
 1-11  Variation of lead saturation capacity with cation exchange  capacity  in
         soil at selected  pH values 	•	    1-31
 1-12  This figure depicts cycling process within major components of a  terrestrial
         ecosystem, i.e. primary  producers, grazers, and decomposers.   Nutrient  and
         non-nutrient elements  are stored  in  reservoirs within  these components.
         Processes that take place within  reservoirs regulate the  flow  of elements
         between reservoirs  along established pathways.  The  rate  of flow is in
         part a  function of the concentration  in  the preceding  reservoir.   Lead
         accumulates in decomposer reservoirs  (Dj-D^ which  have a high binding
         capacity for this metal.   When the  flow  of  nutrients at I,  II,  III,  the
         rate of flow of inorganic nutrients  to primary producers  is  reduced 	    1-51
 1-13  Geometric mean blood lead  levels by race and  age  for  younger  children in  the
         NHANES  II study,  and  the Kellogg  Silver  Valley,  ladho  study  and New York
         childhood screening studies  	    1-83
 1-14  Average blood lead levels  of U.S. population  6 months  -  74  years.  United
         States, February 1976 -  February  1980, based  on  dates  of  examination  of
         NHANES  II examinees with blood lead  determinations  	    1~86
 1-15  Time dependence of blood lead for blacks,  aged 24  to  35  months,  in New York
         City and Chicago 	    1-88
 1-16  Parallel  decreases in blood lead values  observed  in the  NHANES  II study
         and amounts of lead used in gasoline during 1976-1980  	    1-90
 1-17  Change in 206Pb/207Pb ratios  in petrol,  airborne  particulate  and
         blood from 1974 to 1981 	    1-92
 1-18  Geometric mean blood lead levels of New York City  children  (aged 25-36
         months) by ethnic group, and ambient air lead  concentration vs.
         quarterly sampling period,  1970-1976 	     1-96
                                              ix

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                                 LIST OF  FIGURES  (continued).


:1gure                                                                                   Page

 1-19  Geometric  mean blood  lead  levels of  New York  City  children  (aged 25-36
         months)  by ethnic group,  and estimated amount  of lead present in gasoline
         sold in  New York, New Jersey, and  Connecticut  vs.  quarterly  sampling
         period,  1970-1976 	    1-97
 1-20  Effects of lead (Pb)  on heme  biosynthesis  	    1-109
 1-21  Illustration of main  body  compartments  involved  in partitioning, retention
       and excretion of absorbed  lead and selected target organs for  lead toxicity  ...    1-134
 1-22  Multi-organ impact of reductions of  heme body pool  by  Lead  	    1-141
 1-23  Dose-response for elevation of EP  as a  function  of blood  lead  level  using
       probit analysis 	:	    1-152
 1-24  Dose-response curve for FEP as a function  of  blood lead  level:  in sub-
       populations 	    1-152
 1-25  EPA calculated dose-response  for ALA-U  	

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                                        LIST OF TABLES


Table                                                                                     Page

 1-1   Estimated atmospheric lead emissions to the atmosphere for the United
       States, 1984 	      1-17
 1-2   Summary of surrogate and vegetation surface deposition of lead 	      1-28
 1-3   Estimated global deposition of atmospheric lead 	      1-29
 1-4   Atmospheric lead in urban, rural, and remote areas of the world 	      1-34
 1-5   Background lead in basic food crops and meats 	      1-37
 1-6   Summary of environmental concentrations of lead 	      1-38
 1-7   Summary of baseline human exposures to lead 	      1-43
 1-8   Summary of potential additive exposures to lead 	      1-49
 1-9   Weighted geometric mean blood lead levels from NHANES II survey by
       degree of urbanization of place of residence in the U.S. by age
       and race, United States 1976-80 	      1-84
 1-10  Summary of pooled geometric standard deviations and estimated
       analyti c errors 	      1-85
 1-11  Person correlation coefficients between the average blood lead levels
       for six-month periods and the total lead used in gasoline production
       per six months, according to race, sex, and age 	      1"91
 1-12  Estimated contribution of leaded gasoline to blood lead by inhalation
       and non-inhalation pathways 	      1~94
 1-13  Summary of blood inhalation slopes (P) 	      1-99
 1-14  Relative baseline human lead exposures expressed per kilogram body weight 	      1-128
 1-15  Contributions from various media to blood lead levels (ug/dl) of U.S.
       children (age = 2 yrs):  Background levels and incremental contributions
       from air	      1-137
 1-16  Summary of lowest observed effect levels for key lead-induced health effects
       in adults 	      1-143
 1-17  Summary of lowest observed effect levels for key lead-induced health effedts
       in children 	      1-144
 1-18  EPA-estimated percentage of subjects with ALA-U exceeding limits for
       various blood lead  levels 	      1-153
 1-19  Provisional estimate of the number of  individuals in urban and rural
       population segments at greatest potential risk to lead  exposure 	      1-158

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                                     LIST OF ABBREVIATIONS
AAS
Ach
ACTH
ADCC
ADP/0 ratio
AIDS
AIHA
All
ALA
ALA-D
ALA-S
ALA-U
APDC
APHA
ASTM
ASV
ATP
B-cells
Ba
BAL
BAP
BSA
BUN
BW
C.V.
CaBP
CaEDTA
CaNa.EDTA
CBD Z
Cd
CDC
CEC
CEH
CFR
CMP
CNS
CO
COHb
CP-U

cBah
D.F.
DA
6-A LA
DCMU
DPP
DNA
DTH
EEC
EEG
EMC
EP
Atomic absorption spectrometry
Acetylcholine
Adrenocorticotrophic hormone
Antibody-dependent cell-mediated cytotoxicity
Adenosine diphosphate/oxygen ratio
Acquired immune deficiency syndrome
American Industrial Hygiene Association
Angiotensin II
Aminolevulinic acid
Aminolevulinic acid dehydrase
Aminolevulinic acid synthetase
Aminolevulinic acid in urine
Ammonium pyrrolidine-dithiocarbamate
American Public Health Association
Amercian Society for Testing and Materials
Anodic stripping voltammetry
Adenosine triphosphate
Bone marrow-derived lymphocytes
Barium
British anti-Lewisite (AKA dimercaprol)
benzo(a)pyrene
Bovine serum albumin
Blood serum urea nitrogen
Body weight
Coefficient of variation
Calcium binding protein
Calcium ethylenediaminetetraacetate
Calcium sodium ethylenediaminetetraacetate
Central business district
Cadmium
Centers for Disease Control
Cation exchange capacity
Center for Environmental Health
reference method
Cytidine monophosphate
Central nervous system
Carbon monoxide
Carboxyhemoglobin
Urinary coproporphyrin
plasma clearance of p-aminohippuric acid
Copper
Degrees of freedom
Dopamine
delta-aminolevulinic acid
[3-(3,4-dichlorophenyl)-l,l-dimethylurea
Differential pulse polarography
Deoxyribonucleic acid
Delayed-type hypersensitivity
European Economic Community
Electroencephalogram
Encephalomyocarditis
Erythrocyte protoporphyrin
                                              XII

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                              LIST OF ABBREVIATIONS (continued).


EPA                      U.S.  Environmental  Protection Agency
FA                       Fulvic acid
FDA                      Food and Drug Administration
Fe                       Iron
FEP                      Free erythrocyte protoporphyrin
FY                       Fiscal year
G.M.                     Grand mean
G-6-PO                   Glucose-6-phosphate dehydrogenase
GABA                     Gamma-aminobutyric acid
GALT                     Gut-associated lymphoid tissue
GC                       Gas chromatography
GFR                      Glomerular filtration rate
HA                       Humic acid
Hg                       Mercury
hi-vol                   High-volume air sampler
HPLC                     High-performance liquid chromatography
i.m.                     Intramuscular (method of injection)
i.p.                     Intraperitoneally (method of injection)
i.v.                     Intravenously (method of injection)
IAA                      Indol-3-ylacetic acid
IARC                     International Agency for Research on Cancer
ICD                      International classification of diseases
ICP                      Inductively coupled plasma emission spectroscopy
IDMS                     Isotope dilution mass spectrometry
IF                       Interferon
ILE                      Isotopic Lead Experiment (Italy)
IRPC                     International Radiological Protection Commission
K                        Potassium
LDH-X                    Lactate dehydrogenase isoenzyme x
LCj-A                     Lethyl concentration (50 percent)
LD?Q                     Lethal dose (50 percent)
LH                       Luteinizing hormone
LIPO                     Laboratory Improvement Program Office
In                       Natural logarithm
LPS                      Lipopolysaccharide
LRT                      Long  range transport
mRNA                     Messenger ribonucleic acid
ME                       Mercaptoethanol
MEPP                     Miniature end-plate potential
MES                      Maximal electroshock seizure
MeV                      Mega-electron volts
MLC                      Mixed lymphocyte culture
MMD                      Mass  median diameter
MMED                     Mass  median equivalent diameter
Mn                       Manganese
MNO                      Motor neuron disease
MSV                      Moloney  sarcoma  virus
MTD                      Maximum  tolerated  dose
n                        Number of  subjects or observations
N/A                      Not Available
                                               xiii

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                              LIST OF ABBREVIATIONS (continued).
NA
NAAQS
NAD
NADB
NAMS
HAS
NASN
NBS
NE
NFAN
NFR-82
NHANES II
N1
NTA
OSHA
P
P
PAH
Pb
PBA
Pb(Ac)?
PbB   *•
PbBrCl
PBG
RFC
PH
PHA
PHZ
PIXE
PMN
PND
PNS
P.O.
ppm
PRA
PRS
PWM
Py-5-N
RBC
RBF
RCR
redox
RES
RLV
RNA
S-HT
SA-7
S.C.
sent
S.D.
SDS
S.E.M.
Not Applicable
National ambient air quality standards
Nicotinamide Adenine Dinucleotide
National Aerometric Data Bank
National Air Monitoring Station
National Academy of Sciences
National Air Surveillance Network
National Bureau of Standards
Norepinephrine
National Filter Analysis Network
Nutrition Foundation Report of 1982
National Health Assessment and Nutritional Evaluation Survey II
Nickel
Ni tri1otri acetoni tri1e
Occupational Safety and Health Administration
Phosphorus
Significance symbol
Para-aminohippuric acid
Lead
Air lead
Lead acetate
concentration of lead in blood
Lead (II) bromochloride
Porphobilinogen
Plaque-forming cells
Measure of acidity
Phytohemaggluti ni n
Polyacrylamide-hydrous-zirconia
Proton-induced X-ray emissions
Polymorphonuclear leukocytes
Post-natal day
Peripheral nervous system
Per os  (orally)
Parts per million
Plasma  renin activity
Plasma  renin substrate
Pokeweed mitogen
Pyrimide-S'-nucleotidase
Red blood cell; erythrocyte
Renal blood flow
Respiratory control ratios/rates
Oxidation-reduction potential
Reticuloendothelial system
Rauscher leukemia virus
Ribonucleic acid
Serotonin
Simian  adenovirus
Subcutaneously (method of injection)
Standard cubic meter
Standard deviation
Sodium  dodecyl sulfate
Standard error of the mean
                                              xiv

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                              LIST OF ABBREVIATIONS (continued).
SES
SCOT
sig
SLAMS
SMR
Sr
SRBC
SRMs
STEL
SW voltage
T-cells
t-tests
TBL
TEA
TEL
TIBC
TML
TMLC
TSH
TSP
U.K.
UMP
USPHS
VA

V^R
WHQ
XRF
X^
Zn
ZPP
Socioeconomic status
Serum glutamlc oxaloacetic transaminase
Surface immunoglobulin
State and local air monitoring stations
Standardized mortality ratio
Strontlurn
Sheep red blood cells
Standard reference materials
Short-term exposure limit
Slow-wave voltage
Thymus-derived lymphocytes
Tests of significance
Tri-n-butyl lead
Tetraethyl-ammoni urn
Tetraethyllead
Total iron binding capacity
Tetramethyllead
Tetramethyllead chloride
Thyroid-stimulating hormone
Total suspended particulate
United Kingdom
Uridine monophosphate
U.S. Public Health Service
Veterans Administration
Deposition velocity
Visual evoked response
World Health Organization
X-Ray fluorescence
Chi squared
Zinc
Erythrocyte zinc protoporphyrin
                                   MEASUREMENT ABBREVIATIONS
dl
ft
9
g/gal
g/ha-mo
km/hr
1/min
nig/km
ug/m3
mm
pm
jjmol
ng/cm2
nm
nM
sec
t
deciliter
feet
gram
gram/gallon
gram/hectare•month
kilometer/hour
liter/minute
mi 111gram/ki1ometer
microgram/cubic meter
millimeter
micrometer
micromole
nanograms/square  centimeter
nanometer
nanomole
second
tons
                     xv

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                             GLOSSARY VOLUME II
A horizon of soils - the top layer of soil, immediately below the litter layer;
                     organically rich.
anorexia - loss of appetite.
anthropogenic - generated by the activities of man.
apoplast - extracellular portion of the root cross-section.
Brownian movement - the random movement of microscopic particles.
carnivore - meat-eating organism.
catenation - linkage between atoms of the same chemical element.
cation exchange capacity (CEC) - the ability of a matrix to selectively exchange
                                 positively charged ions.
chemical mass balance - the input/output balance of a chemical within a defined
                        system.
coprophilic fungi - fungi which thrive on the biological waste products of
                    other organisms.
detritus - the organic remains of plants and animals.
dictyosome - a portion of the chloroplast structurally similar to a stack of
             disks.
dry deposition - the transfer of atmospheric particles to surfaces by sedimen-
                 tation or impaction.
ecosystem - one or more ecological communities linked by a common set of
            environmental parameters.
electronegativity - a measure of the tendency of an atom to become negatively
                    charged.
enrichment factor - the degree to which the environmental concentration of an
                    element exceeds the expected (natural or crustal)
                    concentration.
galena - natural lead sulfide.
gravimetric - pertaining to a method of chemical  analysis in which the
              concentration of an element in a sample is determined by weight
              (e.g., a precipitate).
herbivore - plant-eating organism.
humic substances - humic and fulvic acids in soil  and surface water.
                                      xvi

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hydropom'cally grown plants - plants which are grown with their roots  immersed
                              in a nutrient-containing solution instead of
                              soil.

Law of Tolerance - for every environmental factor there is both a minimum and
                   a maximum that can be tolerated by a population of  plants
                   or animals.

leaf area index (LAI) - the effective leaf-surface (upfacing) area of  a tree as
                        a function of the plane projected area of the  tree  canopy.

LC50 - concentration of an agent at which 50 percent of the exposed population
       dies.

lithosphere - the portion of the earth's crust subject to interaction  with  the
              atmosphere and hydrosphere.

mass median aerodynamic diameter (MMAD) - the aerodynamic diameter (in pm)  at
                                          which half the mass of particles  in
                                          an aerosol is associated with values
                                          below and half above.

meristematic tissue - growth tissue in plants capable of differentiating into
                      any of several cell types.

microcosm - a small, artificially controlled ecosystem.

mycorrhizal fungi - fungi symbiotic with the root tissue of plants.

NADP - National Atmospheric Deposition Program.

photolysis - decomposition of molecules into simpler units by the application
             of light.

photosystem I light reaction - the light reaction of photosystem converts light
                               to chemical energy (ATP and reduced NADP).
                               Photosystem I of the light reaction receives ex-
                               cited electrons from photosystem II, increases
                               their energy by the absorption of light, and
                               passes these excited electrons to redox
                               substances that eventually produce reduced
                               NADP.

primary producers - plants and other organisms capable of transforming carbon
                    dioxide and light or chemical energy into organic  compounds.

promotional energy - the energy required to move an atom from one valence
                     state to another.

saprotrophs - heterotrophic organisms that feed primarily on dead organic
              material.

stoichiometry - calculation of the quantities  of substances that enter  into
                and are produced by chemical reactions.
                                      xvn

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stratospheric transfer - in the context of this document, transfer from the
                         troposphere to the stratosphere.

symplast - intracellular portion of the root cross-section.

troposphere - the lowest portion of the atmosphere, bounded on the upper level
              by the stratosphere.

wet deposition - the transfer of atmospheric particles to surfaces by precipi-
                 tation, e.g., rain or snow.
                                     xviii

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                              GLOSSARY VOLUME III

                                                i
aerosol - a suspension of liquid or solid particles in a gas

BAL (British Anti-Lewi site) - a chelating agent often used in the treatment of
                              metal toxicity

biliary clearance - an excretion route involving movement of an agent through
                    bile into the GI tract

Brownian diffusion - the random movement of microscopic particles

"chelatable" or systemically active zinc - fraction of body's zinc store
                                           available or accessible to
                                           removal by a zinc-binding agent

chi-square goodness-of-fit tests - made to determine how well the observed
                                   data fit a specified model, these tests
                                   usually are approximately distributed as a
                                   chi-square variable

first-order kinetics - a kinetic process whose rate is proportional to the
                       concentration of the species undergoing change

geochronometry - determination of the age of geological materials

hematocrit - the percentage of the volume of a blood sample occupied by cells

intraperitoneal - within the body cavity

likelihood function - a relative measure of the fit of observed data to a
                      specified model.  In some special cases it is equivalent
                      to the sum of squares function used in least squares
                      analysis.

mass median aerodynamic diameter (MMAD) - the aerodynamic diameter (in urn) at
                                          which half the mass of particles in
                                          an aerosol is associated with values
                                          below and half above

multiple regression analysis -. the fitting of a single dependent variable to a
                               linear combination  of independent variables using
                               least squares analysis  is commonly called multiple
                               regression analysis

plumburesis -  lead excreted  in urine

R2  - this  statistic,  often called  the multiple  R  squared, measures the proportion
     of  total  variation explained.  A value  near  1 means that  nearly  all  of  the
     variation is explained, whereas a value near zero means that almost  none of
     the variation is explained.
                                      xix

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                             GLOSSARY VOLUME IV


ADP/0 ratio - a measure of the rate of respiration;  the ratio of adenosine
              diphosphate concentration to oxygen levels increases as
              respiration is impaired

active transport - the translocation of a solute across a membrane by means  of
                   an energy-dependent carrier system capable of moving against
                   a concentration gradient

affective function - pertaining to emotion

asthenospermia - loss or reduction of the motility of spermatozoa

azotemia - an excess of urea and other nitrogenous compounds in the blood

basal ganglia - all  of the large masses of gray matter at the base of the
                cerebral  hemispheres, including the  corpus striatum, subthalamic
                nucleus,  and substantia nigra

basophilic stippling - a histochemical appearance characteristic of immature
                       erythrocytes

cognitive function - pertaining to reasoning, judging, conceiving, etc.

corpuscular volume - red blood cell volume

cristae - shelf-like info!dings of the inner membrane of mitochondria

cytomegaly - markedly enlarged cells

demyelination - destruction of the protective myelin sheath which surrounds
                most nerves

depolarization - the electrophysiological process underlying neural transmission

desaturation kinetic study - a form of kinetic study in which the rate of release
                             of a species from its binding is studied

desquamation - shedding, peeling, or scaling off

disinhibition - removal of a tonic inhibitory effect

endoneurium - the delicate connective tissue enveloping individual nerve fibers
              within a nerve

erythrocyte - red blood cell

erythropoiesis - the formation of  red blood cells

feedback derepression - the deactivation of a represser

hepatocyte - a parenchymal  liver cell
                                      xx

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hyalinization - a histochemical  marker characteristic of degeneration
hyperkalemia - a greater than normal  concentration of potassium ions  in  the
               circulating blood
hyperplasia - increased numbers  of cells
hypertrophy - increased size of  cells
hypochromic - containing less than the normal  amount of pigment
hyporeninemic hypoaldosteronism  - pertaining to a systemic deficiency  of renin
                                  and aldosterone
inclusion bodies - any foreign substance contained or entrapped within a cell
isocortex - cerebral cortex
lysosomes - a cytoplasmic, membrane-bound particle containing hydrolyzing
            enzymes
macrophage - large scavenger cell that ingests bacteria, foreign bodies, etc.
(Na  , K )-ATPase - an energy-dependent enzyme which transports sodium and
                   potassium across cell membranes
natriuresis - enhanced urinary excretion of sodium
normocytic - refers to normal, heal thy-looking erythrocytes
organotypic - disease or cell mixture representative of a specific organ
oxidative phosphorylation - the generation of cellular energy  in the presence
                            of oxygen
paresis - partial or incomplete paralysis
pathognomic feature - characteristic or  indicative  of a disease
polymorphonuclear leukocytes -  leukocytes (white  blood cells)  having nuclei of
                                various  forms
respiratory control rates (RCRs)  - measure of  intermediary metabolism
reticulocytosis  - an increase in  the  number of circulating immature red blood
                  cells
synaptogenesis  -  the formation  of neural connections  (synapses)
synaptosomes  -  morphological  unit composed  of  nerve terminals  and  the attached
                synapse
teratogenic  -  affecting  the development of  an  organism
teratospermia -  a condition characterized by  the presence of malformed
                 spermatozoa
                                       xx i

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                             AUTHORS  AND  CONTRIBUTORS
Chapter  1:   Executive  Summary

Principal Author

Dr.  Lester D. Grant
Director
Environmental Criteria and Assessment Office
Environmental Protection Agency
MD-52
Research Triangle Park, NC  27711

Contributing Authors:

Dr. J. Michael Davis
Environmental Criteria and
  Assessment Office
MD-52
Research Triangle Park, NC  27711

Dr. Vic Hasselblad
Biometry Division
Health Effects Research Laboratory
MD-55
Research Triangle Park, NC  27711

Dr. Paul Mushak
Department of Pathology
School of Medicine
University of North Carolina
Chapel Hill,  NC  27514
Dr. Robert W. Elias
Environmental Criteria and
  Assessment Office
MD-52
Research Triangle Park, NC  27711

Dr. Dennis J. Kotchmar
Environmental Criteria and
  Assessment Office
MD-52
Research Triangle Park, NC  27711

Dr. David E. Weil
Environmental Criteria and
  and Assessment Office
MD-52
Research Triangle Park, NC  27711
                                     xxi i

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                            SCIENCE ADVISORY BOARD
                    CLEAN AIR SCIENTIFIC ADVISORY COMMITTEE
     The substance of this document and Its addendum was reviewed by the Clean
Air Scientific Advisory Committee of the Science Advisory Board in public
sessions.
                             SUBCOMMITTEE ON LEAD
Chairman

Dr. Morton Lippmann
Professor
Department of Environmental Medicine
New York University Medical Center
Tuxedo, New York  10987
Executive Secretary

Mr. Robert Flaak
Science Advisory Board (A-101F)
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C.  20460
                                 Panel Members
Dr. Carol R. Angle
Professor of Pediatrics and
  Director UNMC Toxicology Program
University of Nebraska Medical Center
COP - Room 4037A
42nd and Dewey Avenue
Omaha, Nebraska  68105

Or. J. Julian Chisolm, Jr.
Associate Professor of Pediatrics
The Kennedy Institute
707 North Boardway
Baltimore, Maryland  21205

*Dr. Anita S. Curren
Commissioner
Westchester County Health Department
112 East Post Road
White Plains, New York  10601

Dr. Ben B. Ewing
Professor of Environmental Engineering
Institute for Environmental Studies
University of Illinois
408 S. Goodwin
Urbana, Illinois  61801
Or. Robert Frank
Professor of Environmental Health
  Sciences
Johns Hopkins School of Hygiene
  and Public Health
615 N. Wolfe Street
Baltimore, Maryland  21205

Professor A. Myrick Freeman III
Department of Economics
Bowdoin College
Brunswick, Maine  04011

Dr. Robert Goyer
Deputy Director
NIEHS
P. 0. Box 12233
RTP, North Carolina  27709

Dr. Paul B. Hammond
Professor of Environmental Health
University of Cincinnati College of Medicine
Kettering Laboratory
3223 Eden Avenue
Cincinnati, Ohio  45267-0056
                                     xx i i i

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Dr. Lloyd G. Humphreys
Professor Emeritus
University of Illinois
Urbana-Champaign
603 East Daniel
Champaign, Illinois  61820

Dr. Warren B. Johnson
Director, Atmospheric Science Center
SRI International
333 Ravenswood Avenue
Menlo Park, California  94025

Dr. Paul Kotin
Adjunct Professor of Pathology
University of Colorado Medical School
4505 S.  Yosemite #339
Denver,  Colorado  80237

Dr. Timothy Larson
Environmental Engineering and
  Science Program
Department of Civil Engineering
FX-10
University of Washington
Seattle, Washington  98195

Dr. Kathryn R.  Mahaffey
Chief, Priorities Research and
  Analysis Branch (C-15)
NIOSH
4676 Columbia Parkway
Cincinnati, Ohio  45226

Professor M. Granger Morgan
Head, Department of Engineering
  and Public Policy
Carnegie-Mellon University
Pittsburgh, Pennsylvania  15253
Professor Roger G. Noll
Department of Economics
Stanford University
Stanford, California  94305

Dr. D. Warner North
Principal
Decision Focus Inc., Los Altos
  Office Center, Suit 200
4984 El Camino Real
Los Altos, California  94022

Dr. Robert D.  Rowe
Vice President, Environmental
  and Resource Economics
Energy and Resource Consultants, Inc.
Boulder, Colorado  80302

*Professor Richard M. Royal 1
Department of Biostatisties
Johns Hopkins University
615 North Wolfe Street
Baltimore, Maryland  21205

Dr. Ellen K. Silbergeld
Chief Toxics Scientist
Toxic Chemicals Program
Environmental  Defense Fund
1525 18th Street, N.W.
Washington, D.C.  20036

Dr. James H. Ware
Associate Professor
Harvard School of Public Health
Department of Biostastics
677 Huntington Avenue
Boston, Massachusetts  02115

Dr. Jerry Wesolowski
Air and Industrial Hygiene Laboratory
California Department of Health
2151 Berkeley Way
Berkeley, California  94704
                                     xxiv

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                         PROJECT TEAM FOR DEVELOPMENT
                                      OF
                         Air Quality Criteria for Lead
Dr.  David E.  Weil, Project Manager
  and Coordinator for Chapters 1 and 13, Volume I and IV, and Addendum
Environmental Criteria and Assessment Office (MD-52)
U.S. Environmental Protection Agency
Research Triangle Park, N.C.  27711

Dr.  J. Michael Davis
Coordinator for Chapters 9, 10, and 12, Volumes III and IV
Environmental Criteria and Assessment Office (MD-52)
U.S. Environmental Protection Agency
Research Triangle Park, N.C.  27711

Dr.  Robert W. Elias
Coordinator for Chapters 3, 4, 5, 6, 7, and 8, Volume II
Environmental Criteria and Assessment Office (MD-52)
U.S. Environmental Protection Agency
Research Triangle Park, N.C.  27711

Dr.  Lester D. Grant
Environmental Criteria and Assessment Office (MD-52)
U.S. Environmental Protection Agency
Research Triangle Park, N.C.  27711

Dr.  Dennis J. Kotchmar
Coordinator for Chapter 11, Volume III
Environmental Criteria and Assessment Office (MD-52)
U.S. Environmental Protection Agency
Research Triangle Park, N.C.  27711
                                       xxv

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                             1.   EXECUTIVE SUMMARY AND CONCLUSIONS
1.1  INTRODUCTION
     This criteria  document evaluates  and  assesses  scientific information on the health  and
welfare  effects  associated with  exposure  to various  concentrations  of lead in ambient air.
According to Section  108  of the Clean  Air  Act  of  1970,  as amended in  June,  1974, a  criteria
document for a specific pollutant or class of pollutants  shall:

          .  .   .  accurately reflect the latest  scientific  knowledge useful  in indicating
     the  kind  and extent  of all  identifiable  effects  on public health or  welfare which
     may be expected  from the  presence of  such  pollutant  in  the ambient  air, in varying
     quantities.

     Air quality criteria  are of necessity based on presently available scientific  data, which
in turn  reflect  the sophistication of the technology used in obtaining those data,  as well as
the  magnitude  of the experimental efforts  expended.   Thus,   air  quality criteria for  atmo-
spheric pollutants are a scientific expression of current knowledge and uncertainties.  Speci-
fically, air quality criteria are expressions of the scientific knowledge  of the relationships
between  various  concentrations—averaged over  a suitable time  period—of pollutants in  the
atmosphere  and their  adverse  effects upon  public  health and the  environment.   Criteria  are
issued  as  a basis  for making  decisions  about  the  need  for  control  of a  pollutant  and  as a
basis  for development of air quality standards governing the  pollutant.  Air quality criteria
are  descriptive;  that is,  they describe the  effects that  have been  observed  to occur  as a
result  of  external  exposure  at specific  levels  of a  pollutant.   In contrast,  air quality
standards are  prescriptive; that is,  they  prescribe what  a  political  jurisdiction has deter-
mined  to be the maximum permissible exposure for a given time in a specified geographic area.
     This criteria  document is  a  revision  of  the previous Air  Quality Criteria Document for
Lead  (EPA-600/8-77-017)  published in  December,  1977.  This  revision  is mandated by the Clean
Air  Act  (Sect. 108 and 109),  as amended  U.S.C. §§7408 and 7409.   The criteria document   sets
forth what  is  known about  the effects of  lead contamination in the environment on human health
and  welfare.   This  requires that  the relationship between levels of exposure to lead, via all
routes  and  averaged over  a suitable  time period, and the biological responses to those levels
be  carefully  assessed.  Assessment of  exposure  must take into consideration the temporal and
spatial  distribution  of  lead and  its  various  forms  in the environment.  Thus,  the literature
through  December,  1985,  has been  reviewed  thoroughly  for information  relevant  to air quality
criteria for  lead;  however, the  document is not intended as a complete and detailed  review of
                                             1-1

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all literature pertaining to  lead.   Also,  efforts are made to identify major discrepancies  in
our current knowledge and understanding of  the effects of lead and its compounds.
1.2  ORGANIZATION OF DOCUMENT
     This document  focuses  primarily on  lead as  found  in  its  various forms in  the  ambient
atmosphere;  in order to assess its effects on human health, however,  the distribution and bio-
logical availability of lead in other environmental media have been considered.   The rationale
for  structuring  the document was based primarily  on  the two major questions of exposure  and
response.  The first portion of the document is devoted to lead in the environment—its physi-
cal and  chemical  properties;  the monitoring of lead in various media; sources,  emissions,  and
concentrations  of  lead;  and the  transport and transformation  of lead within  environmental
media.  The  latter  portion  is devoted to biological responses and effects  on human health and
ecosystems.
     In  order  to facilitate  printing and  distribution  of the present  materials,  this Draft
Final  version  of  the revised EPA Air Quality  Criteria Document for Lead is being  released in
four  volumes.   The  first volume (Volume I) contains  this executive  summary  and  conclusions
chapter  (Chapter  1)  for  the entire document.  Volume  II contains  Chapters  2-8,  which  include
the following:   the introduction for the document (Chapter 2); discussions  of the above listed
topics concerning lead in  the environment  (Chapters  3-7); and evaluation  of  lead effects on
ecosystems (Chapter  8).   The remaining  two volumes contain Chapters 9-13,  which deal with the
extensive available  literature  relevant  to assessment of  health  effects associated with lead
exposure.  In  addition to  the  above materials,  there  is  appended  to  Chapter  1  an addendum
specifically addressing:   the complex  relationship between blood lead  level  and  blood pres-
sure;  and the  effects of fetal and pediatric exposures on growth and neurobehavioral develop-
ment.
     An effort has been made to limit the document to a highly critical assessment  of the sci-
entific  data base through December, 1985.   The  references cited do not constitute an exhaus-
tive bibliography of all  available lead-related literature, but they are thought to be suffi-
cient to reflect  the current state of knowledge on those issues most relevant to the review of
the ambient air quality standard for lead.
     The status  of  control  technology for  lead is not discussed in this document.   For infor-
mation on the  subject, the  reader is referred to appropriate control technology documentation
published by the  Office of  Air Quality Planning and Standards (OAQPS), U.S. EPA.  The subject
of  "adequate margin  of  safety"  stipulated  in Section 108  of  the Clean Air Act  also is not
explicitly  addressed  here;  this topic will  be considered  in depth  by EPA's Office  of Air

                                             1-2

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Quality Planning and  Standards  in documentation prepared as a part of the process  of revising
the National Ambient Air Quality Standard (NAAQS) for Lead.
1.3  CHEMICAL AND PHYSICAL PROPERTIES OF LEAD
     Lead is a  gray-white metal  of silvery luster that, because of its easy isolation and low
melting point,  was  among  the first of the metals to be extensively utilized by man.   Lead was
used as early  as  2000 B.C. by the  Phoenicians.   The most abundant ore  is  galena,  from which
metallic  lead  is  readily smelted.   The  metal  is  soft,  malleable,  and  ductile,  a  poor
electrical conductor, and  highly impervious to corrosion.  This unique combination of physical
properties has  led  to its use in piping and roofing, and in containers for corrosive liquids.
The metal and  the dioxide are used in storage batteries, and organolead compounds are used in
gasoline additives to boost octane levels.  Since lead occurs in highly concentrated ores from
which  it  is  readily separated, the availability of  lead is far greater than its natural abun-
dance  would  suggest.   The great environmental significance  of  lead is the result both of its
utility and of  its availability.
     The properties of organolead compounds (i.e., compounds containing bonds between lead and
carbon) are entirely  different from those of the inorganic compounds of lead. Because of their
use as antiknock  agents  in gasoline  and  other fuels, the most important organolead compounds
have been the tetraalkyl  compounds tetraethyllead (TEL)  and tetramethyllead (TML).  These lead
compounds are removed from internal combustion engines by a process called  lead scavenging, in
which  they  react in  the  combustion  chamber  with  halogenated  hydrocarbon additives (notably
ethylene dibromide and ethylene dichloride) to form  lead halides,  usually bromochlorolead(II).
     The donor  moiety in  an organometallic complex could be almost any basic atom or molecule;
the only  requirement is  that  a  donor,  usually called a ligand, must  have  a pair of electrons
available for  bond  formation.  In general,  the  metal atom occupies a central position  in the
complex,  as exemplified  by  the  lead atom in  tetramethyllead  (Figure  1-la)  which is  tetra-
hedrally  surrounded  by  four  methyl groups.   In  these simple organolead  compounds,  the  lead is
usually  present  as  Pb(IV),   and  the  complexes  are  relatively inert.   These  simple  ligands,
that  bind  to  metal  at  only  a  single  site,  are  called monodentate  ligands.   Some  ligands,
however,  can bind to the metal  atom  by more  than  one donor  atom,  so as  to  form a heterocyclic
ring  structure.   Rings of this  general type  are called chelate rings, and  the  donor molecules
that  form them are called polydentate  ligands or chelating  agents.   In  the chemistry  of lead,
chelation normally  involves  Pb(II).   A wide  variety of biologically  significant  chelates with
ligands  such as  amino  acids,  peptides,   and nucleotides are  known.    The simplest structure
of this type  occurs with the amino acid  glycine,  as  represented in  Figure  1-lb for a  1:2
 (metal:ligand) complex.   The importance of chelating  agents  in  the present context  is their
widespread  use in the treatment  of lead  and other metal poisoning.
                                             1-3

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                                                      H2O
           H3C        CH3

                 >b

           H3C         CH3

  c

CH2
       Pb
NH2
              NH2
                  (a)
       H2O

        (b)
                           Figure 1-1. Metal complexes of lead.

     Metals are  often classified according  to some  combination  of their  electronegativity,
ionic radius, and  formal  charge.   These parameters are used  to construct  empirical  classifi-
cation schemes of  relative  hardness  or softness.   In these schemes,  "hard"  metals  form  strong
bonds with  "hard"  anions and,  likewise, "soft" metals  bond with  "soft" anions.   Some  metals
are  borderline,  having  both  soft and  hard  character.    Pb(II),  although  borderline,  demon-
strates primarily  soft character  (Figure  1-2).  The term  Class A  may also  be  used  to refer  to
hard metals, and Class B to soft metals.   Since Pb(II) is  a relatively  soft (or  class B) metal
ion, it forms strong  bonds  to soft donor  atoms like the sulfur atoms in the cysteine residues
of proteins and  enzymes.   In living systems,  lead  atoms  bind to these peptide  residues in pro-
teins, thereby  changing  the  tertiary  structure  of  the   protein  or  blocking  a  substrate's
approach to the  active  site of an enzyme.  This prevents  the proteins  from carrying  out their
functions.   As has  been  demonstrated  in several studies (Jones and Vaughn,  1978; Williams and
Turner, 1981; Williams et  al.,  1982),  there  is an inverse correlation  between the  LD50  values
of metal  complexes and the chemical  softness  parameter.
     The role of the chelating agents  is to compete with the peptides for the  metal by forming
stable chelate complexes that  can be  transported  from  the  protein and eventually  be excreted
by  the body.  For simple thermodynamic reasons,  chelate  complexes are much more  stable than
monodentate metal  complexes,  and it  is this enhanced  stability  that  is the basis  for their
ability to compete favorably with proteins  and  other ligands for the metal  ions.
     It should  be  noted that both the  stoichiometry and  structures of metal chelates  depend
upon pH, and  that  structures  different from  those manifest in solution may occur in  crystals.
It will suffice  to state,  however,  that several ligands can be found that  are capable of suf-
ficiently strong  chelation  with  lead  present   in  the body under  physiological conditions  to
permit their use in the effective treatment of  lead poisoning.
                                            1-4

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CLASS B OR COVALENT INDEX, X'mr
a.u
1
4.5
4.0
3.5
3.0
2.5
2.0
1.5
1.0
0.5
0
• I I I I | I I I " I " I
t Au'
r ^
• Ag- M" pji> ^
~*Ti- Hg" ~~
_^Cu *Tl' CLASS B_
Pb" • Sbllll)
" £S *Cu"
f •Co" In" * •)
— * *•!¥!" • • F,i- Sn(IV) —
Cr"
Ti" «Tp Zn"
— Mn-« v" G*' * BORDERLINE ~~
— Gd" Lu>- —
Mg" i0« •sc" •
Ci- Ba" • • A(t.
V •••'•' -
^Na- Sr" •
~~ L' CLASS A ~~
I I I I I I I I ,.l ,,l
                                    6    8    10   12   14   16
                                    CLASS A OR IONIC INDEX, Z'/r
20   23
                                Figure 1-2. Softness parameters of metals.
                                Source: Nieboer and Richardson (1980).

1.4  SAMPLING AND ANALYTICAL METHODS FOR  ENVIRONMENTAL  LEAD
     Lead, like  all  criteria pollutants, has a designated  Reference  Method  for monitoring and
analysis  as  required  in  State Implementation Plans  for  determining  compliance with  the  lead
National  Ambient  Air Quality Standard.   The  Reference  Method uses a  high volume  sampler  (hi-
vol)  for sample  collection  and  atomic  absorption  spectrometry   (AAS),  inductively  coupled
plasma emission spectroscopy (ICP), or X-ray fluorescence (XRF)  for analysis.
     For  a  rigorous  quality  assurance program, it  is  essential that  investigators  recognize
all sources of contamination and use every precaution to eliminate  them.  Contamination occurs
on the  surfaces  of collection containers and devices,  on the hands and clothing of the inves-
tigator,  in  the  chemical  reagents, in the laboratory atmosphere, and on the labware and tools
used to prepare the  sample for analysis.
                                             1-5

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1.4.1 Sampling Techniques
     Sampling strategy encompasses  site  selection,  choice of instrument used to obtain repre-
sentative samples,  and choice  of  method used  to preserve  sample  integrity.   In  the  United
States, some  sampling  stations  for air pollutants have  been operated  since the early 1950's.
These  early  stations  were a part of  the  National  Air Surveillance Network  (NASN), which  has
now become the National Filter Analysis Network (NFAN).   Two other types of networks have been
established  to   meet  specific  data  requirements.  State  and  Local Air Monitoring  Stations
(SLAMS) provide  data  from specific areas where pollutant concentrations and population densi-
ties  are  the greatest and  where  monitoring  of  compliance to  standards  is  critical.   The
National Air Monitoring Station (NAMS) network is designed to serve national monitoring needs,
including assessment  of  national ambient trends.   SLAMS and NAMS  stations  are  maintained by
state  and local  agencies  and the air samples are analyzed in their laboratories.   Stations in
the NFAN  network are  maintained by state and  local  agencies,  but the  samples are analyzed by
laboratories in  the U.S.  Environmental Protection Agency, where quality control procedures are
rigorously maintained.
     Data from  all three  networks  are combined  into one data base,  the  National  Aerometric
Data Bank (NADB).  These data may be individual chemical analyses of a  24-hour sampling period
arithmetically averaged over a calendar period, or chemical composites  of several filters used
to determine  a  quarterly  composite.   Data are occasionally not available for a given location
because they do  not conform to strict statistical requirements.
     In September,  1981,  EPA promulgated regulations establishing  ambient  air monitoring and
data  reporting  requirements for lead  comparable  to  those already  established  in May of 1979
for the other criteria pollutants.   Whereas sampling for lead is accomplished by sampling for
total  suspended  particulate (TSP),  the  designs  of  lead and TSP monitoring  stations must be
complementary to  insure  compliance with  the NAMS criteria  for  each pollutant.  There must be
at least  two  SLAMS sites for lead  in any area that has a population greater than 500,000 and
any area  where  lead concentration currently exceeds  the ambient  lead  standard (1.5 ug/m3) or
has exceeded it  since January 1, 1974.
     To clarify the relationship between monitoring objectives and  the  actual siting of a mon-
itor,  the concept of  a spatial scale of representativeness was developed.   The spatial scales
are  described in  terms  of the  physical  dimensions  of the  air space  surrounding the monitor
throughout which  pollutant concentrations are fairly similar.  The time scale may also be an
important factor.   Siting criteria  must include sampling times  sufficiently  long  to include
average windspeed and direction,  or a  sufficient  number of  samples  must  be  collected over
short  sampling periods to provide an average value consistent with  a 24-hour exposure.
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     Airborne lead is  primarily  inorganic participate matter but may occur in the form of  or-
ganic  gases.   Devices used  for  collecting  samples  of ambient  atmospheric  lead include  the
standard  hi-vol   sampler  and  a  variety  of other  collectors  employing  filters,  impactors,
impingers,  or  scrubbers,  either  separately or  in  combination, that  measure lead in  pg/m3.
Some samplers measure lead deposition expressed in ug/cm2;  some instruments separate particles
by size.  As a general rule, particles smaller  in mass median aerodynamic  diameter (MMAD)  than
2.5 urn  are  classified as  "fine," and those larger than 2.5 urn as "coarse."  The present SLAMS
and  NAMS  employ  the  standard  hi-vol  sampler (U.S.  Environmental Protection  Agency,  1971) as
part of their  sampling networks.   As a Federal  Reference  Method Sampler, the hi-vol  operates
with a specific flow rate of 1600-2500 m3 of air per day.
     When sampling ambient  lead  with systems employing filters, it is likely that vapor-phase
organolead  compounds  will  pass through the filter media.   The use of bubblers downstream from
the  filter  containing a  suitable  reagent  or  absorber for collection of these compounds  has
been shown  to be  effective.  Organolead may be  collected on iodine crystals, adsorbed on acti-
vated charcoal, or absorbed in an iodine monochloride solution.
     Sampling of  stationary sources for lead requires the use of a sequence of samplers in the
smokestack.  Since lead in stack emissions may be present in a variety of  physical and chemical
forms,  source sampling trains must be designed to trap and retain both gaseous and particulate
lead.
     Three  principal  procedures have  been used to measure  mobile  source emissions, specifi-
cally auto  exhaust aerosols: a horizontal dilution tunnel, plastic sample collection bags, and
a  low  residence  time proportional  sampler.   In each  procedure,  samples are  air-diluted to
simulate  roadside exposure  conditions.   The  air  dilution  tube segregates  fine combustion-
derived particles from larger  lead particles.  Because the total exhaust  plus dilution airflow
is  not held constant in this  system,  potential  errors can be  reduced  by maintaining a  very
high  dilution  air/exhaust  flow  ratio.   In the bag  technique,  auto  emissions produced during
simulated driving cycles are air-diluted  and collected  in a  large plastic bag.   This technique
may  result  in errors  of  aerosol  size analysis because of condensation  of low  vapor pressure
organic  substances  onto  the lead  particles.  To minimize condensation problems,  a  third tech-
nique,  a  low residence time proportional  sampling  system,  has been  used.  This technique may
be  limited  by the response  time  of  the equipment to  operating cycle phases  that cause rela-
tively  small transients in  the exhaust  flow rate.
      In sampling  for  airborne  lead,  air is  drawn  through filter materials such  as glass fiber,
cellulose acetate, or porous plastic.   These materials  often  include  contaminant lead  that can
interfere with the subsequent  analysis.   The  type of  filter  and  the analytical method to  be
used often  determine the  sample  preparation technique.   In  some methods, e.g.,  X-ray  fluores-
cence,  analysis  can  be performed  directly on  the  filter  if the filter  material  is  suitable.
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The main advantages  of  glass fiber filters are low pressure drop and high particle collection
efficiency at high  flow rates.   The main disadvantage is variability in the lead blank,  which
                                                     /Si
makes  their  use  inadvisable in many  cases.   Teflon   filters  have been  used  since 1975  by
Dzubay et  al.  (1982) and Stevens et al.  (1978), who have shown these filters to have very low
lead blanks  (<2  ng/cm2).   The collection efficiencies of filters, and also of impactors, have
been shown to be dominant factors in the quality of the derived data.
     Other primary  environmental media that may be affected by airborne lead include precipi-
tation, surface  water,  soil, vegetation, and foodstuffs.  The sampling plans and the sampling
methodologies used  in  dealing with these media  depend  on  the purpose of the experiments, the
types of measurements to be carried out, and the analytical technique to be used.
     Lead  concentration at  the  start  of  a rain event  is higher  than  at the  end,  and rain
striking the canopy of a forest  may  rinse dry deposition particles from  the  leaf surfaces.
Rain collection  systems should be  designed to  collect  precipitation  on an event basis  and to
collect sequential  samples  during  the  event.   Two  automated  systems  have recently been used.
The  Sangamo  Precipitation Collector, Type A,  collects  rain  in a single bucket exposed  at the
beginning  of the rain  event  (Samant and Vaidya, 1982).   A second sampler, described by  Coscio
et  al.  (1982),  also remains  covered between  rain  events;  it can collect  a sequence of eight
samples  during  the  period  of rain  and  may  be  fitted  with  a refrigeration unit  for  sample
cooling.
     Because the physicochemical form  of lead often influences environmental effects, there is
a need to  differentiate among the various chemical  forms of lead  in aqueous samples.  Complete
differentiation  among   all  such  forms  is  a complex  task  that has not  yet been fully  accom-
plished.   The most  commonly used  approach is to distinguish  between  dissolved and suspended
forms  of lead.   All  lead passing through a  0.45 \im  membrane filter  is operationally defined as
dissolved, while that   retained on the filter is defined as suspended (Kopp and McKee,  1983).
Containers used  for sample collection and  storage  should  be fabricated  from essentially  lead-
free plastic or glass,   e.g., conventional  polyethylene, Teflon  , or quartz.  These containers
must be leached with hot acid for several days to ensure minimum  lead contamination (Patterson
and  Settle,  1976).
     The  distance from  emission sources and  depth gradients  must  be  considered in designing
the  sampling plan for  lead  in  soil.   Depth samples should be collected at not greater than  2
cm  intervals to preserve vertical  integrity.   Because most soil  lead is in chemical forms un-
available  to plants, and because  lead  is not easily  transported  by  plants, roots typically
contain very little lead and shoots even  less.  Before  analysis  of plants, a decision must be
made as  to whether  or  not  the plant leaf material  should  be washed to remove surface contami-
nation  from  dry deposition  and soil  particles.   If the plants are  sampled  for  total lead

                                            1-8

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content (e.g., if  they  serve  as animal  food sources),  they cannot be washed;  if the effect of
lead on  internal  plant  processes  is being  studied, the  plant samples should  be washed.   In
either case, the decision must be made at the time of sampling, as washing cannot be effective
after the plant materials have dried.

1.4.2  Analytical  Procedures
     The choice of  analytical  method depends on  the nature  of the data required, the type of
sample being  analyzed,   the skill  of the  analyst,  and the  equipment  available.   For general
determination of elemental  lead,  atomic absorption spectroscopy  (AAS)  is widely used and re-
commended.   Optical  emission  spectrometry  and X-ray fluorescence (XRF) are rapid and inexpen-
sive methods  for multielemental analyses.   X-ray fluorescence can measure lead concentrations
reliably to  1  ng/m3 using samples  collected  with  commercial  dichotomous  samplers.   Other
analytical  methods have  specific advantages appropriate for special studies.
     With respect  to measuring lead without contamination during sample handling, several in-
vestigators have shown  that the magnitude  of the problem is quite large. It appears that the
problem may be  caused by failure to control the  blank or by failure to standardize instrument
operation   (Patterson,   1983;  Skogerboe, 1982).  The  laboratory  atmosphere,  collecting con-
tainers,  and the   labware  used  may  be   primary  contributors  to  the  lead   blank problem
(Patterson, 1983;  Skogerboe,  1982).   Failure to  recognize these  and other sources of contami-
nation such as  reagents and hand contact  is very likely to result  in the generation of arti-
ficially high analytical results.   Samples with  less than 100  ng lead should be analyzed in a
clean  laboratory especially designed for the elimination of lead contamination.  Moody  (1982)
has  described the  construction and  application of such a  laboratory at the National  Bureau of
Standards.
     For AAS, the  lead  atoms  in the sample must  be vaporized  either  in a precisely controlled
flame  or  in  a furnace.   Furnace  systems in AAS  offer high  sensitivity as well  as  the ability
to analyze  small samples.   These enhanced capabilities are offset in part by  greater  difficul-
ty  in  analytical  calibration  and by loss of analytical precision [lead analyses  of 995  parti-
culate  samples  from the NASN  were  accomplished by AAS with indicated precision  of 11 percent
(Scott  et  al.,  1976)].   Disks  (0.5  cm2) are punched from air filters and analyzed  by  inser-
tion of nichrome cups containing the disks  into a flame.   Another application involves the  use
of  graphite cups  as particle  filters with  the  subsequent  analysis of  the cups  directly  in  the
furnace system.  These  two  procedures offer the ability to determine particulate lead directly
with minimal  sample handling.
     Techniques for AAS are still evolving.   An alternative  to the graphite  furnace,  evaluated
by  Jin and Taga  (1982),  uses a heated quartz  tube  through  which the  metal   ion  in gaseous

                                             1-9

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hydride  form  flows continuously.   Sensitivities  were  1-3  ng/g for  lead.   The technique  is
similar  to  the hydride  generators  used for  mercury,  arsenic, and selenium.   Other  nonflame
atomization systems, electrodeless  discharge  lamps,  and other equipment refinements  and tech-
nique developments  have  been  reported (Horlick, 1982).  More  specialized  AAS  methods for the
determination  of  tetraalkyl  lead compounds  in water  and  fish tissue have been described  by
Chau et al.  (1979) and in air by Birnie and Noden (1980) and Rohbock et at.  (1980).
     Optical emission  spectroscopy  is based on the  measurement of the light emitted  by  ele-
ments when  they are excited  in an  appropriate  energy  medium.   The technique  has  been used  to
determine the  lead  content  of soils, rocks, and minerals  at the 5-10 ug/g level  with a rela-
tive standard  deviation  of  5-10 percent; this method has also been applied to the analysis  of
a  large  number of air samples.  The primary advantage of this method is that it allows simul-
taneous  measurement of  a large number of  elements  in  a small sample.  In a study of environ-
mental  contamination  by automotive  lead,  sampling  times  were shortened  by  using  a sampling
technique  in  which lead-free  porous graphite was used  both as the  filter medium and as the
electrode in the spectrometer.
     More  recent  activities have  focused  attention on  the  inductively  coupled  plasma (ICP)
system as  a valuable  means  of  excitation  and  analysis (Garbarino and Taylor, 1979).   The ICP
system offers a higher degree of sensitivity with less analytical interference than is typical
of many  of the other emission spectroscopic systems.   Optical emission methods are inefficient
when used  for  analysis  of a single element, since the equipment is expensive and a high level
of  operator training is required.   This problem  is  largely offset when  analysis  for several
elements is required, as is often the case for atmospheric aerosols.
     X-ray  fluorescence (XRF)  allows  simultaneous  identification of several elements,  in-
cluding  lead,  using a  high-energy  irradiation source.   This technique  offers the  advantage
that sample degradation  can  be kept  to  a  minimum.   On the other hand. X-ray emission induced
by  charged-particle excitation (proton-induced  X-ray  emission or  PIXE)  offers an attractive
alternative to  the  more common techniques.  The excellent capability of accelerator beams for
X-ray emission analysis is partially due to the relatively low background radiation associated
with the excitation; this is the basis of the electron microprobe method of analysis.   When an
intense  electron  beam is incident  on  a sample,  it produces  several  forms of  radiation, in-
cluding  X-rays,  whose wavelengths  depend  on  the  elements present in  the  material  and whose
intensities depend  on the relative quantities of these elements.  The method is unique in pro-
viding  compositional  information on  individual  lead particles, thus  permitting  the  study of
dynamic  chemical changes and perhaps allowing improved source  identification.
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     Isotope  dilution  mass  spectrometry (IDMS)  is the  most accurate measurement  technique
known at  the  present time.   No other  techniques  serve more reliably as  a  comparative  refer-
ence; it has been used for analyses of subnanogram concentrations of lead in a variety of sam-
ple  types  (Chow et  al.,  1969, 1974;  Facchetti  and Geiss,  1982; Hirao  and  Patterson,  1974;
Murozumi et al.,  1969;  Patterson  et al., 1976; Rabinowitz et al., 1973).   The isotopic compo-
sition of  lead  peculiar to various ore bodies and crustal sources may also be used as a means
of tracing the origin of anthropogenic lead.
     Colorimetric or  spectrophotometric  analysis  for lead using dithizone (diphenylthiocarba-
zone) as the reagent has been used for many years.  It was the primary method recommended by a
National Academy  of  Sciences (1972) report on lead, and the basis for the tentative method of
testing for lead  in  the atmosphere by the American Society for Testing and Materials (1975b).
Prior to  the  development of the IDMS method, colorimetric analysis served as the reference by
which other methods were tested.
     Analytical  methods based  on  electrochemical  phenomena are  found  in a variety of  forms.
They are characterized  by a  high degree  of sensitivity, selectivity, and  accuracy derived from
the  relationship between  current,  charge,  potential, and  time  for electrolytic reactions in
solutions.  Anodic stripping voltammetry (ASV) is  a two-step  process in which the lead is pre-
concentrated  onto a  mercury electrode by an  extended  but selected period of  reduction.  After
the  reduction step,  the potential  is  scanned either linearly or  by differential pulse to oxi-
dize the  lead and allow measurement of the oxidation (stripping)  current.
     The  majority of  analytical methods  are restricted to measurement of  total  lead  and  cannot
directly  identify the various  compounds  of  lead.   Gas chromatography  (GC) using the electron
capture  detector has  been demonstrated  to  be useful  for  organolead  compounds.   The  use of
atomic  absorption as the GC detector  for organolead compounds has  been described by De  Jonghe
et al.  (1981),  while a plasma emission  detector  has been used by Estes et  al.  (1981).   In  ad-
dition,  Messman  and  Rains  (1981)  have  used  liquid  chromatography with an  atomic  absorption
detector  to measure  organolead compounds.   Mass  spectrometry may also  be used with  gas  chroma-
tography  (Mykytiuk et al.,  1980).
 1.5   SOURCES AND EMISSIONS
      Lead is a  naturally  occurring  element that may be  found in the earth's crust and in all
 components of  the  biosphere.   It  may be  found  in water, soil, plants,  animals,  and humans.
 Because lead also occurs  in  ore bodies that  have  been mined for centuries by man, this metal
 has  been distributed throughout the biosphere by the industrial activities of man.   Of partic-
 ular importance to the human  environment are emissions of lead to the atmosphere.  The sources
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of these emissions  and  the pathways of lead through  the  environment to man are shown  in  Figure
1-3.  This  figure shows  natural  inputs to soil by crustal  weathering and anthropogenic  inputs
to the  atmosphere from automobile emissions and  stationary industrial sources.  Natural  emis-
sions of  lead  to the  atmosphere  from  volcanoes and  windblown soil  are  of minor importance.
                         INDUSTRIAL
                         EMISSIONS
                                                                       SURFACE AND
                                                                      GROUND WATER
                                       FECES  URINE
               Figure 1-3.  Pathways of lead from the environment to man, main compartments
               involved in partitioning of internal body burden of absorbed/retained lead, and
               main routes of lead excretion.
                                               1-12

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     From these emission sources,  lead  moves through the atmosphere to  various  components of
the human environment.   Lead  is  deposited on soil and  plants  and in animals,  becoming  incor-
porated into the  food  chain of man.  Atmospheric  lead  is  a major component of  household and
street dust; lead is also inhaled directly from the atmosphere.
     The history of global  lead emissions has been assembled from chronological  records  of de-
position in polar snow strata, marine and freshwater sediments,  and the annual  rings  of  trees.
These  records  aid in  establishing natural  background  levels  of lead in air,  soils, plants,
animals, and humans,  and they document the sudden increase in  atmospheric lead at the time  of
the  industrial  revolution,  with a  later  burst  during the 1920's when  lead-alkyls were first
added  to  gasoline.   Pond sediment  analyses  have  shown a 20-fold increase  in  lead  deposition
during  the  last  150 years  (Figure 1-4), documenting not only the increasing use of lead since
the  beginning  of the  industrial  revolution  in  western United States,  but  also the relative
fraction  of natural  versus  anthropogenic  lead  inputs.   Other  studies have shown the same
magnitude of increasing  deposition in freshwater marine sediments.  The pond and marine sedi-
ments  also  document the  shift in  isotopic composition of atmospheric lead caused by increased
commercial  use  of the New  Lead Belt  in  Missouri, where the ore body has an isotopic composi-
tion substantially different  from  other ore  bodies of the world.
     Perhaps the  best chronological record  is that of the polar  ice strata of Murozumi   et al.
(1969),  which  extends nearly three thousand years  back in time (Figure 1-4).   At the South
Pole,  Boutron  (1982) observed a 4-fold  increase  of lead in snow from 1957 to 1977 but  saw no
increase  from  1927  to 1957.   The  author suggested  the  extensive atmospheric  lead pollution
that  began  in  the 1920's did not  reach  the  South Pole  until the  mid-1950's.  This interpreta-
tion  agrees with that of Maenhaut et al.  (1979),  who  found  atmospheric  concentrations  of lead
of 0.000076 ug/m3 at  the  same location.  This concentration  is  about 3-fold higher than the
0.000024  ug/m3  estimated by Patterson (1980) and  Servant  (1982)  to  be  the natural lead  concen-
tration in the  atmosphere.    In  summary,  it is  likely that  atmospheric  lead  emissions have
increased 2000-fold since the pre-Roman  era,  that even at  this  early time  the  atmosphere may
have  been contaminated  by  a  factor of  three over natural  levels (Murozumi  et  al.  1969), and
that  global atmospheric  concentrations  have  increased dramatically  since the  1920's.
      The  history of global emissions may also be inferred  from  total  production of lead. The
historical  picture of lead production has been  pieced together from many sources by  Settle  and
Patterson (1980) (Figure 1-5).    Until  the  industrial revolution,  lead production  was deter-
mined largely by the  ability or desire to mine lead for its silver content.   Since  that time,
 lead has been  used  as an  industrial product in  its  own right, and efforts to improve  smelter
 efficiency, including control of stack emissions and fugitive  dusts, have made lead production
 more  economical.    This improved  efficiency is  not  reflected  in  the chronological  record
 because of atmospheric  emissions  of  lead  from  many other anthropogenic  sources,  especially
                                             1-13

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       1.0


       0.9


       0.8


       0.7


    3  0.6


       0.5


       0.4


       0.3


       0.2


       0.1
         1750     1775      1800     1825     1850      1875

                                               YEAR
1900
1925
1950
1975
         Figure 1-4.  Chronological record of the relative increase of lead in snow strata, pond
         and lake sediments, marine sediments, and tree rings. The data are expressed as a
         ratio of the latest year of the record  and should not be interpreted to extend back in
         time to natural or uncontaminated levels of lead concentration.

         Source: Adapted from Murozumi et al. (1969) (O), Shirahata et al. (1980) (D), Edgington
         and Bobbins (1976) (A), Ng and Patterson (1982) (A), and Rolfe (1974) ( • ).

gasoline combustion.   From  this  knowledge of the chronological record, it is possible to sort
out contemporary anthropogenic emissions from natural sources of atmospheric lead.
     Natural  lead enters  the biosphere  from  lead-bearing minerals  in  the lithosphere.   In
natural processes, lead  is  first  incorporated in soil  in  the  active root zone,  from which it
may  be absorbed  by  plants,  leached  into  surface  waters, or  eroded into windborne  dusts.
Calculations  of  natural  contributions  using  geochemical  information  indicate  that  the
natural particulate lead level is  less than  0.0005 ug/m3 (National  Academy of Sciences,  1980)
and probably lower than the 0.000076 ug/m3 measured  at the  South Pole (Maenhaut et al.,  1979).
In contrast, lead concentrations  in some urban  environments may range as  high as  6 ug/m3 (U.S.

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                                                                   SPANISH PRODUCTION
                                                                       OF SILVER
                                                                     IN NEW WORLD
                                                                           INDUSTRIAL
                                                                           REVOLUTION
                                                                      SILVER
                                                                   PRODUCTION
                                                                   IN GERMANY
             EXHAUSTION
             OF ROMAN
             LEAD MINES
                                            INTRODUCTION
                                             OF COINAGE
              DISCOVERY OF
              CUPELLATION
                                                         ROMAN REPUBLIC
                                                           AND EMPIRE
RISE AND FALL
 OF ATHENS
        \
      10°
           5500   5000   4500   4000   3500   3000  2500
                                     YEARS BEFORE PRESENT
        Figure 1-5. The global lead production has changed historically in response to major economic
        and political events. Increases in lead production (note log scale) correspond approximately to
        historical increases in lead emissions shown in Figure 5-1.

        Source: Adapted from Settle and Patterson (1980).
Environmental  Protection  Agency, 1979,  1978).   Evidently, most of this  urban participate  lead
originates  from man-made  sources.
     Lead  occupies an  important position in  the U.S. economy,  ranking  fifth among all metals
in  tonnage used.   Approximately 85  percent  of the  primary lead  produced in  this country  is
from  native  mines,  although often  associated  with  minor  amounts of  zinc,  cadmium, copper,
bismuth,  gold,  silver, and  other minerals  (U.S.  Bureau of  Mines, 1972-1982).   Missouri  lead
ore deposits  account for  approximately 80-90  percent of the domestic  production.   Total  utili-
zation  averaged approximately 1.36xl06  metric  t/yr over the 10-year  period, with  storage  bat-
teries  and gasoline  additives accounting for approximately  70  percent  of  total use.  Certain

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products, especially batteries,  cables,  plumbing,  weights, and ballast, contain  lead  that is
economically recoverable as secondary lead.   Lead in pigments, gasoline additives, ammunition,
foil, solder, and  steel  products is widely dispersed  and  therefore is largely unrecoverable.
Approximately 40-50  percent of  annual  lead production is recovered and eventually  recycled.
     Lead or  its compounds  may  enter the  environment at any point during  mining,  smelting,
processing,  use,  recycling, or  disposal.   Estimates  of the  dispersal  of  lead  emissions  into
the environment by principal sources indicate that the atmosphere is the major initial  recipi-
ent.  Estimated  lead emissions  to the atmosphere are shown in Table 1-1.   Mobile and station-
ary  sources of  lead  emissions,  although found throughout  the nation,  tend to be concentrated
in  areas  of high  population density, and  near  smelters.    Figure  1-6 shows  the approximate
locations of major  lead mines,  primary and secondary  smelters  and  refineries,  and alkyl  lead
paints (International Lead Zinc Research Organization, 1982).
     The majority of lead compounds found in the  atmosphere result from leaded gasoline  com-
bustion.   Several reports  indicate  that  transportation sources contribute  about 90 percent of
the  total atmospheric  lead.   Other  mobile sources, including  aviation  use of leaded gasoline
and diesel and jet fuel combustion,  contribute insignificant  lead emissions to the atmosphere.
     Automotive  lead emissions occur as  PbBrCl  in fresh exhaust particles.  The fate of emit-
ted  lead particles depends upon particle size.    Particles  initially formed by condensation of
lead compounds in the combustion gases are quite  small (well  under 0.1  [in in diameter).  Parti-
cles in this size category are subject to growth  by coagulation and, when airborne, can remain
suspended in  the atmosphere for 7-30 days  and travel  thousands of miles  from  their original
source.    Larger  particles are formed as  the  result of agglomeration  of smaller condensation
particles and have limited atmospheric lifetimes.
     During the lifetime of the vehicle,  approximately 35 percent of the lead contained in the
gasoline burned by the  vehicle is emitted as small  particles  (<0.25  urn  MMAD), and approximate-
ly  40  percent is  emitted as larger  particles  (>10  urn MMAD) (Ter  Haar  et  al.,  1972).   The
remainder of the  lead  consumed  in gasoline combustion  is  deposited in the engine and exhaust
system.
     Although the majority (>90 percent on a mass basis) of vehicular lead  compounds are emit-
ted as inorganic particles (e.g., PbBrCl), some organolead vapors (e.g., lead alkyls) are  also
emitted.   The largest  volume of  organolead vapors arises from the manufacture,  transport, and
handling of leaded gasoline.  Such vapors are photoreactive,  and their  presence in local atmo-
spheres  is  transitory.   Organolead  vapors  are most likely to occur in  occupational settings
and  have been found  to contribute less than 10 percent of the total lead present in the atmo-
sphere.
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         TABLE  1-1.   ESTIMATED  ANTHROPOGENIC  LEAD  EMISSIONS  TO  THE  ATMOSPHERE FOR THE
                                      UNITED  STATES,  1984
Source Category
Gasoline combustion
Waste oil combustion
Solid waste disposal
Coal combustion
Oil combustion
Gray iron production
Iron and steel production
Secondary lead smelting
Primary copper smelting
Ore crushing and grinding
Primary lead smelting
Zn smelting
Other metallurgical
Lead alkyl manufacture
Lead acid battery manufacture
Portland cement production
Miscellaneous
Total
Annual (1984)
emissions,
(t/yr)
34,881
781
352
265
115
54
427
278
29
116
1150
116
11
224
112
70
	 35
39,016a
Percentage of
total U.S.
emissions
89.4%
2.0
0.9
0.7
0.3
0.1
1.1
0.7
0.1
0.3
2.8
0.3
0.1
0.6
0.3
0.2
0.1
100%
Inventory does not include emissions from exhausting workroom air, burning of lead-painted
 surfaces, welding of lead-painted steel structures, or weathering of painted surfaces.
Source:   Updated from Battye (1983).

     The use of  lead additives in gasoline, which  increased  in volume for many years,  is now
decreasing both because automobiles designed to use unleaded fuel constitute the major portion
of the  automotive  population  and because of two  regulations  promulgated by the U.S.  Environ-
mental  Protection  Agency  (F.R., 1973  December 6).   The first  required the  availability of
unleaded  fuel  for use in  automobiles  designed to meet federal  emission  standards  with lead-
sensitive emission control  devices  (e.g., catalytic converters); the second required a reduc-
tion or phase-down of the lead content  in leaded gasoline.  The trend in lead content for U.S.
                                            1-17

-------
I
i—»
CO
                                                                          MINES (11)
                                                                       A SMELTERS AND REFINERIES (5)
                                                                       O SECONDARY SMELTERS AND REFINERIES (39)
                                                                       • LEAD ALKYL PLANTS (4)
                                      Figure 1-6. Locations of major lead operations in the United States.

                                      Source:  International Lead Zinc Research Organization (1985).

-------
gasolines is shown  in  Figure  1-7.   Of the total  gasoline pool,  which includes  both  leaded  and
unleaded fuels, the  average  lead content decreased 73 percent,  from an  average of  1.62 g/gal
in 1975  to  0.44  g/gal  in 1984.  The  current  allowable  lead content of unleaded gasoline  is
0.1 g/Qal (F.R., 1985;  March 7).
     Data describing the  lead  consumed in gasoline and average ambient lead levels  (composite
of maximum quarterly values) versus calendar year are plotted in Figure 1-8.  Between 1975  and
1984, the lead  consumed  in gasoline decreased 73 percent (from 167,400 to 46,000 metric tons)
while the corresponding  composite  maximum quarterly average of ambient lead decreased 71 per-
cent (from 1.23 to 0.36 |jg/m3).  This indicates that control of lead in gasoline over the past
several years has effected a direct decrease in peak ambient lead concentrations.
     Solid waste  incineration  and  combustion of waste oil  are  principal  contributors of lead
emissions from  stationary sources.   The manufacture of  consumer products  such as lead glass,
storage  batteries,  and  lead additives for gasoline also contributes significantly to station-
ary  source  lead emissions.  Since  1970,  the quantity of lead  emitted  from the metallurgical
industry has decreased  somewhat because of the application of control equipment and the clos-
ing of several  plants, particularly in the zinc and pyrometallurgical industries.
     A new locus  for lead  emissions emerged  in the mid-1960s with the opening of the "Viburnum
Trend" or "New  Lead Belt"  in southeastern Missouri.  The presence of eight  mines and three ac-
companying  lead smelters  in  this area  makes  it  the  largest  lead-producing  district in the
world.
 1.6  TRANSPORT AND TRANSFORMATION
 1.6.1  Atmospheric Transport
     At  any particular  location  and time,  the concentration  of  lead found in the  atmosphere
 depends  on the proximity to  the  source,  the amount of  lead  emitted  from  sources, and the de-
 gree  of  mixing provided by the  motion of the atmosphere.  Lead  emissions at  the tailpipe are
 typically  around 24,000 MS/m3. while  lead  values in city air  are  usually between  0.1 and  10
 ug/m3.   These  reduced  concentrations are  the  result  of dilution of  effluent gas with clean air
 and  the  removal  of  particles by wet  or  dry deposition.  Characteristically, lead  concentra-
 tions  are  highest in confined areas  close to  sources and are  progressively reduced by dilution
 or deposition  in districts more  removed  from sources.    In parking garages or tunnels, atmos-
 pheric lead concentrations can  be  ten to a  thousand times  greater than  values measured  near
 roadways or in  urban  areas.   In turn,  atmospheric lead concentrations  are  usually about  2h
 times  greater in  the  central city  than  in  residential  suburbs.   Rural areas have  even  lower
                                             1-19

-------
    2.40
    2.00 -
10
01

O)


M
HI

Z
(9
u.
O
8
0
(9
4
cc
    1.50 -
1.00 -
    0.50 -
    0.00
             SALES WEIGHTED TOTAL

             GASOLINE POOL

             ILEADED AND UNLEADED

             AVERAGE I
          1975     1976     1977    1978     1979     1980


                                    CALENDAR YEAR
                                                        1981
1982
1983
                                                                                 1984
           Figure 1-7.  Trend in lead content of U.S. gasolines, 1975-1984.


           Source:  U.S. Environmental Protection Agency (1985).
                                         1-20

-------
    180
    160
    140
ra
o>

1«
§   120
13   100
o
z
     80
o
Ul


(A
Z

O    60
O
     40
     20
     AMBIENT AIR

LEAD CONCENTRATION
                                    LEAD CONSUMED IN GASOLINE
                                  I
                                         I
                                      I
                                                                           1.2
                                                                           1.1
                                                                           1.0
                                                                                o>

                                                                                (A

                                                                                UJ
                                                                                O

                                                                           0.9   iu
                                                                           0.8
                                                                           0.7
                                                                           0.6
                                                                           0.5
                                                                           0.4
                                                                           03
                                                                           0.2
                                                                           0.1
            1975   1976   1977
                                 1978   1979   1980


                                   CALENDAR YEAR
                                           1981   1982   1983    1984
                                                                                LU
                                                                                O
                                                                                UJ
                                                                       IT
                                                                       Ul

                                                                       C
                                                                       <


                                                                       0
                                                                                D
      figure 1-8. Lead consumed in gasoline and ambient lead concentrations, 1975-1984.

      Source: U.S. Environmental Protection Agency (1985, 1986).
                                             1-21

-------
concentrations.  Particle  size  distribution  stabilizes within a few hundred kilometers of the
sources,  although  atmospheric  concentration continues  to  decrease  with  distance.   Ambient
organolead  concentrations  decrease  more rapidly  than  inorganic lead,  suggesting  conversion
from the organic to the inorganic phase during transport.
     Whitby et al.  (1975) placed atmospheric particles into three different size regimes:   the
nuclei mode  (<0.1  urn);  the accumulation mode (0.1-2 (j"i)i  and the large particle mode (>2 urn).
At  the  source,  lead  particles  are  generally  in the nuclei and large  particle  modes.   Large
particles are  removed  by  deposition close to the source and particles in the nuclei mode dif-
fuse  to  surfaces or agglomerate while  airborne  to form larger  particles  of  the accumulation
mode.   Thus it  is  in  the accumulation  mode  that  particles  are  dispersed  great  distances.
     Particles  in  air  streams are subject to  the  same principles  of fluid mechanics  as  par-
ticles in flowing  water.   The first principle is that of  diffusion along a concentration gra-
dient.  If  the airflow is  steady and free of  turbulence,  the rate of mixing is determined by
the diffusivity of the pollutant.   By making generalizations of windspeed,  stability, and sur-
face  roughness,  it is possible to  construct models using a variable transport  factor called
eddy diffusivity (K),  in  which  K varies  in  each direction, including vertically.   There is a
family  of  K-theory  models  that  describe  the  dispersion of  particulate  pollutants.   The
simplest  K-theory  model  produces a  Gaussian plume, called such because the  concentration of
the  pollutant  decreases  according to a  normal  or  Gaussian distribution in both the vertical
and  horizontal  directions.  These  models have some  utility  and  are  the basis for most of the
air quality simulations performed to date.  Another family of models  is based on the conserva-
tive volume element approach,  where volumes of air are seen as discrete parcels having conser-
vative meteorological properties.   The effect of pollutants on these  parcels of air, which may
be  considered  to move along  a  trajectory that  follows the advective wind direction,  is ex-
pressed as a mixing ratio.   None of the models have been tested for lead, and all require sam-
pling periods of two hours or less in order for the sample to conform to a  well-defined set of
meteorological   conditions;  in most cases, such  a  sample  would be below the  detection limits
for  lead.    The  common  pollutant used to  test models  is S02, which can  be  measured over very
short, nearly instantaneous,  time periods.  The question of whether gaseous S02 can be used as
a surrogate for particulate lead in these models  remains to be answered.
     Dispersion within confined  situations,  such as parking garages,  residential garages, and
tunnels,  and away  from expressways  and other roadways  not  influenced by complex terrain fea-
tures depends  on emission  rates and the volume of clean air available for  mixing.   These fac-
tors are  relatively  easy  to  estimate and some effort  has  been made  to  describe ambient lead
concentrations  that  can  result  under selected conditions.   On an  urban scale,  the routes of
transport are  not  clearly  defined,  but can be inferred from an isopleth diagram, i.e., a plot

                                            1-22

-------
connecting points of identical  ambient concentrations.   These plots always show that lead con-
centrations are maximum where traffic density is highest.
     Dispersion beyond cities to regional  and remote locations is complicated by the fact that
there are  no  monitoring  network data from which  to  construct isopleth diagrams, that removal
by deposition plays a more important role with time and distance, and that emissions from many
different  geographic  locations and  sources  converge.   Dispersion from point  sources  such as
smelters  and  refineries  results   in  a concentration  distribution  pattern similar  to  urban
dispersion, although the available data are notably less abundant.  The 11 mines and 5 primary
smelters  and  refineries  shown  in  Figure 1-6  are  not located in  urban  areas.   Most of the 39
secondary  smelters and refineries are likewise non-urban.   Consequently, dispersion from these
point  sources should be  considered separately,  but in a manner  similar  to  the treatment of
urban regions.   In addition to lead concentrations in air, concentrations  in soil and on vege-
tation  surfaces  are often used to  determine  the  extent of  dispersion  away from smelters and
refineries.
     Beyond  the  immediate vicinity  of urban  areas  and smelter  sites, lead  in air declines
rapidly  to concentrations of  0.1-0.5  ug/m3.   Two mechanisms responsible  for this change are
dilution  with clean air and removal by deposition.  Some attempts have been made to reconcile
air concentrations  and deposition  in remote locations with emission  sources.   Source reconcil-
iation  is based on the concept  that  each type  of natural  or  anthropogenic  emission  has a
unique  combination  of  elemental  concentrations.   Measurements  of  ambient  air,  properly
weighted   during  multivariate  regression analysis,  should reflect  the   relative  amount of
pollutant derived  from each of several sources  (Stolzenburg et  al. ,  1982).   Sievering  et al.
(1980)  used the  method of Stolzenburg et  al.  (1982)  to  analyze  the transport  of urban air  from
Chicago over  Lake  Michigan.  They  found that  95 percent of the  lead  in  Lake Michigan air could
be  attributed to  various  anthropogenic sources,  namely auto emissions,  coal  fly  ash,  cement
manufacture,  iron  and steel manufacture,  agricultural  soil  dust, construction  soil dust, and
incineration  emissions.   Cass and McRae  (1983) used source   reconciliation in the  Los Angeles
Basin  to  interpret  1976 NFAN  data  based on  emission  profiles  from several  sources.  Their
chemical  element balance model showed  that 20-22 percent of the  total  suspended particle  mass
could  be  attributed to  highway sources.
     Harrison and Williams (1982) determined air concentrations, particle size distributions,
and  total deposition flux at  one  urban and  two rural  sites  in  England.   The  urban site, which
had  no apparent  industrial,  commercial,  or municipal emission sources,  had an air lead concen-
tration of 3.8 ug/m3,  whereas  the  two  rural  sites were  about 0.15 ug/m3.   The average particle
size became  smaller toward  the  rural  sites,  as  the MMAD  shifted downward from 0.5 to 0.1 urn.
                                             1-23

-------
     Purdue et al.   (1973)  measured  both particulate and organic lead  in  atmospheric  samples.
They found that  the vapor phase lead was  about  5 percent  of the total lead  in  most  samples.
It  is  noteworthy,   however,  that  in an  underground garage,  total  lead  concentrations  were
approximately five  times those in ambient urban atmospheres,  and the organic lead increased  to
approximately 17 percent.
     Knowledge of  lead concentrations  in  the  oceans and glaciers  provides some  insight  into
the  degree of  atmospheric mixing  and  long-range transport.   Patterson  and co-workers  have
measured  dissolved lead  concentrations in  sea  water  off  the coast  of  California, in the
Central North Atlantic  (near  Bermuda),  and in the Mediterranean.   The profile obtained in the
central  northeast   Pacific  by Schaule  and  Patterson  (1980)  is shown in  Figure 1-9.   These
investigators calculated  that  industrial  lead currently is being added to  the oceans  at  about
10 times  the  rate of  introduction by  natural   weathering,  with   significant  amounts  being
removed  from  the  atmosphere  by  wet and dry deposition directly into the  ocean.   Their  data
suggest considerable contamination  of  surface waters near shore, diminishing  toward  the open
ocean.
     Ninety percent of the particulate pollutants  in  the  global troposphere are  injected  in
the northern hemisphere (Robinson and Robbins, 1971).  Since  the residence  times  for particles
in  the troposphere are much less than  the interhemispheric  mixing time,  it  is  unlikely  that
significant amounts  of particulate pollutants can  migrate from the northern to  the  southern
hemisphere via the troposphere.   Murozumi  et al.  (1969) have  shown  that  long-range transport
of  lead particles  emitted from  automobiles has significantly  polluted  the polar  glaciers.
They collected samples  of snow and ice from Greenland  (Figure 1-10)  and the  Antarctic.  The
authors attribute the gradient increase after 1750 to the Industrial  Revolution and the accel-
erated  increase  after  1940 to the increased  use  of  lead alkyls in gasoline.   The most recent
levels  found  in  the Antarctic snows were,  however, less  than those found in Greenland  by a
factor of 10 or more.
     Evidence from remote areas  of  the world  suggests  that  lead and other fine particle com-
ponents  are  transported  substantial  distances,  up to thousands   of kilometers,  by general
weather systems.   The  degree  of surface contamination  of  remote areas with lead depends both
on weather influences  and on  the degree of air contamination.   However, even in remote areas,
man's primitive activities can play an important role in atmospheric lead  levels.

1.6.2  Deposition
     Before atmospheric lead can have any effect on organisms or ecosystems, it must be trans-
ferred  from  the  air to a surface.   For natural  ground surfaces and  vegetation,  this process
may  be either  dry  or wet deposition.   Transfer  by dry deposition requires  that  the  particle

                                            1-24

-------
                        • DISSOLVED Pb

                        D PARTICIPATE Pb
   5000
                   I    I    I    I    I    I  ,
                                        if*
       0   2   4   6   8   10  12  14  16   0

              CONCENTRATION, ng Pb/kg

 Figure 1-9.  Profile of lead concentrations in the
central northeast Pacific. Values below 1000 m are
an order of magnitude lower than reported by
Tatsumoto and Patterson (1963) and Chow and
Patterson (1966).

Source: Schaule and Patterson (1980).
                     1-25

-------
a
D
                  0.20

                  0.1B

                  0.16

                  0.14

                  0.12

                  0.10

                  0.08

                  0.06

                  0.04

                  0.02
                      800
                                   1750
                           1800     1850
                          	A. O.	
                                                         1900
                                                                 1950
                                        AGE OF SAMPLES

                     Figure 1-10.  Lead concentration profile in snow strata
                     of Northern Greenland.
                     Source:  Murozumi et al. (1969).

move  from  the main airstream  through the boundary  layer to a surface.  The  boundary layer is
defined as the  region of  minimal  air flow immediately adjacent to that surface.   The  thickness
of the  boundary layer depends  mostly on the windspeed and roughness of the surface.   Airborne
particles  do  not follow  a  smooth,  straight  path  in the airstream.  On the contrary, the path
of a  particle may be affected by micro-turbulent air currents, gravitation,  or  its  own iner-
tia.   There are  several mechanisms  that may alter the particle path sufficient to cause  trans-
fer to  a surface.  These mechanisms are  a  function of  particle  size,  windspeed, and surface
characteristics.
     Particles  transported  to  a surface by any mechanism are said to have an  effective deposi-
tion velocity (V .) which  is  measured not by rate of  particle movement but by  accumulation on
surface  as a function  of  air concentration.   Several   recent  models  of  dry  deposition have
evolved  from  the  theoretical  discussion  of Fuchs  (1964) and the  wind  tunnel experiments of
                                             1-26

-------
Chamberlain  (1966).   The models of Slinn  (1982)  and Davidson et al.  (1982)  are  particularly
useful for  lead  deposition.   SI inn's  model considers a  multitude  of vegetation parameters to
find several approximate solutions for particles in the size range of 0.1-1.0 urn MMAD,  estima-
ting deposition  velocities  of 0.01-0.1 cm/sec.  The model  of  Davidson et al.  (1982) is based
on detailed  vegetation  measurements  and wind data to predict a V . of 0.05-1.0 cm/sec;  deposi-
tion velocities are specific for each vegetation type.   Both models show a decrease in  deposi-
tion velocity  as  particle  size decreases down to about 0.1-0.2 |jm MMAD; as diameter decreases
further from 0.1 to 0.001 \im MMAD, deposition velocity increases.
     Several  investigators  have  used  surrogate  surface  devices  to  measure  dry  deposition
rates.  The few studies available on deposition of lead on vegetation surfaces show rates com-
parable to those of surrogate surfaces and deposition velocities in the range predicted by the
models discussed  above  (Table 1-2).   These data show that global emissions are in approximate
balance with global deposition.  The geochemical mass balance of lead in the atmosphere may be
determined  from  quantitative  estimates  of  inputs  and outputs.   Inputs amount  to 450,000-
475,000 metric tons  annually.   The amount of  lead  removed by wet deposition is approximately
208,000  metric  t/yr  (Table  1-3).   The  deposition flux  for  each  vegetation type  shown on
Table  1-3  totals 202,000 metric t/yr.  The  combined wet and dry deposition is 410,000 metric
tons,  which  compares  favorably with the estimated 450,000 - 475,000 metric tons of emissions.
     Concentrations of  lead in ground water appear  to  decrease logarithmically with distance
from a roadway.   Rainwater  runoff has been found to  be an  important transport mechanism in the
removal of  lead  from  a  roadway surface  in  a number of studies.   Apparently, only a light rain-
fall,  2~3  mm,  is sufficient  to remove 90 percent  of  the lead  from  the  road surface  to  sur-
rounding soil  and to waterways.  The  lead concentrations  in off-shore sediments often show  a
marked  increase  corresponding to anthropogenic activity  in  the region.  Rippey et al. (1982)
found  such increases recorded  in the  sediments  of  Lough Neagh,  Northern Ireland, beginning
during  the 1600's and  increasing during  the late 1800's.  Data  on recent  lead  levels  indicate
an  average anthropogenic  flux  of 72  mg/m2-yr, of  which  27 mg/m2*yr  could be attributed to
direct atmospheric deposition.   Prior  to  1650, the total flux  was  12 mg/m2-yr,  so there has
been  a 6-fold increase  since that  time.   Ng and Patterson  (1982) found prehistoric fluxes of
1-7 mg Pb/m2-yr  to three offshore basins  in  southern California, which  have  now increased  3-to
9-fold to  11-21  mg/m2-yr.   Much of  this lead  is  deposited directly  from sewage outfalls,
although at least 25  percent  probably  comes  from  the atmosphere.
                                             1-27

-------
              TABLE 1-2.   SUMMARY OF SURROGATE AND VEGETATION SURFACE DEPOSITION OF  LEAD
Depositions! surface
Tree leaves (Paris)
Tree leaves (Tennessee)
Plastic disk (remote
Flux,
ng Pb/cm2/day
0.38
0.29-1.2
0.02-0.08
Air cone,
ng/m3
—
—
13-31
Deposition velocity,
cm/sec
0.086
—
0.05-0.4
Reference
1
2
3
  California)

Plastic plates                0.29-1.5             110           0.05-0.06
  (Tennessee)
Tree leaves (Tennessee)
Snow (Greenland)
Grass (Pennsylvania)
Coniferous forest (Sweden)
—
0.004
—
0.74
110
0.1-0.2
590
21
0.005
0.1
0.2-1.1
0.41
4
5
6
7
1.  Servant, 1975
2.  Lindberg et al.,  1982
3.  Elias and Davidson, 1980
4.  Lindberg and Harriss, 1981
5.  Davidson et al.,  1981c, 1981b
6.  Davidson et al.,  1982
7.  Lannefors et al., 1983
1.6.3  Transformation

     Lead is emitted  into  the air from automobiles  as  lead  halides and as double  salts  with

ammonium halides  (e.g.,  PbBrCl  •  2NH4C1).   From mines and smelters, PbS04,  PbO-PbS04,  and PbS

appear to be the  dominant  species.   In the  atmosphere,  lead is present mainly as the  sulfate

with minor amounts  of  halides.   It is not completely  clear  just how the chemical composition

changes in transport.

     The ratio of Br  to  Pb is often cited as an indication of automotive emissions.  From the

mixtures commonly used in  gasoline additives,  the  mass  Br/Pb ratio should be  0.4-0.5.   How-

ever, several  authors have  reported loss  of halide,  preferentially bromine,  from lead salts in

atmospheric transport; both photochemical  decomposition  and  acidic gas displacement have  been

postulated as  mechanisms.  The  Br/Pb  ratios  may  be only crude estimates of  automobile  emis-

sions; this  ratio would decrease  with distance  from the highway  from 0.39 to  0.35  at  less

proximate sites and  0.25 in  suburban residential areas.   For an aged aerosol, the Br/Pb  mass


                                            1-28

-------
                 TABLE  1-3.   ESTIMATED GLOBAL  DEPOSITION OF  ATMOSPHERIC  LEAD
                                   Mass  of water,
                                     1017  kg/yr
Lead concentration,
     10-6 g/kg
Lead deposition,
   106 kg/yr
Wet
To oceans
To continents
Dry
To oceans, ice caps, deserts
Grassland, agricultural
areas, and tundra
Forests



4.1 0.4
1.1 0.4
Area Deposition rate
1012 m2 10-3 g/m2-yr
405 0.2
46 0.71
59 1.5
Total dry:
Total wet:
Global:
164
44
Deposition
106 kg/yr
89
33
80
202
208
410
Source:   This report.


ratio is  usually about  0.22.   Habibi et  al.  (1970) studied the composition  of auto exhaust

particles as a function of particle size.   Their main conclusions follow:


     1.    The chemical  composition of emitted exhaust particles is  related to particle
          size.

     2.    There is considerably more soot and carbonaceous material  associated with fine-
          mode  particles than  with  coarse-mode  particles.   Particulate  matter emitted
          under typical driving conditions is rich in carbonaceous material.

     3.    Only small quantities  of 2PbBrCl*NH4Cl  were found  in  samples collected at the
          tailpipe from  the  hot exhaust gas.   Lead-halogen molar ratios  in particles of
          less than 10 urn MMAD indicate that  much  more  halogen is associated with these
          solids than the amount expected from  the presence of 2PbBrCl'NH4C1.


     Lead sulfide is the main constituent of samples associated with ore handling and fugitive

dust  from open mounds  of ore  concentrate.   The major constituents  from  sintering and blast

furnace operations appeared to be  PbS04 and PbO'PbS04, respectively.
                                            1-29

-------
     Atmospheric  lead  may enter  the  soil system  by wet or dry deposition  mechanisms.   Lead
could be  immobilized  by precipitation as less soluble compounds [PbC03,  Pb(P04)2],  by ion ex-
change with  hydrous  oxides or clays, or  by  chelation  with  humic (HA) and fulvic (FA)  acids.
Lead  immobilization  is  more  strongly correlated  with organic chelation  than  with  iron  and
managanese oxide  formation (Zimdahl  and Skogerboe, 1977).  The total  capacity  of  soil  to im-
mobilize lead can be predicted from the linear relationship  developed by  Zimdahl  and Skogerboe
(1977) (Figure 1-11) based on the equation:

                     N = [2.8 x 10"  (A)] + [1.1 x 10"5 (B)] -  4.9  x 10"5
where N  is  the  saturation capacity of the soil expressed in moles/g soil,  A  is  the  cation ex-
change capacity of the soil in meq/100 g soil, and B is the  pH.
     The  soil  humus  model  also  facilitates   the  calculation  of lead  in soil moisture  using
values available  in  the literature for conditional  stability constants  (K)  with fulvic  acid.
The values  reported  for log K are linear in  the pH range of 3-6 so that  interpolations  in the
critical  range  of pH  4-5.5  are  possible (Figure  1-11).  Thus, at pH 4.5, the  ratio of  com-
plexed lead  to  ionic  lead is expected to be  3.8 x 103.  For soils  of 100 ng/g,  the  ionic  lead
in soil  moisture  solution would  be 0.03 ^g/g.  It is also important to consider  the stability
constant of  the  Pb-FA  complex relative to other  metals.  At  normal soil pH  levels  of  4.5-Q
lead  is  bound to FA + HA in preference  to  many  other metals  that are  known plant nutrients
(Zn, Mn, Ca, and Mg).
     Soils have both a liquid and solid  phase, and  trace metals  are normally distributed be-
tween these two phases.  In the liquid phase, metals may exist  as  free ions or as soluble  com-
plexes with  organic  or  inorganic  ligands.    Since  lead rarely occurs  as  a  free  ion in  the
liquid phase,  its mobility  in  the soil  solution depends  on  the   availability  of  organic or
inorganic ligands.  The  liquid phase of soil often exists as  a thin film of  .moisture in inti-
mate contact with the  solid phase.  The availability of metals to  plants depends on the equi-
librium  between  the  liquid and solid phase.    In  the solid  phase,   metals may be incorporated
into crystalline minerals  of  parent  rock material and secondary clay minerals or precipitated
as insoluble organic or inorganic complexes.  They may  also be adsorbed onto the  surfaces of
any of  these solid  forms.   Of these  categories,  the  most mobile form is  in soil  moisture
where lead can  move  freely into  plant roots  or  soil  microorganisms with dissolved  nutrients.
The least mobile  is  parent rock material, where  lead  may be bound within crystalline  struc-
tures over  geologic  periods  of  time; intermediate  are the lead  complexes  and  precipitates.
Transformation from one  form  to  another depends on the chemical environment  of the  soil.   The
water-soluble and  exchangeable forms  of  metals  are generally  considered available  for  plant
                                            1-30

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                                       SO           75
                                        CEC, meq/100 g
100
125
             Figure 1-11. Variation of lead saturation capacity with cation exchange
             capacity in soil at selected pH values.
             Source: Data from Zimdahl and Skogerboe (1977).

uptake.   In  normal  soils,  only  a small   fraction  of the  total lead is in exchangeable form
(about 1 (JQ/g) and none exists  as free lead ions.   Of the exchangeable  lead, 30 percent exists
as stable complexes, 70 percent as labile complexes.
     An outstanding characteristic of lead is its  tendency to form compounds of low  solubility
with  the  major anions of natural water.   The hydroxide, carbonate, sulfide,   and more rarely
the  sulfate  may act as solubility controls  in  precipitating lead from water.  The amount  of
lead  that can  remain  in solution is  a function of the pH of the water and the dissolved salt
content.  A  significant  fraction of the   lead carried  by river water may be in an undissolved
state.  This  insoluble lead  can consist of colloidal particles in suspension  or  larger undis-
solved  particles  of lead carbonate, -oxide,  -hydroxide,  or  other lead compounds incorporated
in  other  components of  particulate  lead  from  runoff;  it may occur either as sorbed ions or
                                            1-31

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surface coatings  on  sediment mineral  particles or be carried as a part of suspended living or
nonliving organic matter.
     The  bulk  of  organic  compounds  in  surface  waters  originates  from  natural  sources.
(Neubecker and Allen, 1983).  The humic and fulvic acids that are primary complexing agents in
soils are  also  found in surface waters at  concentrations  of 1-5 mg/1, occasionally exceeding
10 mg/1.  The  presence of fulvic acid in water has been shown to increase the rate of solution
of lead sulfide  10-60 times over that of a water solution  at the same  pH that did not contain
fulvic acid.  At pH values near 7, lead-fulvic acid complexes are present in solution.
     The  transformation  of  inorganic  lead,  especially in sediment, to  tetramethyllead  (TML)
has  been  observed and biomethylation  has  been postulated.   However,  Reisinger et  al.  (1981)
have  reported extensive  studies of the methylation  of  lead  in the presence  of numerous  bac-
terial  species  known to  alkylate  mercury and  other heavy  metals.   In these experiments no
biological  methylation  of  lead  was   found  under  any  condition.   Chemical  alkylation  from
methylcobalamine  was  found to occur in the presence  of sulfide or of aluminum ion;  chemical
methylation was independent of the presence of bacteria.
1.7  ENVIRONMENTAL CONCENTRATIONS AND POTENTIAL PATHWAYS TO HUMAN EXPOSURE
     In general, typical levels of human lead exposure may be attributed to four components of
the human environment:   inhaled air, dusts of various types, food, and drinking water.  A base-
line level  of  potential  human exposure is determined for a normal adult eating a typical diet
and  living  in  a non-urban community.  This  baseline  exposure  is deemed to be  unavoidable by
any  reasonable means.   Beyond  this level,  additive  exposure factors  can be  determined  for
other environments  (urban, occupational,  smelter communities),  for certain habits and  activi-
ties (smoking,  drinking,  pica,  and hobbies), and  for  variations due to age,  sex,  or socio-
economic status.

1.7.1  Lead in Air
     Ambient airborne  lead concentrations  may influence human exposure through direct  inhala-
tion of  lead-containing particles  and through ingestion of  lead  that has been deposited from
the air  onto  surfaces.   Our  understanding of  the pathways  of  human exposure  is far from com-
plete because  most  ambient measurements  are not taken in conjunction with studies of the con-
centrations of lead in man or in components of his food chain.
     The most  complete set  of  data on ambient  air concentrations may be extracted from  the
National Filter Analysis Network (NFAN) and its predecessors.  In remote regions of the world
air concentrations  are two  or  three  orders  of  magnitude lower than  in  urban  areas,  lending
credence to estimates of the  concentrations of natural lead in the atmosphere.   In the  context
                                            1-32

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of this data  base,  the conditions that modify ambient air (as measured by the monitoring net-
works) to  air inhaled  by  humans cause  changes in particle  size  distributions,  changes with
vertical  distance  above ground,  and  differences between  indoor and  outdoor concentrations.
     The wide range of concentrations is  apparent  from Table 1-4, which  summarizes  data ob-
tained from  numerous  independent measurements.   Concentrations vary  from 0.000076  pg/m3  in
remote areas  to over 10 (jg/m3 near sources such as smelters.  Many of the remote areas are far
from  human habitation  and  therefore  do  not  reflect human  exposure.   However,  a  few of the
regions characterized by small lead concentrations are populated by individuals with primitive
lifestyles; these data provide baseline airborne lead data to which modern American lead expo-
sures can  be  compared.
     The remote  area concentrations reported in Table 1-4 do not necessarily reflect natural,
preindustrial  lead.   Murozumi  et al.  (1969)  and  Ng  and Patterson (1981) have measured  a 200-
fold  increase in  the  lead content of Greenland  snow over the  past  3000  years.   The authors
state  that this  lead  originates in  populated  mid-latitude  regions,  and  is transported over
thousands  of kilometers through  the  atmosphere to the Arctic.  All  of the concentrations in
Table 1-4, including values for remote areas, have been influenced by anthropogenic lead emis-
sions.   It seems likely that  the concentration of natural lead in  the atmosphere is between
0.00002  and  0.00007  |jg/m3.   A value  of 0.00005 will be  used for calculations  regarding the
contribution  of  natural air lead  to total  human uptake.
      The effect  of the 1978 National Ambient Air Quality  Standard for  Lead  has been  to  reduce
the  air  concentration of  lead  in major  urban areas.  Similar trends may also be  seen in urban
areas of  smaller  population  density.    There  are  many   factors  that can  cause  differences
between  the  concentration of  lead  measured  at  a monitoring  station  and the actual inhalation
of air by humans.   Air lead  concentrations  usually  decrease  with  vertical  and  horizontal dis-
tance from emission sources,  and  are  generally  lower indoors  than  outdoors.
      Because people spend much of  their time indoors,  ambient air data may  not accurately in-
dicate  actual  exposure to  airborne  lead.   Some studies  show  smaller indoor/outdoor  ratios
during  the  winter, when  windows  and  doors are  tightly closed.   Overall,  the  data  suggest
indoor/outdoor ratios  of  0.6-0.8 are typical for airborne  lead in  houses without air  condi-
tioning.   Ratios in air-conditioned  houses  are expected  to be in  the  range  of  0.3-0.5 (Yocom,
1982).   Even  detailed knowledge of  indoor  and outdoor airborne lead  concentrations  at fixed
 locations  may still be insufficient  to  assess human exposure  to  airborne lead.   The study  of
Tosteson  et  al.  (1982) included measurement of  airborne lead concentrations using personal
 exposure  monitors,  carried by  individuals  going about their day-to-day  activities.   In con-
 trast to  the lead  concentrations of  0.092 and 0.12 |jg/m3 at fixed locations, the average per-
 sonal exposure was  0.16 ug/m3.   The  authors suggest that the use of fixed monitors  to assess
 exposure is  inadequate at either indoor or outdoor locations.
                                              1-33

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TABLE 1-4.   ATMOSPHERIC LEAD IN URBAN, RURAL, AND REMOTE AREAS OF THE WORLD
Location
Urban
New York
Boston
St. Louis
Houston
Chicago
Los Angeles
Ottowa
Toronto
Montreal
Brussels
Turin
Riyadh, Saudi Arabia
Rural
New York Bight
United Kingdom
Italy
Belgium
Illinois
Remote
White Mtn. , CA
High Sierra, CA
Olympic Nat. Park, WA
Great Smoky Mtns. Nat.
Park, TN
Glacier Nat. Park, MT
South Pole
Thule, Greenland
Thule, Greenland
Prins Christian-
sund, Greenland
Dye 3, Greenland
Eniwetok, Pacific Ocean
Kumjung, Nepal
Bermuda
Abastumani Mtns. USSR
Samp! ing period

1978-79
1978-79
1973
1978-79
1979
1978-79
1975
1975
1975
1978
1974-79
1983

1974
1972
1976-80
1978
1973-74

1969-70
1976-77
1980

1979
1981
1974
1965
1978-79

1978-79
1979
1979
1979
1973-75
1979
Lead cone. ,
(|jg/m3)

1.1
0.8
1.1
0.9
0.8
1.4
1.3
1.3
2.0
0.5
4.5
5.5

0.13
0.13
0.33
0.37
0.23

0.008
0.021
0.0022

0.015
0.0046
0.000076
0.0005
0.008

0.018
0.00015
0.00017
0. 00086
0.0041
0.019
Reference

NEDS, 1982
NEDS, 1982
NEDS, 1982
NEDS, 1982
NEDS, 1982
NEDS, 1982
NAPS, 1971-1976
NAPS, 1971-1976
NAPS, 1971-1976
Roels et al. , 1980
Facchetti and Geiss, 1982
El-Shobokshy, 1984

Duce et al . , 1975
Cawse, 1974
Facchetti and Geiss, 1982
Roels et al. , 1980
Hudson et al. , 1975

Chow et al. , 1972
Eli as and Davidson, 1980
Davidson et al. , 1982

Davidson et al. , 1985
Davidson et al. , 1985
Maenhaut et al. , 1979
Murozumi et al . , 1969
Heidam, 1983

He i dam, 1983
Davidson et al. , 1981c
Settle and Patterson, 1982
Davidson et al. , 1981b
Duce et al. , 1976
Dzubay et al . , 1984
                                  1-34

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1.7.2  Lead in Soil  and Dust
     Studies have determined that  atmospheric  lead is retained  in  the  upper 2-5 cm of undis-
turbed soil, especially  soils  with at least 5 percent  organic  matter and a pH of 5 or above.
There  has  been  no  general  survey  of  this upper  2-5 cm  of  the soil  surface in  the  United
States, but several  studies  of lead in soil near  roadsides and smelters and a few studies of
lead in soil  near  old houses with  lead-based  paint  can provide the backgound information for
determining potential  human  exposures  to  lead from  soil.   Because  lead is immobilized by the
organic component  of  soil,  the  concentration of  anthropogenic lead  in the  upper 2-5  cm is
determined by  the  flux of atmospheric lead to the soil  surface.  Near roadsides, this flux is
largely  by dry  deposition  and  the  rate  depends  on  particle size  and  concentration.   In
general, deposition  flux drops off abruptly with  increasing  distance from the roadway.   This
effect is demonstrated in studies which show that surface  soil lead decreases exponentially up
to  25  m  from  the edge of  the  road.   Roadside soils may contain concentrations of  atmospheric
lead ranging from 30 to  2000 ug/g  in excess of natural levels within 25 meters of the roadbed,
all  in the upper layer of the  soil profile.
     Near  primary  and secondary smelters,  lead  in  soil  decreases exponentially within a 5-10
km  zone  around the smelter complex.  Soil  lead  contamination varies with the  smelter emission
rate,  length  of time  the  smelter has been in operation,  prevailing windspeed and  direction,
regional climatic conditions,  and  local topography.
     Urban  soils  may  be  contaminated   from  a  variety  of  atmospheric  and non-atmospheric
sources.   The major sources of  soil  lead seem to be  paint chips from older houses  and deposi-
tion from  nearby highways.   Lead in soil  adjacent to  a  house  decreases with distance; this may
be  due to paint chips or  to dust of atmospheric origin washing from the  rooftop  (Wheeler and
Rolfe, 1979).
      A definitive  study that  describes the source of soil lead was reported by Gulson et al.
(1981) for soils in the  vicinity of Adelaide,  South  Australia.   In  an urban to rural transect,
stable lead isotopes  were measured  in the top 10  cm of soils over  a 50  km distance.  By  their
isotopic  compositions,  three  sources of  lead  were  identified:   natural, non-automotive  indus-
trial  lead from  Australia,  and tetraethyl lead manufactured in  the  United States.   The  results
indicated  most of  the soil  surface lead originated from leaded  gasoline.
      Lead  may be  found  in  inorganic primary minerals,   on  humic  substances,  complexed  with
Fe-Mn oxide  films,  on  secondary  minerals, or  in soil moisture.   All  of  the lead in  primary
minerals  is  natural  and  is  bound tightly within  the  crystalline  structure  of the minerals.
The  lead   on  the  surface  of  these minerals  is  leached  slowly  into  the  soil  moisture.
Atmospheric  lead  forms  complexes  with  humic substances  or  on oxide films  that  are in equi-
 librium with  soil  moisture,  although  the equilibrium strongly favors  the complexing agents.

                                             1-35

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Except near roadsides and  smelters,  only a few micrograms  of atmospheric  lead  have  been  added
to each gram of soil.   Several  studies indicate that this lead is  available  to  plants  and that
even with small  amounts  of atmospheric lead,  about 75 percent of  the  lead in soil moisture  is
of atmospheric origin.
     Lead on  the surfaces of vegetation  may  be of atmospheric origin.   In internal  tissues,
lead may be of both atmospheric and  soil  origin.   As with soils,  lead on vegetation  surfaces
decreases exponentially with distance away from roadsides and smelters.  This deposited lead  is
persistent.   It  is  neither washed  off by rain nor taken up through the leaf surface.   Lead  on
the  surface of leaves  and bark is proportional  to air lead concentrations and particle size
distributions.    Lead in  internal plant tissues is directly,  although  not  linearly,  related  to
1ead in soi1.

1.7.3  Lead in Food
     In a study  to  determine the  background concentrations  of  lead and other  metals  in  agri-
cultural crops,  the Food and Drug Administration  (Wolnik  et al., 1983),  in cooperation with
the U.S. Department of  Agriculture  and the U.S. Environmental Protection Agency, analyzed over
1500  samples  of the most  common  crops  taken from  a cross  section of geographic  locations.
Collection sites were  remote from  mobile or stationary sources of lead.   Soil  lead  concentra-
tions were within  the  normal range (8-25  pg/g)  of U.S.  soils.   The concentrations  of lead  in
crops are shown  as  "Total" concentrations on  Table  1-5.   The total concentration data should
probably be  seen  as  representing  the  lowest concentrations  of lead in  food  available  to
Americans.   The  data on  these  ten  crops suggest that root vegetables  have lead concentrations
between 0.0046 and  0.009 ug/g,  all  of which  is  soil lead.   Aboveground  parts not exposed  to
significant amounts of atmospheric  deposition (sweet corn and tomatoes) have  less lead inter-
nally.  If it is assumed that this  same concentration is the  internal  concentration for above-
ground parts for other  plants,  it  is apparent that five crops have direct atmospheric deposi-
tion in proportion to surface area  and estimated duration of  exposure.   The deposition rate  of
0.04  ng/cm2«day  in rural  environments  could  account for these amounts of  direct atmospheric
lead.   Lead in food crops varies  according to exposure to the atmosphere  and  in proportion  to
the  effort  taken to separate husks,   chaff, and  hulls from edible parts during processing  for
human or animal  consumption.   Root parts and protected aboveground parts  contain  natural lead
and  indirect  atmospheric lead,  both  of  which  are derived from the soil.    For exposed above-
ground parts,  any  lead in excess  of  the average of unexposed aboveground parts is considered
to have been directly deposited from  the atmosphere.
                                            1-36

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               TABLE  1-5.   BACKGROUND  LEAD  IN  BASIC  FOOD  CROPS  AND MEATS
                                      (pg/g fresh weight)
Crop
Wheat
Potatoes
Field corn
Sweet corn
Soybeans
Peanuts
Onions
Rice
Carrots
Tomatoes
Spinach
Lettuce
Beef (muscle)
Pork (muscle)
Natural
Pb
0.0015
0.0045
0.0015
0.0015
0.021
0.005
0.0023
0.0015
0.0045
0.001
0.0015
0.0015
0.0002
0.0002
Indirect
atmospheric
0.0015
0.0045
0.0015
0.0015
0.021
0.005
0.0023
0.0015
0.0045
0.001
0.0015
0.0015
0.002
0.002
Direct
atmospheric
0.034
--
0.019
—
—
--
--
0.004
--
--
0.042
0.010
0.02
0.06
Total t
0.037
0.009
0.022
0.003
0.042
0.010
0.0046
0.007
0.009
0.002
0.045
0.013
0.02*
0.06*
^Except as indicated, data are from Wolnik et al.  (1983, 1985).
*Data from Penumarthy et al.  (1980).

1.7.4  Lead in Water
     Lead occurs  in  untreated water in either dissolved  or particulate form.   Because atmos-
pheric lead  in  rain  or snow  is  retained  by  soil,  there is little correlation between lead in
precipitation and lead in  streams that drain terrestrial  watersheds.   Rather,  the important
factors seem  to be the chemistry of the stream (pH and hardness) and the volume of the stream
flow.  The  concentration  of  lead in streams  and  lakes is also influenced by the lead content
of sediments.  At neutral pH, lead moves from the dissolved to particulate form; the particles
eventually  pass to sediments.  At  low  pH,  the reverse pathway is  generally  the case.   Hard-
ness, which is a  combination  of the Ca and Mg concentration, can also influence the solubility
of lead; at higher concentrations of Ca and Mg, its solubility decreases.
     For  groundwater,  chemistry  is also  important, as is  the  geochemical  composition of the
water-bearing bedrock.   Municipal  and private wells  typically  have a neutral pH and somewhat
higher-than-average  hardness.  Lead  concentrations are  not  influenced  by  acid rain, surface
runoff, or  atmospheric deposition.  Rather,  the  primary  determinant of lead concentration is
the  geochemical  makeup  of the  bedrock that is the  source of  the water supply.   Groundwater
typically ranges  from  1  to 100 ug  Pb/1  (National Academy  of Sciences,  1980).
                                             1-37

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     Whether from  surface  or ground water supplies, municipal waters  undergo  extensive chem-
ical treatment  prior  to  release to the distribution system.   Although there is no direct ef-
fort to  remove  lead from the water supply, some treatments, such as flocculation and sedimen-
tation, may  inadvertently  remove  lead along with other  undesirable substances.   On the other
hand,  chemical  treatment to  soften water increases the solubility of lead and  enhances the
possibility  that  lead will  be  added to  water  as it passes through the  distribution  system.
For  samples  taken  at  the household tap, lead concentrations are usually higher in the  initial
volume (first daily flush)  than after the tap has been running for some time.   Water standing
in the pipes for several  hours is intermediate between  these two concentrations.   (Sharrett et
al., 1982; Worth et al.,  1981).

1.7.5  Baseline Exposures to Lead
     Lead concentrations in  environmental  media that are in the  pathway  of human consumption
are  summarized on Table 1-6.   Because natural lead is generally three to four orders of magni-
tude  lower  than anthropogenic lead in  ambient  rural  or urban air,  all atmospheric contribu-
tions  of lead  are considered  to be of  anthropogenic  origin.   Natural  soil   lead typically
ranges from  10  to  30 ug/g, but much of this is  tightly bound within the crystalline matrix of
soil minerals at normal  soil  pHs of 4-8.  Lead in the organic fraction  of  soil  is part  natural
and  part  atmospheric.  The  fraction derived from fertilizer is  considered to  be minimal.  1^
undisturbed  rural  and remote soils,  the  ratio  of  natural  to atmospheric  lead  is  about 1:1
perhaps  as  high as  1:3.   This  ratio persists  through soil moisture  and  into  internal plant
tissues.
                 TABLE 1-6.   SUMMARY OF ENVIRONMENTAL CONCENTRATIONS OF LEAD
Medium
Air (urban) (pg/m3)
Air (rural) ((jg/m3)
Natural
lead
0.00005
0.00005
Atmospheric
lead
0.3 - 1.1
0.15 - 0.3
Total
lead
0.3 - l.l
0.15 - 0.3
Soil total    (pg/g)
Food crops    (H9/g)
Surface water (ng/g)
Ground water  (ug/g)
 8-25
0.0025
0.00002
0.003
3-5
0.002 - 0.045
0.005 - 0.030
10 - 30
0.002 - 0.045
0.005 - 0.030
0.001 - 0.1
                                            1-38

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     In tracking air  lead  through  pathways  of human exposure,  it  is  necessary  to  distinguish
between atmospheric lead that  has  passed through the soil,  called  indirect atmospheric  here,
and atmospheric  lead  that  has  deposited directly on crops  or water.   Because indirect atmos-
pheric lead will  remain  in the soil for many decades,  this source  is  insensitive  to projected
changes in atmospheric lead concentrations.
     Initially,  a  current  baseline  exposure  scenario  is  described for an  individual with  a
minimum amount  of  daily  lead consumption.   This person would live  and work in  a  nonurban en-
vironment,  eat  a  normal diet  of food taken  from a  typical  grocery shelf,  and would  have no
habits or activities that would tend to increase lead exposure.  Lead  exposure at  the baseline
level  is  considered  unavoidable without further reductions  of lead  in the  atmosphere  or in
canned foods.  Most of the baseline lead is of anthropogenic origin.
     To arrive at  a minimum or baseline exposure for humans, it is  necessary to begin with the
environmental components (air, soil, food crops, and water) that are the major sources of lead
consumed  by  humans  (Table  1-6).   These components are  measured   frequently,  even monitored
routinely  in  the case of  air, so  that  much data are available on  their concentrations.   But
there  are  several  factors  that modify these components prior to actual human exposure:  We do
not  breathe  air  as  monitored at  an atmospheric sampling  station;  we may be closer  to or
farther  from the  source  of lead  than  is  the  monitor;  we may be  inside  a building,  with or
without  filtered air; water we drink does  not come directly  from a stream  or river, but often
has  passed through a chemical treatment plant  and  a distribution  system.   A similar type of
processing  has  modified the  lead levels  present  in our food.
     Besides  the atmospheric lead  in environmental components, there are two other  industrial
components  that  contribute to  this baseline  of human  exposure:   paint  pigments  and  lead
solder.   Solder contributes directly to the human diet  through canned food and copper water
distribution  systems.  Paint  and   solder are  also  a source  of lead-bearing dusts.  The  most
common dusts  in  the  baseline human environment are street  dusts  and household dusts.    They
originate  as  emissions from mobile  or stationary sources,  as  the oxidation  products  of surface
exposure,  or as products  of frictional  grinding processes.   Dusts  are  different  from  soil,  in
that soil  derives from  crustal rock and  typically  has  a  lead  concentration of 10-30  ug/g,
whereas  dusts come from both  natural and anthropogenic sources and vary in lead  concentration
from 1000  to  10,000 ug/g.
      The route by which many  people receive the largest  portion of their  daily lead intake  is
via foods.   Several  studies have reported average dietary lead intakes  in  the range of 100-500
ug/day for adults, with  individual diets covering  a much greater  range (Nutrition Foundation,
 1982).  The  sources  of  lead in  plants and  animals  are  air, soil,  and untreated waters.   Food
                                             1-39

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crops  and  livestock  contain  lead  in varying  proportions from  the atmosphere  and natural
sources.  From the  farm  to the  dinner table,  lead  is  added to  food  as it  is harvested, trans-
ported, processed,  packaged, and  prepared.  The sources  of this  lead are  dusts of atmospheric
and  industrial origin, metals used  in grinding, crushing,  and  sieving, solder used  in packag-
ing,  and  water used  in  cooking.   It is assumed that this  lead  is  all  of direct atmospheric
origin.  Direct  atmospheric  lead  can be deposited directly on food materials  by dry deposi-
tion,  or  it  can  be lead  in dust that has collected on other surfaces,  then transferred to
foods.  For some  of the  food  items, data are available  on lead  concentrations  just prior to
filling of cans.   In  the case where the food  product  has not undergone extensive modification
(e.g.,  cooking or  added  ingredients),  the  added lead was  most likely derived from  the atmos-
phere or from the machinery used to  handle  the product.
     From the  time  a  product  is packaged in bottles, cans, or plastic containers until it is
opened  in the kitchen, it may  be assumed that  no food  item receives  atmospheric lead.  Most of
the  lead  that is  added  during  this  stage  comes from the  solder used to seal  some types of
cans.   Estimates   by  the  Food  and Drug  Administration,  prepared  in  cooperation  with  the
National Food  Processors Association,  suggested that  lead in   solder contributes more than 66
percent of the lead  in  canned  foods  where  a  lead solder  side  seam was  used.  This lead was
thought to  represent a  contribution of 20  percent  to  the total   lead consumption in foods
(F.R.,  1979,  August 31).   The  contribution of  the canning  process  to  overall  lead levels in
albacore tuna  has  been  reported by Settle and  Patterson (1980).  The  study showed that  lead
concentrations in  canned tuna  are  elevated  above  levels  in fresh  tuna by a  factor of 4000.
Nearly  all of the  increase results from  leaching  of the  lead from the  soldered seam of the
can; tuna from an  unsoldered  can  is elevated by a factor of only 20 compared with  tuna fresh
from  the  sea.   It  is  assumed   that  no further  lead is  added  to  food  packaged  in plastic or
paper containers,  although there are no data to  support or reject this assumption.
     Studies  that  reflect  contributions of  lead added during   kitchen preparation showed  that
lead in acidic foods  stored refrigerated  in open cans can increase  by a factor of 2-8 in  five
days if the cans  have a  lead-soldered side seam not  protected by an interior lacquer coating
(Capar, 1978).  Comparable products  in cans  with the lacquer  coating or  in glass jars showed
little or no  increase.
     As a part of  its  program  to  reduce the  total lead  intake by children (0-5 years of  age)
to less than  100  ug/day  by 1988,  the  U.S. FDA  estimated lead  intakes for individual children
in a large-scale  food consumption  survey (Beloian and  McDowell, 1981).  Between 1973  and 1978
intensive efforts were made by  the  food industry to  remove sources of  lead from infant  food
items.   By 1980,  there had been a 47 percent  reduction in the  lead  concentration of  food  con-
sumed by children in the  age group 0-5 months  and a 7  percent reduction for the 6- to 23-month

                                            1-40

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age group.  Most  of  this  reduction was accomplished by  the  removal  of soldered  cans  used  for
infant formula.
     Because the U.S. FDA is actively pursuing programs to decrease lead in adult foods,  it is
probable that there  will  be a decrease in total  dietary lead consumption over the next decade
independent of  projected decreases  in  atmospheric  lead concentration.  With both  sources  of
lead minimized,  the lowest reasonable estimated dietary lead consumption would be 10-15 ug/day
for adults  and  children.   This  estimate assumes  that about 90  percent of  the  direct atmo-
spheric  lead,  solder lead,  and  lead of  undetermined  origin would be  removed from the diet,
leaving  8  ug/day from  these sources and 3  pg/day of natural and  indirect  atmospheric lead.
     There  have  been several  studies  in North America  and  Europe of the sources  of lead in
drinking water,  and a concentration of 6-8 ug Pb/1 is often cited in the literature for speci-
fic locations.  A recent study in Seattle, WA by Sharrett et al.  (1982) showed that the age of
the house  and the type of plumbing  determined  the  lead concentration  in  tap water.   Lead in
standing water from houses newer than five years (copper pipes)  averaged 31 pg/1, while houses
less than  18  months  old averaged about 70 pg/1.   Houses older than five years and houses with
galvanized  pipe  averaged  less than 6 pg/1.   The source of the water supply,  the length of the
pipe,  and the use of  plastic pipes  in the service  line  had little or  no  effect on  the lead
concentrations.    It  appears  certain  that the source of lead in new homes with copper pipes is
the solder  used to join these pipes,  and  that this lead is eventually  leached away with age.
     Ingestion,  rather than  inhalation, of dust particles appears to be the greater problem in
the baseline  environmental  exposure, especially ingestion during  meals and playtime  activity
by small children.  Although  dusts are of complex origin, they may be  conveniently placed into
a  few categories  relating  to human  exposure.  Generally, the most convenient categories  are
household  dusts,  soil  dust,  street dusts, and  occupational  dusts.   It  is a  characteristic of
dust  particles   that they accumulate  on exposed  surfaces  and  are  trapped  in  the fibers of
clothing  and  carpets.   Two  other features  of dusts are important:   first,  they must be  de-
scribed  in both  concentration and amount.   For example, the concentration  of lead in street
dust  may be the  same  in a rural and urban environment, but  the amount of dust may differ by a
wide margin.  Secondly, each  category represents some  combination of sources.  Household dusts
contain  some atmospheric  lead,  some  paint  lead,  and some  soil  lead;  street  dusts contain
atmospheric,  soil,  and  occasionally  paint  lead.   For  the baseline  human exposure,  it is
assumed  that humans  are not  exposed  to occupational  dusts, nor do  they live in houses with
interior leaded  paints.   Street  dust, soil  dust,  and  some  household dust are the  primary
sources  for baseline potential human exposure.
      In  considering  the impact of street  dust on the human environment,  the obvious question
arises as  to  whether lead  in street  dust varies with traffic density.   It appears that in  non-
urban  environments,  lead in  street dust ranges  from  80 to 130 ug/g,  whereas  urban street dusts
                                             1-41

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range from 1,000 to  20,000  ug/g.   For the purpose of  estimating  potential human exposure, an
average value of 90  ug/g  in street dust is assumed for baseline exposure and 1500 ug/g in the
discussions of urban environments.
     Household dust is also  a normal component of the  home  environment.  It accumulates on all
exposed surfaces,  especially furniture, rugs, and windowsilIs.   Most  of  the  dust values for
nonurban  household  environments  fall  in  the range of 50-500 ug/g.   A value  of 300 ug/g js
assumed.  The only natural  lead in dust would be  some  fraction of  that  derived  from soil  lead.
A  value of 10  ug/g  seems  reasonable, since some of  the soil  lead is of atmospheric origin.
Children  ingest about  five  times  as much dust as adults, with most of  the excess being street
dusts  from sidewalks  and playgrounds.   Exposure to  occupational  lead by children  would be
through clothing brought home by parents.
     The  values for  baseline exposure derived or assumed  in  the  proceeding sections are sum-
marized on Table 1-7.  These values represent only consumption, not absorption, of lead by the
human body.

1.7.6  Additional  Exposures
     There are  many conditions,  even in  nonurban environments,  where an individual may in-
crease  his lead exposure  by choice, habit, or unavoidable  circumstance.  These conditions are
discussed  below as  separate  exposures to be  added  as appropriate  to the baseline of  human
exposure  described above.   Most of these additive effects clearly  derive from air or  dust; few
are from water or food.  Ambient air lead concentrations are typically  higher in  an urban than
a  rural  environment.  This  factor alone  can  contribute  significantly to the potential lead
exposure  of Americans  through increases in inhaled air and consumed dust.  Produce from  urban
gardens  may  also  increase   the  daily  consumption  of  lead.   Other contributing factors not
related only to urban  living are houses with interior lead paint  or lead plumbing, residences
near smelters or  refineries, or family gardens  grown  on high-lead soils.  Occupational  expo-
sures may also be in an urban or rural setting.   These exposures,  whether primarily in  the oc-
cupational environment or secondarily in the home of  the worker, would  be  in addition to  other
exposures  in  an urban  location  or  from  the special   cases  of lead-based paint or  plumbing.
     Urban atmospheres.  The fact that urban atmospheres have more airborne lead  than nonurban
atmospheres contributes not  only  to lead  consumed by  inhalation,  but  to  increased amounts  of
lead  in dust as well.  Typical  urban atmospheres contain  0.5-1.0 ug  Pb/m3.    Other  variables
are the amount  of indoor filtered  air  breathed  by  urban  residents, the amount  of time  spent
indoors,  and the  amount of   time spent on freeways.   Dusts  vary from 500  to 3000  ug/g in  urban
environments.
                                            1-42

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                         TABLE 1-7.  SUMMARY OF BASELINE HUMAN EXPOSURES TO LEAD
                                                 (Mg/day)
Soil
Source
Chfld-2 yr old
Inhaled air
Food, Water &
beverages
Dust
Total
Percent
Adult female
Inhaled air
Food, Water &
beverages
Dust
Total
Percent
Adult male
Inhaled air
Food, Water &
beverages
Dust
Total
Percent
Total
lead
consumed

0.5

25.1
21.0
46.6
100%

1.0

32.0
4.5
37.5
100%

1.0

45.2
4.5
50.7
100%
Natural
lead
consumed

0.001

0.71
0.6
1.3
2.8%

0.002

0.91
0.2
1.2
3.1%

0.002

1.42
0.2
1.6
3.1%
Indirect
atmospheric
lead*

-

1.7
-
1-7
3.5%

-

2.4
-
2.5
6.6%

-

3.5
-
3.5
6.8%
Direct
atmospheric
lead*

0.5

10.3
19.0
29.8
64.0%

1.0

12.6
2.9
17.4
46.5%

1.0

19.3
2.9
23.2
45.8%
Lead from
solder or
other metals

-

11.2
-
11.2
24.0%

-

8.2
-
13.5
36.1%

-

18.9
-
18.9
37.2%
Lead of
undetermined
origin

-

1.2
1.4
2.6
5.6%

-

1.5
1.4
2.9
7.8%

-

2.2
1.4
3.6
7.0%
"Indirect atmospheric lead has been previously incorporated into soil,  and will  probably remain in the
 soil for decades or longer.   Direct atmospheric lead has been deposited on the  surfaces of  vegetation
 and living areas or incorporated during food processing prior to human consumption.

Source:   This report.

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     Houses with interior lead paint.   In 1974,  the  Consumer  Product  Safety Commission collec-
ted household paint  samples  and  analyzed them for lead content  (National Academy of Sciences,
National Research Council, 1976).   The paints with the  greatest  amounts of lead were typically
found  in  the kitchens,  bathrooms,  and  bedrooms.   Peeling and flaking  paint contributes  to
potential   human  exposure vi.a habitual or  inadvertent  consumption  of paint  chips,  but powder
from  painted walls  also  contributes  to the  lead concentration of  household dust.   Flaking
paint can  also  cause elevated lead concentrations in  nearby soil.   For  example, Hardy et  al.
(1971) measured soil  lead levels  of 2000 ug/g next to a barn  in  rural  Massachusetts.  A steady
decrease in  lead  level  with  increasing distance from  the  barn  was shown, reaching 60 ug/g at
fifty feet  from  the  barn.   Ter Haar and Aronow  (1974) reported elevated soil lead levels  in
Detroit near  eighteen  old wood frame  houses painted with  lead-based  paint.   The average soil
lead  level  within  two  feet of a house was  just  over 2000 ug/g; the  average  concentration at
ten feet was  slightly  more than  400 ug/g.   The same authors  reported smaller  soil  lead 'eleva-
tions  in   the vicinity of eighteen brick  veneer houses  in  Detroit.  Soil  lead  levels near
painted barns located  in rural  areas were  similar to urban  soil  lead concentrations near
painted houses,  suggesting the  importance  of leaded paint at both urban and  rural locations.
The baseline  lead  concentration  for household dust of  300 ug/g  was increased  to 2000 ug/g  for
houses  with interior lead-based  paints.   The additional 1700 ug/g would add  85 ug Pb/day to
the potential exposure  of a  child.   This increase would  occur  in either an urban  or nonurban
environment  and  would  be in  addition to  the  urban  residential  increase  if the lead-based
painted house were in an urban environment.
     Family gardens.   Several studies  have  shown potentially higher  lead exposure  through  the
consumption of home-grown produce from family gardens grown on  high-lead  soils or near sources
of atmospheric  lead.   In family  gardens, lead may  reach  the edible  portions  of vegetables by
direct  atmospheric deposition  onto  aboveground  plant parts or  onto soil, or by the flaking of
lead-containing paint  chips  from  houses.   Air concentrations and particle size distributions
are the important  determinants of deposition to soil  or  vegetation  surfaces.   It  is unlikely
that  surface  deposition alone can  account  for  more than 2-5  ug/g  lead on the surface of a
leafy vegetable such as lettuce during a 21-day growing period.   It appears  that a  significant
fraction of the lead in both leafy and root vegetables  derives  from the  soil.
     Houses with lead plumbing.    The  Glasgow  Duplicate  Diet  Study   (United  Kingdom Central
Directorate on Environmental  Pollution, 1982) reports that children approximately 13 weeks  old
living  in  lead-plumbed  houses consume 6-480 ug  lead/day.  Water  lead levels  in the 131  homes
studied ranged  from  less than 50 to over  500 ug/1.  Those children  and  mothers living  in  the
homes  containing  high  water lead  levels  generally had  greater total  lead consumption  and
higher  blood  lead levels, according  to the  study.  Breast-fed infants were exposed to  much

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less lead  than  bottle-fed infants.   The results of  the  study suggest that infants  living  in
lead-plumbed homes  may have exposure  to considerable amounts  of lead.   This conclusion was
also demonstrated by Sherlock et al.  (1982)  in a duplicate diet study in  Ayr,  Scotland.
     Residences near smelters and refineries.    Air  lead  concentrations  within  2  km of  lead
smelters and refineries average 5-15 ug/m3.   Considering  both inhaled air and  dust,  a child  in
this circumstance would  be  exposed  to 1300  pg lead/day above background  levels.   Exposures  to
adults would be  much  less,  since they consume  only  20 percent of the dusts children consume.
     Occupational exposures.  The highest and most prolonged exposures to lead are found among
workers in  the  lead smelting,  refining,  and manufacturing  industries  (World  Health Organiza-
tion, 1977).  In  all  work areas, the major  route of lead exposure.is by  inhalation and  inges-
tion of lead-bearing  dusts  and fumes.   Airborne dusts settle out of the  air onto food,  water,
the  workers'  clothing, and other objects,  and  may  be subsequently transferred  to  the  mouth.
Therefore,  good  housekeeping and good ventilation have a major impact on exposure.   Even tiny
amounts (e.g.,  10 mg) of dust containing 100,000 ug  lead/g can account  for 1,000 ug/day lead
exposure.
     The greatest potential for high-level occupational exposure exists in the process of lead
smelting and refining.   The most hazardous  operations are those in which molten lead and lead
alloys are  brought  to high temperatures, resulting  in the vaporization  of lead, because con-
densed  lead vapor  or fume has,  to  a substantial  degree, a  small  (respirable)  particle size
range.
     When  metals  that contain  lead or are protected with a lead-containing coating are heated
in  the  process  of welding or cutting, copious quantities of lead in the respirable size range
may  be  emitted.   Under conditions of poor ventilation, electric arc welding of zinc silicate-
coated steel (containing  4.5 mg  lead/cm2 of coating) produces breathing-zone concentrations of
lead reaching 15,000  pg/m3,  far in  excess of  the  current  occupational  short-term exposure
limit  in  the United  States (450 ug/m3).   In  a study of salvage  workers using oxy-acetylene
cutting torches on  lead-painted  structural steel under conditions of good ventilation, breath-
ing-zone concentrations  of  lead  averaged 1200 ug/m3 and ranged as high as 2400 ug/m3.
     At all stages  in battery manufacture except for final assembly and finishing, workers are
exposed  to high  air  lead concentrations, particularly  lead  oxide dust.  Excessive concentra-
tions,  as  great as 5400  pg/m3,  have been quoted by the World Health Organization (1977).  The
hazard  in  plate  casting, which  is  a molten-metal  operation, is  from the  spillage of molten
waste products,  resulting in dusty floors.
      In  both  the  rubber products  and  the plastics  industries,  there  are  potentially high
exposures  to  lead.   The  potential hazard of  the use  of  lead stearate  as a stabilizer  in  the
manufacture of polyvinyl chloride was  noted  in the 1971 Annual  Report  of the  United  Kingdom
                                             1-45

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Department of Employment,  Chief  Inspector of Factories (1972).   The source of this  problem is
is the dust  that  is  generated when the  lead  stearate  is milled and mixed  with  the polyvinyl
chloride and  the  plasticizer.   An  encapsulated stabilizer  that greatly  reduces the  occupa-
tional hazard was  reported by Fischbein et al.   (1982).   Sakurai  et al.  (1974),  in  a study of
bioindicators of  lead exposure,  found  ambient  air  concentrations  averaging 58 (jg/m3  in  the
lead-covering department of a rubber hose manufacturing plant.
     The manufacture  of cans with  leaded seams may expose workers to elevated  environmental
lead  levels.   Bishop (1980)  reports  airborne lead  concentrations of 25-800  ug/m3  in  several
can manufacturing  plants  in  the United  Kingdom.   Between  23  and 54 percent of the airborne
lead  was  associated  with  respirable  particles.  Firing  ranges  may also  be  characterized by
high  airborne lead concentrations;  hence, instructors  who spend  considerable amounts  of time
in such areas may  be exposed to  lead.   Anderson et al.  (1977)  discuss plumbism  in  a 17-year-
old male employee of a New York City firing range,  where airborne lead concentrations as great
as 1000  ug/m3 were measured  during sweeping  operations.   Removal of leaded  paint  from walls
and other surfaces in old houses may pose a health  hazard.   Feldman  (1978)  reports an airborne
lead  concentration of  510  ug/m3  after 22 minutes of sanding an  outdoor post coated  with paint
containing 2.5 mg lead/cm2.  After only five minutes of sanding  an indoor window  sill contain-
ing 0.8-0.9  mg  lead/cm2,  the air contained 550  ug/m3.  Garage mechanics may also  be  exposed to
excessive  lead  concentrations.    Clausen and Rastogi  (1977) report airborne lead   levels of
0.2-35.5 ug/m3  in  ten  garages in Denmark; the  greatest  concentration was  measured  in a paint
workshop.   Used motor  oils were  found to contain 1500-3500 ug  lead/g, while one  brand of gear
oil,   unused,  contained 9280  ug/g.   The  authors  state that absorption  through  damaged  skin
could be  an important  exposure  pathway.  Other occupations involving  risk  of  lead exposure
include stained glass  manufacturing  and repair, arts and  crafts, and soldering  and splicing.
     Workers  involved  in  the manufacture of both  tetraethyl  lead and tetramethyl  lead,  two
alkyl   lead  compounds,  are  exposed  to  both  inorganic  and alkyl lead.   The major potential
hazard in the manufacture of tetraethyl  lead and tetramethyl  lead is from skin absorption,  but
this  is guarded against by the use of protective clothing.
     Secondary occupational exposure.   The amount of lead contained in  pieces of cloth 1 cm2
cut from bottoms  of  trousers worn by lead workers  ranged from 110  to 3,000 ug,  with a median
of 410 ug.   In all  cases, the trousers were worn under coveralls.  Dust  samples  from 25 house-
holds  of smelter workers ranged from 120 to 26,000  ug/g, with a  median of 2,400 ug/g.
     Special habits or activities.   The  quantity   of  food  consumed  per  body  weight  varies
greatly with age  and somewhat with sex.  A  two-year-old  child  weighing  14 kg eats  and drinks
1.5 kg food  and water per day.   This is 110 g food/kg body wt,  or three  times the consumption
of an  80 kg adult male, who eats 39 g/kg.

                                            1-46

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     Children  place  their  mouths  on dust-collecting  surfaces and  lick  non-food items  with
their tongues.   This fingersucking  and  mouthing activity  are natural forms of  behavior for
young children that  expose  them to some of the  highest concentrations of lead  in their envi-
ronment.   A  single gram of  dust may contain ten times  more  lead than the total  diet  of the
child.
     On  the  other hand, pica  is the compulsive, habitual consumption of  non-food items.  In
the case  of  paint chips and soil, this  habit can present a significant lead exposure for the
afflicted person. There are very little data on the amounts of paint or soil eaten by children
with  varying degrees of  pica  and  exposure can  only be expressed on a unit  basis.   A  single
chip  of paint can  represent greater exposure  than any  other source of  lead.   For example,
Billick  and  Gray  (1978)  report lead concentrations  of  1000-5000 (jg/cm2  in  lead-based paint
pigments.  A gram of urban soil may have 150-2000 ug lead.
     Lead  is  also present in tobacco.  The World Health Organization (1977) estimates a lead
content  of 2.5-12.2  ug per cigarette; roughly 2-6  percent  of this lead may be inhaled by the
smoker.   The  National  Academy  of Sciences (1980) has used these data to conclude that a  typi-
cal urban resident who smokes  30 cigarettes  per day may inhale roughly equal amounts of lead
from smoking and  from breathing urban air.  The  average adult  consumption of table wine in the
U.S.  is  about  12  g/day.  Even at 0.1 ug/g, which  is ten times  higher than drinking water, wine
does  not appear  to  represent  a significant  potential  exposure.   At one liter/day, however,
lead consumption  would  be greater than the total  baseline consumption.  McDonald  (1981) points
out that older wines with  lead  foil caps may represent a hazard,  especially  if they have been
damaged or corroded.   Wai et al.  (1979)  found the lead  content of wine rose from 200 to 1200
ug/liter when  the wine was  allowed  to pass over the thin ring of  residue  left by  the corroded
lead  foil  cap.   Newer wines  (1971 and later)  use other  means  of sealing.

1.7.7   Summary
      Ambient airborne  lead  concentrations  showed no marked  trend  from 1965  to 1977.  Decreases
from  1977 to  1982 reflect  the  smaller  lead  emissions  from  mobile  sources in  recent years.
Airborne size distribution data indicate  that most of  the  airborne  lead mass is  found  in sub-
micron  particles.  Atmospheric lead  is  deposited on vegetation and soil surfaces,  entering the
human food chain  through contamination  of grains and  leafy  vegetables,  of pasture  lands,  and
of soil moisture taken up by all crops.   Lead contamination of drinking water supplies  appears
to originate mostly from within the  distribution system.
      Environmental contamination by lead should be measured  in  terms of the total  amount of
 lead  emitted to  the biosphere.   American industry contributes several hundred thousand tons of
                                             1-47

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lead to the environment each year:   61,000 tons from petroleum additives,  44,000 tons  from am-
munition, 45,000 tons in glass and ceramic products, 16,000 tons in paint  pigments,  8,000  tons
in food can solder, and untold thousands of tons of captured wastes during smelting,  refining,
and coal  combustion.   These  are uses of  lead  which are  generally not recoverable;  thus,  they
represent  a  permanent contamination  of the human  or natural environment.  Although much  of
this lead  is  confined to municipal and industrial  waste  dumps,  a large amount  is  emitted  to
the atmosphere, waterways, and soil, to become a part of  the biosphere.
     Potential human exposure can be expressed as the concentrations of lead in those  environ-
mental components (air, dust, food, and water) that interface with man.   It appears  that,  with
the exception  of  extraordinary  cases of  exposure,  about  100  |jg  of lead are consumed  daily by
each American.
     Beyond the baseline  level  of human  exposure,  additional  amounts  of  lead consumption are
largely  a matter of  individual  choice or  circumstance.   Most of  these  additional  exposures
arise  directly or indirectly from atmospheric  lead,  and  in one or more ways  probably  affect
90  percent of the  American  population.   In  some  cases,  the additive exposure  can  be  fully
quantified and the amount  of lead  consumed  can be added to  the  baseline  consumption  (Table
1-8).    These  may be  continuous (urban residence)  or seasonal  (family gardening)  exposures.
Some factors  can  be quantified  on a unit basis because of wide ranges in  exposure duration or
concentration.  For  example,  factors affecting occupational  exposure are  air  lead  concentra-
tions  (10-4000 |jg/m3), use  and efficiency of respirators,  length of time  of exposure,  dust
control techniques, and worker training in occupational hygiene.
                                            1-48

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                  TABLE 1-8.   SUMMARY  OF  POTENTIAL ADDITIVE  EXPOSURES  TO  LEAD
                                           (pg/day)
    Exposure
  Total
  lead
consumed
Atmospheric
   lead
 consumed
  Other
  lead
sources
Baseline exposure:

Child
 Inhaled air
 Food, water & beverages
 Dust

Total baseline
    0.5
   25.1
   21.0

   46.6
     0.5
    10.3
    19.0

    29.7
   15.6
    2.0

   17.6
Additional exposure due to:
 Urban atmospheres1
 Family gardens2
 Interior lead paint3
 Residence near smelter4
 Secondary occupational5

Baseline exposure:

Adult male
  Inhaled air
  Food, water & beverages
  Dust

Total baseline
   91
   48
  110
  880
  150
    50.7
    91
    12

   880
      1.0
    20.3
      2.9

    24.2
   36
  110
   34.4
    1.6

   36.0
Additional exposure due to:
Urban atmospheres1
Family gardens2
Interior lead paint3
Residence near smelter4
Occupational6
Secondary occupational5
Smoking7
Wine consumption8

28
120
17
100
1100
44
30
100

28
30

100
1100

27
7


17




3
?
 ^ncludes  lead  from  household  (1000  ug/g)  and  street  dust  (1500 ug/g) and  inhaled air
  (0.75  ug/m3).
 2Assumes soil  lead concentration  of  2000 ug/g;  all  fresh leafy and  root vegetables,  and  sweet
  corn of Table  7-12  replaced by produce from garden.   Also assumes  25% of  soil  lead  is of
  atmospheric  origin.
 3Assumes household dust rises  from 300 to  2000 ug/g.   Dust consumption remains  the  same
  as  baseline.
 4Assumes household and street  dust increase to 10,000 ug/g.
 5Assumes household dust increases to 2400  ug/g.
 6Assumes 8-hr shift  at 10 ug Pb/m3 or 90%  efficiency  of respirators at 100 ug Pb/m3, and
  occupational  dusts  at 100,000 ug/m3.
 70ne and a half packs per day.
 8Assumes unusually high consumption of one liter per  day.
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1.8  EFFECTS OF LEAD ON ECOSYSTEMS
     To function properly, ecosystems  require  an adequate  supply  of  energy, which  continually
flows through the systems, and an adequate supply of nutrients,  which for  the  most  part,  cycle
within the ecosystem.   There is evidence that lead can interfere with both of  these processes.
Energy usually enters the ecosystem in the form of sunlight and  leaves as  heat of respiration.
Unlike energy,  nutrient and  non-nutrient  elements are  recycled  by the  ecosystem  and  trans-
ferred from reservoir to reservoir in a pattern usually referred to as a biogeochemical  cycle.
The  reservoirs  correspond approximately  to  the  food  webs of energy  flow  (see Figure  1-12).
Although  elements  may enter (e.g., weathering  of soil)  or leave  the  ecosystem (e.g.,  stream
runoff),   the  greater  fraction of the available  mass  of  the element is usually cycled  within
the ecosystem.   The  boundaries  of ecosystems may be as distinct as the border of a pond or as
arbitrary as  an  imaginary circle drawn on a map.   Many  trace metal  studies  are conducted in
watersheds where some  of the boundaries are  determined by  topography.   For atmospheric  inputs
to  terrestrial   ecosystems,  the  boundary  is  usually  defined as  the surface of  vegetation
exposed  rock,  or soil.   Non-nutrient  elements  differ little from nutrient elements  in their
biogeochemical cycles.   Quite often,  the  cycling patterns  are similar  to  those  of a major
nutrient.   In  the  case  of  lead, the  reservoirs and  pathways  are very  similar  to  those of
calcium.
     Atmospheric lead  is  deposited  on the surfaces of soil,  vegetation,  and water.   Lead may
also be  introduced  to natural  ecosystems as  spent ammunition.  In agricultural and other eco-
systems  more  directly  influenced  by  the activities  of  man,  lead may enter  as components of
fertilizers, pesticides,  and  paint  chips,  or by  the  careless disposal of lead-acid batteries
or  other industrial  products.   The  movement of  lead within ecosystems  is  influenced  by the
chemical   and  physical  properties of lead and by  the  biogeochemical  properties of  the ecosys-
tem.   In the appropriate  chemical  environment, lead may  undergo  transformations  that  affect
its  solubility (e.g.,  formation of lead sulfate  in  soils),  its bioavailability (e.g.,  chela-
tion with humic  substances), or its toxicity  (e.g., chemical methylation).
     In prehistoric times, the contribution of lead from weathering of soil was probably about
4g/ha-yr  and,  from  atmospheric deposition,  about 0.02 g/ha-yr.  Weathering rates  are presumed
to  have  remained the  same,  but  atmospheric  inputs  are  believed  to  have  increased  to  180 g/
ha-yr  in natural and  some  cultivated  ecosystems, and up  to  3000  g/ha-yr in  urban ecosystems
and along roadways.  There is, however,  wide variation in the amount of lead transferred from
the  atmosphere to  terrestrial  ecosystems.   For  example, Eli as  et al. (1976) found 15 g/ha-yp
in  a  remote  subalpine ecosystem of California;  Lindberg and Harriss  (1981) found 150 g/ha«yr
in  the Walker Branch  watershed  of  Tennessee;  Smith and Siccama  (1981) report 270 g/ha-yr in
the  Hubbard  Brook  forest of New  Hampshire;  Getz et al.  (1977c)  estimated  240 g/ha-yr  by wet

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                                                                     GRAZERS
Figure 1-12. This figure depicts cycling processes within the major components of a terrestrial
ecosystem, i.e. primary producers, grazers and decomposers. Nutrient and  non-nutrient
elements are stored in reservoirs within these components. Processes that take place within
reservoirs regulate the flow of elements between reservoirs along established pathways. The
rate of flow is in part  a function of the concentration in  the preceding reservoir.  Lead
accumulates in decomposer reservoirs (DrD4) which have a high binding capacity for this
metal. When the flow of nutrients is reduced at I. II, or III. the rate of flow of inorganic
nutrients to primary producers is reduced.

Source: Adapted from Swift et al. (1979).
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precipitation  alone  in  a  rural  ecosystem  largely cultivated,  and  770 g/ha-yr  in  an urban
ecosystem; Jackson  and Watson (1977) found  1,000,000  g/ha-yr  near a smelter in  southeastern
Missouri.   Factors  causing  great variation  are  remoteness  from source  (leading to lower  air
concentrations, difference in particle  size,  and greater dependence  on  wind  as  a  mechanism of
deposition) and type of vegetation cover.   For example,  deciduous leaves may,  by the nature of
their  surface  and orientation in the wind  stream,  be  more suitable deposition surfaces than
conifer needles.
     Many of the effects of  lead on plants,  microorganisms,  and ecosystems  arise from the fact
that lead from atmospheric and weathering  inputs  is retained by soil.  (One effect of cultiva-
tion is that  atmospheric  lead is mixed to a  greater depth  than the  0-5 cm of natural  soils).
Although no firm  documentation  exists,  it is reasonable to  assume from  the known  chemistry of
lead in soil  that other metals may be displaced  from binding sites on organic matter and that
the chemical  breakdown of inorganic soil fragments may  be retarded by the  interference  of lead
with the  action  of  fulvic  acid on  iron  bearing crystals.   Soil cation exchange  capacity,  a
major  factor,  is  determined  by  the relative size  of the clay  and organic  fractions, soil  pH
and the amount of Fe-Mn oxide films present  (Nriagu, 1978a).  Of these,  organic  humus and high
soil pH are the  dominant factors in immobilizing lead.   Under  natural conditions,  most of  the
total  lead in  soil  would be tightly bound within  the  crystalline structure  of  inorganic soil
fragments, unavailable  to  soil  moisture.   Available lead,  bound on clays,  organic colloids
and  Fe-Mn  films,  would  be  controlled by the  slow  release  of  bound  lead  from  inorganic rock
sources.   Because lead is  strongly immobilized   by humic substances,   only  a  small  fraction
(perhaps 0.01  percent  in soils  with  20 percent  organic  matter,  pH  5.5)   is   released  to soil
moisture.
     In soils  with lead concentrations  within  the range of natural lead (15-30  |jg/g), only
trace  amounts  of  lead  are  absorbed by plants.  The amount absorbed increases when the  concen-
tration of  lead  in  soil  increases or when  the  binding capacity of  soil   for lead decreases
Uptake by root systems does  not necessarily  mean  the lead reaches the stems,  leaves or  fruits.
Rather, the process should be seen as a soil-plant continuum that strongly  favors  retention of
lead by the soil  and the root system.
     The soil-root continuum  is  a complex structure that consists of the  soil  particles,  the
soil  solution,  the  mutigel  or  other  remnants  of root exudates,  the epidermal cells with
elongated  root  hairs,  and the  root cortical cells.  The walls of the  epidermal   cells are a
loose  matrix of  cellulose and hemicellulose fibers.   Much of  this continuum is of biological
origin and contains  compounds  active  in ion exchange,   such  as hemicelluloses and pectic sub-
stances that  are  heavily  endowed  with  -COOH  groups,  and  proteins that also have  charged
groups.  As a  cation  moves  from the soil  particle to the root  cortex, whether by  mass  flow or

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diffusion,  it is continually  proximate  to root structures with a high binding  capacity.   Lead
is more  tightly bound at these  sites than  other cations, even  calcium.   Consequently,  rela-
tively little lead passes  through the roots into the shoot.   It appears that most  of  the soil
lead is  retained within the  root.   However,  some  plants may allow more  lead to  translocate
than others.
     Hutchinson  (1980) has  reviewed  the effects of acid precipitation on the ability  of  soils
to retain cations.   Excess  calcium and other metals are leached from the A horizon  of  soils  by
rain with  a  pH  more  acidic than 4.5.  Most soils  in the eastern United  States are  normally
acidic (pH 3.5-5.2) and  the leaching process  is  a  part of the complex equilibrium maintained
in the soil system.   By increasing the leaching rate, acid rain can reduce the  availability  of
nutrient metals  to organisms  dependent  on the  top  layer  of  soil.   It appears  that acidifica-
tion of  soil may increase  the rate  of  removal  of lead from  the  soil,  but not before several
major nutrients  are removed first.   The effect of  acid rain on the retention  of lead by soil
moisture is not  known.
     Atmospheric lead may   enter  aquatic  ecosystems  by wet  or dry deposition or  by  the ero-
sional transport  of   soil particles.  In  waters not polluted  by  industrial, agricultural,  or
municipal  effluents,  the  lead  concentration  is  usually  less  than  1 ug/1.   Of this amount,
approximately 0.02 ug/1 is  natural lead and the rest is anthropogenic lead, probably of atmos-
pheric origin  (Patterson,   1980).   Surface  waters  mixed  with  urban  effluents may frequently
reach  lead concentrations  of 50 ug/1,  and occasionally higher.   In  still  water,   lead  is
removed  from  the water column by the settling of  lead-containing particulate matter,  by the
formation  of insoluble  complexes, or by the adsorption of lead onto suspended organic parti-
cles.  The rate of  sedimentation is determined by temperature, pH, oxidation-reduction poten-
tial, ionic competition, the chemical form of  lead in water, and certain biological activities
(Jenne and Luoma,  1977).   In the sediments  of streams, rivers, and lakes, lead appears to be
immobile,  in  the sense  that it  is  not easily transported  by  redissolution  in fresh water.

1.8.1  Effects on Plants
     Some  physiological  and biochemical effects of  lead  on vascular plants have been detected
under laboratory conditions at concentrations  higher  than those normally found in the environ-
ment.  The commonly  reported  effects  are  the inhibition of photosynthesis,  respiration,  or
cell  elongation,  all  of which reduce the  growth of the  plant  (Koeppe,  1981).   Lead  may also
induce premature senescence,  which may affect the  long-term  survival of the plant or the eco-
logical  success of the plant population.  Most of the  lead in  or on a plant occurs on the sur-
faces of leaves and  the trunk or stem.   The  surface  concentration of  lead  in trees, shrubs,
and  grasses  usually  exceeds the  internal concentration by a  factor of  at  least  five  (Elias et
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al,  1978).  The  major  effect  of surface lead at  ambient  concentrations  seems to be on subse-
quent components of  the  grazing food chain and  on the  decomposer  food chain  following litter-
fall (Elias et al.,  1982).
     Two  defensive mechanisms  appear to exist in the  roots  of  plants  for removing lead  from
the stream of nutrients flowing to the above-ground portions  of  plants.   Lead may be deposited
with cell wall material exterior to the individual root cells, or  may be  sequestered in organ-
elles within the root cells.   Any lead not  captured by  these  mechanisms would likely move  with
nutrient metals  from cell  to  cell  through  the symplast and  into  the vascular system.  Uptake
of lead by plants may be enhanced by symbiotic associations with mycorrhizal  fungi.  The three
primary  factors  that control   the  uptake of  nutrients  by plants  are the following:  (1)  the
surface area  of  the  roots;  (2) the ability of the root to absorb  particular  ions;  and (3)  the
transfer of ions  through the  soil.  The symbiotic  relationship between  mycorrhizal fungi  and
the  roots  of  higher plants  can increase  the uptake of  nutrients  by  enhancing all three  of
these factors.
     The translocation  of lead to aboveground portions  of  the plant  is not clearly  understood
Lead may  follow  the  same pathway and be subject to the same  controls as  a nutrient metal  such
as calcium.   There may be several  mechanisms that  prevent the  translocation of lead to other
plant parts.   The primary  mechanisms may  be storage in cell organelles  or adsorption on  cell
walls.   Some  lead passes into the vascular tissue,  along with  water and dissolved nutrients
and is  carried  to physiologically  active tissue of the plant.   Evidence  that lead  in contami-
nated soils can  enter  the vascular  system of plants and  be  transported to  aboveground parts
may be found in the  analysis of tree rings.   These chronological records  confirm that lead can
be translocated in proportion  to the concentrations of  lead in soil.
     Because most of the physiologically active tissue of plants  is involved in growth, main-
tenance,  and  photosynthesis,  it  is  expected that  lead might   interfere with  one or more  of
these processes.  Indeed,  such  interferences  have been observed  in laboratory  experiments at
lead concentrations  greater than those  normally  found  in the  field,  except near  smelters  or
mines (Koeppe, 1981).  Inhibition of photosynthesis by  lead may  be by direct  interference  with
the  light reaction  or  the  indirect  interference  with  carbohydrate synthesis.   Miles et  al
(1972) demonstrated  substantial inhibition  of photosystem  II  near  the site of water splitting
a biochemical  process believed to require manganese.  Devi Prasad  and Devi Prasad  (1982) found
a 10 percent  inhibition  of pigment production in  three species of  green algae  at  a lead  con-
centration of  1 ug/g,  increasing  to 50 percent  inhibition  at  3  ug/g.   Bazzaz et al.  (1974
1975) observed  reduced  net  photosynthesis  that  may  have  been caused indirectly by lead inhi-
biting carbohydrate  synthesis.
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     The stunting of plant  growth may be by the inhibition of the growth hormone IAA (indole-
3-ylacetic acid) by  lead.   Lane  et al.  (1978)  found  that 10 pg/g lead as lead nitrate in the
nutrient medium of wheat  coleoptiles  produced a 25 percent reduction in elongation.   Lead may
also interfere with  plant growth by reducing respiration or inhibiting cell  division.   Miller
and Koeppe (1971) and  Miller et al.  (1975)  showed succinate oxidation inhibition in isolated
mitochondria as  well as  stimulation  of exogenous  NADH oxidation with  related mitochondrial
swelling.
     Hassett et  al.  (1976),  Koeppe  (1977),  and  Malone  et  al.  (1978)  described significant
inhibition by  lead of  lateral  root initiation  in  corn.   The interaction of lead with calcium
has been  shown by several  authors,  most  recently by Garland and Wilkins  (1981),  who demon-
strated that  barley  seedlings (Hordeum  vulgare),  which were growth inhibited  at 2  ng lead/g
sol. with  no  added  calcium,  grew  at about half  the control rate with  17  ug calcium/g sol.
This relation persisted up to 25 ug lead/g sol. and 500 |jg calcium/g sol.
     These studies of the physiological effects of lead on plants all show some effect at con-
centrations of 2-10  ug/g  in the  nutrient  medium  of hydroponically-grown agricultural plants.
It  is  certain  that  no effects would  have  been observed at  these  concentrations  had the lead
solutions been added to normal soil, where the  lead would have been bound by humic substances.
There  is  no  firm relationship between soil  lead and  soil moisture lead because each soil type
has a  unique  capacity  to retain  lead and  to release that lead to the soil moisture film sur-
rounding  the  soil particle.   Once in soil  moisture, lead seems to pass  freely to the plant
root  according to the  capacity  of the  plant  root to  absorb water  and dissolved substances.
     Some plant  species  have developed  populations tolerant to  high lead soils.  Using popu-
lations taken  from  mine waste and  uncontaminated  control areas, some authors  have quantified
the degree  of  tolerance of Agrostis  tenuis  (Karataglis, 1982) and  Festuca  rubra (Wong, 1982)
under  controlled  laboratory conditions.    Root  elongation  was used as the index  of tolerance.
At  lead concentrations of  36  |jg/g nutrient solution,  all populations  of A.  tenuis were com-
pletely  inhibited.   At 12  ug/g, the control  populations  from low-lead soils were completely
inhibited,  but the  populations  from  mine soils  achieved  30 percent  of  their  normal  growth
(growth at no  lead in  nutrient solution).   At  6 ug/g, the control  populations  achieved 10 per-
cent of their  normal growth, and tolerant  populations achieved 42  percent.   There were no mea-
surements of lead below 6 ug/g.
     The  plant effect  studies  support the  conclusion  that inhibition of  plant  growth  begins  at
a  lead concentration of  less  than 1  ug/g  soil  moisture and  becomes  completely inhibitory at a
level  between 3  and 10  ug/g.   Plant populations that are  genetically adapted  to  high  lead
soils  may achieve 50  percent  of their normal  root growth at lead concentrations above 3 ug/g.
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     Even under  the  best of  conditions where soil  has  the highest capacity to retain  lead,
most plants would  experience  reduced  growth rate (inhibition of photosynthesis, respiration,
or cell elongation) in soils containing 10,000 pg lead/g  or greater.   Concentrations  approach-
ing  this  value typically occur  around smelters  and near major highways.  These  conclusions
pertain to  soil  with  the ideal  composition and pH to retain the maximum amount  of  lead.   Acid
soils  or  soils  lacking  organic  matter would inhibit plants at much lower lead concentrations.

1.8.2  Effects on Microorganisms
     It appears  that  microorganisms are more sensitive than plants to soil  lead pollution and
that changes  in the  composition of bacterial  populations  may be an early  indication of  lead
effects.   Delayed decomposition  may occur at lead concentrations of 750 ug/g soil and nitrifi-
cation inhibition at 1000 ug/g.
     Tyler  (1972)  explained  three  ways in which lead might interfere with the normal  decompo-
sition processes  in a terrestrial  ecosystem.  Lead  may  be  toxic  to specific groups  of  decom-
posers, it  may  deactivate  enzymes  excreted by decomposers to break down organic matter,  or it
may bind with the organic matter to render it resistant to the action of decomposers.  Because
lead  in  litter may selectively  inhibit decomposition by soil bacteria  at concentrations of
2000-5000 ug/g,  forest  floor nutrient cycling processes may  be  seriously disturbed  near lead
smelters.    This  is  especially   important  because approximately 70 percent of  plant biomass
enters the  decomposer food  chain.   If decomposition of the biomass is inhibited, then much of
the energy and nutrients remain  unavailable to subsequent components of the food chain.   There
is  also  the possibility that the  ability of  soil  to  retain lead  would  be reduced,  as  humic
substances  are  byproducts  of bacterial  decomposition.  Because they  are interdependent, the
absence of  one  decomposer  group in the decomposition food chain seriously affects  the success
of subsequent groups,  as well as the rate at which plant tissue decomposes.   Each group  may be
affected  in a  different way and at different  lead  concentrations.   Lead concentrations toxic
to decomposer microbes may be as low as 1-5 ug/g or as high as 5000 ug/g.  Under conditions of
mild contamination, the loss of one sensitive bacterial  population may result  in its replace-
ment by a more lead-tolerant strain.   Delayed decomposition  has been reported  near  smelters
mine waste  dumps,  and roadsides.  This delay is generally in the breakdown of  litter from the
first  stage (0-^)  to  the second   (Op),   with  intact plant  leaves and  twigs  accumulating  at the
soil surface.   The substrate concentrations at which lead inhibits decomposition appear to be
very low.
     The conversion of ammonia to nitrate in soil is a two-step process mediated by two  genera
of bacteria,  Nitrosomonas  and Nitrobacter.   Nitrate is  required by all plants, although some
maintain  a  symbiotic  relationship  with nitrogen-fixing bacteria as an alternate source  of ni-
trogen.   Those  which  do not  would be  affected by a loss  of  free-living nitrifying  bacteria
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and it is  known  that  many trace metals inhibit this nitrifying process.   Lead  is  the  least  of
these, inhibiting  nitrification 14 percent  at concentrations  of  1000 ug/g soil.  Even a  14
percent inhibition of nitrification can reduce the potential  success of a plant population,  as
nitrate is usually the limiting nutrient in terrestrial  ecosystems.

1.8.3  Effects on Animals
     Forbes and  Sanderson (1978)  have reviewed reports of  lead toxicity in domestic  and wild
animals.    Lethal  toxicity can usually be traced to consumption of lead battery casings, lead-
based  paints,  oil wastes,  putty,  linoleum,  pesticides,  lead  shot, or  forage near smelters.
Awareness  of  the routes  of uptake is  important  in interpreting the exposure and accumulation
in vertebrates.  Inhalation rarely accounts for more than 10-15 percent of the daily intake  of
lead (National Academy of Sciences, 1980); food is the largest contributor of lead to animals.
The type  of  food an animal eats determines the rate of lead ingestion.  In the case of herbi-
vores, more  than 90 percent  of the total  lead in leaves and  bark  may be surface deposition,
but relatively little  surface deposition may be found on some  fruits, berries, and seeds that
have  short exposure times; roots  intrinsically have no surface deposition.  Similarly, inges-
tion of lead  by  a carnivore depends mostly on deposition on herbivore  fur and  somewhat  less on
lead in herbivore tissue.
     The  type of  food  eaten  is  a major  determinant  of lead  body burdens in small  mammals.
Goldsmith  and Scanlon  (1977) and  Scanlon  (1979) measured higher lead  concentrations in insec-
tivorous  species than in herbivorous  species,  confirming the  earlier work of Quarles et al.
(1974)  which  showed  body burdens  of  granivores
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was no evidence  of  toxic effects on the earthworms.   Ash and Lee (1980)  cleared  the  digestive
tracts of earthworms  and still  found direct correlation of lead in earthworms  with soil  lead;
in this  case,  soil  lead was inferred  from  fecal  analyses.   Ireland and Richards (1977)  also
found  some  localization of lead  in  subcellular organelles of the chloragogue and intestinal
tissue.  In view of the fact that chloragocytes are believed to be involved  with  waste  storage
and glycogen  synthesis,  the authors concluded  that  this  tissue  is used to sequester  lead  In
the manner of vertebrate livers.
     Chmiel  and Harrison (1981)  showed that  the bones of small  mammals  had  the  highest  concen-
trations of  lead, with  kidneys  and livers somewhat  less.   They  also showed greater  bone  con-
centrations  in  insectivores than  herbivores,  both at control  and contaminated  sites.   Clark
(1979) found  lead  concentrations  in shrews,  voles, and brown bats from roadside  habitats  near
Washington,  D.C., to  be higher  than any previously reported.   There are few studies  reporting
lead  in  vertebrate  tissues  from  remote sites.   Elias et al.  (1976, 1982) reported tissue  con-
centrations in voles,  shrews,  chipmunks, tree squirrels, and pine martens from  the remote  High
Sierra.  Bone  concentrations  were  generally  only 2 percent of  those reported  from roadside
studies  and  10 percent of the controls  of  roadside  studies,  indicating that  the controls  in
the roadside studies were themselves contaminated to a large degree.
     While it is impossible to establish a safe limit of daily  lead consumption,  it is  reason-
able  to  generalize  that  a  regular diet  of  2-8  mg  lead/kg-day body weight over an extended
period of time  (Botts,  1977)  will cause death  in  most animals.   Animals of the  grazing  food
chain are affected  most directly by the accumulation  of  aerosol  particles  on  vegetation  sur-
faces, and  somewhat  indirectly  by the  uptake of lead  through plant  roots.   Many  of  these
animals  consume  more  than  1  mg   lead/kg-day in habitats  near  smelters and roadsides, but  no
toxic  effects  have  been  documented.   Animals   of  the  decomposer food chain are  affected in-
directly by lead in soil, which  can eliminate populations of microorganisms  proceeding  animals
in the food  chain  or  occupying  the digestive  tract  of animals and aiding  in the breakdown  of
organic  matter.   Invertebrates  may also accumulate  lead  at levels toxic to their predators.
     Borgmann et al. (1978) found increased  mortality in a freshwater snail, Lymnaea  palutris.
associated with  stream water with  a lead content as  low as 19 ug/1.   Full life cycles  were
studied to estimate population productivity.   Although individual growth rates  were not affec-
ted,   increased  mortality,  especially at the  egg hatching  stage,  effectively  reduced  total
biomass production at the population level.   Production was 50  percent at a  lead  concentration
of 36 (jg/1  and 0 percent at 48 (jg/1.
     Aquatic animals  are  affected by lead at water  concentrations  lower than  previously  con-
sidered  safe  (50 ug/1)  for wildlife.  These  concentrations  occur commonly,  but the  contri-
bution of atmospheric lead to specific sites of high aquatic lead is not clear.  Hematological

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and neurological responses are  the  most commonly reported effects  of  extended lead  exposures
in aquatic vertebrates.   Hematological  effects include the disabling and destruction  of  mature
erythrocytes and the inhibition of the  enzyme ALA-D  required  for hemoglobin synthesis.   At low
exposures,  fish compensate  by  forming additional  erythrocytes,   which  often  do  not  reach
maturity; at higher exposures,  the fish become anemic.  Symptoms of neurological  responses are
difficult to detect  at  low exposure, but higher exposure can induce neuromuscular distortion,
anorexia, and muscle  tremors.   Spinal  curvature eventually occurs  with time or increased con-
centration.

1.8.4  Effects on Ecosystems
     Recent studies  have  shown  three areas of concern where  the effects of lead on ecosystems
may  be  extremely  sensitive.    First,  decomposition  is  delayed by lead,  as  some  decomposer
microorganisms and invertebrates are inhibited by soil lead.   Secondly, some ecosystems exper-
ience  subtle shifts toward lead-tolerant plant populations.  Thirdly, the natural processes of
calcium  biopurification are  circumvented by the accumulation of lead on the surfaces of vege-
tation  and  in  the  soil  reservoir.   These  problems  all  arise  because  lead  in  ecosystems is
deposited on vegetation  surfaces,  accumulates in the  soil reservoir,  and is not removed with
the surface and ground water passing out of the ecosystem.
     Terrestrial ecosystems,  especially forests, accumulate a  tremendous  amount of cellulose
as woody tissue of trees.   Few animals can digest cellulose and most of these require symbio-
tic associations with specialized bacteria.  It is no surprise then, that most of this cellu-
lose must eventually pass through the  decomposer food chain.    Because 80 percent or more of
net primary production passes through the decomposing  food chain, the energy of this litter is
vital  to the rest  of the plant community  and  the  inorganic  nutrients  are  vital  to plants.
     Babich et  al.  (1983) introduced the concept of ecological dose as it applies to the ef-
fects  of metals on ecological processes  in  soil.  The  inhibition of microbe-mediated processes
can  be  used to quantify  the effects of environmental pollutants  on natural  ecosystems.  The
ecological  dose of  50 percent  (EcDso) is  the  concentration  of  a toxicant  that  inhibits  a
microbe-mediated ecologic  process by 50 percent.   Since microbes  are an  integral part of the
biogeochemical  cycling of elements  and  the flow of energy  through an  ecosystem,  they are an
important indicator of the  productivity of  the ecosystem.   This  concept is  superior to the
lethal  dose (LD)  concept  because  it  is based  on  an assemblage of heterogeneous populations
that are important to the ecosystem and that might  be comparable to similar population  assem-
blages of other ecosystems.   The  LD  concept relies  on the elimination of single  population
that may be insignificant  to the  ecosystem  or not comparable to other  ecosystems.
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     The amount  of lead that  causes litter  to  be resistant  to  decomposition is not known.
Doelman and  Haanstra  (1979) demonstrated the effects  of  soil  lead content on delayed decom-
position:  sandy soils  lacking  organic  complexing compounds showed a 30 percent inhibition  of
decomposition at 750 ug/g,  including the complete loss  of  major bacterial species, whereas the
effect was reduced in clay  soils and non-existent in peat  soils.   Organic matter maintains the
cation exchange capacity of soils.   A  reduction  in decomposition  rate was  observed by Doe1 man
and Haanstra (1979) even at the lowest  experimental  concentration  of  lead,  leading to the con-
clusion that some effect might have occurred at even lower concentrations.
     When decomposition is  delayed,  the availability  of nutrients may be  limited for plants
In  tropical  regions  or areas with  sandy soils,  rapid  turnover of nutrients is essential for
the success  of  the forest  community. Even  in a  mixed  deciduous forest, a  significant portion
of the nutrients, especially nitrogen and sulfur, may  be found  in  the litter reservoir (Likens
et  al.  1977).   Annual  litter inputs of calcium  and nitrogen to the  soil account  for about  60
percent of  root uptake.   With delayed decomposition,  plants  must rely on precipitation and
soil weathering for the bulk of their nutrients.   Furthermore,  the organic  content of soil may
decrease, reducing the cation exchange  capacity of soil.
     It has  been  observed  that plant   communities  near smelter sites are composed mostly  of
lead-tolerant plant populations.   In some  cases, these populations  appear  to  have adapted  to
high lead soils, since populations of the same species  from low lead  soils  often do not thrive
on  high lead soils.   In some  situations, it  is  clear  that soil  lead concentration has become
the dominant  factor  in determining the success   of plant  populations and the  stability of the
ecological community.
     Biopurification  is a  process  that  regulates the relative  concentrations  of nutrients
versus  non-nutrient  elements  in  biological  components of  a  food chain.    In  the absence  of
absolute knowledge of  natural  lead concentrations, biopurification can  be  a convenient method
for estimating  the degree  of  contamination.   It  is  now  believed that calcium reservoirs  in
members of  grazing and decomposer  food chains were contaminated  by  factors of 30-500,  i.e.
that  97-99.9 percent  of  the   lead  in organisms  is   of  anthropogenic  origin.   Burnett and
Patterson (1980) have shown a similar pattern for a marine food chain.
     Ecosystem  inputs   of  lead by  the atmospheric route have established  new  pathways and
widened old ones.   Insignificant amounts of lead  are removed by surface  runoff  or  ground  water
seepage.  It  is  likely that the ultimate fate of atmospheric  lead will  be  a gradual elevation
in  lead concentration  of all reservoirs in the  system, with most of the  lead  accumulating  in
the detrital  reservoir.  Because there is  no protection  from  industrial  lead once it enters
the atmosphere,  it is  important to fully understand the effects of industrial  lead emissions
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     Of the  450,000 metric  tons  emitted annually on  a  global  basis, 115,000 metric  tons  of
lead  fall  on terrestrial ecosystems.   Evenly  distributed,  this would amount to  0.1  g/ha-yr,
which  is  much  lower than the range  of  15-1,000,000  g/ha-yr reported in ecosystem  studies  in
the United States.   Consequently,  it is apparent that lead has  permeated these  ecosystems  and
accumulated in the soil reservoir, where it will remain for decades.  Within 20 meters  of every
major highway, up  to 10,000 ug lead have been added to each gram of  surface soil  since 1930
(Getz et  al.,  1977b).   Near smelters,  mines, and in  urban areas, as  much as 130,000 ug/g have
been  observed  in  the upper 2.5 cm of soil  (Jennett et al., 1977).   At increasing distances up
to 5  km away  from sources,  the gradient of  lead added since 1930 drops to less than 10 |jg/g
(Page  and Ganje,  1970), and  1-5 ug/g  have been added in  regions more  distant than  5 km
(Nriagu,  1978a).    In  undisturbed ecosystems,  atmospheric  lead is  retained by  soil  organic
matter in  the  upper layer of soil surface.   In cultivated soils, this lead is mixed with soil
to a depth of 25 cm.
     The  ability  of an ecosystem to compensate for atmospheric lead inputs, especially in the
presence  of  other  pollutants  such as  acid  precipitation,  depends not so  much  on  factors of
ecosystem recovery, but on undiscovered factors of ecosystem stability.   Recovery implies that
inputs  of the perturbing pollutant  have ceased and  that the pollutant  is  being removed from
the ecosystem.  In  the case of lead, the pollutant is not being eliminated from the system nor
are the  inputs ceasing.   Terrestrial ecosystems will never return to their original, pristine
levels of  lead concentrations.
1.9  QUANTITATIVE EVALUATION OF LEAD AND BIOCHEMICAL INDICES OF LEAD EXPOSURE IN PHYSIOLOGICAL
     MEDIA
     A  complete  understanding  of  a toxic agent's  biological  effects (including any statement
of dose-effect  relationships)  requires quantitative measurement  of  either  that agent in some
biological medium or a physiological parameter associated with exposure to the agent.  Quanti-
tative  analysis  involves a number  of  discrete steps,  all of which  contribute  to the overall
reliability  of  the  final analytical result:   sample collection  and shipment, laboratory han-
dling,  instrumental analysis, and criteria  for internal and external quality control.
     From  a historical  perspective,  the definition of "satisfactory  analytical  method" for
lead has  been changing  steadily as  new and more  sophisticated equipment has become available
and  understanding of  the hazards  of pervasive  contamination along  the analytical course has
increased.   The  best example of this  change is  the current use  of  the definitive method for
lead   analysis,   isotope-dilution  mass   spectrometry,   in  conjunction  with   "ultra-clean"
facilities  and  sampling methods,  to  demonstrate conclusively  not only the  true extent  of
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anthropogenic input of  lead  to the environment over the years  but  also the relative limita-
tions of most of the methods  used today  for lead measurement.

1.9.1  Determinations  of Lead in  Biological  Media
     The low levels of  lead  in biological  media,  even in  the face  of excessive exposure, and
the fact that sampling of such media  must be done  against a backdrop of  pervasive lead contam-
ination necessitates that samples  be  collected and  handled carefully.   Blood lead sampling is
best done by venous puncture and collection into  low-lead  tubes  after careful cleaning of the
puncture site.   The use of  finger puncture  as  an  alternative  method  of sampling should be
avoided, if feasible, given  the  risk of contamination  associated with  the practice in indus-
trialized areas.  While  collection of blood onto  filter paper enjoyed  some popularity in the
past, paper deposition  of blood  requires special  correction for hematocrit/hemoglobin level
     Urine sample collection  requires the use of lead-free  containers as well as addition of  a
bactericide.   If  feasible,  24-hr  sampling  is preferred  to spot collection.   Deciduous teeth
vary in  lead content  both within and across type of dentition.  Thus,  a  specific tooth type
should  be  uniformly obtained  for all  study subjects  and,  if  possible,  more than  a single
sample should be obtained from each subject.
     Many reports  over  the   years  have  purported to offer satisfactory  analysis  of  lead in
blood and other  biological media,  often with severe inherent  limitations  on accuracy and pre-
cision, meager  adherence to  criteria  for accuracy and  precision, and a  limited utility across
a  spectrum of analytical applications.   Therefore,  it  is  only useful to  discuss "definitive"
and, comparatively speaking,  "reference" methods presently  used.
     In the case  of  lead in  biological  media, the  definitive method is isotope-dilution mass
spectrometry (IDMS).  The accuracy and  unique precision  of IDMS arise  from the fact that all
manipulations are on a  weight basis  involving simple procedures, and measurements entail only
lead isotope ratios and not  the absolute determinations of  the isotopes  involved, which great-
ly  reduces  instrumental  corrections  and errors.   Reproducible  results  to a precision of one
part in 104-105  are routine  with appropriately designed  and competently operated instrumenta-
tion.  Although  this  methodology  is  still  not recognized in many  laboratories,  it  was the
first  breakthrough,  in  tandem with  "ultra-clean"  procedures and  facilities,  in definitive
methods for  indexing  the progressive increase in lead contamination  of the environment over
the centuries.   Given the expense,  required level of operator expertise, and time and effort
involved for measurements  by  IDMS,  this methodology  mainly  serves for analyses  that either
require  extreme  accuracy and precision, e.g., geochronometry,  or for the  establishment of
analytical  reference material  for  general  testing purposes or the validation of other method-
ologies.

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     While the term  "reference  method"  for lead in biological  media  cannot be rigorously  ap-
plied to  any  procedures  in popular use, the technique of atomic absorption spectrometry (AAS)
in  its  various configurations,  or  the electrochemical  method, anodic stripping  voltammetry
(ASV), come closest  to  meriting the designation.   Other methods that  are  generally applied in
metal analyses are  either limited in sensitivity  or  are not feasible for  use  on  theoretical
grounds for lead analysis.
     Measurement of Lead in Blood.  Atomic  absorption  spectrometry, as applied to analysis of
whole blood,  generally  involves flame or flameless micromethods.   One macromethod, the Hessel
procedure,  still  enjoys  some  popularity.   The Delves  cup  procedure,  which  employes flame
raicroanalysis, can  be  applied to blood lead with an apparent operational  sensitivity of about
10  ug/dl  blood and  a relative precision of approximately 5 percent in the range of blood lead
seen  in  populations  in industrialized areas.  The flameless, or electrothermal, method of AAS
enhances  sensitivity about tenfold,  but precision can be more problematic because of chemical
and spectral  interferences.
     The  most widely used and sensitive electrochemical method for lead in blood is ASV.  For
most  accurate results,  chemical wet-ashing of samples must be carried out, although this pro-
cess  is  time consuming and  requires  the  use of lead-free  reagents.   Metal  exchange reagents
have  been employed  in  lieu of  the  ashing  step  to liberate  lead  from  binding sites, although
this  substitution  is associated with less  precision.   For  the ashing method, relative preci-
sion  is  approximately  5 percent; in terms of accuracy and sensitivity, problems appear at low
lead  levels,  e.g.,  5 ug/dl or  below,  particularly if samples  contain elevated copper  levels.
      Lead  in  Plasma.   Since  lead in whole blood is virtually all confined to the erythrocyte,
plasma  levels are quite low  and  extreme care must be employed  to measure plasma levels relia-
bly.   The  best  method  for  such measurement  is  IDMS,  employed  in an  ultra-clean facility.
Atomic  absorption  spectrometry (AAS) is satisfactory  for  comparative  analyses across  a range
of  relatively high whole blood  values.
      Lead in  Teeth.   Lead measurement  in  teeth has  involved either  whole  tooth sampling or
analysis  of specific regions  such as  dentine or circumpulpal  dentine.   In either case,  samples
must  be solubilized after careful  surface  cleaning to  remove contamination;  solubilization is
usually  accompanied by either wet-ashing directly  or ashing subsequent to a dry-ashing step.
      Atomic absorption  spectrometry  and ASV have been  employed  more frequently  for  such deter-
minations than any other  method.   With AAS, the high  mineral content  of teeth  argues  for  pre-
liminary isolation  of lead via  chelation/extraction.   The  relative precision  of  analysis for
within-run measurement  is  around  5-7 percent,  with  the  main  determinant  of  variance in
regional  assay being the  initial  isolation step.   One change  from the usual  methods  for  such
measurement is the  TJA  sjtu measurement  of  lead  by  X-ray  fluorescence  spectrometry  in children.

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Lead  measured  in this  fashion  allows observation  of ongoing lead accumulation, rather  than
waiting for exfoliation.
      Lead in Hair.  The analysis of lead  in  hair  as  an exposure indicator offers the  advan-
tages of  being  a noninvasive procedure that  uses  a medium  of indefinite stability.   However,
there is still the crucial problem of external surface contamination,  which  is  such that it  is
still not possible  to state that any cleaning protocol  reliably  differentiates between  exter-
nally and internally deposited lead.
      Studies that demonstrate a correlation between increasing hair  lead and increasing  sever-
ity of a measured effect probably support arguments for using hair as  an external  indicator  of
exposure.   However,  such measurement using cleaning protocols that have  not  been independently
validated will  overstate the relative accumulation of  "internal" hair  lead in terms of  some
endpoint and will also underestimate the relative sensitivity of  changes in  internal  lead con-
tent  with exposure.   One consequence of this would be,  for  example,  an  apparent threshold for
a  given effect  in  terms  of hair  lead  which  is  significantly  above  the  actual threshold.
Because of  these  concerns,  the  analysis of hair lead is  best used with the simultaneous  mea-
surement of blood lead.
      Lead in Urine.   The analysis of lead in urine  is  complicated by  the relatively low  levels
of the  element  in this  medium,  as well as the complex mixture of other  mineral elements pres-
ent.   Urine  lead levels  are most useful  and also somewhat  easier  to  determine in  cases  of
chelation mobilization  or chelation  therapy,  where levels are high  enough to permit  good pre-
cision and dilution of matrix interference.
      Samples are  probably best  analyzed by prior chemical wet-ashing, using the usual mixture
of acids.   Both ASV and AAS  have been applied to urine analysis,  with  the latter more routine-
ly used and usually with a chelation/extraction step.
      Lead in Other Tissues.   Bone  samples require cleaning  procedures  for removal  of  muscle
and connective  tissue and chemical  solubilization  prior to  analysis.  Methods  of analysis are
comparatively limited and fTameless  AAS is the technique of  choice.
      Iji vivo lead measurements  in bone have been reported with lead workers using X-ray fluo-
rescence analysis and a radioisotopic  source for excitation.  One problem  with this approach
with moderate lead exposure  is the detection limit, which is approximately 20 ppm.  Soft organ
analysis poses a problem in  terms of heterogeneity  in  lead distribution  within  an organ  (e.g.
brain and  kidney).   In such cases,  regional  sampling or homogenization must  be  carried  out
Both  flame  and  fTameless AAS appear to be  satisfactory  for soft tissue analysis and are the
most widely used analytical  methods.
     Quality Assurance Procedures in Lead Analyses.    In  terms of  available information,  the
major focus  in  establishing quality  control protocols for lead has  involved whole blood meas-
urements.   Translated into practice,  quality control  revolves around  steps employed within the
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laboratory, using a  variety  of  internal  checks, and the  further  reliance on external  checks,
such as a formal continuing multi-laboratory proficiency testing program.
     Within the  laboratory,  quality  assurance  protocols can be divided into start-up  and rou-
tine  procedures.  The  former  involves  establishment of  detection  limits,  within-run  and
between-run precision, analytical  recovery,  and comparison with some reference technique  with-
in or  outside  the  laboratory.   The reference method is  assumed to be accurate for the parti-
cular  level  of  lead  in  some matrix at a particular point in time.  Correlation  with such  a
method  at  a satisfactory  level,  however, may  simply  indicate that  both  methods  are  equally
inaccurate  but performing with the  same  level  of precision proficiency.   More  preferable is
the  use of certified  samples  having  lead  at  a  level  established by  the definitive  method.
     For blood  lead,  the  Centers  for Disease Control  (CDC)  periodically survey overall  accu-
racy  and  precision of methods  used  by reporting laboratories.  In terms  of overall  accuracy
and precision, one such survey found that ASV,  as well  as the Delves cup and extraction varia-
tions  of AAS,  performed  better than other procedures.   These results do not mean that a given
laboratory cannot perform better with a particular technique; rather, such data are of assist-
ance for new facilities choosing among methods.
     Of  particular  value  to  laboratories carrying out  blood  lead analyses are the  external
quality  assurance programs at  both the State and Federal levels.  The most comprehensive pro-
ficiency testing program is that carried out  by the CDC.  This program actually consists of
two  subprograms,  one directed  at facilities involved in lead poisoning prevention and screen-
ing  (Center for  Environmental Health) and the other concerned with  laboratories seeking certi-
fication under  the Clinical  Laboratories  Improvement Act of 1967, as  well  as under regulations
of  the Occupational  Safety and Health Administration's  (OSHA) Laboratory Improvement Program
Office.  Judging from the relative overall improvements  in  reporting laboratories  over the
years  of  the programs'  existence, the proficiency  testing programs  have  served their purpose
well.   In  this regard,  OSHA criteria  for laboratory  certification require  that eight of  nine
samples  be analyzed  correctly  for the previous quarter.   This level of  required proficiency
reflects the ability  of a  number  of  laboratories to actually perform  at  this level.

1.9.2   Determination  of Biochemical  Indices  of  Lead Exposure  in Biological  Media
     Determination of Erythrocyte Porphyrin  (Free Erythrocyte  Protoporphyrin,  Zinc Protopor-
phyrin).   With  lead  exposure,  erythrocyte  protoporphyrin  IX accumulates because of  impaired
placement  of  divalent  iron to form heme.   Instead, divalent  zinc occupies the place of the
native iron.   Depending upon the  method  of analysis,  either  metal-free  erythrocyte porphyrin
(EP)  or zinc  protoporphyrin (ZPP)  is  measured, the former  arising  from loss of zinc  in the
chemical manipulation.   Virtually all methods  now  in  use for  EP  analysis exploit the ability
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of  the  porphyrin to  undergo  intense fluorescence  when  excited by  ultraviolet  light.   Such
fluorometric methods  can  be  further  classified as wet  chemical  micromethods or direct mea-
suring  fluorometry  using  the hematofluorometer.   Because  of  the high  sensitivity  of such
measurement, relatively small  blood samples are required,  with  liquid  samples  or  blood collec-
ted on filter paper.
     The most common  laboratory  or wet  chemical  procedures  now in  use represent  variations of
several  common  chemical  procedures:   (1) treatment of blood samples  with a mixture of ethyl
acetate/acetic acid followed  by  a  repartitioning into an inorganic acid  medium; or (2) solu-
bilization  of  a blood sample directly   into  a detergent/buffer solution  at a high dilution.
Quantification has been done  using protoporphyrin,  coproporphyrin, or zinc protoporphyrin IX
plus pure  zinc  ion.    The  levels of  precision for  these laboratory  techniques  vary somewhat
with the specifics of analysis.   The Piomelli method  has a  coefficient of variation of 5 per-
cent, while  the  direct ZPP method using buffered detergent solution  is higher and more vari-
able.
     The recent development of the hematofluorometer has  made it possible  to carry out EP mea-
surements in high numbers,  thereby making population screening  feasible.   Absolute calibration
is  necessary and requires  periodic  adjustment  of  the  system  using  known concentrations of
EP  in  reference blood samples.   Since   these  units are  designed for oxygenated blood  (i.e.
capillary blood), use of  venous blood requires an oxygenation step, usually a  moderate shaking
for several minutes.   Measurement of low or moderate levels  of  EP  can  be affected by interfer-
ence  with   bilirubin.   Competently  employed,  the  hematofluorometer  is  reasonably precise
showing a  total  coefficient  of variation of 4.1-11.5  percent.   While  the  comparative accuracy
of  the  unit has  been reported to be  good  relative  to the reference wet chemical technique,  a
very recent study has shown that commercial units carry with them  a significant negative bias
which may  lead  to  false  negatives in subjects having  only moderate EP elevation.  Such  a bias
in accuracy has been difficult to detect in existing EP proficiency testing programs.  By com-
parison to  wet methods,  the  hematofluorometer  should be restricted  to field use rather than
becoming a  substitute in the  laboratory for  chemical  measurement, and this  field use  should
involve periodic split-sample comparison testing with  the wet method.
     Measurement of Urinary Coproporphyrin.    Although  EP measurement has  largely  supplanted
the  use of  urinary   coproporphyrin  (CP-U) analysis  to   monitor  excessive  lead exposure  in
humans,  this measurement  is   still  of  value  in that it  reflects active  intoxication.   The
standard analysis is  a fluorometric  technique, whereby  urine  samples  are  treated with buffer
and  an  oxidant  (iodine)  is added to  generate  CP from its precursor.   The CP-U  is then  parti-
tioned  into  ethyl acetate  and re-extracted with dilute  hydrochloric  acid.   The  working curve
is  linear below 5 ug CP/dl  urine.

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     Measurement of Delta-Aminolevulinic Acid Dehydrase Activity.   Inhibition of  the  activity
of the erythrocyte enzyme delta-aminolevulinic acid dehydrase (ALA-D)  by lead is the  basis  for
using such activity in screening for excessive lead exposure.   A number of sampling and  sample
handling  precautions  attend such  analysis.   Since zinc  (II)  ion will  offset  the  degree  of
activity  inhibition by  lead,  blood collecting tubes  must have  extremely low zinc  content,
which essentially rules out the use of rubber-stoppered blood tubes.   Enzyme stability is such
that  the  activity  measurement  is best carried out  within  24 hr of blood collection.   Porpho-
bilinogen,  the  product  of  enzyme action, is  light labile and requires the  assay be done in
restricted  light.   Various procedures  for  ALA-D  measurement are based  on  measurement  of  the
level of  the chromophoric pyrrole (approximately 555 nm) formed by condensation of the porpho-
bilinogen with p-dimethylaminobenzaldehyde.
      In the  European  Standardized Method for ALA-D activity  determination, blood samples are
hemolyzed  with  water; ALA  solution is  then added, followed  by incubation  at 37°C, and the
reaction  terminated by  a solution  of  mercury (II)  in trichloroacetic acid.   Filtrates  are
treated  with  modified  Ehrlich's  reagent  (p-dimethylaminobenzaldehyde)  in trichloroacetic/
perchloroacetic acid mixture.   Activity  is quantified  in terms of micromoles  ALA/min  per liter
of erythrocytes.
      One  variation  in  the above procedure is  the initial use of  a thiol  agent,  such as dithio-
threotol,  to reactivate  the  enzyme and give a measure  of the  full native activity  of the
enzyme.   The ratio of activated/unactivated activity versus blood  lead   levels  accommodates
genetic differences between individuals.
      Measurement  of Delta-Aminolevulinic Acid in Urine and Other Media.     Levels  of   delta-
aminolevulinic  acid (ALA)  in   urine and plasma increase  with elevated lead exposure.  Thus,
measurement  of this  metabolite, generally  in  urine,  provides  an  index of the level of  lead
exposure.   ALA content  of  urine samples (ALA-U)  is stable for about  2 weeks  or more  with  sam-
ple   acidification  and  refrigeration.   Levels of ALA-U  are adjusted  for  urine density or
expressed per  unit creatinine.   If feasible, 24-hr collection  is more desirable than  spot  sam-
pling.
      Virtually all the  various procedures  for ALA-U   measurement employ preliminary  isolation
of  ALA from the  balance of urine constituents.   In one method,  further separation of ALA  from
the  metabolite aminoacetone is done because aminoacetone  can  interfere with colorimetric  mea-
surement.  ALA is  recovered,  condensed with a beta-dicarbonyl compound, e.g.,  acetyl acetone,
to  yield a pyrrole   intermediate.  This  intermediate is  then  reacted with p-dimethylamino-
benzaldehyde in  perchloric/acetic  acid, followed  by  colorimetric reading at  553 nm.   In one
 variation of the  basic  methodology, ALA is condensed with ethyl acetoacetate directly and the
 resulting pyrrole  extracted with ethyl acetate.    Ehrlich's reagent  is then added as in other
 procedures and the resulting chromophore is measured  spectrophotometrically.
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     Measurement of ALA in plasma is much more difficult  than  in  urine,  since plasma ALA is at
nanogram/milliter levels.   In one  gas-liquid  chromatographic  procedure,  ALA is isolated from
plasma, reacted with acetyl  acetone and partitioned  into a  solvent that  also serves for pyro-
lytic methylation of the  involatile pyrrole  in the  injector port of the  chromatograph, making
the derivative more volatile.   For quantification, an internal  standard,  6-amino-5-oxohexanoic
acid, is used.  While  the method is more involved,  it is more  specific  than the older colori-
metric technique.
     Measurement of Pyrimidine-5'-Nuc1eotidase Activity.     Erythrocyte   pyrimidine-5'-nucleo-
tidase (Py5N) activity  is  inhibited with lead exposure.   Currently, two  different methods are
used for assaying the  activity  of this enzyme.  The  older  method is  quite laborious in time
and effort, whereas the more  recent approach  is shorter and  uses  radioisotopes  and radiometric
measurement.
     In the older method,  heparinized  venous  blood  is filtered  through  cellulose to separate
erythrocytes  from  platelets  and  leukocytes.   Cells  are  then  freeze-fractured and the hemo-
lysates dialyzed to remove nucleotides  and other phosphates.   This dialysate is then  incubated
in the presence of  a  nucleoside monophosphate and cofactors,  the enzyme  reaction being termi-
nated by  treatment  with  trichloroacetic  acid.   The  inorganic  phosphate isolated from added
substrate is measured colorimetrically  as the  phosphomolybdic  acid complex.
     In the  radiometric assay,   hemolysates  obtained as  before  are  incubated with pure 14C-
cytidinemonophosphate.   By addition  of  a barium hydroxide/zinc sulfate  solution, proteins and
unreacted nucleotide are  precipitated,  leaving labeled cytidine  in the  supernatant.  Aliquots
are  measured  for  14C-activity  in  a liquid scintillation counter.   This method shows a good
correlation with the earlier  technique.
     Measurement of Plasma 1,25-Pihydroxyvitamin D.   Measurement  techniques  for this  vitamin  D
metabolite, all of  recent  vintage,  consist of three  main parts:   (1)  isolation from  plasma or
serum by  liquid-liquid extraction;  (2)  preconcentration of the extract and  chromatographic
purification  using  Sephadex  LH-20  or Lipidex  5000 columns,  as  well as high  performance liquid
chromatography (HPLC)  in some cases; and (3)  quantification  by  either  of  two radiometric bind-
ing  techniques,  the more  common competitive  protein binding  (CPB) assay or  radioimmunoassay
(RIA).   The  CPB assay  uses  a  receptor  protein  in  intestinal  cytosol  of chicks made vitamin
D-deficient.
     In  one  typical   study,  human  adults had  a  mean  1,25-dihydroxyvitamin D  level  of 31
picograms/ml.    The  limit  of detection  was  5 picograms/analytical  tube,  and within-run and
between-run coefficients  of  variation  were  17 and  26  percent, respectively.   In  a recent
interlaboratory survey  involving  15 laboratories, the level of  variance was  such that it was
recommended that each laboratory should establish its own reference values.
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1.10  METABOLISM OF LEAD
     Toxicokinetic parameters of lead absorption,  distribution,  retention,  and excretion rela-
ting external  environmental  lead exposure  to various  adverse  effects are discussed  in  this
section.    Also  considered  are  various  influences on  these  parameters,  e.g.,  nutritional
status, age, and  stage  of development.   A number  of specific issues regarding lead metabolism
by animals and humans are addressed, including the following:

     1.   How does the  developing  organism (from  gestation to maturity) differ from the adult
          in toxicokinetic response to lead intake?
     2.   What do  these differences  in  lead  metabolism portend for relative  risk of  adverse
          effects?
     3.   What are the  factors  that significantly change the toxicokinetic parameters in ways
          relevant to assessing health risk?
     4.   How do  the various interrelationships  among body  compartments of  lead translate to
          assessment of internal exposure and changes in internal exposure?

1.10.1  Lead Absorption in Humans and Animals
     There are four*ways  in which lead may be absorbed by the body.  The amount of  lead enter-
ing  the bloodstream  via these routes of absorption  is influenced not only by the levels of the
element in  a given medium, but  also  by various  physical and chemical parameters  and specific
host factors, such as age and nutritional status.
     Respiratory Absorption of  Lead.  The movement  of lead from ambient air to the  bloodstream
is  a two-part process:   deposition of  some fraction of  inhaled air  lead in the deeper part of
the  respiratory  tract and absorption  of the deposited fraction.  For adult humans,  the deposi-
tion rate of  particulate airborne lead  as likely  encountered by  the  general  population is
around  30-50 percent,  with  these  rates  being modified by  such factors as  particle size and
ventilation  rates.   All of the  lead deposited  in  the lower respiratory tract appears to be ab-
sorbed, so that  the  overall  absorption  rate is governed  by the  deposition rate, i.e., approxi-
mately 30-50  percent.   Autopsy  results  showing no lead  accumulation  in the lung indicate total
absorption of deposited lead.
     All  of  the available data  for lead uptake  via the respiratory tract in  humans have been
obtained  with adults.   Respiratory uptake  of  lead in children, while  not fully quantifiable,
appears  to be comparatively greater  on a body-weight basis.   A second  factor influencing the
relative  deposition  rate in children is  airway  dimensions; one report  has  estimated  that the
10-year-old  child has  a deposition  rate 1.6- to  2.7-fold  higher  than  the  adult  on  a  weight
basis.
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     The chemical form of  the  lead compound  inhaled  does  not  appear to be a major determinant
of the extent of alveolar absorption of  lead.   While  experimental animal data for quantitative
assessment of  lead  deposition and  absorption  for the  lung  and upper  respiratory  tract are
limited, available  information  from the  rat,  rabbit, dog,  and nonhuman  primate support the
findings that respired lead  in  humans  is  extensively and  rapidly absorbed.  Over the range of
air lead encountered by  the  general  population,  absorption rate does not appear to depend on
air lead level.
     Gastrointestinal  Absorption  of Lead.   Gastrointestinal (GI) absorption of lead mainly in-
volves  lead uptake  from  food and beverages as  well as lead deposited  in the upper respiratory
tract and eventually swallowed.   It also includes  ingestion of non-food material, primarily in
children via normal mouthing activity  and pica.   Two issues of concern with lead uptake from
the gut are the comparative rates of such  absorption  in developing versus adult organisms, in-
cluding humans,  and how the relative bioavailability  of lead affects such uptake.
     By use of  metabolic  balance and isotopic  (radioisotope  or stable isotope)  studies, var-
ious laboratories have provided  estimates  of lead absorption in the  human adult on the order
of  10-15  percent.   This  rate  can be significantly  increased  under  fasting  conditions to 45
percent, compared to lead  ingested with food.   The  latter figure also suggests  that beverage
lead  is absorbed  to  a  greater  degree since  much  beverage   ingestion occurs  between meals
     The relationship of  the chemical/biochemical  form  of lead in the gut to absorption rate
has been studied, although interpretation  is  complicated by the  relatively small  amounts given
and the presence of various  components  in food already present in the gut.  In  general, how-
ever, chemical  forms of  lead and their incorporation into biological matrices seem to have  a
minimal impact on lead  absorption in the human  gut.   Several studies have focused on the ques-
tion of differences in GI  absorption rates for lead  between  children and adults.  Such rates
for children are considerably higher than  for adults:   10-15 percent for adults versus approx-
imately 50 percent for  children.   Available data  for  the absorption of lead from  nonfood items
such as dust and  dirt  on hands  are  limited, but  one study has estimated a figure of 30 per-
cent.  For paint chips,  a value of about 17 percent has been estimated.
     Experimental animal  studies show that,  like humans,  the  adult  animal  absorbs  much less
lead from the gut  than  the developing  animal.  Adult rats maintained  on ordinary rat chow ab-
sorb 1  percent  or  less  of the dietary lead.  Various animal studies make  it  clear that the
newborn absorbs a much greater  amount  of  lead  than the adult, supporting studies showing this
age-dependency in humans.  For example,  compared  to  an absorption rate of about 1 percent in
adult rats, the  rat pup  has  a rate  40-50  times  greater.   Part, but not most, of this differ-
ence can  be  ascribed to  a difference  in  dietary composition.   In nonhuman primates, infant
monkeys absorb  65-85  percent of lead  from  the  gut, compared  to  4   percent for the adults

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     The bioavailability of lead  in  the GI tract as a  factor in its absorption has  been the
focus of  a  number of  experimental  studies.   These data show that:   (1)  lead in a number of
forms is  absorbed about equally, except  for lead sulfide; (2)  lead  in  dirt and dust and as
different chemical  forms  is absorbed  at  about  the  same  rate as  pure  lead salts added to  a
diet; (3)  lead in paint  chips undergoes  significant  uptake from  the  gut;  and  (4)  in some
cases, physical size of particulate  lead can affect the  rate of GI  absorption.   In  humans, the
GI absorption  rate of  lead appears  to be  independent of the quantity of lead  already  in the
gut  up  to  a level of at least 400 ug.   In animals, dietary lead  levels  between 10  and 100 ppm
result in reduced absorption of lead from the GI tract.
     Percutaneous Absorption of Lead.  Absorption of inorganic lead compounds through  the skin
is of much  less  significance  than absorption through respiratory and GI  routes.   On the other
hand, absorption  through  skin is far more  significant  than other routes of  exposure for the
lead alkyls  (see  Section  1.10.6).   One recent  study using human volunteers and 203Pb-labeled
lead  acetate  showed that  under  normal  conditions,  skin absorption of lead alkyls  approached
0.06 percent.
     Transplacental Transfer of Lead.  Lead uptake by the human and animal fetus occurs readi-
ly;  this  uptake  is apparent by the  12th  week of gestation in humans and increases throughout
fetal  development.   Cord  blood contains  significant  amounts of  lead,  correlating  with but
somewhat  lower than  maternal  blood lead  levels.   Further  evidence for  such transfer, besides
the  measured  lead  content of cord blood,  includes fetal  tissue  analyses  and  reduction  in
maternal  blood lead  during pregnancy.   There  also appears  to  be  a seasonal effect  on  the
fetus,  with summer-born children showing a trend  to higher blood lead levels than those born
in the  spring.

1.10.2  Distribution of Lead in Humans and Animals
      In this subsection, the distributional characteristics of lead in various portions of the
body (blood,   soft tissue,  calcified tissue,  and the  "chelatable"  or  potentially toxic body
burden) are discussed  as a  function  of  such variables as exposure history and age.
      Lead in Blood.   More  than  99  percent of  blood  lead in humans is associated  with  the
erythrocytes  under steady-state conditions, but  it  is  the very  small fraction transported  in
plasma  and  extracellular fluid that provides lead to the  various body organs.  Most  (^50 per-
cent)  of  the erythrocyte  lead  is bound within the cell,  primarily associated with hemoglobin
(particularly  HbA2),  with approximately  5  percent  bound to a 10,000-dalton  fraction, 20 per-
cent to a  heavier molecule, and 25 percent to  lower-weight species.   Several  studies  with lead
workers and patients  indicate  that the  fraction of  lead in plasma  versus  whole  blood  increases
above approximately  50-60  pg/dl  blood  lead.

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     Whole blood lead  in  daily equilibrium with other compartments  in adult  humans  appears  to
have a biological  half-life  of 25-28 days and  amounts  to  about 1.9 mg in  total  lead  content,
based  on  isotope  studies.   Other data  from  lead-exposed  workers  indicate  that half-life
depends on mobile  lead burden.   Human blood lead responds  rather quickly to  abrupt  changes  in
exposure.  With  increased  lead intake,  blood lead achieves a new value in  approximately  40-60
days, while a decrease in exposure may be associated with variable new blood  values, depending
upon the  exposure  history.   This  dependence presumably reflects lead resorption  from  bone.
With age,  furthermore,  a  moderate increase occurs in blood  lead during adulthood.  Levels  of
lead in blood of children tend to show a peak at 2-3 years  of age (probably caused  by  mouthing
activity),  followed  by a  decline.   In  older children  and  adults, levels  of  lead are  sex-
related, with females  showing lower levels than males  even  at  comparable  levels of exposure.
     In plasma,  virtually  all  lead is bound  to  albumin  and  only trace amounts  to  high-weight
globulins.   Which  of  these  binding  forms  constitutes  an  "active"  fraction for movement  to
tissues  is  impossible  to  state.   The most  recent  studies  of the erythrocyte/plasma relation-
ship in  humans  indicate an equilibrium between  these blood  compartments,  such  that levels  in
plasma  rise  with levels in whole  blood  in fixed proportion up  to  approximately 50-60 (jg/dl,
whereupon the relationship becomes curvilinear.
     Lead Levels in Tissues.    Of  necessity,  various  relationships of tissue lead  to  exposure
and  toxicity  in  humans must  generally be obtained from autopsy  samples.   Limitations  on  these
data include  questions of  how such samples represent  lead behavior in the living  population,
particularly with reference to prolonged illness and disease states.  The  adequate  characteri-
zation  of exposure for  victims  of  fatal  accidents  is  a  problem,  as  is  the  fact that such
studies  are  cross-sectional  in nature,  with  different  age groups assumed  to have  had similar
exposure  in the  past.
     Soft tissues.   After  age 20,  most  soft tissues  (in  contrast to bone) in  humans do not
show age-related changes.   Kidney  cortex shows  an  increase in  lead with  age, which may  be
associated  with  the formation of  nuclear inclusion bodies.   Absence  of lead accumulation  in
most soft tissues results from a turnover rate for lead similar to that in blood.
     Based  on several   autopsy  studies,  soft-tissue lead  content for  individuals  not occupa-
tional ly  exposed is generally below 0.5 |jg/g wet weight, with higher values for aorta  and kid-
ney  cortex.   Brain tissue  lead  level is  generally below  0.2  pg/g wet weight and  shows  no
change  with  increasing age,  although  the  cross-sectional  nature  of  these data  would make
changes  in  low  levels  of brain lead  difficult to discern.   Autopsy data for both children and
adults  indicate  that  lead  is selectively  accumulated  in  the  hippocampus,  a finding that  is
also consistent  with the regional distribution in experimental animals.
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     Comparisons of lead levels in soft-tissue autopsy samples  from children  with  results  from
adults indicate that  such  values  are lower in  infants  than  in older children,  while  children
aged 1-16 years had levels comparable to those for adult women.   In one  study,  lead  content  of
brain  regions  did not  materially differ for  infants and older children compared  to  adults.
Complicating these  data somewhat are changes  in  tissue mass with age, although  such  changes
are less than for the skeletal system.
     Subcellular distribution of lead in soft tissue is not uniform.   High amounts of  lead are
sequestered in  the  mitochondria and nucleus of the  cell.   Nuclear accumulation is  consistent
with the  existence  of lead-containing nuclear  inclusions  in various  species and  a  large  body
of data demonstrating the sensitivity of mitochondria to injury by lead.
     Mineralizing tissue.  Lead becomes  localized and accumulates in human calcified  tissues,
i.e.,  bones  and  teeth.   This accumulation  in humans begins with fetal  development  and  con-
tinues to approximately 60 years of age.  The extent of lead accumulation in bone  ranges up to
200 mg in men  ages 60-70 years,  while  in women  lower  values  have  been  measured.   Based upon
various  studies,  approximately 95 percent of  total  body  lead  is lodged in the bones  of human
adults,  with  uptake  distributed  over trabecular  and compact bone.   In the  human adult,  bone
lead  is  both  the most  inert  and  the largest body pool, and accumulation can serve to  maintain
elevated  blood  lead  levels  years  after  exposure,  particularly  occupational exposure,  has
ended.
     By  comparison to  human  adults, only 73  percent of  body lead is lodged  in  the  bones of
children,  which is consistent with other  information that the skeletal  system of children is
more  metabolically active than that of  adults.   Furthermore,  bone tissue in children is less
dense  than in  adults.   While  the  increase  in  bone lead  level across childhood is modest, about
two-fold  if  expressed as concentration,  the  total  accumulation rate is actually 80-fold when
one  takes into account  the  40-fold increase  in  skeletal  mass  that  children undergo.   To the
extent that  some significant  fraction  of  total bone lead  in children and adults  is relatively
labile,  in terms of  health  risk  for  the whole organism it is  more appropriate  to consider the
total  accumulation rather than just changes  in concentration.
      The traditional view  that  the  skeletal  system is a "total" sink  for  body  lead (and by
implication a  biological  safety feature to permit significant  exposure in industrialized  popu-
lations)  never did agree with even older information  on  bone  physiology, e.g.,  bone  remodel-
ling.   This  view  is  now giving way to  the  idea  that there  are at least  several  bone  compart-
ments for lead,  with different mobility profiles.   Bone  lead,  then, may be more of  an  insid-
 ious  source of long-term  internal  exposure than a  sink  for  the element.   This aspect of  the
 issue is  summarized  more fully  in the  next section.   Available information  from studies  of
 uranium miners  and  human volunteers who ingested  stable isotopes indicates  that there is a
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relatively inert bone compartment  for  lead,  having a  half-life  of  several decades, as well as
a rather labile compartment that permits  an  equilibrium between  bone  and  tissue  lead.
     Tooth lead also increases with age at a rate  proportional to exposure and roughly propor-
tional  to  blood lead in  humans and experimental  animals.   Dentine  lead is the component of
teeth that is perhaps the most responsive to lead  exposure  since it is  laid  down from the time
of  eruption  until  shedding.   This characteristic  underlies the  usefulness  of dentine lead
levels in assessing long-term exposure.
     Chelatable lead.  Mobile lead in  organs and systems is potentially more active toxicolog-
ically  in  terms of  being  available to  biological  sites of action.   Hence, this fraction of
total body  lead burden  is  a more  significant  predictor  of  imminent  toxicity.  In reality,
direct  measurement of  such a  fraction   in  human  subjects  would  not be possible.   In this
regard,  chelatable  lead, measured  as  the extent of plumburesis in  response to  administration
of a  chelating  agent, specifically CaNa2EDTA,  is  now  viewed as  the most  useful  probe of undue
body burden in children  and adults.
     A  quantitative description  of the  inputs to the  body lead  fraction that is chelant-
mobilizable is  difficult to define fully, but  it  most  likely includes a labile lead compart-
ment within bone  as well  as within soft  tissues.   Support for  this view includes the follow-
ing:  (1)  the  age-dependency of  chelatable lead,  but not  lead  in  blood or  soft tissues;
(2)  evidence  of removal  of bone lead  in  chelation studies with experimental  animals;  (3) in
vitro studies  of  lead mobilization in bone organ explants under closely defined conditions;
(4) tracer-modeling estimates in human subjects; and (5) the complex nonlinear relationship of
blood lead  and lead  intake through various media.   Data  for  children  and adults showing  a
logarithmic relationship of  chelatable  lead to  blood lead  and  the  phenomenon of "rebound" in
blood lead elevation  after  chelation  therapy regimens  (without obvious  external  re-exposure)
offer further support.
     Animal studies.  Animal  studies  have helped  to define some of  the  relationships of  lead
exposure to jji  vivo distribution of the  element,  particularly  the  impact of  skeletal lead on
whole body  retention.   In  rats,  lead administration  results in  an initial increase of  lead
levels  in  soft  tissues,  followed by loss of lead  from soft tissue via excretion and transfer
to bone.   Lead  distribution appears to be relatively independent  of dose.   Other studies  have
shown that lead loss from  organs  follows first-order  kinetics  except  for  loss  from bone, and
that  the  skeletal  system in rats and  mice is the kinetically rate-limiting  step in whole-body
lead clearance.
     The neonatal  animal seems  to retain proportionally higher  levels  of tissue lead compared
to the adult and manifests  slow decay  of brain  lead levels  while showing  a  significant decline
over  time  in other tissues.   This decay appears to  result from enhanced lead entry to  the

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brain because of  a  poorly developed brain barrier system as well  as from enhanced body reten-
tion of lead by young animals.
     The effects  of  such  changes as metabolic stress and nutritional status on body redistri-
bution of  lead  have  been  noted.   Lactating mice, for example, are known to demonstrate tissue
redistribution  of lead,   specifically  bone-lead  resorption with  subsequent transfer  of  both
lead and calcium  from mother to pups.

1.10.3  Lead Excretion and Retention in Humans and Animals
     Human Studies.    Dietary  lead  in  humans  and animals that is not  absorbed passes through
the  GI  tract  and is eliminated with  feces,  as is the fraction of  air lead that is swallowed
and  not absorbed.   Lead  entering  the  bloodstream  and  not  retained  is  excreted through the
renal  and  GI tracts,  the latter  via biliary clearance.  The amounts excreted through these
routes are a function of  such factors as species, age, and exposure characteristics.
     Based upon the  human metabolic balance data and isotope  excretion findings of various in-
vestigators,  short-term   lead excretion  in adult  humans amounts to 50-60  percent  of the ab-
sorbed  fraction,  with the  balance moving primarily to  bone  and  some  fraction (approximately
half)  of  this  stored  amount  eventually  being  excreted.   This estimated overall  retention
figure  of  25 percent necessarily  assumes  that isotope clearance reflects  the  clearance rates
for  body  lead in all compartments.   The  rapidly excreted fraction  has  a biological  half-life
of 20-25 days,  similar to that for lead removal  from blood, based on isotope data.  This simi-
larity  indicates  a  steady rate  of lead clearance from  the body.   In  terms of  partitioning of
excreted  lead between urine and  bile,  one study indicates that  the rate of biliary  clearance
is about 50 percent  that  of renal  clearance.
      Lead  accumulates in  the human  body,  mainly in  bone,  up  to around 60 years of  age, when a
decrease  occurs  with changes  in  intake  as  well  as  in  bone mineral  metabolism.   As noted
earlier,  the total  amount of  lead in long-term retention can approach  200 mg (and  even much
higher  in the  case of occupational  exposure).   This  rate  corresponds to a  lifetime  average
retention  rate of  9-10 ug  Pb/day.  Within  shorter  time frames,  however,  retention  will vary
considerably  because of  such factors  as  development,  disruption in the individuals'  equilib-
rium with  lead  intake, and  the onset of such states  as osteoporosis.
      The  age-dependency  of lead  retention/excretion  in  humans has not  been well studied,  but
most of the  available information indicates that children, particularly infants,  retain a sig-
nificantly higher amount  of lead than adults.   While autopsy data indicate  that pediatric sub-
jects at isolated points in  time actually have  a  lower fraction of  body  lead lodged in bone
 (which probably relates to  the less dense bones of children as well as high bone mineral  turn-
 over),  a full understanding of longer-term retention over childhood must consider the exponen-
 tial growth rate occurring  in  children's skeletal systems over  the time period  for which bone
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lead concentrations have been  gathered.   This  parameter itself represents a 40-fold mass  in-
crease.   Thus,  this significant skeletal  growth rate  has an  impact  on  an  obvious question:   if
children take  in  more  lead  on a body-weight  basis  than  adults,  absorb  and retain more lead
than adults, and show only  modest elevations  in blood lead compared to adults in the face of a
more active skeletal  system, where  does  the lead go?   A  second  factor is  the assumption that
blood lead  in  children  relates  to  body  lead  burden in  the  same  quantitative  fashion as  In
adults,  an assumption that  remains to  be  proven adequately.
     Animal  Studies.   In rats and other experimental  animals,  both  urinary  and fecal excretion
appear  to  be  important routes of lead removal  from  the organism.   The  relative partitioning
between the  two modes  is  species-  and  dose-dependent.   With regard to species differences,
biliary clearance of  lead  in the dog is  but 2 percent  of that for the rat, while  such excre-
tion in the rabbit is 50 percent that  of  the  rat.
     Lead movement from laboratory animals to their offspring  via milk constituents  is a route
of excretion for the mother as  well  as a  route  of  exposure for the  young.   Comparative studies
of lead retention in developing versus adult  animals  such  as rats,  mice,  and nonhuman primates
make it clear that retention is significantly greater in the young  animal.  These observations
support those  studies  showing  greater lead retention in children.   Some  recent data indicate
that a  differential  retention of  lead  in young  rats  persists  into the post-weaning period
calculated as either uniform dosing  or uniform  exposure.

1.10.4  Interactions of Lead with Essential Metals and Other Factors
     The toxicological  behavior  of elements such as lead is  affected by  interactions with a
variety of biochemical factors, particularly  nutrients.
     Human Studies.   In  humans,  the interactive behavior  of lead and  various nutritional fac-
tors  is expressed  most significantly  in young  children,  with  such interactions occurring
against a  backdrop of  deficiencies  in  a  number  of  nutritional  components.   Various surveys
have indicated  that  iron,  calcium,  zinc, and  vitamin  deficiencies are widespread among  the
pediatric population, particularly the poor.   A number  of reports  have documented  the associ-
ation of lead absorption with suboptimal  nutritional  states  for iron and  calcium, with reduced
intake being associated with increased lead absorption.
     Animal  Studies.    Reports  of  lead-nutrient  interactions in   experimental  animals  have
generally described  such relationships  for  a   single nutrient,  using relative absorption or
tissue  retention  in the animal  to index  the  effect.  Most of  the recent  data are for calcium
iron, phosphorus,  and vitamin D.   Many studies  have established that diminished dietary calci-
um is associated  with  increased  blood and soft-tissue  lead  content in such diverse  species as
the rat, pig,  horse,  sheep,  and domestic fowl.   The  increased body burden  of lead  arises from

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both  increased  GI  absorption  and  retention,   indicating  that  the  lead-calcium  interaction
operates  at both  the  gut  wall   and within  body compartments.   Lead appears  to  traverse
the gut via both passive and active transfer.   It involves  transport  proteins  normally operat-
ing for calcium transport, but is  taken up at the site of phosphorus,  not calcium,  absorption.
     Iron deficiency is associated with an increase of lead in tissues and  increased toxicity,
effects that  are expressed  at  the level  of lead  uptake  by the gut wall.   Iji  vitro studies
indicate an interaction  through  receptor-binding competition at a common site,  which probably
involves  iron-binding  proteins.   Similarly,  dietary phosphate deficiency  enhances  the extent
of  lead retention  and  toxicity  via increased uptake of lead at the gut wall,  as both lead and
phosphate are absorbed at the same site in the small intestine.   Results of various studies of
the  resorption  of phosphate  along with  lead  have not  been able to  identify  conclusively a
mechanism for the elevation of tissue lead.  Since calcium  plus phosphate retards lead absorp-
tion to a greater degree than simply the sums of the interactions, an insoluble complex of all
these elements may be the basis of this retardation.
     Unlike the  inverse relationship existing for calcium,  iron, and phosphate versus lead up-
take,  vitamin  D levels  appear  directly  related to the rate of  lead  absorption  from the GI
tract, since the vitamin stimulates the same region of the duodenum where lead is absorbed.  A
number  of other nutrient  factors are  known  to have  an interactive  relationship  with lead:

     1.   Increases  in  dietary  lipids increase  the extent of lead absorption, with the extent
          of the increase being highest with polyunsaturates  and lowest with saturated fats,
          e.g.,  tristearin.
     2.   The  interactive  relationship  of  lead and  dietary protein  is  not  clear  cut,  and
          either suboptimal or excess protein intake will increase lead absorption.
     3.   Certain  milk components, particularly lactose,  greatly  enhance lead absorption in
          the  nursing animal.
     4.   Zinc  deficiency promotes lead absorption, as does  reduced dietary copper.

     Taken  collectively,  human and animal  data  dealing with  the  interaction of  lead and nutri-
ents  indicate  that children having multiple nutrient deficiencies are  in  the highest exposure
risk category.

1.10.5  Interrelationships  of Lead Exposure with Exposure  Indicators  and Tissue  Lead  Burdens
     Three  issues  involving lead toxicokinetics evolve  toward  a full connection between  lead
exposure  and  its  adverse effects:   (1)  the temporal characteristics  of  internal indices of
lead  exposure;  (2)  the biological   aspects  of the relationship  of  lead  in various media to
                                            1-77

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various indicators in internal exposure; and  (3) the relationship of various internal  indica-
tors of exposure to target tissue lead burdens.
     Temporal Characteristics of Internal Indicators of Lead Exposure.    The  biological  half-
life  for newly  absorbed lead  in  blood may  be as  short  as weeks,  several  months,  or  even
longer,  depending  on  the mobile lead burden  in the body.   Compared to  mineral tissues,  this
medium  reflects  relatively  recent  exposure.   If recent exposure is fairly  representative  of
exposure over a  considerable  period of time,  e.g., as in the case of lead workers,  then  blood
lead  is  more useful  than for cases where  exposure is intermittent or different across  time
as  in  the case  of lead exposure  of  children.   Accessible  mineralized  tissue, such  as  shed
teeth, extend the  time  frame  back to years of  exposure,  since teeth accumulate lead with age
and as a function of the extent of exposure.   Such  measurements are, however, retrospective in
nature, in that identification of excessive exposure occurs after the fact and thus  limits the
possibility of timely medical  intervention, exposure abatement, or regulatory policy concerned
with ongoing control  strategies.
     Perhaps  the most  practical  solution  to  the dilemma  posed by  the different temporal
characteristics of tooth and  blood  lead analyses  is  i_n  situ measurement of lead in teeth  or
bone during the time when active accumulation  occurs, e.g., 2- to 3-year-old  children.  Avail-
able data using  X-ray  fluorescence  analysis  do  suggest that  such approaches are  feasible and
can be reconciled with such issues as  acceptable radiation hazard risk to subjects.
     Biological  Aspects of External  Exposure/Internal Indicator Relationships.   The  literature
indicates clearly  that  the  relationship between lead in media relevant for human  exposure and
blood  lead  is curvilinear  when viewed  over  a   relatively broad  range  of blood  lead  values.
This curvilinearity implies  that the unit change in blood lead per unit intake of  lead  in some
medium  varies  across  this  range  of exposure,  with comparatively smaller blood  lead  changes
occurring as internal  exposure increases.
     Given our present knowledge,  such a relationship cannot be taken to  mean that body uptake
of  lead  is  proportionately lower  at  higher  exposure,  because it may simply mean  that  blood
lead becomes an  increasingly  unreliable measure of  target-tissue lead burden  with  increasing
exposure.  While the basis  of  the  curvilinear  relationship remains to be  identified, available
animal data  suggest that  it may be  related to the  increasing fraction of blood lead in plasma
as blood lead increases above  approximately 50-60 |jg/dl.
     Internal Indicator/Tissue Lead  Relationships.    In  living  human subjects, direct deter-
mination of  tissue lead burdens or  how  these relate to adverse effects  in  target  tissues  is
not possible.  Some accessible  indicator (e.g., measurements of  lead  or a biochemical surro-
gate of  lead  such  as  erythrocyte  protoporphyrin in a medium such as blood),  must  be employed.
While  blood  lead  still remains  the  only practical  measure of  excessive lead exposure  and

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health  risk,  evidence  continues  to  accumulate  that such  an index  has  some limitations  in
either  reflecting  tissue  lead burdens  or changes  in  such  tissues with changes  in  exposure.
     At present, the  measurement  of plumburesis  associated  with  challenge  by a  single  dose  of
a  lead-chelating  agent  such as  CaNa2EDTA  is considered  the best  indicator of the  mobile,
potentially toxic  fraction  of  body  lead.   Chelatable lead is logarithmically related to  blood
lead,  such that  an  incremental  increase in  blood  lead is  associated  with an  increasingly
larger  increment of mobilizable lead.   The problems associated with this  logarithmic  relation-
ship may be  seen  in studies of children  and  lead workers in whom moderate elevation in  blood
lead levels can disguise levels of mobile body lead.   In one recent multi-institution study  of
210  children,  for  example,  12 percent of children with blood lead 30-39  ug/dl,  and  38  percent
with levels  of 40-49  ug/dl, had a positive EDTA-challenge response and required further  eval-
uation  or  treatment.   At  blood lead  levels  such as these, the margin  of protection  against
severe  intoxication  is  reduced.    The  biological basis  of the  logarithmic chelatable-lead/
blood-lead  relationship  rests, in  large  measure,  with  the  existence of a sizeable  bone lead
compartment  that  is mobile enough to undergo chelation removal and, hence, potentially mobile
enough  to move  into target  tissues.
     Studies  of the  relative mobility  of chelatable lead over time  indicate that,  in former
lead workers,  removal from exposure  leads to  a  protracted  washing out of lead (from bone re-
sorption of  lead)  to  blood and tissues, with preservation of a bone burden amenable to subse-
quent chelation.   Studies with children are inconclusive, since the one investigation directed
to  this end employed  pediatric subjects who all  underwent chelation therapy  during periods of
severe  lead  poisoning.   Animal studies demonstrate  that changes in blood  lead with increasing
exposure  do not agree with tissue  uptake in a time-concordant  fashion,  nor does decrease in
blood  lead with reduced exposure signal  a  similar decrease in target tissue, particularly in
the  brain  of  the developing organism.

1.10.6  Metabolism of Lead  Alkyls
     The  lower alkyl  lead components  used  as gasoline  additives,  tetraethyl  lead (TEL)  and
tetramethyl  lead  (TML), may themselves pose  a toxic risk to  humans.  In  particular,  there is
among  children a problem of sniffing  leaded  gasoline.
     Absorption of Lead Alkyls  in Humans  and  Animals.   Human volunteers  inhaling labeled  TEL
and TML show lung deposition  rates  for the lead alkyls of 37  and 51 percent,  respectively,
values  which  are  similar   to  those for  particulate inorganic lead.  Significant portions of
these  deposited amounts were  eventually  absorbed.   Respiratory  absorption of organolead bound
to particulate matter has  not been  specifically  studied as  such.
                                            1-79

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     While specific data  for  the GI absorption of  lead  alkyls  in humans and animals are  not
available, their close  similarity  to organotin compounds, which  are  quantitatively  absorbed,
would argue  for  extensive GI  absorption.   In contrast to inorganic lead salts,  the  lower lead
alkyls are extensively absorbed through the skin and animal  data show lethal  effects  with per-
cutaneous uptake as the sole route of exposure.
     Biotransformation and Tissue Distribution of Lead Alkyls.   The  lead alkyls  TEL and  TML
undergo  monodealkylation  in  the  liver  of mammalian  species  via the  P-450-dependent  mono-
oxygenase enzyme system.   Such  transformation is very rapid.   Further transformation involves
conversion to  the  dialkyl  and inorganic lead forms,  the  latter accounting  for  the  effects on
heme  biosynthesis  and  erythropoiesis  observed  in  alkyl  lead  intoxication.   Alkyl lead  is
rapidly  cleared  from  blood,  and shows  a higher partitioning  into plasma than  inorganic  lead,
with triethyl lead clearance being more rapid than the methyl  analog.
     Tissue distribution  of alkyl  lead in  humans and  animals primarily involves  the trialkyl
metabolites.   Levels are highest in liver,  followed by kidney,  then brain.   Of  interest  is  the
fact  that  there  are detectable amounts of trialkyl  lead  from autopsy samples of human  brain
even  in  the  absence  of occupational exposure.  In  humans,  there  appear to  be  two tissue com-
partments for triethyl lead, having half-times of 35 and  100 days.
     Excretion of Lead Alkyls.  With alkyl lead  exposure,  excretion of lead through  the  renal
tract  is the  main route  of elimination.   The  chemical  forms being  excreted  appear   to  be
species-dependent.   In humans, trialkyl lead  in workers chronically exposed  to  alkyl  lead is a
minor component of urine lead, approximately  9 percent.
1.11  ASSESSMENT OF LEAD EXPOSURES AND ABSORPTION IN HUMAN POPULATIONS
     Chapter 11  describes  the effect  of  environmental  lead exposure on human populations  in
terms of  a  change in an internal  exposure  index that follows changes in external  exposures.
The index of internal  lead exposure most frequently  cited  is  blood lead level,  but other in-
dices such as levels of lead in tooth and bone are also  presented.   Blood lead  level  estimates
the body's recent  exposure to environmental lead, while  teeth and  bone  lead levels represent
cumulative exposures.
     Measurement of  lead  in blood and other  physiological  media has been accomplished via  a
succession of  analytical  procedures over the  years.  With these changes in technology there
has been increasing recognition of the importance of controlling  for contamination  in the  sam-
pling and analytical procedures (see Section 1.9).   These advances,  as well  as  the  institution
of external  quality control  programs,  have  resulted  in markedly  improved analytic results.  A
generalized  improvement in  analytic  results across many  laboratories occurred during Federal
Fiscal  Years  1977-1979.
                                          1-80

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     The  main discussion  in  Chapter  11  is  structured to achieve four main objectives:

     (1)   Elucidation  of  patterns  of internal  lead exposures  in U.S. populations and identi-
          fication of  important  demographic  covariates.
     (2)   Characterization  of relationships  between  external and  internal  exposures to
          lead by exposure medium  (air,  food,  water, or dust).
     (3)   Identification  of  specific sources  of  lead  which result in increased internal
          exposure levels.
     (4)   Estimation of the  relative contributions of  various sources  of  lead  in the environ-
          ment to total internal exposure  as indexed by blood lead  level.

     A question  of  major interest in understanding  environmental pollutants  is the extent  to
which  current ambient  exposures  exceed  background   levels.   Ancient Nubian samples  (dated
3300-2900 B.C.)  averaged 0.6 ug  lead/g  for  bone  and 0.9  ug lead/g for teeth.  More  recent
Peruvian  Indian   samples  (12th  Century)  had  teeth  lead levels of  13.6 ug/g.   Contemporary
Alaskan Eskimo samples had a mean of 56.0 ug/g, while  Philadelphia samples  had a mean  of 188.3
ug/g.  These data suggest an increasing pattern of lead absorption.
     Studies  of  current populations living  in remote areas far from urbanized cultures  show
blood  lead  levels in the range of  1-5  ug/dl.   In  contrast to the blood lead levels  found in
remote populations,  data from current U.S.  populations  have  geometric  means  ranging from <10
to  20  ug/dl  depending on  age,  race,  sex,  and degree of  urbanization.  These higher current
exposure  levels  appear to be associated  with  industrialization  and  widespread commercial use
of  lead,  e.g., as gasoline  additives.

1.11.1   Levels of Lead and  Demographic  Covariates in U.S. Populations
     The  National Center for Health Statistics has provided the best currently available pic-
ture of  blood lead levels  among  United States residents as part of the second National Health
and Nutrition Examination  Study  (NHANES  II) conducted  from  February,  1976 to February,  1980
(Mahaffey and Michaelson,  1980;  McDowell et  al.,  1981;  Mahaffey et al., 1982; Annest et al.,
1982;  Annest and Mahaffey, 1984).  The  national  estimates  are based on  9933 persons whose
blood  lead levels  ranged from  2.0  to  66.0 ug/dl.   The  median  blood  lead  for the entire U.S.
population  for the  years of the NHANES  II study X1976-1980)  is  13.0 ug/dl.
      Age appears to  be  one of  the  most important demographic covariates of blood lead  levels,
with blood  lead  levels  in  children generally higher than  those  in  non-occupationally  exposed
 adults;  children aged 2-3 years tend to have the highest blood  lead  levels.   The  age  trends in
 blood lead  levels  for children under  10  years old, as  seen in  three  studies, are presented in
                                            1-81

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Figure 1-13.   Blood lead  levels  in non-occupational!;/ exposed  adults may increase slightly
with age due to skeletal  lead accumulation.
     Sex has a differential impact on blood  lead levels  depending on  age.   No  significant  dif-
ference exists between males and females less than seven years  of age.  Males  above  the age  of
seven generally have higher blood lead levels than females.
     Race  also  plays  a  role,  in  that  blacks  generally  have  higher  blood  lead  levels  than
either whites  or  Hispanics,  and  urban  black  children  (aged 6 mo-5 yr)  have markedly higher
blood lead  concentrations  than  any other racial or age  group.   Possible  genetic factors asso-
ciated with  race  have yet to be  fully  untangled  from differential  exposure levels and other
factors as important determinants of blood lead levels.
     Blood lead levels also seem to increase with  degree of  urbanization.   Data from NHANES  II
show that  blood lead  levels in the United States, averaged  from  1976 to  1980, increase from a
geometric mean of  11.9 ug/dl  in rural populations to 12.8  ug/dl  in  urban  populations of  less
than one million  and  increase again to  14.0 ug/dl in urban  populations of  one million or  more
(see Table 1-9).   Results obtained from  the  NHANES II study  show  that urban children generally
have the highest  blood lead levels of any  non-occupationally  exposed  population  group.   Fur-
thermore,  black urban children have  significantly  higher  blood  lead levels than white urban
children.   Several  case  control  studies  of children have  shown that blood  lead  levels are
related  to  hand  lead  levels,  house dust levels,  lead  in  outside  soil,  interior  paint  lead
level, and history of pica.
     Knowledge of  the distributional form of  blood  lead  levels  in  a population  is important
because the distributional form determines which measure of  central  tendency (arithmetic mean
geometric mean, median)  is most appropriate.   It is even  more  important  in estimating percen-
tiles in the  tail  of the distribution,  which  represents  those individuals at highest risk  of
excess exposure.
     Based on examination  of  NHANES II  data,  as  well as  results of  several  other studies,  it
appears  that  the  lognormal  distribution is  the most  appropriate  for describing the distribu-
tion of  blood  lead levels in populations thought to be  homogenous in terms of demographic and
lead  exposure characteristics.   The lognormal distribution  appears to fit  well  across the
entire range, including  the upper tail  of the distribution.   The geometric standard deviation
for four different studies are shown in  Table 1-10.   The values,  including  analytic  error, are
about 1.4 for children and possibly somewhat smaller for adults.   This allows  an estimation  of
the upper  tail of  the blood lead  distribution, the  group  at higher risk.   A somewhat  larger
geometric standard deviation of 1.42 maybe derived from  the  NHANES II study when only gasoline
and  industrial air lead emission  exposures  are assumed to  be controllable sources of  varia-
tion.
                                           1-82

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  40
  35
  30
1
9"
UJ
_l
O
§
25
  20
  15
                                                   IDAHO STUDY
                                                 NEW YORK SCREENING - BLACKS
                                                 NEW YORK SCREENING - WHITES
                                                 NEW YORK SCREENING - HISPANICS
                                                 NHANES II STUDY - BLACKS
                                                 NHANES II STUDY - WHITES

                                                    '
                                              N.
                                                      \
                                           5
                                         AGE. yr
                                                                                  10
      Figure 1-13. Geometric mean blood lead levels by race and age for younger children in the
      NHANES II Study (Annest et al., 1982), the Kellogg Silver Valley, Idaho Study (Yankel et
      al., 1977), and the New York Childhood Screening Studies (Billick et al., 1979).
                                        1-83

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                     TABLE 1-9.   WEIGHTED GEOMETRIC MEAN BLOOD LEAD LEVELS
                  FROM NHANES II SURVEY BY DEGREE OF URBANIZATION OF PLACE OF
             RESIDENCE IN THE UNITED STATES BY AGE AND RACE, UNITED STATES 1976-80
Race and age
All races
All ages
6 months-5 years
6-17 years
18-74 years - men:
women:
Whites
All ages
6 months-5 years
6-17 years
18-74 years - men:
women:
Blacks
All ages
6 months-5 years
6-17 years
18-74 years - men:
women:

Urban,
£1 million

14.0*
16.8
13.1
16.9
12.2

14.0
15.6
12.6
16.9
12.4

14.4
20.8
14.6
17.4
11.8
Degree of urbanization
Urban,
<1 million

12.8
15.4
11.7
15.7
11.0

12.5
14.4
11.4
15.4
10.8

14.8
19.2
13.6
18.6
12.4

Rural
11.9
13.0
10.7
15.1
9.8

11.8
12.7
10.5
14.8
9.8

14.4
16.5
13.0
18.3
11.3
*Values are geometric means in ug/dl.

Source:  Annest and Mahaffey,  1984; Annest et al.  (1982).
                                           1-84

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1.11.2  Time Trends in Blood Lead Levels Since 1970
     Studies in the United States.   Recent U.S. blood  lead  levels  show that a  downward  trend
has occurred  consistently across race,  age,  and  geographic  location.   The downward  pattern
commenced in the early  part of the 1970's and  has continued  into  1980.  This  downward  trend
has occurred as a shift in the entire distribution and not just via a truncation in high  blood
lead levels.  This  consistency suggests a general  causative  factor  and attempts  have been made
to  identify the causative  element;  reduction of  lead emitted from the combustion  of leaded
gasoline is a prime candidate.

  TABLE 1-10.   SUMMARY OF POOLED GEOMETRIC STANDARD DEVIATIONS AND  ESTIMATED ANALYTIC ERRORS
Study
NHANES II
N.Y. Childhood
Pooled geometric standard deviations
Inner-city Inner-city Adult
Black children White children females
1.37a 1.39a 1.36b
1.41 1.42

Adult
males
1.40b
Estimated
analytic
error
0.021
(c)
Screening Study
Tepper- Levin
Azar et al .
1.30
1.29
0.056
0.042d
Note:  To calculate an estimated person-to-person GSD,
       compute Exp [(In(GSD))2 - Analytic Error)^].
 A geometric standard deviation of 1.42 may be derived when only gasoline and industrial air
 lead emission exposures are assumed to be controllable sources of variability.
 pooled across areas of differing urbanization.
cnot known, assumed to be similar to NHANES II.
 taken from Lucas (1981).

     Blood  lead  data from the  NHANES  II  study demonstrate well that,  on a nationwide basis,
there has been a significant downward  trend over time (Annest et al., 1983a).  Mean blood lead
levels dropped  from 14.6 ug/dl during the  first six months of the survey  to 9.2 ug/dl during
the  last  six  months.   Mean values  from these national  data presented  in six-month increments
from February, 1976 to February, 1980  are displayed  in Figure 1-14.
      Billick  and colleagues  (Billick et  al., 1979) have  analyzed  the results of blood lead
screening  programs  conducted  by  the  City  of  New  York.   Geometric  mean blood lead  levels
decreased  for all  three racial groups  and  for almost all  age  groups  in  the period  1970-76.
                                            1-85

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                25
             5  20
             3
             _f
             UJ
             §
                15
                10
CD
             0
             o
             o
             o
WINTER 1978
   (FEB.)
WINTER 1977
   (FEB.)
WINTER 1978
   (FEB.)
FALL 1978 WINTER 1979
 (OCT.I      (FEB.)
WINTER 1980
   (FEB.)
                                                    I
                                          I
                                         I
                                   10       15       20       25       30      35

                                                 CHRONOLOGICAL ORDER. 1 unit = 28 days
                                                                   40
                                                         45
                                           50
                                       55
                     Figure 1-14. Average blood lead levels of U.S. population 6 months—74 year*. United States,
                     February 1976—February 1980, based on dates of examination of NHANES II examinees with
                     blood lead determinations.
                    Source:  Annest et al. (1983).

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Figure 1-15 shows  that  the  downward trend covers the  entire  range  of  the  frequency  distribu-
tion of blood  lead levels.   The decline in blood lead levels  showed seasonal  variability,  but
the decrease in time was consistent for each season.
     Cause et  al.  (1977)  present data from Newark, New  Jersey,  which  reinforces  the findings
of Billick and coworkers.   Gause et al.  studied the levels of blood lead among 5- and 6-year-
old children tested  by  the  Newark Board of Education during the academic years 1973-74,  1974-
75, and 1975-76.  Blood lead levels declined markedly during this three-year period.
     Rabinowitz  and  Needleman  (1982)  report a more recent  study of umbilical cord blood lead
levels from 11,837 births between April, 1979 and April,  1981 in the Boston area.   The overall
mean  blood  lead concentration was 6.56 ±  3.19  (standard deviation) with a  range of 0.0-37.0
(jg/dl.  A downward trend in umbilical cord blood  lead levels was noted over the  two years of
the study.
     European  Studies.   There  has been  a series  of publications from  various workers  in
England who  have  been  examining the  question  of whether  or not  time  trends in  blood lead
levels exist  there as well  as  in the United States (Oxley, 1982; Elwood, 1983a,  1983b; Quinn,
1983;  Okubo  et al. ,  1983).    These  papers  cover a variety  of  exposure situations and popula-
tions.   All  of them  obtained  findings  analogous to those  described  above  for  the United
States, in  that there has  been a  general  decline in  blood lead  levels  over  the  decade of the
1970's; they  differ, however,  with regard to the magnitude  of  the decline,  when the decline
began,  and  to  what  extent  the decline may  be  attributable  to  a  particular source of lead.
      In an  international  study, Friberg and  Vahter  (1983) compared data on  blood lead levels
obtained  in 1967 with data  for  1981.  For areas of the  world where there  were  data collected by
Goldwater and  Hoover (1967) as  well  as the UN/WHO study,  there  was  a  substantial reduction in
reported  blood  lead  levels.  A cautionary note must  be made,  however,  that the  analytic and
human  sampling procedures are  not  the same in the two  studies.   Therefore  these data should be
thought of  as  providing further,  but limited,  evidence  supporting  a  recent  downward trend in
blood lead  levels  worldwide.

1.11.3 Gasoline Lead as  an Important Determinant  of  Trends in Blood Lead  Levels
      Explanations  have been  sought for declining trends  in  blood  lead levels observed among
population  groups  in the  United  States   and certain  other countries  since  the early  1970s.
 Extensive evidence points  towards  gasoline  lead as being an  important  determinant  of changes
 in blood lead  levels associated with exposures to airborne  lead of populations  in  the United
 States and  elsewhere.
                                            1-87

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       1970 1971  1972 1973 1974 1976 1976 1977 1978 1979 1980

                        YEAR (Beginning Jan. 1)

Figure 1-15. Time-dependence of blood lead for blacks, aged 24 to 35
months, in New York City and Chicago.

Source: Adapted from Billick (1982).
                            1-f

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     A striking  feature  of the  NHANES  II data was  a  dramatic decline in nationwide average
blood lead levels in the  United States during the  period  (1976-1980)  of  the survey.   In evalu-
ating possible  reasons for the observed decrease in the  NHANES  II blood lead values, Annest
(1983) and Annest  et  al.  (1983b) found  highly significant  associations  between  the  declining
blood lead concentrations  for  the  overall  U.S.  population and  decreasing amounts of  lead  used
in gasoline in  the United States during the  same  time  period (see  Figure 1-16).   The associa-
tions persisted after adjusting for race,  age, sex,  region of the country,  season,  income,  and
degree of  urbanization (see  Table  1-11).   Analogous strong associations (r = 0.95; p < 0.001)
were  also  found for  blood lead levels  for  white  children  aged 6 mo-5 yr  in  the  NHANES  II
sample and gasoline lead  usage.
     Two field  investigations  have  attempted to derive an estimate of the amount of  lead  from
gasoline that  is  absorbed by the blood  of individuals.  Both of these investigations used the
fact  that  the  isotopes  of lead are stable; thus,  the varying proportions of  the isotopes  pre-
sent  in  blood  and environmental  samples  can  indicate the source  of the  lead.   The Isotopic
Lead  Experiment (ILE), reported in Facchetti  and Geiss (1982) and Facchetti  (1985), was  a  mas-
sive  study that attempted to utilize differing proportions of the  isotopes in geologic  forma-
tions  to   infer  the  proportion of lead in gasoline that is absorbed by  the  body.   The  other
study (Manton,  1977; Manton, 1985) utilized existing natural shifts in isotopic proportions in
an attempt to do the same  thing.
      The  ILE was  a large-scale community  trial in  which the geologic  source of lead used in
antiknock  compounds  in gasoline was manipulated to change the isotopic composition of lead in
the  atmosphere  (Garibaldi  et al., 1975; Facchetti,  1979).   The  isotopic lead ratios obtained
in the samples  analyzed are displayed in Figure 1-17.  It can easily be seen that the airborne
particulate  lead  rapidly  changed  its  isotope  ratio in  line with  expectation.  Ratios  in the
blood samples  appeared to lag  somewhat  behind.   Background  blood  lead isotopic ratios  were
1.1591 ± 0.0043  in rural  areas  and 1.1627  ± 0.0022  in Turin  in 1975.  In Turin school children
in  1977-78,  blood lead isotopic ratios tended  to be somewhat lower than the ratios for Turin
adults.
      Preliminary  analysis of the isotope  ratios  in  air  lead has allowed the estimation of the
fractional contribution  of gasoline  lead  in  the  city  of  Turin,  in small communities within 25
km  of Turin,  and  in  small  communities  beyond 25 km (Facchetti  and Geiss, 1982).  At the time
of  maximal use  of  Australian lead  isotope  in  gasoline  (1978-79), about  87.3 percent  of the air
lead in  Turin and  58.7 percent of the  air  lead  in the  countryside was attributable to  gaso-
line.   The determination  of lead isotope ratios was  essentially  independent of  specific air
lead concentrations.   During   that  time, air  lead averaged  about  2.0 ug/m3  in Turin  (from
0.88-4.54 ug/m3 depending  on  location  of the sampling  site),  about 0.56 ug/m3  in  the nearby
communities  (0.30-0.67 ug/m3),  and about  0.30 ug/m3 in distant locations.
                                           1-89

-------
          110
          100
I
ID
O
        o
        •c
I
UI
CL
I-
a.
a
           90
           70
           80
           50
                                                  I


                                        LEAD USED IN
                                            . GASOLINE
                   AVERAGE
                   BLOOD
                  LEAD LEVELS
                                                        A
                    1976
                               1977
                                                  1978


                                                 YEAR
1979
                                                                                                  16
                                                                                                         15
                                                                                                          14
                                                                                                          13
                                                                                                         12
                                                                                                          11
                                                                                                  10
                                                                                                       o>

                                                                                                       3
                                                                                                       O
                                                                                                       O
                                                                                                       O
                                                                                                       3
                                                                                                       IB
                                                                                                       ui
                                                                                                       s
                                                                                                       oc
1980
                  Figure 1-16. Parallel decreases in blood lead values observed in tfie NHANES II Study and
                  amounts of lead used in gasoline during 1976-1980.
                 Source: Annest (1983).

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     TABLE  1-11.   PEARSON CORRELATION COEFFICIENTS BETWEEN THE AVERAGE BLOOD LEAD LEVELS
             FOR  SIX-MONTH PERIODS AND THE TOTAL  LEAD USED IN GASOLINE PRODUCTION
                        PER  SIX MONTHS, ACCORDING TO RACE, SEX, AND AGEa


Overall (all races)
All
All
By

By


black6
whites
sex: Male
Female
age: 0.5-5 yr
6-17 yr
18-74 yr
Coefficients for
January-June
and July-December
0.920
0.678
0.929
0.944
0.912
0.955
0.908
0.920
6-month Periods
Apri 1- September .
and October-March
0.938
0.717
0.955
0.960
0.943
0.969
0.970
0.924
Averages
0.929
0.698
0.942
0.952
0.928
0.962
0.939
0.922
 The lead values used to compute the averages were preadjusted by regression analysis to
 account for the effects of income, degree of urbanization, region of the country, season,
 and, when appropriate, race, sex, and age.
 All correlation coefficients were statistically significant (p < 0.001) except those for
 blacks (p < 0.05).
cAverages were based on six-month periods, except for the first and last, which covered only
 February 1976 through June 1976 and January 1980 through February 1980, respectively.
 Averages were based on six-month periods, except for the last, which covered only October
 1979 through February 1980.
eBlacks could not be analyzed according to sex and age subgroups because of inadequate sample
 sizes.

Source:  Annest et al. (1983b).
                                           1-91

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              12
   1.20
                     24
                             36
                                    48
                        TIME, months
                          60      72
                                                           84
                                                                  96
                                                                         108
                                                                                 120
                                                                                        132
   1.18
   1.16
   1.14
 tr
o
CM
   1.10
   1.08
   1.06
       — PHASE 0-
-h
                      PHASE 1	•>
                             O GASOLINE
                             Q BLOOD, ADULTS. TURIN
                             A BLOOD, ADULTS, >25 km
                             O BLOOD. ADULTS. «^2S km
                             • BLOOD, SCHOOL CHILDREN
                             • BLOOD, TRAFFIC WARDENS
                             A AIRBORNE PARTICULATE, TURIN
                              AIRBORNE PARTICULATE, RURAL
                                     -PHASE 2-
                                                                 - PHASE 3-
                                                           I
   1.04
    1974    1975    1976    1977    1978    1979    1980    1981    1982    1983   1984
                                                  YEAR
    Figure 1-17.  Change  in 206p5/207pb ratjOs in gasoline, blood, and airborne particulate from
    1974 to  1984.
   Source:  Facchetti (1985).
                                            1-92

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     Isotope ratios  in the  blood  of 63  subjects  also  changed,  and the fraction of  lead  in
blood attributable to  gasoline  could be estimated independently of blood level  concentration.
The mean  fraction decreased from  21.4  ± 10.4 percent in Turin  to 11.4 ±7.3 percent  in  the
nearby  countryside,  and to  10.1  ±  9.3  percent in the  remote countryside  (Facchatti,  1985).
     These results can be  combined with the  actual blood  lead concentrations to estimate  the
fraction of  the gasoline uptake that is  attributable to direct inhalation.  The  results  are
shown in Table 1-12 based upon  a concept outlined in Facchetti  and  Geiss (1982).   As  concluded
earlier, an  assumed  value of  p=1.6 is plausible  for predicting the amount of  lead  absorbed
into blood at  air lead concentrations less than 2.0 ug/m3.   The  predicted values for airborne
lead derived from leaded gasoline range  from 0.28 to 2.79 HQ/dl  in  blood due to  direct inhala-
tion.   The total  contribution  to  blood  lead from gasoline lead is  much larger,  from  3.21-4.66
ug/dl, suggesting  that the  non-inhalation total contribution of gasoline  increases  from 1.88
|jg/dl  in  Turin to 2.33  M9/dl  in  the near  region  and 2.93  (jg/dl in the  more distant region.
The non-inhalation sources include ingestion of dust and soil lead  and lead in food and drink-
ing water.   Efforts are being made to quantify their magnitude.   The average direct inhalation
of  lead  in  the air from gasoline is 9-19 percent of the total  intake attributable to gasoline
in the countryside and an estimated 60 percent in the  city of Turin.
     The strongest kind  of  scientific evidence  about  causal relationships  is based on an  ex-
periment in  which all  possible extraneous  factors  are  controlled.   The evidence derived from
the Isotopic Lead Experiment  comes very  close.   The experimental  intervention consisted of
replacing the normal 206Pb/207Pb isotope ratio by a very different ratio.  There is no plausi-
ble mechanism by which other concurrent lead  exposure variables  (e.g., food, water, beverages,
paint,  industrial  emissions) could  have also  changed their  isotope  ratios.   Hence the very
large changes  in  isotope ratios in blood were responding to  the  change in gasoline.  There was
no  need  to  carry out  detailed aerometric and ecological modeling to track the leaded gasoline
isotopes through  the various environmental  pathways.   In fact, EPA analyses* show that inhala-
tion of community  air  lead will substantially underestimate  the  total effect of  gasoline lead,
at  least in  the 35 subjects  whose  blood  leads were  tracked  in the  ILE Preliminary Study.  Non-
inhalation  sources include  ingestion of  dust and soil, and lead  in food and drinking water.
The  higher  water  lead concentrations  in the country  and consumption  of wine containing lead
may  be  factors  unaccounted  for  in  the analysis.   Dietary  lead thus  may in part explain the
large excess of gasoline lead  isotope  ratio in blood beyond  that  expected  from inhalation of
 *
 Note:   The term EPA  analyses  refers  to calculations done  at  EPA.   A brief discussion of the
 methods used  is  contained in  Appendix 11-B;  more  detailed  information is available  at EPA
 upon request.

                                            1-93

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            TABLE  1-12.   ESTIMATED  CONTRIBUTION  OF  LEADED GASOLINE TO BLOOD LEAD
                           BY INHALATION  AND  NON-INHALATION  PATHWAYS




Location
Turin
<25 km
>25 km

Air lead
fraction
from
gaso-
line3
0.873
0.587
0.587


Air
leadb
cone. ,
(jg/m3
2.0
0.56
0.30

Lead
fraction
from
gaso-
1 i ne
0.214
0.114
0.101

Mean
blood
lead d
cone. ,
^g/di
21.77
25.06
31.78
Blood
lead
from
gaso-
line,
|jg/dl
4.66
2.86
3.21

Lead
from
gasoline.
in air,
ug/dl
2.79
0.53
0.28
Non-
inhaled
lead from
gaso-
line,9
|jg/dl
1.88
2.33
2.93


Estimated
fraction
gas-lead .
Inhalation
0.60
0.19
0.09
 Fraction of air lead in Phase 2  attributable  to  lead  in  gasoline.
 Mean air lead in Phase 2.
cMean fraction of blood lead in Phase 2 attributable to  lead  in  gasoline.
 Mean blood lead concentration in Phase 2.
Estimated blood lead from gasoline = (c)  x  (d)
 Estimated blood lead from gas inhalation  =  6  x  (a) x  (b),  p  = 1.6.
^Estimated blood lead from gas, non-inhalation =  (f)-(e)
 Fraction of blood lead uptake from gasoline attributable to  direct  inhalation =  (f)/(e).
Data from Facchetti  and Geiss (1982); Facchetti  (1985).

ambient air  lead; this  could occur both from gasoline  lead  entering the  food chain  and  being
added during food processing and  preparation.  The subjects in the  ILE study cannot be  said  to
represent some defined population, and it  is not  clear how the results can be extended  to U.S.
populations.  Turin's unusual  meteorology,  high  blood lead levels,  and the  "reversed" urban-
rural gradient  of blood  lead levels in the subjects in  the  ILE study indicate the need  for
future research.  However,  in spite of the variable  gasoline lead  exposures of  the  subjects
there is  strong evidence that changes  in gasoline lead  produce large changes  in blood  lead.
     Manton  (1977) conducted  a long-term  study  of 10 subjects  whose blood lead  isotopic com-
position was monitored  for  comparison with the  isotopic composition of the air  they  breathed.
Manton had  observed  that the ratio of  206Pb/204Pb in the air  varied with  seasons in  Dallas,
Texas; therefore, the  ratio of those isotopes should  vary in the blood.   By comparing  the ob-
served variability,  estimates could then be made  of the amount of lead in  air that  is absorbed
by  the  blood.   From the  Manton  study, it is estimated  that between 7 and 41 percent of  the
blood lead  in  study  subjects in Dallas results  from  airborne  lead.  Additionally, these data
provide  a  means of  estimating the  indirect contribution  of air lead to blood  lead.  By one
                                           1-94

-------
estimate, only  10-20 percent of  the total airborne  contribution  to blood lead in Dallas  is
from direct inhalation.
     Another approach to identifying the determinants of trends in  blood lead levels  over time
was taken in New York City.   Billick et al.  (1979) presented several  possible explanations for
observed declines in blood lead levels, as well as evidence supporting and refuting each.   The
suggested contributing  factors  were the following:   (1) the active  educational  and  screening
program of the New York City Bureau of Lead Poisoning Control;  (2)  a decrease in the amount of
lead-based paint exposure as a result of rehabilitation or removal  of older housing stock, and
(3) changes  in  total environmental  lead exposure.   However,  information was  only  partially
available for ambient  air lead levels; air lead measurements for the entire study period were
available for only one  station, which was located on the west side of Manhattan at a height of
56 m.   Superimposition  of the air  lead  and  blood lead levels indicated  a  similarity  in both
upward  cycle  and decline.   The authors  cautioned against  overinterpretation by assuming that
one  air monitoring  site  was representative of  the  air lead exposure  of New York City resi-
dents.  With this in mind, the  investigators fitted a multiple regression model to the data to
try  to  define the important determinants of blood lead levels for this population.  Age, eth-
nic  group,  and  air  lead level  were all  found  to be  significant  determinants of blood lead
levels.   The authors further point  out  the possibility of  a change  in  the  nature  of the popu-
lation  being screened before and after  1973.   They reran  this  regression  analysis separately
for  years both  before  and  after  1973.   The  same  results were still  obtained,  although the
exact coefficients derived varied.
      Billick et al.  (1980)  extended  their previous  analysis of  the  data  from the  single moni-
toring  site mentioned  earlier  and  examined the  possible  relationship between blood lead  level
and  the amount  of lead  in gasoline  used in the New  York City area.   Figures 1-18 and 1-19 pre-
sent illustrative trend lines  in  blood leads  for blacks  and  Hispanics and air lead and  gaso-
line lead,  respectively.    Several  different  measures of gasoline  lead  were used:   (1) mid-
Atlantic Coast  (NY, NJ,  Conn);  (2) New York City plus New Jersey;  and (3) New York City plus
Connecticut.   The lead in gasoline trend line appears  to fit  the  blood lead trend line  better
than the air lead trend,  especially in the summer of 1973.

1.11.4   Blood Lead versus Inhaled Air Lead Relationships
      The mass of data on the relationship of blood lead level  and  air lead exposure is compli-
cated by the need for reconciling the results  of experimental  and  observational studies.  Fur-
 ther, the process of determining the best form of the statistical  relationship deduced is pro-
 blematic due to the lack of consistency in the range of the air lead exposures encountered in
 the various studies.
                                            1-95

-------
E
8
01
Q
O
O
00
<
Ul
o
E
    35
    30
    25
20
    15
    10
            I  I  I
                         i  i  i TIT I
                                       I  I  I
                               i    BLACK
                           — — — HISPANIC
                           — • — AIR LEAD
n
        Mil  I  I  I  I  M  I  I  I  I  I  I  1  >  i  1  I  I  I  1  I  I  I  '
                                                                2.5
                                              2.0
                                                                1.5
                                                                1.0
                                                                0.0
                                                                 LU
                                                                 w
                                                                 O
                                                                 <
                                                                 u
                                                                 LU
                                                                 8
                                                                 K
                                                                 UJ
     1970
         1971
   1972    1973
1974
1975    1976
                      QUARTERLY SAMPLING DATE
      Figure 1-18. Geometric mean blood lead levels of New York
      City children (aged 25-36 months) by ethnic group, and am-
      bient air lead concentrations versus quarterly sampling period,
      1970-1976.
      Source: Billick et al. (1980).
                                    1-96

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      1 1 I I I

  35)—
  30
s
UJ
UJ

I
co

UJ

EC
t
u
o
  25
   20
  r-7   \  / \
  7    \/   v
                  1 I  I I  I I  I I  I  I 1  I 1  M I I  I  I


                       —— BLACK

                       — — — HISPANIC
                       —•• — GASOLINE LEAD
•\       v\;. V  \Wy
7 \ A  M  AV    v  -
      v    \'    •    \  .    \
                        \'    \
15




10



 0
 1970   1971
                                   '.  .-•    ' V
                                     •  v
                                                 6.0
                                                 5.0
                                                  4.0
                                                  3.0
      I  I I  I I  I  I I  | I  I I  1  I I  I I  I  I I  I I  I I  I I I  Inn
                1972   1973   1974    1976

                  QUARTERLY SAMPLING DATE
                                         1976
    Figure 1-19. Geometric mean blood lead levels of New York
    City children (aged 25-36 months) by ethnic group, and esti-
    mated amount of lead present in gasoline sold in New York,
    New Jersey, and Connecticut versus quarterly sampling period,
    1970-1976.

    Source:  Billick et al. (1980).
                                                     Q
                                                     (3

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     The model used  is  especially critical  in situations where  lead  is  present  in  relatively
low concentrations in one  or more environmental  media.  A  large number  of  statistical models
have been  used to predict  the contribution  to  blood lead  level  from  various  environmental
media.   There  is  no  question that the relationship between  blood lead and environmental  expo-
sure  is  nonlinear across  the  entire  range  of potential  exposures, from very  low to  high
levels.  At  lower levels of  exposure,  however,  various  models  all provide adequate  descrip-
tions  of  the observed  data.   The choice of  a model  must  be  based  at  least in part on  the
biological mechanisms;  at  the  very  least,  no model  should be  adopted  which  is  inconsistent
with biological reality.
     Because the main purpose of this document is  to examine relationships between lead  in air
and lead in blood under ambient conditions,  EPA has chosen to emphasize the  results  of studies
most appropriately addressing  this  issue.   A  summary  of  the  most  appropriate studies appears
in Table  1-13.   At air  lead exposures  of 3 jjQ/ro3  or  less,  there is no statistically signifi-
cant difference  between curvilinear  and  linear blood lead-inhalation relationships.  At air
lead exposures  of 10 ug/m3 or  more,  either nonlinear or linear relationships can  be fitted.
Thus,  a  reasonably consistent  picture  emerges  in  which  the blood  lead-air  lead relationship
for direct  inhalation  is  approximately linear in the range  of normal  ambient exposures  (0.1 -
2.0 ug/m3.)  Therefore EPA has fitted linear relationships to blood lead  levels in the studies
to  be  described  with the  explicit  understanding  that the  fitted  relationships  are intended
only to describe  changes  in blood due  to modest  changes in air lead  among  individuals  whose
blood  lead levels do  not exceed 30 ug/dl.
     The blood lead inhalation slope estimates vary appreciably from one  subject to another in
experimental and  clinical  studies, and from one study to  another. The weighted slope and stan-
dard error  estimates from  the Griffin et al.  (1975) study (1.75 ±  0.35) were  combined with
those  calculated  similarly for the  Rabinowitz et  al.  (1973, 1976, 1977) study  (2.14 ±  0.47)
and  the  Kehoe (1961a,b,c)  study  (1.25 ±  0.35,  setting  DH = 0), yielding  a pooled weighted
slope  estimate of 1.64 ±  0.22 ug/dl  per M9/m3-   There are  some  advantages in  using  these
experimental  studies  on adult  males, but certain deficiencies are  acknowledged.   The  Kehoe
study  exposed  subjects  to  a wide range of  lead  levels while in the exposure chamber, but did
not  control  air  lead  exposures outside  the  chamber.  The  Griffin  study  provided reasonable
control of  air lead  exposure during  the  experiment, but  difficulties  in defining  the non-
inhalation  baseline  for blood  lead   (especially  in the  important experiment  at  3  ug/m3) add
much  uncertainty  to  the  estimate.    The  Rabinowitz study controlled well  for diet and other
factors  and,  since  stable  lead  isotope tracers  were used,  there  was  no  baseline problem.
However,  the actual  air  lead  exposure of  these  subjects outside the metabolic ward was not
well determined.
                                           1-98

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                       TABLE 1-13.  SUMMARY OF BLOOD INHALATION SLOPES
                                      (pg/dl per pg/m3)
Population
Children


Adult
Male



Study
Angle and Mclntire
(1979) Omaha, NE
Roels et al. (1980)
Belgium
Yankel et al. (1977);'
Walter et al. (1980)
Idaho
Azar et al. (1975).
Five groups
Griffin et al .
(1975) NY
prisoners
Gross
(1979)
Rabinowitz et al.
(1973, 1976, 1977)
Study
type N
Population 1074
Population 148
Population 879
Population 149
Experiment 43
Experiment 6
Experiment 5
Slope
1.92
2.46
1.52
1.32
1.75
1.25
2.14
Model sensitivity3
of slope
(1.40-4.40)b'c'd
(1.55-2.46)b'c
(1.07-1.52)b'C>d
(1.08-1.59)C'd
(1.52-3.38)6
(1.25-1.55)C
(2.14-3.51)f
aSelected from among the most plausible statistically equivalent models.   For nonlinear
 models, slope at 1.0 vg/m3.
 Sensitive to choice of other correlated predictors such as dust and soil lead.
cSensitive to linear versus nonlinear at low air lead.
 Sensitive to age as a covariate.
eSensitive to baseline changes in controls.
 Sensitive to assumed air lead exposure.
                                            1-99

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     Among population studies, only  the  Azar  study provides  a  slope  estimate  in which  indivi-
dual  air  lead exposures  are  known.   However,  there was  no control  of dietary lead intake or
other factors that  affect  blood  lead levels,  and  slope  estimates  assuming only air lead and
location as covariables  (1.32  ±  0.38)  are not significantly  different from the pooled  experi-
mental  studies.
     There are no experimental inhalation studies  on  adult females or on  children.  The  inha-
lation  slope  for women  should be roughly the  same  as  that  for men,  assuming proportionally
smaller air  intake  and blood volume.  The assumption  of proportional size is less plausible
for  children.   Slope estimates  for  children  from  population  studies are used in which  some
other important  covariates of lead  absorption  were  controlled  or measured,  e.g., age,  sex,
dust exposure in the environment or on  the hands.   Inhalation slopes were estimated  for the
studies of  Angle and Mclntire  (1979)  [1.92  ±  0.60],  Roels  et al.  (1980) [2.46 ± 0.58], and
Yankel  et al.  (1977) [1.53  ± 0.064)].  The standard error of  the  Yankel study  is  extremely low
and  a weighted  pooled  slope  estimate for children  would  reflect  essentially that  study alone;
in this case  the small  standard  error  estimate  is  attributable to  the very large  range of air
lead exposures of children  in the Silver Valley  (up to 22 ug/m3).   The relationship is  in fact
not  linear, but increases more rapidly  in the  upper range of  air  lead exposures,  and the  slope
estimate at lower air  lead concentrations may  not wholly reflect  uncertainty about the  shape
of the  curve  at higher concentrations.   The  median  slope of the three studies  is 1.92  ug/dl
per ug/m3.
     Chapter  11  evaluates  the effects  of atmospheric lead  on blood lead in a  disaggregate
manner  broken  down  according  to exposure media,  including  direct  inhalation of  atmospheric
lead, ingestion of particulate lead that has  fallen out as dust and surface soil,  and  air lead
ingested  in consuming  food and beverages (including lead absorbed  from soil  and added during
processing and preparation).   Disaggregate analyses based on various pathways for environmen-
tal  lead  of  the  type presented  appear to provide  a sensitive tool  for predicting blood lead
burdens  under changes  of  environmental  exposure.  However,  some  authors,  e.g.,  Brunekreef
(1984) make a strong argument for the use of  air lead as  the  single exposure criterion.  Their
argument is that exposure to air  lead is usually of sufficient duration that the  contributions
along other pathways  have  stabilized and are proportional to  the  air lead concentration.   In
that case, the  ratio between blood  lead  and  air  lead plus  dust,  food, and other proportional
increments must be much larger than for air lead by direct inhalation alone.
     The range of p values  that Brunekreef (1984) reports is  very large, and typical  values  of
3-5  are larger  than those adjusted  slopes  (1.52-2.46)  derived by EPA in preceding  sections.
If the  aggregate approach  is accepted,  then  the blood  lead  versus total  (both direct and in-
direct) air lead slope for children may be approximately double the slope (~2.0) estimated for
the  direct contribution due to inhaled air lead alone.
                                           1-100

-------
     The following statements summarize the  situation  briefly:   (1) The experimental studies
at lower  air  lead levels  (3.2  |jg/m3  or less) and  lower  blood  levels  (typically 30 ug/dl or
less) have  linear  blood  lead inhalation relationships with  slopes  p.  of 0-3.6 for most  sub-
jects.   A  typical value  of  1.64 ±  0.22  may be  assumed for adults;  (2)  Population cross-
sectional  studies at  lower air lead and blood lead  levels  are approximately  linear with slopes
P of  0.8-2.0;  (3) Cross-sectional  studies in occupational  exposure situations in which air
lead levels are higher (much above 10  |jg/m3)  and  blood  lead  levels  are  higher  (above 40 ug/dl)
show a  much more shallow  linear blood lead  inhalation  relation.   The  slope p is  in the  range
of 0.03-0.2; (4) Cross-sectional and experimental studies  at levels of  air  lead somewhat  above
the  higher  ambient exposures  (9-36  ^g/m3) and  blood  leads  of  30-40  ug/dl  can be described
either  by  a nonlinear relationship  with  decreasing  slope  or by  a linear relationship  with
intermediate slope,  approximately p  = 0.5.   Several  biological  mechanisms for  these differ-
ences have  been  discussed (Hammond et al.,  1981;  O'Flaherty et  al., 1982;  Chamberlain,  1983;
Chamberlain and Heard, 1981).  Since no explanation for the  decrease in steepness of  the  blood
lead inhalation  response  to higher air lead  levels has  been generally accepted at this  time,
there is little basis on which to select a formula for interpolating from low  air lead to high
air  lead  exposures.   The  increased steepness of the  inhalation curve  for  the Kellogg/Silver
Valley  study is  inconsistent with the other studies presented.   It may be  that smelter  situa-
tions are  unique  and  must be  analyzed  differently,  or  it may  be that the  curvatuve  is the
result of imprecise exposure estimates; (5) The blood-lead inhalation slope for children is  at
least as  steep  as  that for  adults, with  a median  estimate  of 1.92  from three major studies.
These slope estimates  are based on the assumption that  an  equilibrium level  of blood lead  is
achieved  within  a few months after exposure begins.   This   is only  approximately  true,  since
lead stored  in  the skeleton may  return to blood after some years.  Chamberlain et al.  (1978)
suggest that  long-term inhalation slopes  should be about 30 percent  larger  than  these  esti-
mates.  Inhalation slopes quoted here are associated with a  half-life of blood lead in  adults
of about 30 days.  O'Flaherty et al.  (1982) suggest that  the  blood lead half-life may increase
slightly  with   duration  of  exposure, but this  has not  been confirmed (Kang et  al.,  1983).
(6)  Slopes which include  both direct  (inhalation)  and indirect (via soil, dust, etc.) air lead
contributions are  necessarily higher  than  those  estimates for inhaled air lead alone.   Studies
using aggregate  analyses  (direct  and  indirect air  impacts) typically yield  slope values in the
range of  3-5,  about  double  the  slope due  to  inhaled air  lead alone.  [Other  studies, reviews,
and  analyses of  the  study are discussed in Section 11.4,  to  which  the reader  is  referred  for a
detailed  discussion  and for a review  of the  key  studies and their  analyses.]
      It must  not  be assumed that the direct inhalation  of  air  lead is  the only air  lead con-
 tribution that  needs  to  be considered.    Smelter  studies allow  partial  assessment of the  air
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lead contributions to soil,  dust,  and finger lead.   Useful  ecological  models  to  study  the  pos-
sible propagation of  lead through  the food chain have  not  yet been  developed.   The  direct in-
halation relationship does provide useful  information on changes  in  blood  lead as  responses  to
changes in air  lead  on  a time scale  of several  months.   The indirect pathways through dust,
soil, and the  food  chain may thus delay the total  blood lead response to  changes  in air lead,
perhaps by one or more years.

1.11.5  Studies Relating Dietary Lead Exposures  (Including  Water)  to Blood Lead
     Dietary absorption  of  lead varies  greatly  from one person to  another and  depends on the
physical and chemical form  of the carrier, on nutritional  status,  and on whether lead is in-
gested with food or between  meals.   These  distinctions  are  particularly important  for  consump-
tion of leaded  paint,  dust, and soil by children.   Typical values of 10 percent absorption  of
ingested lead into blood have been assumed for adults and 25-50 percent for children.
     It is difficult  to  obtain accurate dose-response  relationships between  blood lead levels
and  lead  levels in  food or water.   Dietary  intake must  be estimated by duplicate  diets  or
fecal  lead  determinations.   Water lead levels can  be  determined  with some  accuracy, but the
varying amounts  of water consumed  by different  individuals adds  to  the uncertainty of the
estimated relationships.
     Quantitative analyses relating blood  lead levels and dietary  lead exposures have  been re-
ported and studies  on infants provide estimates that  are  in close  agreement.   While  only one
individual study has  been done on adults, another estimate from a number  of pooled studies  is
also  available;  these  two  estimates  are  in  good  agreement.   Most  of  the subjects in the
Sherlock  et  al.  (1982)  and  United  Kingdom  Central  Directorate on  Environmental  Pollution
(1982)  studies  received quite  high  lead  levels  in their diets  (>300  MQ/day)-   Although the
fitted cube  root  equations  give high slopes at lower dietary lead levels, the  linear  slope of
the United Kingdom  Central  Directorate on Environmental Pollution (1982)  study  is probably an
underestimate of the  slope  at lower dietary lead  levels.   Most  of  the dietary  intake supple-
ments used in  these  two studies were so high that many of the subjects had blood  lead concen-
trations  much  in excess of 30 ng/dl  for  a considerable part of the  experiment.   Blood  lead
levels thus may not completely reflect lead exposure, due to the previously noted  nonlinearity
of blood  lead  response  at high exposures.  For  these  reasons,  the  Ryu et al.  (1983)  study is
the most  believable,  although it  only applies to  infants  and also  probably underestimates to
some extent the value of the slope.
     The  slope  estimates for  adult  dietary lead  intake are an  approximately  0.02 MQ/dl in-
crease  in blood  lead per ng/day intake, but consideration of blood lead kinetics  may increase
this value to  about 0.04 (jg/dl per pg/day intake.   Such values are  somewhat lower (about 0.05
|jg/dl per |jg/day) than those estimated from population  studies extrapolated to typical dietary
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intakes; the value  estimated  for infants is much  larger  (0.16).   Estimates for adults  should
be taken  from  the  experimental  studies or  calculated  from assumed absorption  and  half-life
values.
     The relationship  between  blood lead and water  lead  is  not clearly defined and  is  often
described as nonlinear.  Water lead intake varies greatly from one person  to another.   It has
been assumed that  children  can absorb 25-50 percent of  lead in water.   Many authors chose to
fit cube root models to their data, although polynomial  and logarithmic models were also used.
Unfortunately,  the  form  of  the model greatly influences  the estimated contributions to blood
lead levels from relatively low water lead concentrations.
     Although there is close agreement in quantitative analyses of relationships between blood
lead  levels and  dietary lead concentrations,   there  is  a   larger  degree of  variability in
results of the various water lead studies.   The relationship is curvilinear but its exact form
is yet  to  be determined.  At  typical water lead levels for U.S. populations, the relationship
appears  to  be  linear.   The only  study  that determines  the  relationship based  on  lower water
lead values  (<100  M9/1)  is the Pocock et al. (1983) study.  The data from this study, as well
as  the  authors themselves,  suggest that  the  relationship is  linear  for  this  lower range of
water  lead  levels.  Furthermore,  the  estimated contributions  to  blood  lead levels  from this
study are quite  consistent  with the polynomial models from  other  studies.   For these reasons,
the  Pocock  et al.  (1983)  slope  of 0.06  is  considered to  represent  the  best estimate.  The
possibility  still  exists,  however, that the higher estimates of the other studies may be cor-
rect in certain situations, especially at higher water lead  levels (>100 |jg/1).

1.11.6  Studies Relating Lead  in Soil and Dust to Blood Lead
     The relationship  of exposure to lead  contained  in soil and  house dust  and the amount of
lead absorbed by humans, particularly children,  has been  the subject of a  number of scientific
investigations.  Some  of these studies  have been concerned  with  the  effects of exposures re-
sulting  from the ingestion of  lead in dust  (Duggan and Williams, 1977; Barltrop, 1975; Creason
et  al. , 1975);  others  have  concentrated  on  the means  by  which the  lead  in  soil  and  dust
becomes  available   to  the  body  (Sayre  et  al.,  1974).   Sayre  et  al.  (1974) demonstrated the
feasibility of house dust as  a  source  of  lead  for  children in Rochester, NY.  Two  groups of
houses,  one inner  city  and the  other suburban,  were chosen  for the  study.   Lead-free sanitary
paper  towels were   used  to collect dust samples from house  surfaces and the hands of children
(Vostal  et  al.,  1974).  The medians  for the hand and household  samples were used as the cut-
points  in the  chi-square contingency analysis.   A statistically significant difference  between
the  urban  and suburban  homes  for  dust  levels was noted,  as was a relationship between house-
hold dust  levels and hand dust levels  (Lepow et al.,  1975).
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     Studies relating soil  lead  to  blood lead levels are difficult to compare.   The  relation-
ship obviously depends on  depth  of  soil lead, age  of  the children,  sampling method,  cleanli-
ness of the home, mouthing activities of the children,  and possibly many other factors.   Vari-
ous soil sampling methods  and sampling depths have  been  used  over time;  as  such they may  not
be directly comparable and may produce a dilution effect of the major lead concentration con-
tribution from dust, which is located primarily in the  top 2 cm of the soil.
     Increases  in  soil   lead  significantly  increase  blood  lead  in  children.   From  several
studies, EPA estimates an  increase  of 0.6-6.8 ug/dl in  blood  lead for each  increase  of 1000
ug/g in  soil  lead  concentration.   This range  is  similar  to  the range of 1.0 to  10.0 reported
by Duggan  (1980, 1983).   Two studies providing good data for slope estimates are the Stark et
al. (1982)  study and the Angle and  Mclntire (1982) study.   These two studies gave slope esti-
mates of 2.2 and 6.8 ug/dl  per 1000  M9/9> respectively.
     The  relationship  of  house  dust  lead  to blood lead  is even  more difficult to  obtain.
Three studies have  data  permitting  such calculations.   The median value of 1.8 |jg/dl  per 1000
ug/g for children  2-3 years old in the  Stark study may also represent a reasonable  value  for
use here.

1.11.7  Additional  Exposures
     A major source  of  environmental  lead exposure for many members of the general population
comes from lead contained  in both  interior  and  exterior paint on dwellings.   The  amount of
lead present,  as well as  its accessibility,  depends  upon the age of  the residence (because
older buildings contain  paint manufactured before lead content was regulated) and the physical
condition  of  the paint.    In a survey  of  lead levels  in 2370  randomly  selected dwellings in
Pittsburgh, PA  (Shier and  Hall,  1977),  paints with high levels of lead  were most frequently
found in pre-1940 residences.  One cannot assume,  however, that high-level leaded paint is  ab-
sent in  dwellings  built  after 1940.   In the  case of the houses surveyed in  Pittsburgh, about
20  percent of the  residences built after 1960 have at  least one surface with  more  than  1.5
mg/cm2  lead.   In  fiscal  year 1981,  the  U.S.  Centers  for  Disease Control  (1982)  screened
535,730 children and found 21,897 with  lead  toxicity.   Of these cases, 15,472 dwellings were
inspected and 10,666 (approximately 67 percent) were found to have leaded paint.
     A  number  of  specific  environmental  sources  of  airborne  lead  have been  identified as
having a direct  influence  on blood lead levels.   Primary lead smelters, secondary lead smel-
ters, and battery plants emit lead directly into the air and ultimately increase soil and dust
lead concentrations  in   their  vicinity.  Adults,  and especially children, have  been shown to
exhibit elevated blood  lead levels  when living close  to these sources.  Blood lead levels in
these residents  have been  shown to be  related to air, as well  as  to soil or dust exposures.
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The habit of  cigarette  smoking is a source  of  lead exposure.   Other sources include the fol-
lowing:   lead based cosmetics, lead-based folk remedies,  and glazed pottery.
1.12  BIOLOGICAL EFFECTS OF LEAD EXPOSURE
1.12.1  Introduction
     Lead has diverse  biological  effects in humans and  animals.   Its effects are seen at the
subcellular  level  of organellar structures and processes  as  well  as at the  overall  level  of
general functioning  that  encompasses all systems of  the  body operating in a coordinated, in-
terdependent fashion.
     This review  not only seeks to  categorize  and  describe the various biological effects of
lead,  but also  attempts to identify  the  exposure  levels at which such  effects  occur and the
mechanisms  underlying  them.  The  dose-response curve for the  entire  range  of biological ef-
fects  exerted  by  lead is  rather  broad,  with  certain biochemical changes  occurring at  rela-
tively  low  levels of exposure  and perturbations in other systems, such as the liver, becoming
detectable  only at  relatively  high  exposure  levels.   In  terms  of  relative vulnerability to
deleterious  effects of  lead,  the developing organism generally  appears  to  be more  sensitive
than the mature individual.
     It  should  be noted that lead has no known beneficial  biological effects.  Available evi-
dence  does  not demonstrate  that lead is  an essential  element.

1.12.2 Subcellular Effects of  Lead
     The  biological basis of lead toxicity  is  its  ability to  bind  to  ligating groups  in bio-
molecular  substances  crucial   to  various physiological  functions,   thereby interfering with
these  functions  by,  for example, competing  with native  essential  metals for binding  sites,
inhibiting  enzyme activity, or  inhibiting or  otherwise altering essential  ion transport.  These
effects  are modulated by:  1)  the inherent  stability of  such  binding  sites for  lead;  2)  the
compartmentalization  kinetics  governing  lead  distribution  among   body  compartments,  among
tissues,  and within cells;  and  3)  the differences in  biochemical  organization across  cells  and
tissues  due to their  specific  functions.  Given  the  complexities introduced by  items 2 and 3,
it is not surprising  that  no  single unifying mechanism  of lead toxicity across  all  tissues in
humans and  experimental  animals has  yet  been demonstrated.
      Insofar as the effects of lead on  the  activity  of  various enzymes are  concerned,  many of
the available studies examined the  jjn vitro behavior of relatively  pure enzymes and have only
marginal  relevance  to various  effects  HI vivo.  On  the  other hand, certain enzymes are basic
to the effects  of lead at the  organ or organ system level, and discussion is best reserved for
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such effects  in  the  summary  sections below which deal  with lead's effects on particular organ
systems.   This section  is  mainly concerned with organellar effects  of  lead, especially those
which provide  some rationale for  lead  toxicity at higher levels  of  biological  organization.
Particular emphasis is  placed  on the mitochondrion, because  this organelle is not only affec-
ted by lead  in  numerous ways but  has also  provided the most data bearing  on the subcellular
effects of lead.
     The  critical  target organelle  for lead toxicity  in  a  variety of cell  and  tissue types
clearly is the mitochondrion,  followed  probably by cellular  and intracellular membranes.   The
mitochondrial effects take the form of structural changes and marked disturbances in mitochon-
drial function  within the cell,  particularly  in energy metabolism and  ion  transport.   These
effects in turn are associated with demonstrable accumulation of lead in mitochondria, both i_n
vivo  and  J_n vitro.   Structural  changes  include  mitochondrial  swelling  in  a variety of cell
types, as well   as  distortion  and  loss  of cristae, which occur  at  relatively  moderate lead
levels.    Similar changes have  also been documented  in lead workers across  a range  of expo-
sures.
     Uncoupled  energy metabolism,  inhibited cellular  respiration  using both  succinate  and
nicotinamide adenine dinucleotide (NAD)-linked substrates, and altered kinetics of intracellu-
lar  calcium  have  been  demonstrated j_n  vivo  using mitochondria of both  brain and non-neural
tissues.   In  some  cases, the lead  exposure  level  associated  with such changes has been rela-
tively low.   Several  studies document the relatively greater sensitivity of  this organelle in
young versus  adult animals in terms of  mitochondrial  respiration.   The  cerebellum appears to
be  particularly  sensitive,  providing a connection between mitochondrial impairment  and lead
encephalopathy.   Lead's  impairment of mitochondrial function in the developing brain has also
been  consistently  associated with delayed brain development, as indexed  by  content of  various
cytochromes.  In the  rat pup,  ongoing  lead exposure from birth is required  for this  effect to
be expressed, indicating that such  exposure must occur  before, and is inhibitory to,  the burst
of oxidative metabolic activity  that occurs in the young rat at 10-21 days postnatally.
      l£i vivo  lead  exposure of adult  rats also markedly  inhibits calcium turnover in a cellular
compartment of the cerebral  cortex  that appears to be the mitochondrion.  This effect has been
seen  at  a brain lead level  of  0.4 ug/g.   These results  are  consistent with a separate study
showing  increased  retention  of calcium in  the  brain  of lead-dosed guinea pigs.   Numerous re-
ports  have  described  the j_n  vivo  accumulation  of  lead in mitochondria  of  kidney,  liver,
spleen,  and  brain  tissue,  with  one  study showing  that  such uptake was  slightly more  than that
which  occurred  in the  cell nucleus.  These  data are not  only  consistent with deleterious
effects  of  lead on  mitochondria,  but  are  also  supported by other  investigations  HI  vitro.
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Significant decreases in mitochondria!  respiration  jji vitro using both NAD-linked  and  succi-
nate substrates  have been  observed for brain  and  non-neural  tissue mitochondria in the pre-
sence of lead  at  micromolar  levels.   There appears  to be substrate specificity  in  the  inhibi-
tion of  respiration across  different  tissues, which  may be a  factor in  differential  organ
toxicity.   Also, a number of  enzymes involved in intermediary metabolism in  isolated mitochon-
dria have been observed to  undergo significant inhibition of activity with lead.
     Of particular  interest  regarding  lead's effects on  isolated  mitochondria  are  ion  trans-
port effects,  especially in  regard  to calcium.   Lead movement  into  brain and other  tissue
mitochondria  involves  active  transport,  as  does  calcium.   Recent  sophisticated  kinetic
analyses of desaturation  curves  for  radiolabeled  lead or  calcium  indicate  that there  is
striking overlap in  the cellular metabolism of calcium and lead.   These studies not  only
establish the basis for the easy entry of lead into cells and cell compartments, but also pro-
vide a basis for  lead's impairment of intracellular ion transport, particularly in neural cell
mitochondria,  where the capacity  for  calcium  transport is 20-fold  higher  than  even in heart
mitochondria.
     Lead  is  also selectively taken up in isolated mitochondria  i_n  vitro,  including the mito-
chondria of synaptosomes  and brain capillaries.  Given  the diverse and extensive evidence of
lead's  impairment of mitochondrial structure  and function  as viewed from a subcellular level,
it  is not  surprising that these  derangements are logically  held to be the basis of dysfunction
of  heme  biosynthesis,  erythropoiesis,  and the central nervous system.  Several key enzymes in
the  heme biosynthetic pathway are  intramitochondrial, particularly  ferrochelatase.  Hence, it
is  to  be  expected  that entry of  lead  into mitochondria  will  impair  overall heme biosynthesis,
and,  in fact, this  appears  to  be the case  in  the  developing cerebellum.   Furthermore, rela-
tively  moderate levels of lead  may  be associated  with  its entry into  mitochondria and conse-
quent expressions of mitochondrial  injury.
     Lead  exposure  provokes  a typical  cellular  reaction in humans  and other species that has
been morphologically characterized as a  lead-containing nuclear  inclusion  body.  While  it has
been  postulated  that  such   inclusions  constitute  a cellular  protection  mechanism,  such  a
mechanism  is an  imperfect one.   Other organelles,  e.g., the mitochondrion, also take  up  lead
and sustain injury  in  the presence of  nuclear  inclusion  formations.
     In  theory,  the  cell  membrane  is the  first  organelle to  encounter  lead and  it  is not
surprising that  cellular  effects of  lead  can be  ascribed  to  interactions  at cellular and
 intracellular membranes in  the form  of  disturbed  ion transport.  The inhibition  of  membrane
 (Na ,K  )-ATPase  of erythrocytes  as  a  factor  in   lead-impaired erythropoiesis  is  noted  in
 Section 1.12.3.   Lead also appears to  interfere with the normal  processes of  calcium transport
 across  membranes  of  different  tissues.   In  peripheral  cholinergic  synaptosomes,   lead  is
 associated with  retarded  release of acetylcholine  owing to  a blockade of calcium binding  to
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the membrane, while calcium accumulation within nerve endings can be ascribed to inhibition of
membrane (Na ,K )-ATPase.
     Lysosomes accumulate  in  renal  proximal  convoluted tubule cells of rats and rabbits given
lead over a  range  of dosing.   This also  appears  to occur in the  kidneys  of lead workers and
seems to represent  a disturbance in normal lysosomal function,  with the accumulation of lyso-
somes being  due  to  enhanced degradation of proteins  because of the effects of lead elsewhere
within the cell.

1.12.3  Effects of Lead on Heme Biosynthesis,  Erythropoiesis, and Erythrocyte Physiology in
        Humans and Animals
     The effects of  lead  on heme biosynthesis are well known because of their clinical  promi-
nence  and  the  numerous  studies  of  such effects  in  humans  and experimental  animals.   The
process of  heme  biosynthesis  starts  with glycine  and succinyl-coenzyme  A,  proceeds through
formation of protoporphyrin IX, and  culminates with the  insertion of  divalent  iron into the
porphyrin ring to  form heme.   In addition to  being a constituent of  hemoglobin,  heme  is the
prosthetic group of many tissue hemoproteins having variable functions, such as myoglobin, the
P-450  component   of the  mixed-function  oxygenase  system,  and the  cytochromes  of cellular
energetics.   Hence, disturbance of heme biosynthesis by lead poses the potential for multiple-
organ toxicity.
     In  investigations of  lead's  effects on  the  heme synthesis  pathway  (Figure 1-20), most
attention has  been  devoted  to the following:  (1)  stimulation of mitochondrial delta-amino-
levulinic  acid  synthetase  (ALA-S),  which mediates  formation  of  delta-aminolevulinic acid
(ALA);  (2)  direct  inhibition  of  the cytosolic  enzyme,  delta-aminolevulinic  acid dehydrase
(ALA-D), which catalyzes  formation of porphobilinogen  from  two units of ALA; and (3) inhibi-
tion  of insertion  of  iron (II)  into protoporphyrin  IX  to form  heme,  a  process mediated by
ferrochelatase.
     Increased ALA-S  activity has been found  in  lead workers  as well as in lead-exposed ani-
mals, although an actual decrease in  enzyme activity has also been observed in several experi-
mental  studies using different exposure methods.    It  appears,  then, that the effect on ALA-S
activity may depend on the nature of the exposure.   Using  rat  liver  cells  in culture, ALA-S
activity was stimulated in vitro at  levels as low as 5.0 |jM or 1.0 ug Pb/g preparation.  The
increased activity  was due to biosynthesis of more enzyme.  The blood  lead threshold for sti-
mulation of  ALA-S  activity  in humans,  based on  a study  using leukocytes  from lead workers,
appears  to   be  about  40  ug/dl.   Whether this  apparent  threshold applies to  other tissues
depends on  how well the sensitivity  of  leukocyte  mitochondria mirrors that in  other systems.
The  relative impact of ALA-S activity  stimulation  on ALA accumulation at lower  lead exposure
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                                    MITOCHONDRION
                               MITOCHONDRIA!. MEMBRANE
                         GLYCINE
                       SUCCIN YL-CoA
                                                        HEME
                             ALA SYNTHETASE
                                (INCREASE)
                                                FERRO-
                                               CHELATASE =f
                                                               Pb
                                  Pb (DIRECTLY OR
                                  BY DEREPRESSION)
                         IRON+PROTOPORPHY RIN

                                        t
                                        t
                    AMINOLEVULINIC ACID
                          (ALA)
                                                                    IRON
   ALA
DEHYDRASE
(DECREASE)
                                 Pb
                                                   COPROPORPHYRIN
                                                      (INCREASE)
                    PORPHOBILINOGEN
                        Figure 1-20.  Effects of lead (Pb) on heme biosynthesis.
levels appears  to  be much less than  the  effect of ALA-D activity  inhibition.  ALA-D activity
is  significantly  depressed at  40 pg/dl  blood lead,  the  point at  which ALA-S activity only
begins to be affected.
     Erythrocyte ALA-D  activity is very  sensitive  to  inhibition by lead.  This inhibition  is
reversed by  reactivation  of the sulfhydryl group with agents such as dithiothreitol, zinc,  or
zinc and glutathione.   Zinc levels that  achieve reactivation,  however, are well above physio-
logical  levels.   Although zinc appears to offset the inhibitory effects of  lead observed  in
animal studies  and in human erythrocytes jm vitro, lead workers exposed  to both zinc and lead
do  not show  significant changes in the relationship of ALA-D activity to blood lead when com-
pared with workers exposed just to lead.   Nor does the range  of physiological zinc levels  in
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nonexposed subjects affect ALA-D  activity.   In contrast, zinc deficiency  in  animals  signifi-
cantly inhibits ALA-D  activity, with  concomitant accumulation of ALA  in  urine.   Because  zinc
deficiency has also been  demonstrated to increase lead absorption,  the possibility exists for
the following dual effects of such deficiency on ALA-D activity:   (1)  a direct effect  on acti-
vity  due  to reduced zinc  availability;  and  (2) increased lead absorption leading  to  further
inhibition of activity.
     Erythrocyte  ALA-D  activity  appears  to  be  inhibited  at  virtually all blood  lead  levels
measured so  far,  and  any  threshold for this  effect in either  adults or children  remains to be
determined.   A further  measure of this enzyme's sensitivity to lead is a  report  that  rat  bone
marrow suspensions show inhibition  of ALA-D  activity by  lead  at  a  level  of  0.1  ug/g  suspen-
sion.    Inhibition of  ALA-D activity  in  erythrocytes  apparently reflects  a similar effect in
other tissues.  Hepatic ALA-D  activity in lead workers was inversely correlated  with  erythro-
cyte  activity  as  well  as  blood   lead  levels.   Of  significance  are experimental  animal  data
showing that (1) brain ALA-D activity is inhibited with lead exposure,  and (2) this inhibition
appears to  occur  to  a greater extent in developing animals than in  adults, presumably reflec-
ting  greater retention of lead in  developing  animals.   In the avian  brain,  cerebellar ALA-D
activity is  affected  to a greater extent than that of the cerebrum  and, relative to lead  con-
centration,  shows  inhibition approaching that occurring in erythrocytes.
     Inhibition of  ALA-D  activity by  lead is  reflected by elevated levels of its substrate,
ALA,  in blood,  urine,  and soft tissues.  Urinary  ALA is employed extensively as an indicator
of excessive lead exposure in lead workers.   The diagnostic value of this  measurement  in pedi-
atric screening,  however,  is  limited  when only  spot  urine  collection  is  done;  more satisfac-
tory  data  are  obtainable with 24-hr collections.   Numerous  independent studies  document  a
direct correlation  between blood  lead and the  logarithm of  urinary ALA  in  human  adults and
children;  the  blood lead  threshold for  increases  in urinary ALA is  commonly accepted as 40
jjg/dl.  However, several studies  of lead workers indicate that the correlation between urinary
ALA and  blood lead continues  below this value; one  study  found  that  the slope  of the dose-
effect curve in lead workers depends on the level of exposure.
     The health significance of lead-inhibited ALA-D activity and accumulation of ALA  at lower
lead exposure  levels  is controversial.   The  "reserve capacity" of ALA-D activity is such  that
only  the  level of  inhibition  associated with marked accumulation of  the  enzyme's substrate,
ALA,  in accessible  indicator  media may be significant.   However,  it is not possible  to quan-
tify at lower  levels  of lead exposure the relationship of urinary ALA to  target  tissue levels
nor to  relate  the potential  neurotoxicity of ALA at any accumulation level to levels  in indi-
cator media.   Thus,  the blood lead threshold  for  neurotoxicity of ALA may be different  from
that associated with increased urinary excretion of ALA.
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     Accumulation of protoporphyrin  in  erythrocytes  of lead-intoxicated individuals has been
recognized since  the  1930s,  but it  has  only  recently been possible to quantitatively assess
the nature of this effect via development of sensitive, specific  microanalysis methods.  Accu-
mulation of protoporphyrin IX  in erythrocytes results from impaired placement of  iron  (II)  in
the porphyrin moiety  in  heme formation, an intramitochondrial  process  mediated  by ferrochela-
tase.   In  lead  exposure,  the porphyrin acquires a zinc ion in  lieu of  native iron,  thus form-
ing zinc protoporphyrin  (ZPP),  which is tightly bound  in  available heme  pockets  for the  life
of the erythrocytes.   This  tight sequestration contrasts with  the relatively mobile nonmetal,
or  free,   erythrocyte  protoporphyrin (FEP)  accumulated in  the  congenital  disorder  erythro-
poietic protoporphyria.
     Elevation of erythrocyte  ZPP  has been extensively documented as exponentially correlated
with blood lead in children and adult lead workers and is presently considered one of the  best
indicators of  undue lead  exposure.   Accumulation of  ZPP  only  occurs  in  erythrocytes formed
during lead's presence in erythroid tissue; this  results  in a lag of  at  least several weeks
before  its buildup  can be measured.  The  level  of ZPP accumulation in erythrocytes  of  newly
employed  lead  workers continues to  increase  after blood lead  has  already  reached  a plateau.
This influences  the  relative correlation of ZPP and blood lead in workers with short exposure
histories.  Also, the  ZPP level in blood declines much more slowly than blood lead, even after
removal from exposure  or after a drop  in  blood lead.   Hence,  ZPP  level  appears  to be a  more
reliable indicator of  continuing intoxication from lead resorbed from bone.
     The threshold  for detection of lead-induced ZPP accumulation is affected by the relative
spread  of blood lead  and corresponding  ZPP values measured.  In young children  (<4 yr old),
the ZPP  elevation associated with iron-deficiency anemia must also be  considered.  In adults,
numerous  studies indicate that the blood  lead threshold for  ZPP elevation is  about 25-30
ug/dl.  In children 10-15 years old, the threshold is  about  16 ug/dl; for this age group,  iron
deficiency is  not a factor.    In one study, children over 4 years old  showed the same thresh-
old,  15.5  ug/dl, as a second  group  under 4 years  old,  indicating that  iron  deficiency was not
a  factor  in  the study.   At  25 ug/dl blood lead,  50 percent of  the children had  significantly
elevated FEP levels (2 standard deviations  above the  reference mean  FEP).
     At  blood  lead levels below 30-40  ug/dl,  any  assessment of  the  EP-blood lead relationship
is  strongly  influenced  by the relative analytical proficiency  of  measurements of both blood
lead and  EP.  The types  of statistical  analyses  used  are also  important.   In a  recent  detailed
statistical  study involving 2004 children,  1852 of whom had blood  lead values  below 30 ug/dl,
segmental  line and probit analysis  techniques were employed to assess the  dose-effect thres-
hold  and  dose-response  relationship.    An  average blood  lead  threshold  for the effect  using
both  statistical techniques was 16.5  ug/dl  for  the  full  group  and   for those  subjects  with

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blood lead below  30  ug/dl;  the effect of iron deficiency was tested for and  removed.   Of  par-
ticular interest was the finding that blood lead values of 28.6 and 35.7 |jg/dl  corresponded to
EP elevations of  more  than  1 or 2 standard deviations, respectively,  above the reference  mean
in 50 percent of  the children.   Hence,  fully  half  of  the children had significant elevations
of EP at  blood  lead levels around  30  |jg/dl,  which  was the previously  accepted  cut-off value
(now 25  jjg/dl)  for  undue  lead exposure  specified  by  the Centers for  Disease  Control.   From
various reports,  children and  adult females appear to  be  more sensitive to  lead's effects on
EP accumulation  at any given blood lead level; children are somewhat more sensitive than adult
females.
     Lead's effects on heme  formation are not restricted to the erythropoietic  system.   Recent
studies show that the reduction of serum 1,25-dihydroxyvitamin D seen with even low-level  lead
exposure  is   apparently the  result  of  lead-induced   inhibition  of  the activity of renal
1-hydroxylase,  a  cytochrome  P-450-mediated enzyme.   Reduction  in  activity  of the  hepatic
enzyme tryptophan pyrrolase and concomitant  increases  in plasma tryptophan as  well as brain
tryptophan,  serotonin,  and  hydroxyindoleacetic acid  have been shown  to be  associated  with
lead-induced reduction of the hepatic heme pool.  The heme-containing protein cytochrome P-450
(an  integral  part of the hepatic  mixed-function  oxygenase system) is  affected  in  humans and
animals by  lead  exposure,  especially  acute  intoxication.   Reduced P-450 content  correlates
with impaired activity  of detoxifying enzyme systems such as aniline hydroxylase and aminopy-
rine demethylase.   It is also responsible for reduced 6p-hydroxylation of cortisol in children
having moderate  lead exposure.
     Studies of  organotypic  chick and mouse dorsal root ganglion in culture show that the  ner-
vous system  has  heme biosynthetic capability and that  not only is such capability reduced in
the  presence of  lead,  but  production  of porphyrinic material is  increased.   In the neonatal
rat,  chronic lead exposure resulting in  moderately  elevated blood  lead is  associated  with
retarded  increases  in  the  hemoprotein cytochrome C and with  disturbed electron transport in
the developing cerebral cortex.   These data parallel effects of lead on ALA-D activity and ALA
accumulation  in  neural  tissue.   When both  of  these effects  are  viewed  in  the toxicokinetic
context of  increased retention of  lead  in  both developing animals and  children,  there is an
obvious and  serious potential for impaired heme-based metabolic function in the nervous system
of lead-exposed children.
     As can  be  concluded from the  above  discussion,  the health significance of ZPP accumula-
tion  rests  with  the  fact  that it  is  evidence of impaired heme  and  hemoprotein formation in
many tissues that arises from entry of lead into mitochondria.  Such evidence for reduced  heme
synthesis  is consistent  with  a  great  deal  of  data  documenting  lead-associated  effects on
mitochondria.  The  relative value of  the lead-ZPP relationship in erythropoietic tissue as an
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index of this effect in other tissues hinges  on the  relative  sensitivity  of  the  erythropoietic
system compared with  other  organ systems.   One study of  rats  exposed over their lifetime to
low levels of  lead  demonstrated  that protoporphyrin accumulation in  renal  tissue was already
significant at levels  of  lead exposure which produced little  change  in  erythrocyte  porphyrin
levels.
     Other steps  in the  heme biosynthesis  pathway are also  known  to  be  affected by  lead,  al-
though these have not been  as well  studied on a biochemical  or molecular level.  Coproporphy-
rin levels are increased in  urine, reflecting active lead  intoxication.   Lead  also affects  the
activity of the enzyme uroporphyrinogen-I-synthetase in  experimental  animal  systems,  resulting
in an accumulation of its substrate, porphobilinogen.  The erythrocyte enzyme  has been  report-
ed to be  much  more  sensitive to lead than  the hepatic species, presumably accounting for much
of the accumulated  substrate.   Unlike the  case with experimental  animals, lead-exposed  humans
show  no  rise  in  urinary  porphobilinogen,  which  is a differentiating characteristic of lead
intoxication versus the  hepatic porphyrias.   Ferrochelatase is an  intramitochondrial  enzyme,
and impairment of its activity either directly by lead  or via impairment of iron  transport to
the enzyme is evidence of the presence of lead in mitochondria.
     Anemia  is a manifestation  of  chronic  lead  intoxication and is  characterized  as  mildly
hypochromic and usually normocytic.    It is associated with reticulocytosis, owing to shortened
cell  survival,  and  the variable  presence  of basophilic stippling.   Its  occurrence  is  due to
both  decreased production and increased rate of  destruction of erythrocytes.  In young chil-
dren  (<4 yr old), iron deficiency anemia is exacerbated by lead uptake, and vice versa.   Hemo-
globin  production is  negatively  correlated  with blood  lead  in young children,  in  whom iron
deficiency may be a confounding  factor, as well  as in lead  workers.  In  one  study,  blood lead
values that were usually below 80 ug/dl were  inversely correlated with hemoglobin content.   In
these subjects no iron deficiency was  found.  The blood  lead  threshold  for reduced hemoglobin
content is about 50 (jg/dl in  adults  and somewhat  lower (~40  pg/dl) in children.
      The  mechanism  of lead-associated anemia  appears to be a combination  of reduced hemoglobin
production  and shortened erythrocyte survival  due to direct  cell  injury.   Lead's  effects on
hemoglobin production involve disturbances of both heme  and globin biosynthesis.   The hemoly-
tic  component  to lead-induced anemia  appears to  be caused by  increased  cell  fragility and in-
creased  osmotic  resistance.  In  one  study using  rats, the heraolysis  associated with vitamin E
deficiency,  via  reduced cell deformability,  was  exacerbated by lead exposure.  The molecular
basis for increased  cell  destruction  rests  with  inhibition  of  (Na , K )-ATPase and pyrimi-
dine-5'-nucleotidase.   Inhibition of the former  enzyme  leads to cell "shrinkage" and inhibi-
tion  of  the  latter  results  in impaired pyrimidine nucleotide phosphorolysis and disturbance of
the  activity of  the purine  nucleotides necessary  for  cellular energetics.

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     In lead intoxication,  the  presence of both basophilic stippling  and  anemia with a hemo-
lytic component  is due  to  inhibition by  lead of the activity  of  pyrimidine-5'-nucleotidase
(Py-5-N),   an  enzyme  that mediates  the dephosphorylation  of pyrimidine  nucleotides  in  the
maturing erythrocyte.  Inhibition of  this  enzyme by  lead has  been documented in lead workers,
lead-exposed children, and experimental  animal  models.   In one study of lead-exposed children,
there was  a negative  correlation  between  blood  lead  and enzyme activity, with  no  clear  re-
sponse threshold.  A  related  report  noted that,  in addition,  there  was a positive correlation
between  cytidine  phosphate  and  blood   lead  and an  inverse  correlation  between  pyrimidine
nucleotide and enzyme activity.
     The metabolic significance  of  Py-5-N  inhibition and cell nucleotide accumulation is that
they affect erythrocyte  stability  and survival as well as potentially affect mRNA and protein
synthesis  related  to globin chain synthesis.   Based  on  one study of  children,  the threshold
for the inhibition of Py-5-N activity appears  to be  about 10 (jg/dl blood lead.   Lead's inhi-
bition of Py-5-N activity and a threshold for such inhibition are not by themselves the issue.
Rather, the  issue  is the relationship of  such inhibition to a  significant  level  of impaired
pyrimidine nucleotide  metabolism  and  the consequences for erythrocyte stability and function.
The  relationship  of  Py-5-N activity  inhibition by  lead to  accumulation of  its  pyrimidine
nucleotide substrate  is  analogous  to  lead's inhibition  of ALA-D activity  and accumulation of
ALA.
     Tetraethyl  lead  and tetramethyl  lead, components of leaded  gasoline,  undergo transforma-
tion  in  vivo to  neurotoxic trialkyl  metabolites  as well as  further  conversion to inorganic
lead.  Hence, one might anticipate that exposure to such agents may result in effects commonly
associated with  inorganic  lead,  particularly  in terms  of heme  synthesis  and erythropoiesis.
Various surveys and case reports show that the habit of sniffing  leaded gasoline is associated
with  chronic  lead intoxication  in children  from socially deprived  backgrounds in  rural  or
remote areas.   Notable in these subjects is evidence of impaired  heme biosynthesis, as indexed
by  significantly reduced ALA-D  activity.  In several case reports of frank lead toxicity from
habitual  leaded  gasoline sniffing, effects  such as basophilic  stippling  in erythrocytes  and
significantly reduced hemoglobin have also been noted.
     The  role  of  lead-associated  disturbances of heme  biosynthesis as a possible factor in
neurological effects  of  lead  is of  considerable  interest due  to:   (1) similarities between
classical   signs  of  lead  neurotoxicity  and several neurological   components  of the congenital
disorder  acute intermittent porphyria;  and (2) some  of the  unusual  aspects of  lead neuro-
toxicity.    There  are  three possible  points  of connection  between  lead's  effects  on heme
biosynthesis and the nervous system.  Associated with both lead  neurotoxicity and acute inter-
mittent porphyria  is  the common feature of excessive systemic  accumulation and excretion of
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ALA.   In addition, lead neurotoxicity reflects, to some degree,  impaired synthesis of heme and
hemoproteins involved in crucial cellular functions; such an effect on heme is now known to be
relevant within neural tissue as well as in non-neural  tissue.
     Available  information  indicates  that ALA  levels  are  elevated in  the  brains  of  lead-
exposed animals and arise through iji situ inhibition of brain ALA-D activity or through trans-
port of  ALA to  the  brain after  formation in other  tissues.   ALA  is  known  to  traverse the
blood-brain barrier.   Hence,  ALA  is accessible  to,  or formed within,  the brain  during lead
exposure and may express its neurotoxic potential.
     Based  on  various i_n vitro and i_n  vivo  neurochemical studies  of  lead  neurotoxicity,  it
appears  that  ALA can  inhibit release  of the  neurotransmitter  gamma-aminobutyric  acid (GABA)
from presynaptic  receptors  at which ALA appears to  be very potent even at low levels.  In an
ID. vitro  study,  ALA  acted as an agonist at levels as low as 1.0 uM ALA.  This i_n vitro obser-
vation  supports  results  of  a study  using  lead-exposed rats in which there was  inhibition of
both resting  and K -stimulated  release of preloaded 3H-GABA from nerve terminals.  The obser-
vation that ir\ vivo  effects of lead on neurotransmitter function cannot be duplicated with iji
vitro preparations containing added  lead is further evidence of an effect of some agent (other
than  lead) that  acts directly on  this function.  Human data on  lead-induced associations
between  disturbed  heme  synthesis  and neurotoxicity, while  limited,  also suggest that ALA may
function as a  neurotoxicant.
     A  number  of studies strongly suggest that  lead-impaired  heme production itself may be a
factor  in the  lead's  neurotoxicity.  In  porphyric rats,  lead inhibits tryptophan pyrrolase
activity  owing to reductions in the hepatic  heme  pool, thereby leading to elevated  levels of
tryptophan  and serotonin  in the brain.    Such elevations  are  known to induce many of the  neuro-
toxic  effects  also seen with lead exposure.   Of great  interest is the  fact that heme  infusion
in  these animals  reduces brain levels of these substances  and also restores enzyme  activity
and  the  hepatic heme pool.    Another line of evidence  for  the heme-basis of lead neurotoxicity
is  that  mouse dorsal  root  ganglion  in culture  manifests morphological  evidence  of  neural
injury  with   rather  low lead  exposure,  but  such changes  are  largely  prevented  with co-
administration of heme.   Finally, studies also  show that heme-requiring cytochrome  C  produc-
tion  is impaired along with  operation  of  the  cytochrome C respiratory  chain  in  the brain when
neonatal  rats  are exposed to  lead.
     Awareness of the interactions  of  lead  and  the vitamin D-endocrine  system  has  been grow-
ing.   A  recent  study has  found  that  children with blood lead levels  of 33-120 |jg/dl  showed
significant reductions  in  serum  levels  of  the  hormonal  metabolite  1,25-dihydroxyvitamin  D
(1,25-(OH)2D). This  inverse dose-response  relationship  was   found throughout  the  range  of
measured blood lead values  (12-120  ug/dl),  and appeared  to be the result of lead's effect on

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the production  of  the  vitamin D hormone.  The  1,25-(OH)2D  levels  of children with blood lead
levels of  33-55 vg/d]  corresponded  to  the  levels that  have  been observed  in  children with
severe renal  dysfunction.   At  higher  blood lead  levels  (>62 ug/dl), the  1,25-(OH)2D  values
were similar  to those  that have been measured  in  children  with various  inborn metabolic dis-
orders. Chelation therapy of the lead-poisoned children (blood lead levels >62 ug/dl) resulted
in a return to normal 1,25-(OH)2D levels within a short period.
     In addition  to its well  known actions  on bone remodeling and  intestinal  absorption  of
minerals,  the vitamin D hormone has several other physiological  actions at the cellular level.
These  include cellular calcium  homeostasis  in virtually all  mammalian  cells  and associated
calcium-mediated processes that  are  essential  for cellular integrity  and function.   In addi-
tion,  the  vitamin  D hormone  has newly  recognized  functions  that involve cell differentiation
and  essential  immunoregulatory capacity.   It  is  reasonable  to  conclude,  therefore,  that
impaired  production of  1,25-(OH)2D  can have  profound  and pervasive  effects on  tissues  and
cells of diverse type and function throughout the body.

1.12.4  Neurotoxic Effects of Lead
     An assessment of the impact of lead on human and animal neurobehavioral function raises a
number of  issues.   Among the key points addressed here are the following:   (1) the internal
exposure levels, as  indexed  by blood lead  levels,  at which various neurotoxic effects occur;
(2)  the persistence or reversibility of such  effects;  and  (3) populations that appear to  be
most  susceptible  to neural  damage.   In  addition,  the question arises  as to  the utility  of
using animal  studies to draw parallels to the human condition.
     Internal Lead Levels at which Neurotoxic Effects Occur.    Markedly  elevated  blood  lead
levels are  associated with  the most serious  neurotoxic  effects  of  lead exposure (including
severe, irreversible brain  damage  as indexed by the occurrence of acute or chronic encephalo-
pathic symptoms,  or both)  in both  humans and animals.  For  most  adult humans, such damage
typically does  not occur until  blood lead levels exceed 120 ug/dl.  Evidence does exist, how-
ever,  for  acute encephalopathy  and death  occurring  in  some human  adults at blood lead levels
as low as 100 ug/dl.  In children,  the effective blood lead level for producing encephalopathy
or death is lower,  starting at approximately 80-100 ug/dl.  It should be emphasized that, once
encephalopathy  occurs,  death  is not an  improbable outcome,  regardless of the quality of medi-
cal treatment available at the time of acute crisis.  In fact, certain diagnostic or treatment
procedures  themselves  may  exacerbate  matters  and  push  the outcome  toward fatality  if the
nature and  severity  of the problem are  not diagnosed or fully recognized.  It is also crucial
to note the rapidity with which acute encephalopathic symptoms can develop or death can occur
in apparently asymptomatic individuals or  in those apparently only mildly affected by elevated
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lead body  burdens.   Rapid deterioration often  occurs,  with convulsions or coma suddenly  ap-
pearing with progression to death within 48 hours.   This strongly suggests  that even  in  appar-
ently asymptomatic individuals,  rather severe neural  damage probably exists at  high blood  lead
levels even though it is not yet overtly manifested in obvious encephalopathic  symptoms.   This
conclusion  is  further  supported by  numerous studies  showing that overtly  lead-intoxicated
children with high blood lead levels,  but not observed to manifest acute encephalopathic symp-
toms, are permanently cognitively impaired, as are most children who survive acute episodes of
frank lead encephalopathy.
     Recent studies  show that overt  signs  and  symptoms of neurotoxicity  (indicative of  both
CNS and peripheral nerve dysfunction)  are detectable in some human adults at blood lead  levels
as  low  as 40-60 ug/dl,  levels well below  blood lead concentrations previously thought to be
"safe" for  adult  lead exposures.   In addition, certain  electrophysiological  studies of peri-
pheral nerve function in lead workers indicate that slowing of nerve conduction velocities in
some peripheral  nerves  are associated with  blood  lead levels as low as  30-50 ug/dl  (with no
clear threshold  for  the effect  being evident).  These  results are indicative of neurological
dysfunctions occurring  at  relatively  low lead levels  in  non-overtly lead intoxicated adults.
     Other  evidence  confirms  that neural dysfunctions exist  in  apparently asymptomatic chil-
dren at  similar  or even lower levels of blood lead.  The body of studies on low- or moderate-
level lead  effects  on  neurobehavioral functions in  non-overtly  lead intoxicated children, as
discussed in Chapter 12, presents an array of data pointing to that conclusion.  At high expo-
sure  levels, several  studies point toward average 5-point  IQ  decrements occurring in asympto-
matic  children  at  average  blood levels  of 50-70  ug/dl.   Other  evidence  is  indicative of
average  IQ  decrements of  about  4 points being associated with  blood levels  in a  30-50 ug/dl
range.  Below 30  ug/dl, the evidence for IQ  decrements is quite mixed, with some studies show-
ing  no  significant  associations  with   lead  once  other  confounding factors  are  controlled.
Still,  the  1-2 point differences in IQ  generally  seen  with blood lead  levels  in  the 15-30
(jg/dl  range are  suggestive  of  lead  effects that  are  often dwarfed by  other  socio-hereditary
factors.   Moreover,  a  highly significant linear  relationship between  IQ  and  blood  lead   over
the  range of 6 to 47 pg/dl  found in low-SES Black  children  indicates  that IQ effects may be
detected  without evident threshold even  at  these  low levels, at  least  in this population of
children.   In  addition,  other  behavioral (e.g.,  reaction time, psychomotor performance) and
electrophysiological  (altered EEC patterns, evoked  potential  measures, and peripheral nerve
conduction  velocities are  consistent  with  a  dose-response function  relating neurotoxic  effects
to  lead exposure levels as  low  as 15-30 ug/dl  and possibly lower.   Although the comparability
of  blood lead  concentrations across  species is  uncertain (see discussion  below), studies  show
neurobehavioral  effects in rats  and  monkeys at maximal  blood lead levels  below 20 ug/dl;  some
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studies demonstrate  residual  effects long after  lead  exposure has terminated and  blood  lead
levels have returned to approximately normal  levels.
     Timing, type,  and duration  of  exposure are  important factors in both animal  and  human
studies.   It is  often  uncertain whether observed blood  lead  levels represent  the levels  that
were responsible for observed behavioral deficits or electrophysiological  changes.   Monitoring
of  lead  exposures in  pediatric subjects in  all  cases  has  been highly  intermittent  or  non-
existent during  the  period  of life preceding neurobehavioral  assessment.   In  most studies of
children, only one  or  two blood  lead values  are  provided per subject.  Tooth lead  may  be an
important  cumulative exposure  index,  but its  modest,  highly  variable correlation to  blood
lead, FEP,  or  external  exposure levels makes findings  from  various studies difficult to com-
pare  quantitatively.   The complexity  of the many important  covariates and their interaction
with dependent variable measures of modest validity, e.g., IQ tests, may also account for many
of the discrepancies among the different studies.
     The Question of Irreversibility.   Little  research on humans is  available  on persistence
of  effects.  Some work suggests that mild forms  of peripheral neuropathy in lead workers may
be  reversible  after  termination of lead exposure,  but  little is known regarding the reversi-
bility of  lead  effects  on  central  nervous  system function  in  humans.   A two-year follow-up
study of 28 children of battery  factory workers found a continuing relationship between blood
lead  levels  and  altered slow wave voltage of cortical  slow wave potentials indicative of per-
sisting CMS  effects  of lead; a five-year follow-up  of some of the same children revealed the
presence of  altered  brain stem auditory evoked potentials.   Current population studies, how-
ever, will  have  to be supplemented by longitudinal studies of the effects of lead on develop-
ment  in  order  to address  the  issue of  the reversibility  or persistence of  the neurotoxic
effects of  lead  in humans more satisfactorily.   (See the Addendum to this document for a dis-
cussion  of recent results  from prospective  studies linking  perinatal  lead exposure to post-
natal mental development.)
     Various animal  studies  provide evidence that alterations in neurobehavioral function may
be  long-lived, with  such alterations being evident long after blood  lead  levels have returned
to  control  levels.   These persistent effects have been demonstrated  in monkeys as well as rats
under a variety  of learning performance test paradigms.  Such  results are  also consistent with
morphological, electrophysiological,  and biochemical studies  on  animals  that  suggest lasting
changes  in  synaptogenesis,  dendritic  development,  myelin  and fiber  tract  formation,  ionic
mechanisms  of neurotransmission,  and energy metabolism.
      Early  Development and the  Susceptibility to Neural  Damage.   On  the   question  of  early
childhood  vulnerability,  the neurobehavioral data are  consistent  with morphological and bio-
chemical  studies of the  susceptibility of  the heme  biosynthetic  pathway to  perturbation by

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lead.   Various lines of evidence suggest that the order of susceptibility to lead's  effects  is
as follows:   (1) young  >  adults and (2) female  >  male.   Animal  studies also have  pointed  to
the perinatal  period of  ontogeny  as a particularly  critical  time for a variety of  reasons:
(1) it is  a  period of rapid development of  the  nervous system;  (2)  it is a period  where  good
nutrition is  particularly  critical;  and (3)  it is a period where the caregiver  environment  is
vital  to normal development.   However,  the  precise boundaries of  a critical  period are not yet
clear and may vary depending on the species  and function or endpoint that is being assessed.
One analysis of lead-exposed children suggests that differing effects on cognitive performance
may be a  function  of the different  ages at  which children are  subjected to  neurotoxic  expo-
sures.  Nevertheless, there is general  agreement that human infants and toddlers below the age
of three  years are  at  special  risk because of  j_n utero  exposure  (see Addendum), increased
opportunity  for exposure  because  of normal  mouthing behavior,   and  increased  rates  of  lead
absorption due to various factors,  e.g., nutritional deficiences.
     Utility of Animal Studies in Drawing Parallels to the Human Condition.  Animal  models are
used to shed  light on questions where it is impractical or ethically unacceptable to use human
subjects.  This  is  particularly true in the  case  of exposure to environmental  toxins such as
lead.   In  the case of lead, it has been effective and convenient to expose developing animals
via their  mothers'  milk or by gastric gavage, at  least until weaning.   In many studies, expo-
sure was continued in the water or food for some time beyond weaning.  This approach simulates
at least two  features commonly found in human exposure:  oral intake and exposure during early
development.   The  preweaning period in rats  and mice is of particular  relevance in terms of
parallels with the first two years or so of human  brain development.
     Studies  using  rodents and monkeys have  provide  a variety of evidence of neurobehavioral
alteration  induced  by  lead  exposure.   In  most  cases  these effects  suggest  impairment  in
"learning," i.e, the processes of appropriately modifying one's  behavior  in response to infor-
mation  from  the environment.   Such behavior involves the  ability  to  receive,  process, and
remember information in various forms.  Some  studies  indicate behavioral alterations of a more
basic type,  such as delayed development of certain reflexes.  Other evidence suggests changes
affecting rather complex behavior in the form of social interactions.
     Most  of  the  above effects are evident  in rodents and  monkeys  with blood lead levels
exceeding  30 ug/dl, but  some  effects  on  learning ability  are apparent  even  at maximum blood
lead exposure levels below 20  ug/dl.  Can these  results with animals be  generalized to humans?
Given differences  between humans,  rats, and  monkeys  in heme chemistry, metabolism, and other
aspects  of physiology  and anatomy, it  is  difficult  to  state what  constitutes an equivalent
internal  exposure  level (much  less  an equivalent  external  exposure  level).   For  example, is a
blood  lead level  of 30  ug/dl  in  a suckling rat equivalent to 30  ug/dl in a three-year-old
child?   Until an  answer  is  available  for this  question,  i.e.,  until  the  function describing
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the relationship of  exposure  indices  in different species is available, the utility of animal
models for deriving dose-response functions relevant to humans will be limited.
     Questions also  exist regarding  the  comparability of neurobehavioral  effects  in animals
with human behavior  and  cognitive function.   One difficulty in comparing behavioral endpoints
such as locomotor activity is the lack of a consistent operational  definition.   In addition to
the lack  of  standardized methodologies,  behavior is notoriously difficult to "equate" or com-
pare meaningfully  across species  because  behavioral analogies do  not  demonstrate  behavioral
homologies.   Thus,  it is improper to assume,  without knowing more about the responsible under-
lying neurological  structures and processes,  that a rat's performance on an operant condition-
ing schedule  or  a monkey's  performance on  a stimulus  discrimination  task corresponds  to a
child's  performance  on  a cognitive  function test.   Nevertheless, interesting  parallels  in
hyper-reactivity and  increased response variability do exist  between  different  species,  and
deficits  in  performance on various tasks  are indicative of altered CNS  functions,  which are
likely to parallel  some type of altered CNS function in humans as well.
     In  terms  of morphological  findings,  there  are reports of  hippocampal lesions  in both
lead-exposed rats and humans that are consistent with a number of behavioral findings suggest-
ing an  impaired  ability  to  respond appropriately to altered contingencies  for rewards. That
is, subjects tend to persist in certain patterns of behavior even when changed conditions make
the behavior  inappropriate.   Other morphological  findings  in  animals,  such as demyelination
and glial cell decline,  are  comparable to human  neuropathologic  observations  mainly at rela-
tively high exposure levels.
     Another neurobehavioral endpoint  of  interest in comparing human and animal neurotoxicity
of lead is electrophysiological function.   Alterations of electroencephalographic patterns and
cortical  slow wave voltage  have been reported for lead-exposed children, and various electro-
physiological alterations  both jji  vivo  (e.g.,  in  rat visual  evoked  response)  and  i_n vitro
(e.g., in frog miniature endplate potentials) have also been noted in laboratory animals.  At
this time,  however,  these lines of work have not converged sufficiently  to allow  for strong
conclusions regarding the electrophysiological aspects of lead neurotoxicity.
     Biochemical  approaches to  the experimental  study of lead's effects on the nervous system
have generally  been  limited to  laboratory animal subjects.   Although  their linkage  to human
neurobehavioral   function is  at this  point somewhat speculative,  such  studies  do provide in-
sight to  possible  neurochemical  intermediaries of lead  neurotoxicity.   No single neurotrans-
mitter system  has  been  shown  to  be  particularly sensitive to the effects  of  lead exposure;
lead-induced alterations  have  been demonstrated in various neurotransmitters,  including dopa-
mine,  norepinephrine, serotonin, and Y~amin°butyric acid.  In addition, lead has been shown to
have subcellular effects in  the central nervous system at the level of mitochondria! function
and protein synthesis.
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     Given the above-noted difficulties  in  formulating a comparative  basis  for  internal  expo-
sure levels among different species, the primary value of many animal  studies, particularly  ui
vitro studies, may be in the  information they can provide on basic  mechanisms  involved  in lead
neurotoxicity.  A  number of  i_n  vitro studies show that  significant, potentially  deleterious
effects on nervous  system  function occur at j_n  situ  lead concentrations of 5 uM and possibly
lower, suggesting that  no  threshold may exist for  certain  neurochemical  effects of lead on a
subcellular or molecular  level.   The relationship between  blood lead levels  and lead  concen-
trations at such  extra- or intracellular sites  of  action,  however,  remains to  be determined.
Despite the  problems in  generalizing from  animals to humans,  both the animal   and  the  human
studies show  great  internal  consistency in that they support a continuous dose-response  func-
tional relationship between lead and neurotoxic biochemical, morphological,  electrophysiologi-
cal, and behavioral effects.

1.12.5  Effects of Lead on the Kidney
     It  has   been  known  for  more  than  a century  that  kidney  disease  can  result  from lead
poisoning.  Identifying the contributing causes  and mechanisms of lead-induced nephropathy has
been  difficult,  however,  in  part because  of the complexities of human  exposure  to lead and
other nephrotoxic agents.  Nevertheless, it  is possible  to  estimate at least  roughly the range
of  lead  exposure  associated  with detectable  renal  dysfunction  in  both  human adults and chil-
dren.   Numerous  studies of  occupationally-exposed workers  have provided  evidence  for  lead-
induced  chronic  nephropathy being  associated with blood lead levels ranging from 40  to more
than 100 ug/dl, and some are suggestive  of renal  effects, possibly occurring  even  at levels as
low as 30 ug/dl.  In children, the  relatively  sparse  evidence available points to  the manifes-
tation  of  nephropathy  only at quite  high blood  lead  levels  (usually exceeding 100-120 ug/dl).
The current lack of evidence for  nephropathy  at  lower blood  lead levels  in  children may  simply
reflect  the  greater clinical  concern with neurotoxic effects of lead intoxication in children
or, possibly, that much longer-term  lead  exposures are necessary to induce  nephropathy.  The
persistence  of lead-induced  nephropathy in  children also  remains to  be more   fully  investi-
gated,  although  a few  studies indicate  that children diagnosed  as being acutely lead poisoned
experience lead nephropathy effects  lasting  throughout adulthood.
      Parallel  results   from  experimental animal  studies  reinforce the  findings in humans and
help  illuminate the mechanisms  underlying such  effects.   For example,  a number  of transient
effects  in human  and  animal  renal function  are consistent with experimental findings  of  re-
versible  lesions  such  as  nuclear inclusion  bodies, cytomegaly,  swollen mitochondria, and  in-
creased numbers of iron-containing  lysosomes  in proximal tubule cells.  Irreversible lesions
such as  interstitial  fibrosis  are also well  documented in both humans and  animals following
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chronic exposure to high doses of lead.   Functional  renal  changes observed in humans have also
been confirmed  in  animal  model  systems  with respect to increased excretion of amino acids and
elevated serum  urea nitrogen and  uric  acid  concentrations.   The inhibitory  effects  of lead
exposure on renal blood flow and glomerular filtration rate are currently less clear in exper-
imental model  systems; further  research  is  needed  to clarify  the  effects of  lead  on these
functional  parameters  in animals.    Similarly,  while lead-induced perturbation  of  the renin-
angiotensin system  has been  demonstrated  in experimental animal models,  further  research is
needed to  clarify  the  exact relationships among lead exposure (particularly chronic low-level
exposure),  alteration  of the renin-angiotensin  system,  and  hypertension in  both  humans and
animals.
     On the biochemical  level,  it  appears that  lead  exposure produces changes at a number of
sites.  Inhibition  of  membrane  marker enzymes,  decreased mitochondrial  respiratory function/
cellular energy production,  inhibition  of renal heme  biosynthesis, and  altered nucleic acid
synthesis  are  the  most marked changes to have been reported.   The extent to which these mito-
chondrial   alterations  occur is  probably mediated in part by the intracellular bioavailability
of  lead,  which  is  determined by  its  binding to high-affinity  kidney  cytosolic proteins and
deposition within intranuclear inclusion bodies.
     Among the  questions  remaining to be answered more definitively about the effects of lead
on the kidneys  is the  lowest blood lead level at which  renal effects occur.  In this regard it
should be  noted that recent studies in  humans  have indicated that the EDTA lead-mobilization
test  is  the most  reliable  technique for  detecting persons  at  risk for chronic nephropathy;
blood  lead measurements  are  a   less  satisfactory indicator  because  they may  not accurately
reflect cumulative absorption some  time  after  exposure  to lead  has terminated.   Other ques-
tions  include the following:  Can a distinctive lead-induced renal lesion be identified either
in  functional   or  histologic terms?   What  biologic measurements are  most  reliable  for the
prediction  of   lead-induced  nephropathy?   What  is  the incidence of  lead  nephropathy  in the
general  population  as  well  as  among  specifically  defined  subgroups  with  varying exposure?
What  is the  mechanism  of lead-induced hypertension  and renal injury?   What are the contribu-
tions  of  environmental and  genetic  factors  to  the  appearance  of  renal  injury due to  lead?
Conversely,  the most difficult question of  all  may well  be  to  determine the contribution of
low levels of  lead exposure to possible exacerbation of  renal disease of non-lead etiologies.

1.12.6  Effects of Lead on Reproduction and Development
     The most  clear-cut  data described  in  this section on  reproduction and development are
derived from studies employing  high lead  doses  in  laboratory animals.  There is still  a  need
for more critical research to evaluate the possible subtle toxic effects of  lead on the  fetus,
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using biochemical,  ultrastructural,   or  behavioral  endpoints.   An  exhaustive evaluation  of
lead-associated changes in  offspring  should  include consideration of possible effects  due  to
paternal  lead burden  as well.   Neonatal  lead intake via consumption  of  milk from  lead-exposed
mothers  may also be a factor at times.  Moreover, it must be recognized  that lead's  effects  on
reproduction  may  be  exacerbated  by  other environmental  factors  (e.g., dietary  influences,
maternal  hyperthermia, hypoxia, and co-exposure to other toxins).
     There are  currently  no reliable  data pointing to adverse effects in human offspring fol-
lowing  lead   exposure  of  fathers  per se.   Early  studies  of pregnant  women exposed to  high
levels of lead  indicated toxic, but not teratogenic, effects on the conceptus.   Unfortunately,
the  collective  human data  regarding  lead's effects  on reproduction or  i_n utero development
currently  do  not lend  themselves to  accurate  estimation of  exposure-effect   or  no-effect
levels.    This  is  particularly  true  regarding  lead  effects  on reproductive performance  in
women, which  have not  been well  documented  at  low  exposure  levels.   Still,  prudence would
argue for  avoidance  of lead exposures resulting  in blood lead levels exceeding 25-30 M9/dl  in
pregnant  women or  women  of  child-bearing  age  in general,  given  the  equilibration  between
maternal  and  fetal   blood lead   concentrations  that  occurs   and   the  growing  evidence  for
deleterious  effects  in young  children as blood lead  levels approach  or exceed  25-30 ng/dl.
Industrial exposures  of  men to lead  at  levels resulting in blood lead  values of 40-50 ug/dl
also appear to  result  in altered testicular function.
     The paucity  of  human exposure data forces  an examination of the animal studies for indi-
cations  of  threshold levels for effects of  lead on the conceptus.   It  must be noted that the
animal  data  are almost entirely derived  from  rodents.   Based on these  rodent data, it seems
likely  that  fetotoxic effects  have   occurred  in animals at chronic exposures to 600-800 ppm
inorganic  lead  in the diet.  Subtle  effects  appear to have been observed  at  5-10 ppm in the
drinking water, while  effects of inhaled lead  have been seen at  levels of 10 mg/m3.  With mul-
tiple exposure  by gavage, the  lowest observed effect level  is 64 mg/kg  per day,  and for expo-
sure via injection,  acute  doses  of 10-16 mg/kg appear effective.  Since  humans are most  likely
to  be exposed to  lead  in  their  diet,  air,  or water, the data from other  routes of exposure  are
of  less value  in estimating harmful  exposures.   Indeed,  it appears that  teratogenic  effects
occur in experimental  animals  only when  the maternal  dose  is given by injection.
     Although human  and animal responses  may  be dissimilar, the animal  evidence  does document
a  variety  of effects  of  lead  exposure on reproduction and  development.  Measured or apparent
changes  in production of or response to  reproductive  hormones,  toxic  effects on the  gonads,
and toxic or teratogenic effects on the conceptus  have  all  been  reported.  The animal data
also suggest  subtle  effects on such parameters as metabolism and cell structure that should be
monitored   in  human  populations.   Well-designed  prospective   human epidemiological   studies

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(beyond the  few presently available)  involving large  numbers  of subjects are  still  needed.
Such data  could clarify the  relationship  of  exposure periods,  exposure durations, and  blood
lead concentrations associated with  significant effects and are  needed  for  estimation of no-
effect levels as well.   (Recent  studies, most of which are prospective epidemiological inves-
tigations, on the relationship between relatively low-level lead exposure and effects  on fetal
and  child development,  along with  supporting experimental  evidence  on possible  underlying
mechanisms are reviewed in an Addendum to this document.)

1.12.7  Genotoxic and Carcinogenic Effects of Lead
     It is hard  to  draw clear conclusions concerning what role  lead may play in the induction
of  human  neoplasia.   Epidemiological  studies  of lead-exposed  workers provide  no  definitive
findings.   However,  statistically significant  elevations  in respiratory tract  and digestive
system cancer in workers exposed to  lead  and  other agents warrant some concern.   Since lead
acetate can produce renal tumors in some experimental animals, it seems reasonable to conclude
that at least this  particular lead compound should be regarded  as a carcinogen and prudent to
treat  it  as  if it were also  a  human carcinogen (as concluded by the International Agency for
Research  on   Cancer).   However,   this  statement  is qualified  by noting  that  lead  has been
observed  to  increase tumorigenes is  rates  in animals only at relatively high concentrations,
and  therefore  it does  not appear to be a potent carcinogen.   In vitro studies further support
the  genotoxic and carcinogenic  role of  lead,  but  also  indicate that lead  is  not potent in
these systems either.

1.12.8  Effects of Lead on the Immune System
     Lead renders animals  more  susceptible to endotoxins and infectious agents.   Host suscep-
tibility  and  the humoral  immune system appear to be particularly sensitive.   As postulated in
recent studies,  the macrophage may  be  the primary  immune target cell  of  lead.   Lead-induced
immunosuppression occurs   in  experimental  animals  at  low lead  exposures  that,  although not
inducing  overt  toxicity,  may nevertheless be  detrimental to health.   Available data provide
good evidence that  lead affects  immunity,  but additional studies are  necessary to elucidate
the  actual  mechanisms  by  which  lead exerts  its immunosuppressive action.   Knowledge of the
effects of  lead on  the  human immune  system is  lacking and must be  ascertained  in  order to
determine  permissible  levels  for human  exposure.   However, in  view  of  the fact that lead
affects immunity in  laboratory  animals  and  is  immunosuppressive at  very   low  dosages, its
potential  for serious effects in humans should be carefully considered.
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1.12.9  Effects of Lead on Other Organ Systems
     The cardiovascular, hepatic, gastrointestinal,  and endocrine systems  generally  show  signs
of dysfunction  at relatively high  lead  exposure  levels.   Consequently,  in most clinical and
experimental  studies,  attention has  been  primarily focused on more sensitive and  vulnerable
target organs,  such as the heraatopoietic and nervous systems.   However, some work does  suggest
that humans and  animals show significant increases in blood pressure  following chronic  expo-
sure to  low  levels  of lead (see Addendum to this  document for a detailed discussion of the
relationship  between blood  lead and  blood  pressure and  the  possible biological  mechanisms
which may be responsible for this association).   It should also be noted  that overt gastroin-
testinal  symptoms associated  with  lead  intoxication  have been  observed to  occur  in  lead
workers at blood lead levels as  low  as  40-60 pg/dl.   These findings suggest  that  effects  on
the  gastrointestinal  and cardiovascular  systems  may occur at  relatively  low exposure levels
but remain to be more conclusively demonstrated  by further scientific investigations.  Current
evidence indicates that various endocrine processes may be affected by lead at relatively high
exposure  levels.   However,   little  information  exists on endocrine  effects at lower exposure
levels,  except  for   alterations   in  vitamin-D   metabolism  previously  discussed  earlier  as
secondary to heme synthesis effects and occurring at blood lead levels ranging below 30 ug/dl
to  as  low as  12 ug/dl.  (Evidence  relating endocrine function  to  various  recently reported
lead-associated  effects  on  human fetal and child development,  including effects on growth and
stature, is reviewed  in the Addendum to this document.)
1.13   EVALUATION OF HUMAN  HEALTH RISKS  ASSOCIATED  WITH EXPOSURE  TO LEAD  AND  ITS COMPOUNDS
1.13.1  Introduction
     This section attempts to integrate key information and conclusions discussed in preceding
sections  into  a coherent framework by which interpretation and judgments can be made concern-
ing  the risk  to human  health  posed  by  present  levels of  lead  contamination  in  the United
States.   In discussion  of  the various  health effects of  lead,  the main  emphasis  is on the
identification  of  those effects most relevant to various segments of the general U.S. popula-
tion and  the placement  of such effects in a dose-effect/dose-response framework.  With regard
to the  latter,  a crucial  issue  has to do  with  the relative response of various segments of the
population  in  terms of  observed effect levels  as indexed by some exposure indicator.  Further-
more,  it  is of interest to assess  the  extent to  which  available  information supports the
existence  of a  continuum of effects  as  one proceeds  across  the  spectrum of exposure levels.
Discussion  of  data on the  relative  number or percentage  of members  of  specific population
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groups that can  be  expected to experience a particular effect at various  lead exposure  levels
(i.e., "responders") is  also  important in order to permit delineation of  dose-response  curves
for the relevant effects in different segments of the population.   These matters  are  discussed
in Sections 1.13.4 and 1.13.5.
     Melding of  information from  the  sections on  lead exposure, metabolism, and biological
effects permits  the  identification of  population segments at special  risk in terms of physio-
logical and other host characteristics, as well as heightened vulnerability to a  given effect;
these risk groups are discussed in Section 1.13.6.  With demographic  identification of indivi-
duals at risk,  one may then draw upon population data from other sources to obtain a  numerical
picture of  the  magnitude of population groups  at potential  risk.   This is  also  discussed  in
Section 1.13.6.

1.13.2  Exposure Aspects:  Levels of Lead in Various Media of Relevance to Human  Exposure
     Human populations in the United States are exposed to lead in air, food, water,  and dust.
In rural areas,  Americans not occupationally exposed to lead are estimated to consume 40-60  Ug
lead/day.    This  level  of  exposure is  referred  to  as the baseline exposure  for  the American
population because it is unavoidable except by drastic change in lifestyle or by  regulation  of
lead in foods or ambient air.   There are several environmental circumstances that can increase
human exposures  above  baseline levels.   Most of  these  circumstances  involve the accumulation
of atmospheric dusts  in  the work  and  play  environments.   A few, such as  pica and family home
gardening,  may   involve  consumption of lead  in  chips  of  interior  or exterior  house  paint.
     Ambient Air Lead Levels.   Monitored  ambient  air lead concentration values  in the  United
States  are  contained in  two  principal data  bases:   (1) EPA's  National Air Sampling Network
(NASN), recently renamed National Filter Analysis Network (NFAN); and (2)  EPA's National Aero-
metric Data Bank,  consisting  of measurements by  state  and  local  agencies in conjunction with
compliance monitoring for the current ambient air lead standard.
     NASN data for  1982, the  most current  year  in  the annual  surveys, indicate  that most  of
the urban  sites  show reported annual averages  below  0.7 ug Pb/m3, while  the  majority  of the
non-urban  locations  have  annual  figures  below  0.2  ug  Pb/m3.   Over the  interval 1976-1982,
there  has  been   a  downward trend  in  these averages,  mainly attributable to  decreasing lead
content of leaded gasoline and the increasing usage of lead-free gasoline.   Furthermore, exam-
ination of  quarterly  averages  over this interval shows  a typical  seasonal variation, charac-
terized by maximum air lead values in summer and minimum values in winter.
     With  respect  to the  particle size distribution  of ambient air  lead,  EPA  studies using
cascade impactors in  six U.S.  cities have  indicated  that 60-75 percent of  such  air lead was
associated with  sub-micron particles.   This  size distribution  is significant in considering
the distance particles  may be transported and  the deposition of particles  in  the  pulmonary
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compartment of the  respiratory  tract.   The relationship between airborne  lead  at  the monitor-
ing station and the lead inhaled by humans is complicated by such variables  as  vertical  gradi-
ents, relative positions  of  the source, monitor, and the  person,  and the ratio of indoor to
outdoor lead  concentrations.  Personal  monitors  would probably be the most  effective means to
obtain an  accurate  picture  of the amount  of  lead  inhaled  during the normal activities of an
individual, but  the information gained would be insignificant,  considering  that  inhaled  lead
is  generally  only  a small fraction of  the total  lead exposure, compared  to the lead  in food,
beverages, and dust.   The critical question  in  regard  to  airborne lead is how much lead be-
comes  entrained  in dust.   In this respect,  the existing  monitoring network may  provide  an
adequate  estimate  of  the air concentration  from  which the rate of  deposition can be  deter-
mined.
      Levels  of  Lead In Dust.   The lead content  of dusts  can  figure prominently  in the total
lead  exposure picture  for young children.   Lead in aerosol particles deposited on rigid sur-
faces  in  urban areas  (such  as  sidewalks,  porches,  steps,  parking lots, etc.) does not  undergo
dilution  compared  to  lead  transferred by deposition onto  soils.   Lead  in dust  can  approach
extremely  high concentrations and can  accumulate  in  the interiors  of dwellings as well  as in
the outside surroundings, particularly  in  urban  areas.
      Measurements  of soil lead to a  depth of 5  cm  in areas of the  United States were shown in
one study to range from  150 to 500 ug/g  dry  weight close  to roadways (i.e., within 8 meters).
By contrast,  lead  in  dusts  deposited on  or near heavily traveled traffic arteries  show levels
 in major U.S. cities  ranging up  to 8000  ng/g and  higher.   In residential areas,  exterior dust
 lead levels  are approximately  1000  ug/g or less  if contaminated  only  by atmospheric  lead.
 Levels of lead  in  house  dust can be significantly elevated;  a study of  house dust samples in
 Boston and New  York  City  revealed  levels of 1000-2000 ug/g.  Some soils adjacent to houses
 with exterior lead-based paints may  have lead concentrations greater than 10,000  M9/9-
      Forty-four percent of the  baseline consumption of lead by children is  estimated to result
 from consumption of 0.1 g of dust per day, as noted earlier in Table 1-7  (and in  Table  1-14 on
 a  body weight basis).   Ninety  percent of  this  dust  lead is of atmospheric origin.   Dust also
 accounts for more  than 90 percent of the additive lead attributable to living in an  urban en-
 vironment or near a smelter  (see  earlier Table 1-8).
      Levels of  Lead in Food.   The route  by  which  adults  and older children  in  the  baseline
 population  of  the United  States receive the  largest proportion  of  lead intake is  through
 foods, with  reported  estimates of the dietary  lead  intake  for Americans ranging from 40 to 60
 ug/day.   The added exposure from living  in  an  urban environment is  about 28 ug/day for adults
 and 91 ug/day for  children,  all of which  can be attributed  to  atmospheric lead.
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     TABLE 1-14.   RELATIVE BASELINE HUMAN LEAD EXPOSURES EXPRESSED PER KILOGRAM BODY WEIGHT*
                                  Total
                                  lead
                                consumed,
                                 (jg/day
                 Total lead consumed
                    per kg body wt,
                       |jg/kg-day
                   Atmospheric lead
                    per kg body wt,
                       ug/kg-day
Child (2-yr-old)
 Inhaled air
 Food and beverages
 Dust

               Total

Adult female
 Inhaled air
 Food and beverages
 Dust

               Total

Adult male
 Inhaled air
 Food and beverages
 Dust

               Total
 0
25
21.0

46.6
 1.0
32.0
 4.5

37.5
 1.0
45.2
 4.5

50.7
0.05
2.5
2.1

4.65
0.02
0.64
0.09

0.75
0.014
0.65
0.064

0.73
0.05
1.0
1.9

2.95
0.02
0.25
0.06

0.33
0.014
0.28
0.04

0.334
*Body weights:  2-year-old child = 10 kg; adult female - 50 kg; adult male = 70 kg.

Source:   This report.


     Atmospheric lead may  be  added to food crops  in  the field or pasture, during transporta-
tion to the  market,  during processing,  and during kitchen preparation.   Metallic lead, mainly
solder,  may  be  added  during processing and packaging.  Other sources of lead, as yet undeter-
mined, increase the  lead content of food  between  the field and dinner table.  American chil-
dren, adult  females,  and adult males consume  19,  25, and 36 pg Pb/day, respectively, in milk
and nonbeverage foods.   Of these amounts, 49 percent is of direct atmospheric origin, 31 per-
cent is  of metallic origin, and 11 percent is of undetermined origin.
     Processing of foods, particularly canning, can significantly add to their background lead

content,   although  it appears  that the  impact  of  this  is being lessened  with  the  trend away
from use  of   lead-soldered  cans.   The canning  process  can increase  lead  levels  8-to 10-fold
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higher than  for  the corresponding uncanned food items.  Home  food  preparation can also be a
source of  additional  lead  in  cases  where  food  preparation  surfaces  are exposed to moderate
amounts of high-lead household dust.
     Lead Levels  in Drinking Water.   Lead  in  drinking  water  may result from contamination of
the water  source or  from  the use of  lead  materials  in the  water distribution system.  Lead
entry  into  drinking water  from  the  latter is  increased  in  water supplies which are  plumbo-
solvent, i.e., with  a pH below 6.5.    Exposure of  individuals  occurs  through direct  ingestion
of the water or via food preparation  in such water.
     The interim EPA  drinking  water  standard  for lead  is  0.05 ug/g (50 pg/1)  and several  ex-
tensive  surveys  indicate  that  few public water supplies exceed this standard.   For example, a
survey of  interstate  carrier water supplies conducted by EPA showed that only  0.3 percent  ex-
ceeded the  standard,  whereas mean levels of approximately 4.0 ug/1  have been  reported  in 1971
and 1980 (as discussed in Section 7.2.3.1.1).
     The major source of lead contamination of  drinking water is the distribution system  it-
self,  particularly  in older urban areas.  Highest levels are encountered in "first-draw" sam-
ples,  i.e.,  water  sitting  in the piping system for  an extended period of time.  In  a large
community water  supply  survey of 969  systems carried  out  in 1969-1970, it was found that  the
prevalence of samples exceeding 0.05 ug/g was  greater where water was plumbo-solvent.
     Most  drinking water,  and  the  beverages  produced from  drinking water,  contain 0.007-
0.011  ug  lead/g.   The exceptions  are  canned  juices  and soda pop, which  range from 0.018 to
0.040  ug/g.   About  15  percent of the lead consumed  in drinking  water  and   beverages  is of
direct atmospheric origin;  60 percent  comes from solder and other metals.
      Lead  in Other Media.   Flaking lead  paint  as  well as paint  chips and weathered powdered
paint  in and around deteriorated housing  stock in urban areas  of the Northeast  and Midwest has
long  been  recognized as  a  major  source of lead exposure for young  children  residing there,
particularly  for  children  with  pica.   Census  data,  for example,  indicate   that  there  are
approximately  27 million residential  units in  the  United States  built  before 1940,  many of
which  still  contain  lead-based paint.  Individuals who  are cigarette smokers may  inhale signi-
ficant amounts  of  lead  in  tobacco  smoke.   One study has  indicated  that the  smoking of 30
cigarettes  daily results in lead  intake equivalent to  that  of inhaling lead in ambient air at
a  level  of  1.0 ug/m3.
      Cumulative  Human Lead  Intake  From Various Sources.   Table  1-7  earlier   illustrated  the
baseline of human  lead  exposures in  the United States as  described  in  detail in Chapter 7.
These data show that atmospheric  lead accounts  for at least  40  percent of the baseline adult
consumption and 60  percent of the daily consumption  by  a 2-yr-old child.  These percentages
are  conservative  estimates because  a part of  the  lead  of  undetermined origin  may originate
from atmospheric lead not yet accounted  for.
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     From Table 1-14,  it  can be seen that young children have a dietary lead  intake  rate  that
is fivefold greater  than  for adults, on a  body  weight basis.  To these observations must  be
added that absorption  rates  for lead are higher in children than in adults by at least  three-
fold.  Overall,  then,  the  rate of  lead  entry into  the bloodstream of children,  on a  body
weight basis,  is  estimated  to be twice that  of  adults from the respiratory  tract and  six  to
nine  times  greater  from  the GI  tract.   Since  children consume more  dust  than adults, the
atmospheric fraction of the  baseline exposure is sixfold higher for children  than for adults,
on a  body weight  basis.   These differences generally  tend  to place young  children  at greater
risk,  in terms of relative  amounts  of atmospheric  lead  absorbed per  kg body weight,  than
adults under any given lead exposure situation.

1.13.3  Lead Metabolism:   Key Issues for Human Health Risk Evaluation
     From the  detailed discussion  of those various quantifiable characteristics of  lead toxi-
cokinetics in humans and animals presented in Chapter 10, several clear issues emerge as being
important for full evaluation of the human health risk posed by lead:

     (1)  Differences in systemic or internal  lead exposure of groups within the general  popu-
          lation  in  terms  of  such  factors  as  age/development  and nutritional status; and
     (2)  The  relationship of indices  of internal lead exposures to both environmental  levels
          of lead and tissue  levels/effects.

     Item 1 provides  the  basis for identifying segments within human populations at increased
risk  in  terms  of  exposure criteria, and is used along with additional information on relative
sensitivity to  lead health  effects  for identification of at-risk populations.   Item 2 deals
with  the  adequacy of current means of  assessing  internal  lead exposure in terms of providing
adequate margins of protection  from lead exposures producing health effects of concern.
     Differential  Internal Lead Exposure Within Population Groups.    Compared  to adults,  young
children take  in  more  lead through the gastrointestinal and respiratory tracts on a unit body
weight basis, absorb a greater  fraction of this lead intake, and also retain a greater propor-
tion  of  the  absorbed amount.   Unfortunately,  such  amplification of  these  basic toxicokinetic
parameters in children versus adults also occurs at the time when:   (1) humans are developmen-
tally more vulnerable to the  effects of toxicants such as lead in terms of metabolic activity;
and (2) the interactive relationships of lead with such factors as nutritive elements are such
as to induce a negative course  toward further exposure risk.
     Typical of physiological differences in children versus adults in terms of lead exposure
implications  is  a more metabolically  active  skeletal system  in children.  Turnover rates  of

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bone elements such as calcium and phosphorus are greater in children than  in  adults, with cor-
respondingly  greater mobility of  bone-sequestered  lead.   This  activity  is a  factor in  the
observation that  the  skeletal  system of children is relatively less effective  as  a  depository
for lead than in adults.
     Metabolic  demand  for nutrients,  particularly  calcium,  iron,  phosphorus,  and  the  trace
nutrients,  is such  that  widespread deficiencies of these  nutrients  exist,  particularly  among
poor children.  The  interactive  relationships of these elements with lead are  such  that  defi-
ciency  states  enhance lead  absorption  and/or retention.   In the case of lead-induced  reduc-
tions  in  1,25-dihydroxyvitamin  D,  furthermore,  there may exist an increasingly adverse  inter-
active  cycle  between lead effects on 1,25-dihydroxyvitamin D and associated increased absorp-
tion of lead.
     Quite  apart  from the  physiological  differences which enhance  internal lead exposure in
children  is  the unique relationship of 2-  to 3-year-olds  to their exposure setting by way of
normal  mouthing behavior; the  extreme manifestation  of  this  behavior is  called pica.   This
behavior  occurs in  the same age group  which  studies  have consistently identified as having a
peak  in blood  lead.   A   number  of investigations  have  addressed the quantification  of this
particular  route  of  lead exposure, and  it is  by now clear that  such  exposure will  dominate
other  routes when  the child's  surroundings,  e.g.,  dust and soil,  are  significantly contami-
nated  by  lead.
     Information  provided in Chapter 10 also  makes  it  clear that  lead traverses the human pla-
cental  barrier, with lead uptake  by the  fetus occurring throughout  gestation.   Such uptake of
lead poses  a potential threat to  the  fetus via an  impact  on the  embryological  developement of
the  central  nervous and  other systems.   Hence, the only logical  means of protecting the fetus
from lead exposure  is  exposure control  during pregnancy.
     Within  the general  population, then,  young  children  and  pregnant women qualify as well-
defined high-risk groups for lead  exposure.   In  addition, certain  emerging  information (noted
in  Section  13.5 and described in  detail  in the Addendum  to this document)  indicates that  in-
creases in  blood pressure  are associated  with  blood  lead concentrations ranging from >30-40
ug/dl  down  to  possibly as  low  as 7 pg/dl; this  association appears to be particularly robust
in  white males,  aged  40-59.  Occupational  exposure to lead, particularly among  lead workers,
logically defines these  individuals as  also  being  in  a  high-risk category;  work-place contact
is  augmented by  those same  routes and levels of lead  exposure  affecting  the rest of  the adult
population.   From  a biological  point  of view,  lead  workers  do  not  differ from the general
adult  population with respect to  the  various toxicokinetic parameters and  any differences in
exposure control—occupational  versus  non-occupational  populations—as   they exist,  are based
on  factors  other than toxicokinetics.
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     Indices of Internal Lead Exposure and Their Relationship To External Lead Levels and
Tissue Burdens/Effects.  Several  points are  of importance  to  consider in this  area  of lead
toxicokinetics:   (1) the temporal  characteristics  of indices of  lead  exposure;  (2)  the rela-
tionship of the indicators to external lead levels; (3) the validity of indicators of exposure
in  reflecting  target  tissue  burdens;  (4)  the interplay between these  indicators  and  lead in
body compartments;  and (5)  those  various aspects  of the issue with  particular  reference to
children.
     At this time, blood lead is widely held to be the most convenient, if imperfect, index of
both lead  exposure and relative risk  for  various  adverse health effects.  In terms of expo-
sure, however, it is generally accepted that blood lead is a temporally variable  measure which
yields an  index  of relatively recent exposure because of the rather rapid clearance  of absor-
bed  lead from  the blood.   Such a measure, then, is of limited usefulness in cases where expo-
sure is variable or intermittent over time, as is often the case with pediatric lead  exposure.
Mineralizing tissues (specifically,  deciduous teeth), on the other hand, accumulate  lead over
time in  proportion  to  the  degree of  lead  exposure,  and analysis of this material provides an
assessment integrated over a greater time period.
     These two methods of assessing internal  lead exposure have obvious shortcomings.  A blood
lead value will  say little about any excessive lead intake at early periods,  even though such
remote exposure  may have resulted in  significant  injury.   On the other hand, whole tooth or
dentine analysis is retrospective in nature and can only be done after the particularly vulne-
rable age  in  children—under  4-5  years—has  passed.   Such a measure,  then,  provides little
utility upon which to implement regulatory policy or clinical intervention.
     It  may  be possible to  resolve the dilemmas  posed  by these existing methods by  i_n situ
analysis of  teeth and  bone  lead,  such  that the  intrinsic  advantage of mineral  tissue as  a
cumulative index  is combined  with  measurement which  is temporally  concordant with on-going
exposure.  Work in several  laboratories offers promise for such j_n situ analysis  (see Chapters
9 and 10).
     A  second  issue concerning  internal  indices  of  exposure and  environmental  lead  is  the
relationship of changes in  lead content of some medium with changes in blood content.  Much of
Chapter 11 is  given over to description of  the mathematical relationships  of blood  lead with
lead in  some external  medium—air,  food, water, etc.--without consideration of the biological
underpinnings for these relationships.
     Over a relatively  broad range of lead exposure  through some medium, the relationship of
lead in  the external  medium to blood  lead is curvilinear, such that relative change in blood
lead per unit  change   in  medium level  generally  becomes increasingly  less  as  exposure  in-
creases.   This behavior may  reflect  changes  in tissue lead kinetics, reduced lead absorption,
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or  increased  excretion.   With  respect  to changes  in  body  lead  distribution,  the relative
amount of whole blood  lead in plasma increases significantly with  increasing whole  blood lead
content; i.e., the plasma erythrocyte ratio increases.   Limited animal  data  would  suggest that
changes in absorption  may  be one factor in this  phenomenon.   In any event, modest  changes  in
blood levels with  exposure at the higher  end  of  this  range are in  no way  to  be  taken  as re-
flecting concomitantly  modest changes in  body or tissue lead uptake.  Evidence  continues  to
accumulate which  suggests  that  an  indicator   such  as  blood  lead  is an imperfect  measure  of
tissue  lead burdens  and of changes in such tissue  levels  in relation to changes in external
exposure (see Figure 1-21).
     In Chapter 10, it  is pointed out that blood lead is logarithmically related  to  chelatable
lead (the  latter  being a more useful measure  of the potentially toxic fraction of body  lead),
such that  a unit  change  in  blood  lead  is associated  with an  increasingly larger amount  of
chelatable lead.   One  consequence of this relationship is that moderately elevated  blood  lead
values  will tend  to mask the "margin of  safety"  in terms of  mobile  body  lead burdens.  Such
masking  is  apparent in  several  studies  of children where chelatable  lead  levels in  children
showing moderate  elevations  in  blood lead overlapped those obtained in subjects showing frank
plumbism,  i.e.,  overt  lead  intoxication.   In  a  multi-institutional  survey involving  several
hundred  children,  it  was  found that  a  significant percentage of  children  with  moderately
elevated  blood lead  values  had chelatable  lead  burdens  which  qualified them for  medical
treatment.
     Related  to  the above is the question of  the source of  chelatable  lead.   It is  noted in
Chapter 10 that some  sizable fraction of  chelatable lead  is  derived from  bone;  this  compels
reappraisal  of the  notion that  bone is  an "inert sink" for  otherwise  toxic  body  lead.   The
notion  of bone lead as  toxicologically inert never  did accord  with what was known from studies
of  bone physiology,  i.e.,  that bone  is a "living" organ.  The  thrust  of recent studies of che-
latable lead,  as  well  as  interrelationships  of  lead and  bone  metabolism, supports  the  view
that bone  lead is  actually an insidious  source of long-term  systemic  lead exposure  rather than
a protective  mechanism which permits significant  lead  contact in  industrialized populations.
     The  complex  interrelationships  of  lead  exposure,  blood  lead,  and  lead  in body compart-
ments  is of  particular interest  in  considering  the disposition  of  lead  in  young children.
Since  children take in  more  lead on a  weight  basis, and  absorb and retain more of this lead
than  the adult,  one  might expect either  that  tissue and  blood levels would be  significantly
elevated  or  that  the  child's skeletal  system  would be  more efficient in  lead sequestration.
Average blood lead  levels  in young children  are  generally  either  similar to adult males or
somewhat  higher  than for adult  females.   Limited  autopsy data, furthermore, indicate that soft
tissue levels in  children  are  not  markedly different from adults, whereas  the skeletal system
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                          PERIPHERAL
                           NERVES
Figure 1-21. Illustration of main body compartments involved in partitioning, retention, and excretion
of absorbed lead and selected target organs for lead toxicity. Inhaled and ingested lead circulates via
blood (1) to mineralizing tissues such as teeth and  bone (2), where long-term retention occurs reflective of
cumulative past exposures. Concentrations of lead  in blood circulating to "soft tissue" target organs
such as brain (3), peripheral nerve, and kidney,  reflect both recent external exposures and lead re-
circulated from internal reservoirs (e.g. bone). Blood lead levels used to index internal body lead
burden tend to be in equilibrium with lead concentrations in soft tissues'and, below 30 yg/dl, also
generally appear to reflect accumulated lead stores. However, somewhat more elevated current blood
lead levels may "mask" potentially more toxic elevations of retained lead due to relatively rapid declines
in blood  lead in response to decreased external exposure. Thus, provocative chelation of some children
with blood leads of 30-40 pg/dl, for example, results in mobilization of lead from bone and other
tissues into blood and movement of the lead (4) into kidney (5), where it is filtered  into urine and
excreted (6) at concentrations more typical of overtly lead-intoxicated children with higher blood lead
concentrations.
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shows  an  approximate  twofold increase  in  lead  concentration  from  infancy to  adolescence.
Neglected in  this  observation is  the fact  that the  skeletal  system  in children grows at an
exponential  rate,  so that  skeletal  mass  increases 40-fold  during the interval  in  childhood
when  bone  lead  levels increase  twofold,  resulting  in an  actual  increase of  approximately
80-fold in  total  skeletal  lead.   If  the  skeletal  growth  factor is taken into  account, along
with growth in  soft  tissue and the expansion  of  vascular  fluid volumes,  the question  of  lead
disposition  in  children  is better  understood.   Finally,  limited  animal  data  indicate  that
blood  lead  alterations with changes  in  lead exposure are  poor indicators of such changes  in
target tissue.  Specifically,  it  appears that abrupt  reduction  of  lead exposure will  be  more
rapidly reflected  by  decreases  in  blood  lead than by decreased lead  concentrations  in  such
target tissues  as the  central  nervous  system,  especially  in the  developing  organism.   This
discordance may underlie  the observation that severe lead neurotoxicity in children  is assoc-
iated with a rather broad range of blood lead  values  (see Section 12.4).
     The above discussion of some of the problems with the use of blood lead in assessing  tar-
get  tissue  burdens  or the toxicologically active fraction of total body lead is really a  sum-
mary  of  the inherent toxicokinetic problems with use of blood lead levels in defining margins
of  safety  for avoiding internal  exposure  or undue  risk of  adverse effects.  If, for example,
blood  lead  levels of 30-50 ug/dl  in "asymptomatic"  children  are  associated with chelatable
lead  burdens  which  overlap  those encountered in  frank pediatric  plumbism, as documented in
several  studies of  lead-exposed  children,  then  there is  no margin  of safety  at these blood
levels for severe effects which are not at all a matter of controversy.  Were it both  logisti-
cally  feasible  to do  so on  a large scale  and  were the  use   of chelants free of  health risk to
the  subjects,  serial provocative chelation  testing would  appear to be  the better indicator of
exposure  and  risk.   Failing this, the  only prudent alternative is the  use  of a large safety
factor applied  to blood lead which  would translate to an "acceptable" chelatable burden.  It
is  likely that this  blood  lead  value would lie well  below  the  currently accepted upper  limit
of  25 ug/dl,  since  the safety factor would have to  be  large enough  to protect  against  frank
plumbism  as well  as more subtle health effects  seen with non-overt  lead intoxication.  This
rationale  from  the standpoint of  lead  toxicokinetics is also in accord with the growing data
base for  dose-effect relationships  of lead's effects  on heme biosynthesis, erythropoiesis, and
the nervous system  in  humans  as  detailed in  Sections  12.3  and  12.4  (see also  Section 1.13.4,
below).
      Further  development  and routine use of HI situ mineral  tissue  testing  at time points con-
cordant  with  on-going exposure and the  comparison of  such  results with  simultaneous  blood lead
and chelatable lead  measurement  would  be of  significant  value  in  further  defining  what  level
of  blood lead is  indeed an acceptable upper limit.

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     Proportional Contributions of Lead In Various Media to Blood Lead in  Human  Populations.
The various mathematical  descriptions  of  the relationship of blood lead to lead in  individual
media--air, food, water, dust, soil—are discussed in some detail in Chapter 11.  Using values
for lead  intake/content of these media which appear to represent the current exposure picture
for human  populations  in the United States,  these  relationships are further employed in this
section to  estimate  proportional  inputs to total blood lead levels in U.S. children.   Such an
exercise  is of  help  in providing an  overall  perspective on which routes of exposure  are of
most  significance  in terms of  contributions  to  blood lead levels, especially  in urban chil-
dren,  which represent  the  population  group  in  the United  States  at  greatest  risk  for lead
exposure and its toxic effects.
     Table  1-15  tabulates  the relative direct and indirect contributions  of air lead to blood
lead  at  different ambient  air-lead  levels  for  calculated typical background  levels  of lead
from  food,  water,  and dust for U.S.  children.   Calculations  and assumptions used in deriving
the estimates shown in Table 1-15 are summarized in footnotes to that table.   The dietary con-
tributions  listed  in the table,  for example,  are based on:   (1) the  estimated average back-
ground levels  of lead (from non-air and  air  sources)  in food ingested per  day by  U.S. chil-
dren,  as  delineated  in Table 7-19;  and (2) the value of 0.16 ug/dl of blood lead increase per
ug/day food lead intake found by Ryu  et  al.  (1983) for infants.  Similarly, values for other
parameters  used  in Table 1-15 are obtained from work discussed in Chapters 7 and 11.
      It is  of  interest to compare (1)  estimated blood  lead values predicted in Table 1-15 to
occur  at  particular air  lead concentrations  with  (2)  actual blood  lead  levels observed for
U.S.  children  living  in areas with  comparable  ambient  air  concentrations.   As an  example,
NHANES II  survey results for children  living  in rural  areas and urban areas of less than one
million population or  more than one million were presented in Table 11-5.  For children (aged
0.5-5  yr)  living in  urban areas >1 million, the mean blood lead value was 16.8 ug/dl, a value
representative of  average  blood lead levels nationwide for preschool children living in large
urban  areas during the NHANES survey period  (1976  to February,  1980).  Ambient air lead con-
centrations  (quarterly  averages)  during the same time period (1976-1979)  for a geographically
diverse sample of large urban areas in the United States  (population >1 million) are available
from  Table  7-2.   The air  lead levels during  1976-1979 averaged  1.08 ug/m3  for  all  cities
listed  in Table 7-2  and 1.20 pg/m3  for  eight cities  in the table that were  included in the
NHANES II study  (i.e., Boston, New York,  Philadelphia, Detroit,  Chicago, Houston, Los Angeles,
and Washington,  DC).  The Table  1-15  blood  lead values of 12.6-14.6  ug/dl  estimated for air
lead  levels of  1.0-1.25  ug/m3 approximate  the  observed NHANES II average  of  16.8 |jg/dl for
children  in large  urban areas with average air  lead levels of 1.08-1.20 ug/m3.   The NHANES II
blood  lead values for  preschool  children would be expected  to be  somewhat  higher than the
estimates  in Table 1-15  because  the latter  were derived from  FDA  data  for 1981-1983, which
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         TABLE 1-15.   CONTRIBUTIONS FROM VARIOUS MEDIA TO BLOOD LEAD LEVELS (ug/dl)  OF
   U.S.  CHILDREN (AGE = 2 YEARS):   BACKGROUND LEVELS AND INCREMENTAL CONTRIBUTIONS FROM AIR


                        	Air lead, ug/m3	
     Source             0         0.25      0.50       0.75       1.00       1.25       1.50

Background-non air
Food, Water and
  Beverages3            2.37      2.37      2.37       2.37       2.37       2.37       2.37
Dust0                   0.30      0.30      0.30       0.30       0.30       0.30       0.30
Subtotal                2.67      2.67      2767       2767       2.67       2.67       2.67

Background-air
Food, Water and
  Beveragesc            1.65      1.65      1.65       1.65       1.65       1.65       1.65

Ingested dust (with
deposited from air)
Inhaled aire
Total
0.00
0.00
4.32
1.57
0.50
6.39
3.09
1.00
8.41
4.70
1.50
10.52
6.27
2.00
12.59
7.84
2.50
14.66
9.40
3.00
16.72
aFrom Table 7-19, (25.1 - 10.3) pg/day x (0.16 from Ryu et al., 1983) = 2.37 ug/dl.

 From Chapter 7, 1/10 dust not atmospheric.  Using Angle et al. (1984) low area (Area S)
 for soil and house dust and their regression equation, we have:  (1/10) x (97 ug/g x
 0.00681 + 324 |jg/g x 0.00718) = 0.30 pg/dl.  Alternatively, the consumption from non air
 would be (1/10) x (97 ug/g soil dust + 324 ug/g house dust) x 0.05 grams ingested of
 each = 2.1 ug ingested.  Using Ryu et al. (1983), 2.1 x 0.16 = 0.34 ug/dl added to blood.
GAs in (a) above, but using 10.3 instead of (25.1 - 10.3) yields 1.67 (jg/dl.  Values are
 derived for component of background Pb in food from past deposition from air onto soil and
 into other media leading into human food chain (not expected to change much except over
 long-term).

 The regression equations of Angle et al. (1984) are used, as well as levels of soil dust
 and house dust in the low area (S) and high area (C) of that study.  For example, the
 increase at 1.0 |jg/m3 in air would result in increases in soil as follows:
                                              <519 - 97>   = 526
 Similarly the  increase  in house dust would be:

                                '
                           o     - O
 The effect on blood  lead would  be (526 x 0.00681) +  (374 x 0.00718) = 6.27 ug/dl.

eUsing  the 2.0 slope  from Angle  et al. (1984),  i.e.,  1.93 rounded  up.
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were lower than  the  FDA values for the  1976-1980  NHANES  II period (see Chapter 7).   FDA data
for food, water,  and beverages for the  1976-1980  period  are not in a form exactly comparable
to  the  1981-1983  data  used   in  calculating background  contributions  in Table 1-15, but  do
suggest  that lead levels in those media declined by about 20 percent from the 1976-1980 period
to  1981-1983.   If background  contributions  in Table 1-15 were corrected  (i.e.,  increased  by
20 percent) to  be  comparable  to the 1976-1980  period,  then the blood lead levels of children
exposed  to 1.25  ug/m3  air  lead would increase  to  15.5  |jg/dl,  a value even closer to the mean
of  16.8  ug/dl  found for NHANES  II  children  living in  urban environments  (>1 million) during
1976-1980.

1.13.4   Biological Effects of  Lead Relevant to the General Human Population
     It  is  clear from  the wealth  of  available literature reviewed in  Chapter  12 that  there
exists a continuum of biological effects  associated  with lead across a broad  range of  expo-
sure.  At rather low levels of lead exposure, biochemical  changes, e.g., disruption of certain
enzymatic activities involved in heme biosynthesis and erythropoietic  pyrimidine metabolism,
are  detectable.  Heme biosynthesis  is  a generalized  process  in  mammalian species,  including
man,  with importance  for normal  physiological  functioning of  virtually all  organ systems.
With increasing  lead exposure, there are  sequentially  more  intense  effects on heme synthesis
as well  as  a  broadening of effects  to  additional  biochemical  and physiological mechanisms  in
various  tissues.  In addition to heme biosynthesis impairment at relatively low levels of lead
exposure, disruption of normal functioning of the erythropoietic and nervous systems are among
the  earliest  effects observed  as  a function of increasing  lead  exposure.   With increasingly
intense  exposure, more  severe disruption of the erythropoietic  and  nervous systems occur and
additional  organ systems  are  affected,  resulting,  for  example,  in manifestation  of  renal
effects,  disruption  of  reproductive functions, and impairment of immunological functions.  At
sufficiently high  levels  of  exposure,  the damage  to  the  nervous system and other effects can
be  severe enough to  result  in  death  or,  in  some cases of  non-fatal   lead  poisoning,  long-
lasting  sequelae such as permanent mental retardation.
     As  discussed in Chapter 12 of this document, numerous new studies, reviews, and critiques
concerning lead-related  health effects  have  been published  since the  issuance of the earlier
EPA Lead Criteria Document in 1977.  Of particular importance for present criteria development
purposes  are those  new findings, taken  together with information available at the writing of
the  1977 Criteria Document,  which have  bearing on  the  establishment  of  quantitative  dose-
effect or dose-response relationships  for which can be  potentially viewed  as adverse health
effects  likely  to  occur among the  general population at  or near existing ambient air concen-
trations  of lead in  the United States.  Key information  regarding observed health effects and
their implications are discussed below for adults and children.
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     For the latter group,  children,  emphasis  is placed on  the  discussion  of  (1) heme biosyn-
thesis effects, (2) certain  other  biochemical  and hematological effects,  and  (3)  the disrup-
tion of nervous system  functions.   All  of these appear to be  among  those effects of most con-
cern for potential occurrence  in  association with exposure to  existing  U.S.  ambient air lead
levels  for  the population group  at greatest  risk  for lead-induced  health effects  (i.e.,
children §6 years  old).   Emphasis  is also placed on the delineation of internal  lead exposure
levels, as defined mainly  by blood lead (PbB)  levels likely associated with the  occurrence  of
such effects.  Also discussed  are  characteristics of the subject effects  that are of crucial
importance with regard  to  the  determination of which might reasonably be  viewed as constitu-
ting "adverse health effects" in affected human populations.
     Criteria for Defining Adverse Health Effects.   Over the years,   there  have  been  super-
imposed  on  the continuum  of lead-induced  biological  effects  various  judgments as to  which
specific effects observed  in man constitute "adverse health effects".   Such judgments  not only
involved medical  consensus regarding the health  significance of particular effects  and their
clinical management, but also incorporate societal value judgments.   Such societal  value judg-
ments often vary depending upon the specific overall contexts to which they are applied, e.g.,
in judging permissible exposure levels for occupational  versus general population exposures to
lead.   For  some  lead  exposure effects,  e.g.,  severe nervous system damage resulting in death
or  serious  medical sequelae  consequent to  intense lead exposure, there  exists  little or no
disagreement as to these being significant  "adverse health effects."  For many other effects
detectable at  sequentially lower levels  of lead exposure, however,  the demarcation lines as to
which  effects  represent adverse health  effects and  the  lead  exposure  levels  at which they are
accepted  as occurring  are neither  sharp  nor  fixed,  having  changed  markedly during  the past
several  decades.   That is, from an  historical  perspective, levels of  lead exposure deemed to
be  acceptable  for  either  occupationally-exposed persons or  the  general  population have been
steadily  revised  downward as more  sophisticated  biomedical techniques have  revealed formerly
unrecognized biological  effects and concern has  increased  in regard  to the medical and social
significance of such effects.
      It is  difficult to provide a definitive  statement of  all  criteria by which specific bio-
logical  effects  associated with any  given  agent can be judged  to be  "adverse health effects."
Nevertheless,  several  criteria are  currently  well-accepted as  helping to  define which  effects
should be viewed as "adverse."  These  include the  following:   (1)  impaired normal  functioning
of  a specific tissue  or  organ system itself;   (2)  reduced  reserve  capacity of that tissue or
organ system  in  dealing  with  stress due  to  other causative  agents; (3) the  reversibility/
 irreversibility  of the particular  effect(s); (4) the relative frequency of a  given effect;  (5)
the presence of  the effect in a vulnerable segment of the population;  and (6)  the cumulative
                                            1-139

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or aggregate  impact  of  various effects on individual  organ systems on the overall  functioning
and well-being of the individual.
     Examples of  possible  uses of such criteria  in evaluating  lead effects can be cited  for
illustrative purposes.  For  example,  impairment of heme synthesis intensifies  with increasing
lead exposure until  hemoprotein  synthesis is inhibited in many  organ systems, leading to  re-
ductions  in  such functions  as oxygen transport, cellular energetics,  neurotransmitter  func-
tions, detoxification of xenobiotic  agents,  and biosynthesis of  important  substances  such as
1,25-dihydroxyvitamin D.  In Figure 1-22,  the far-ranging impact of lead on the body heme pool
and associated disruption of many physiological  processes is  depicted, based on data discussed
in Sections 12.2 and 12.3.   Furthermore,  inspection of Figure 1-22 reveals effects  that can be
viewed as  intrinsically  adverse,  as  well  as  those that reduce the body's ability to cope with
other forms of toxic stress, e.g., reduced hepatic detoxification of many types of  xenobiotics
and, possibly,  impairment  of the immune system.  The  hepatic  effect can also be  cited  as an
example of  reduced  reserve capacity  pertinent to consideration of the effects  of lead, as  the
reduced capacity  of the liver to detoxify  certain  drugs or other  xenobiotic agents  results
from lead effects on hepatic detoxification enzyme systems.
     In regard to the issue of reversibility/irreversibility of lead effects, there are really
two dimensions to the issue that need to be considered, i.e.: (1) the biological reversibility
or  irreversibility  characteristic of the  particular  effect  in  a given  organism;  and  (2)  the
generally  less-recognized  concept  of  exposure  reversibility   or   irreversibility.   Severe
central nervous  system  damage resulting  from intense, high level  lead  exposure  is generally
accepted  as  an  irreversible effect of lead  exposure;  however,  the reversibility/irreversibi-
lity of certain more difficult-to-detect neurological  effects occurring at lower lead exposure
levels, remains  a matter of some controversy.  The concept of exposure reversibility/irrever-
sibility  can  be  illustrated by the case of urban children of low socioecomomic status showing
disturbances in heme biosynthesis and erythropoiesis.   Biologically, these various effects  may
be considered reversible;  the extent to which actual  reversibility occurs, however, is deter-
mined by  the feasibility of removing these  subjects  from their particular lead exposure set-
ting.   If such  removal  from exposure is  unlikely  or does not occur,  then  such  effects will
logically persist and, de facto, constitute essentially irreversible effects.
     The  issues  of  frequency  of effects  and vulnerable segments  of the population  in whom
these effects occur are intimately related.  As discussed later in Section 1.13.6,  young chil-
dren—particularly  inner city children—constitute a high risk group because  they do show a
high frequency of certain health effects as summarized below.
     Dose-Effect  Relationships for Human Adults.  The  lowest observed effect  levels (in terms
of blood  lead concentrations) thus far credibly  associated  with particular health effects of
concern for human  adults  in relation to  specific organ  systems  or generalized physiological
                                           1-140

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ERVTHROPOIETIC
EfflCTS



NEURAL
EFFECTS





RfNJl ENOOCRIN*
EFFECTS










EHiCTS






REDUCED
SYNTHESIS



REDUCED HEMOPROTEINS
lt,|.. CVTOCHROMESj





REDUCED USIOHlj-
VITAMm 0











TRANSFOHMAIIONS















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t
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1


ANEMIA -REDUCED
TO All TISSUES



IMPAIRED
ENERGETICS



OlSTURItDIMUNO
REGULATORV ROLE
OF CAICIUM

DISTURBED CAICIUM
METAI01ISM

DISTURBED ROLE IK
TUMOHIGENESIS
CONTROL



DETOXIFICATION
OF KENOBIOTICS







Cf ENDOGENOUS
AGONISTS




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/
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s
EXACERBATIOHOF
OTNEfl STRESS AGEMTS

EFFECTS ON NEURONS
AXDNS.AND
SCHWAKN CEL1S
,
IMPAIRED MVELINATION
AND NERVE CONDUCTION

IMPAIRED DEVELOPMENT
OF NERVOUS SYSTEM

IMPAIRED MINERAL
TISSUE HOMEDSTA5IS

IMPAIRED CAICIUM
ROLE AS SECOND
MESSENGER

IMPAIRED CALCIUM
ROLE IN CYCLIC
NUCLEQTIDE METABOLISM

IMPAIRED DETOXIFICATION
OF ENVIRONMENTAL


IMPAIRED
DETOXIFICATION




ALTEREDMETAIC'.ISM
OF THVtTOPHAN


IMPAIRED
HYDRO XYIATIO*
OF COR1ISDI
CARDIOVASCULAR
OTHER HVPOXIC EFFECTS








IMPAIRED (ONE AND
TOOTH DEVELOPMENT














E1EVATED BRAIN
•*- LEVELS 01 TRTPTOPHAN

*
OlSTURefOINDOlEAMINE
NEURdTRANSMITTER
fUNCIIDN
Figure 1-22. Multi-organ impact of reductions of heme body pool by lead. Impairment of heme
synthesis by lead (see Section 12.3) results in  disruption of a wide variety of important physio-
logical processes in many organs and tissues. Particularly well documented are erythropoietic,
neural, renal-endocrine, and hepatic effects indicated above by solid arrows (	*-). Plausible
further consequences of heme synthesis interference by lead which remain to be more conclu-
sively established are indicated by dashed arrows (	•»•).

                                               1-141

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processes, e.g., heme synthesis,  are summarized in Table 1-16.   That table  should  be  viewed  as
representing lowest  blood  lead  levels  thus far credibly associated with unacceptable risk for
a given effect  occurring  among  at least some adults.   As such,  many other  individuals may not
experience the stated effect until distinctly higher blood lead  levels  are  reached due to wide
ranges of  individual biological  susceptibility,  variations  in  nutritional status,  and other
factors.
     The most serious  effects associated with markedly elevated blood  lead  levels are  severe
neurotoxic effects  that include  irreversible  brain damage, as  indexed by the occurrence  of
acute or  chronic encephalopathic  symptoms  observed in both humans and  experimental  animals.
For most  human  adults, such  damage typically does  not occur  until blood lead levels  exceed
100-120 ug/dl.   Often associated  with  encephalopathic  symptoms  at these or higher blood lead
levels are  severe gastrointestinal symptoms and  objective  signs  of effects on several other
organ systems.   Precise threshold(s) for occurrence of overt neurological and  gastrointestinal
signs and symptoms of lead exposure in cases of subencephalopathic lead intoxication  remain  to
be established,  but such effects have been observed in adult lead  workers at  blood lead  levels
as low as  40-60 ug/dl,  notably  lower than  levels  earlier  thought  to be "safe"  for adult lead
exposure.   Other  types of health  effects  occur  coincident with the above overt  neurological
and gastrointestinal symptoms indicative of marked lead intoxication.   These  range from frank
peripheral neuropathies to chronic nephropathy and anemia.
     Toward the  lower  range of blood  lead  levels associated with overt lead intoxication  or
somewhat  below,  less severe but  important  signs  of impairment in  normal  physiological func-
tioning  in several  organ  systems  are  evident  among  apparently asymptomatic  lead-exposed
adults, including the  following:   (1)  slowed nerve conduction velocities  indicative of peri-
pheral nerve  dysfunction  (at levels  as low as 30-40 ug/dl); (2)  altered  testicular function
(at 40-50 ug/dl); and  (3)  reduced hemoglobin production (at approximately 50 ug/dl)  and other
signs of  impaired  heme synthesis  evident at still  lower blood  lead levels.   All  of  these ef-
fects point toward a generalized impairment of normal physiological functioning  across several
different  organ  systems,  which becomes  abundantly evident as  adult blood lead levels  exceed
30-40 pg/dl.   Evidence for impaired  heme  synthesis  effects  in blood  cells  exists  at still
lower blood lead levels in adults, as does evidence for elevated blood pressure  in middle-aged
white males (aged 40-59);  the significance  of this and evidence  of impairment of other bio-
chemical  processes  important  in  cellular  energetics  are discussed  below in   relation  to
children.
     Dose-Effect Relationships for Children.   Table  1-17  summarizes  lowest  observed  effect
levels for a  variety of important health effects observed in children.   Again,  as for adults,
it can  be seen  that lead  impacts many  different  organ systems and biochemical/physiological
                                           1-142

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                           TABLE 1-16.  SUMMARY OF LOWEST OBSERVED EFFECT LEVELS FOR KEY LEAD-INDUCED HEALTH EFFECTS IN AOULTS
Lowest
effect
100-120
observed *
level (PbB}
ug/dl
Heme synthesis and
hema to logical effects
Neurological Effects on Reproductive Cardiovascular
effects the kidney function effects effects
Encephalopathic signs Chronic
and symptoms nephropathy
80
60

50


40

30
ug/dl
ug/dl

ug/dl


ug/dl

ug/di
Frank anemia


Reduced hemoglobin
production

Increased urinary ALA and
elevated coproporphyrins

"I"
f
Overt subencephalopathic
neurological symptoms
f
Peripheral nerve dysfunction -J
(slowed nerve conduction)
I

Female reproductive
effects
Altered testicular
function
I
.1-









-*- Elevated blood
pressure
(White males,}
25-30

15-20

<10
Mg/dl

Mg/dl

ug/dl
Erythrocyte protoporphyrin
(EP) elevation in males
Erythrocyte protoporphyrin
(EP) elevation in females
ALA-D inhibition
aged 40-59





\


i
7
 PbB = blood lead concentrations.
Source:   This report.

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                          TABLE 1-17.   SUMMARY OF  LOWEST OBSERVED EFFECT LEVELS FOR KEY LEAD-INDUCED HEALTH EFFECTS IN CHILDREN
Lowest observed
effect level (PbB)
80-100 yg/dl
70 MQ/dl
60 MQ/dl
50 Mg/d1
40 |jg/dl
Heme synthesis and
Hematological effects

Frank anemia


Reduced hemoglobin
Neurological
effects
EncephalopatMc
signs and symptoms

Peripheral neuropathies
1
7
Peripheral nerve dysfunction
Renal system
effects
Chronic nephropathy
(aminoaciduria, etc.)




Gastrointestinal
effects
Colic, other overt
gastrointestinal symptoms

-t_


30


15 pg/dl


10 pg/dl
                           synthesis

                         Elevated coproporphyrin

                         Increased urinary ALA
Erythrocyte protoporphyin
  elevation

ALA-D inhibition
      I
Py-5-N activity
  inhibition
      *
                                                     (slowed NCV's)

                                                   CMS cognitive effects
                                                     (IQ deficits, etc.)
                                                                                          Vitamin  D  metabolism
                                                                                            interference
                                                       Altered CMS electrophysiological
                                                         responses
?PbB = blood lead concentrations.
°Py-5-N = pyri»idine-5'-nucleotidase.
Source:  This report.

-------
processes  across  a wide  range  of exposure  levels.   Also,  again,  the most  serious of  these
effects  is the  severe,  irreversible  central  nervous  system damage  manifested  in terms  of
encephalopathic signs  and symptoms.   In  children,  effective blood lead  levels for producing
encephalopathy or  death are  lower  than  for  adults,  starting at  approximately 80-100 ug/dl.
Permanent severe mental  retardation  and other marked neurological deficits are among  lasting
neurological  sequelae  typically  seen   in  cases of  non-fatal  childhood  lead  encephalopathy.
Other overt neurological  signs  and  symptoms  of subencephalopathic lead  intoxication are evi-
dent in  children at  lower blood lead levels  (e.g.,  peripheral  neuropathies have been detected
in  some  children  at  levels  as low  as  40-60  ug/dl).   Chronic nephropathy, indexed by amino-
aciduria, is  most  evident at high exposure levels producing blood lead levels over  100 ug/dl,
but may  also  exist at lower levels  (e.g., 70-80  ug/dl).   In addition, colic  and other  overt
gastrointestinal symptoms  clearly occur at similar or still  lower  blood lead levels  in  chil-
dren,  at least down to 60 ug/dl.   Frank  anemia is  also evident by 70 ug/dl,  representing  an
extreme  manifestation  of  reduced  hemoglobin  synthesis observed at blood lead levels as low as
40 ug/dl, along with  other signs  of marked heme  synthesis inhibition at that exposure level.
All  of these  effects  are reflective of  the  widespread  marked  impact of  lead on  the normal
physiological  functioning  of many different  organ systems and some are evident in children at
blood  lead levels as  low as 40 ug/dl.   All  of these effects are widely accepted  as  clearly
adverse  health effects.
     Additional studies demonstrate evidence for further,  important  health effects occurring
in  non-overtly lead-intoxicated  children at similar  or  lower  blood lead levels  than  those
indicated above for overt  intoxication  effects.   Among the most important of the effects dis-
cussed  in  Chapter 12  are  neuropsychological  and  electrophysiological  effects  evaluated as
being  associated  with  low-level  lead exposures  in  non-overtly  lead-intoxicated children.
Indications  of peripheral  nerve  dysfunction,  indexed  by slowed  nerve  conduction  velocities
(NCV),  have been  shown in children  down  to  blood lead levels as  low  as  30 ug/dl.  As for CNS
effects,  none of the available  studies  on the subject, individually, can  be said to prove con-
clusively  that significant  cognitive   (IQ) or  behavioral effects occur in children at blood
lead levels <30 ug/dl.   However,  the most recent  neurobehavioral studies  of CNS cognitive (IQ)
effects  collectively demonstrate  associations  between neuropsychologic  deficits and low-level
lead exposures in  young children  resulting  in blood lead  levels  ranging to below 30  ug/dl.
The magnitudes of average observed  IQ  deficits generally appear to  be  approximately  5  points
at mean blood lead  levels  of 50-70 ug/dl, about 4  points at mean blood  lead levels  of 30-50
ug/dl, and 1-2 points at mean blood lead levels of 15-30 ug/dl.   Somewhat  larger decrements
have  been  reported  for  the  latter blood lead  range  among  children of  lower  socioeconomic
 status families.
                                            1-145

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     Additional recent studies  have  obtained results at blood lead values  mainly  in the  15-30
jjg/dl range  indicative of  small,  but not unimportant,  effects of lead on the ability to  focus
attention, appropriate social  behavior,  and other types of  behavioral  performance.   However,
due  to  specific  methodological problems  with  each  of  these various  studies  (as  noted  in
Chapter 12),  much caution  is  warranted  that precludes conclusive acceptance of  the observed
effects being  due  to  lead  rather than other (at times  uncontrolled for) potentially confound-
ing variables.   This caution is particularly warranted  in view of other well-conducted studies
that have appeared in the literature which did not find statistically significant  associations
between lead  and  similar  effects  at blood  lead levels below 30 ug/dl.   Still,  because such
latter  studies  even  found  some  small  effects  remaining  after  correction for  confounding
factors,  lead  cannot  be  ruled out as an  etiological  factor contributing  to  the  induction  of
such effects in the 15-30 (jg/dl range, based on existing published studies.
     Also  of considerable   importance  are studies which  provide evidence  of changes in  EEG
brain wave patterns and  CNS evoked potential responses  in  non-overtly lead intoxicated  chil-
dren.  The work  of Burchfiel  et al.  (1980)  indicates  significant associations  between IQ de-
crements,   EEG  pattern changes, and  lead  exposures  among  children  with  average  blood lead
levels falling in  the range of 30-50 ug/dl.   Research results provided by Otto et al. (1981,
1982, 1983) also demonstrate clear, statistically significant associations  between electrophy-
siological (SW voltage)  changes and blood lead  levels  in  the range of 30-55 ug/dl and analo-
gous associations  at  blood lead levels below 30 ug/dl  (with no evident threshold  down  to  15
ug/dl or somewhat  lower).  In this case,  the presence of electrophysiological changes observed
upon follow-up of  some  of  the  same  children two years and  five years  later suggests persis-
tence of  such  effects even in the face of later declines in blood lead levels and, therefore,
possible long-term persistence of the observed electrophysiological CNS changes.   However, the
reported electrophysiological  effects  in  this case were not found to be significantly associ-
ated with IQ decrements.
     While the precise medical  or health significance  of  the neuropsychological  and electro-
physiological  effects found by the  above studies to be associated with low-level  lead  expo-
sures is  difficult to fully define at this time, the IQ deficits and other behavioral changes
likely  impact  the  intellectual  development, school performance, and social development of the
affected  children  sufficiently so as to  be  regarded as adverse.  This  is  especially true  if
such impaired  intellectual  development  or school performance and disrupted social development
are reflective of  persisting, long-term effects of low-level lead exposure in early childhood.
The  issue  of persistence of such lead effects still remains to be more clearly resolved, with
some  study results reviewed  in Chapter  12  and  mentioned  above  suggesting relatively  short-
lived or  markedly decreasing  lead effects  on  neuropsychological functions  over a few years

                                           1-146

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from early  to later childhood and  other  studies suggesting that significant  low-level  lead-
induced neurobehavioral and EEC  effects  may,  in fact, persist  into  later childhood.   Despite
any remaining  ambiguities  of the above  type,  however,  the medical community  has  highlighted
(CDC,  1985) lead-induced neurobehavioral  effects (e.g. ,  IQ deficits  and other neuropsychologic
effects) as one basis for viewing pediatric blood lead levels  below 25-30 |jg/dl as  being  asso-
ciated with unacceptable risk for lead-induced toxicity.
     In regard  to additional studies  reviewed  in  Chapter 12 concerning  the  neurotoxicity  of
lead,   certain  evidence exists which  suggests  that neurotoxic effects may be  associated with
lead-induced alterations in heme synthesis, resulting in an accumulation of ALA in  brain  which
affects CNS GABA  synthesis,  binding,  and/or inactivation by  neuronal  reuptake after synaptic
release.   Also,  available experimental  data  suggest that  these effects  may  have functional
significance  in  the  terms of this  constituting  one  mechanism by which  lead may  increase the
sensitivity of  rats  to drug-induced seizures and, possibly,  by which GABA-related behavioral
or physiological  control  functions  are disrupted.   Unfortunately, the available research data
do not allow  credible  direct estimates of blood lead levels at which such effects might occur
in  rats,  other non-human  mammalian species, or man.   Inferentially,  however,  one can  state
that threshold  levels  for any marked  lead-induced ALA  impact on CNS GABA mechanisms are most
probably at  least as high as blood lead levels  at which significant accumulations of ALA have
been detected  in  erythrocytes or non-blood soft tissues (see below).  Regardless of any dose-
effect  levels inferred, though, the functional and/or medical significance of  lead-induced ALA
effects on CNS  mechanisms at low levels  of  lead exposure remains to be  more  fully determined
and cannot, at this  time, be  unequivocably seen  as an adverse health effect.
     Research concerning  lead-induced effects on heme  synthesis also provides information of
importance in evaluating what blood lead levels  are associated with significant health effects
in  children.   As  discussed earlier,  in Chapter  12 and Section  13.4,  lead affects  heme synthe-
sis at several points  in  its  metabolic pathway,  with consequent  impact on the  normal function-
ing of many body  tissues.  The activity of the  enzyme ALA-S,  catalyzing  the rate-limiting step
of  heme synthesis,  does not  appear to be  significantly affected until blood lead  levels  reach
or  exceed  approximately 40 ug/dl.  The enzyme  ALA-0, which catalizes the conversion of  ALA to
porphobilinogen  as  a further step  in  the  heme  biosynthetic pathway,  appears to be  affected at
much  lower blood lead  levels as indexed directly by observations  of ALA-D inhibition or in-
directly  in terms  of  consequent accumulations  of ALA in  blood and non-blood tissues.   More
specifically,  inhibition of  erythrocyte ALA-0  activity has  been observed .in  humans and other
mammalian  species at  blood  lead levels  even below 10-15 pg/dl, with no clear threshold  evi-
dent.   Correlations between  erythrocyte and  hepatic  ALA-D  activity inhibition in  lead workers
at  blood lead levels  in  the  range  of 12-56 (jg/dl  suggest  that ALA-D activity in  soft tissues
                                            1-147

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(e.g., brain, liver, kidney, etc.) may be inhibited at similar blood lead levels  at which  ery-
throcyte ALA-D activity inhibition occurs,  resulting in accumulations of ALA in both blood and
soft tissues.
     Some studies indicate  that  increases  in both blood and  urinary ALA occur below the  cur-
rent commonly-accepted blood  lead level  of 40 ug/dl.   Such increases in blood and urinary ALA
are detectable in humans  at blood lead levels below 30 ug/dl, with no clear threshold evident
down to  15-20  (jg/dl,  although other data exist which  fail  to show any  relationship  below 40
ug/dl   blood  lead.   Other  studies have  demonstrated  significant elevations in rat  brain,
spleen, and kidney ALA levels consequent to acute or chronic lead exposure,  but no clear blood
lead levels can yet be specified at which such non-blood tissue ALA increases occur in humans.
It  is  reasonable  to assume, however,  that ALA increases in non-blood tissues likely begin to
occur  at roughly  the same  blood lead  levels  associated  with  increases  in  erythrocyte  ALA
levels.
     Lead also  affects heme  synthesis  beyond metabolic steps involving ALA, leading  to the
accumulation of  porphyrin in erythrocytes as the  result of impaired iron  insertion  into the
porphyrin moiety to  form  heme.   The porphyrin acquires a zinc ion in lieu of the native iron,
and the  resulting accumulation of blood  zinc protoporphyrin  (ZPP) tightly  bound to  erythro-
cytes  for their  entire life (120  days) represents  a  commonly employed index of  lead exposure
for medical  screening purposes.   The  threshold for  elevation of  erythrocyte protoporphyrin
(EP) levels  is well-established  as being 25-30 ug/dl  in adults and approximately 15 ug/dl for
young  children, with  significant  EP  elevations (>l-2 standard deviations above reference  nor-
mal EP mean  levels)  occurring in  50 percent  of  all  children  studied as blood lead approaches
or moderately exceeds 30 ug/dl.
     Medically, small  increases  in EP  levels were  previously not  viewed  as being  of great
concern  at  initial  detection levels  around  15-20  ug/dl  in children.   However,  EP increases
become more worrisome when markedly greater,  significant elevations occur as blood lead levels
reach  20 to 30 ug/dl and additional  signs  of significantly deranged heme  synthesis  begin to
appear, along with indications of  functional  disruption of  various organ systems.   Previously,
such other  signs of  significant  organ system  functional  disruptions had  only  been  credibly
detected at blood lead levels distinctly in excess of 30 ug/dl, e.g., inhibition  of hemoglobin
synthesis starting  at 40 ug/dl and significant  nervous system effects  at  50-60  ug/dl.   This
served as  a basis  for CDC's 1978 statement establishing  30 ug/dl blood  lead as a  criteria
level   for undue  lead exposure for young children.  At the present time, however, the medical
community (CDC, 1985)  accepts EP  elevations associated with  PbB  levels of 25 ug/dl or higher
as being unacceptable in pediatric populations.
                                           1-148

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     Recently,  it has  also  been demonstrated in children that  lead  is negatively correlated
•with circulating  levels of the  vitamin D  hormone,  1,25-dihydroxyvitamin  D,  with the negative
association  existing  down to 12 ug/dl  of  blood  lead.   This effect of  lead is of considerable
significance  on two counts:   (1) altered  levels  of l,25-(OH)2-vitamin D  not only impact cal-
cium homeostasis  (affecting  mineral metabolism,  calcium as a second messenger, and calcium as
a  mediator of cyclic nucleotide metabolism), but also  likely impact its  known role in immuno-
regulation and mediation of tumorigenesis; and (2) the effect of  lead  on l,25-(OH)2-vitamin D
is  a  particularly robust one, with blood  lead levels of 30-50 H9/dl resulting in decreases in
the  hormone that overlap comparable degrees  of  decrease seen in  severe  kidney  injury or cer-
tain genetic  diseases.
     Erythrocyte  Py-5-N activity in children has  also  been demonstrated to be  negatively im-
pacted  by lead at exposures  resulting  in  blood  lead levels markedly  below 30 ug/dl  (i.e., to
levels  below 5 ug/dl with no  evident  threshold).   Extensive reserve  capacity exists for this
blood enzyme,  such  that it is  not markedly depleted until  blood  lead levels reach approximate-
ly 30-40 |jg/dl,  arguing  for  the Py-5-N effect in  and  of  itself as perhaps  not  being particu-
larly  adverse  until  such blood lead levels  are  reached.   However,  the observation of  Py-5-N
inhibition is  a better  indicator  of  more  widespread impacts on pyrimidine  metabolism in
general  in additional  organs and tissues besides  blood,  such  that  lead exposures lower than 30
|jg/dl  resulting in  measurable Py-5-N  inhibition  in erythrocytes  may  be of greater medical con-
cern when viewed from this broader  perspective.
     Also adding to the  concern about  relatively low  lead exposure  levels  are  the  results of
an expanding  array  of animal  toxicology  studies  which  demonstrate:   (1) the  persistence of
 lead-induced neurobehavioral alterations  well into adulthood long after termination of peri-
 natal  lead exposure early in development  of several mammalian species; (2)  evidence  for  uptake
and retention  of lead  in  neural  and  non-neuronal  elements of the  CNS,  including  long-term
persistence in brain tissues after termination of external lead  exposure  and blood lead  levels
 return   to  "normal";  and (3)  evidence  from  various  j_n vivo  and in  vitro  studies  indicating
 that,  at  least  on  a  subcellular-molecular  level,  no  threshold may  exist for  certain  neuro-
 chemical effects of lead.
      Given the above new evidence that is now  available, indicative  of significant  lead  ef-
 fects  on  nervous system functioning and other important physiological processes as  blood lead
 levels  increase  above  15-20 ug/dl  and  reach 20 to  30  ug/dl,  the rationale for considering 30
 |jg/dl  as  a "maximum  safe"  blood  lead level (as  was  the case in  setting the  1978 EPA lead
 NAAQS)  was  called  into  question  and  substantial  impetus provided for  revising the criteria
 level   downward.   At  this  time,  it is   difficult  to   identify specifically what  blood lead
 criteria  level would  be  appropriate   in  view  of  the  existing  medical information.   Clearly,
                                            1-149

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however, 30  ug/dl  does not afford any  margin  of safety before blood lead  levels  are  reached
that are associated with unacceptable risk of notable adverse health effects occurring  in some
children.  This  is  based on at least two  grounds:   (1) blood lead levels  in  the  30-40 ug/dl
range  are  now  known  to "mask",  for some children, markedly  elevated chelatable body  lead
burdens  that  are comparable to lead burdens seen in other children displaying overt signs and
symptoms of  lead intoxication  and  (2)   blood  lead  levels  in  the 30-40 ug/dl  range are  also
associated with  the onset  of deleterious effects  in several  organ systems which  are  either
individually  or  collectively  seen as  being adverse.  These  and  other  considerations have led
the medical  community  (CDC, 1985) to define 25 ug/dl PbB as a level associated with unaccept-
able risk for pediatric  lead toxicity.
     At  levels  below  25-30 ug/dl,  many of  the different  smaller  effects reported as  being
associated with  lead  exposure might be  argued as separately not being of clear medical  signi-
ficance, although each are  indicative  of  interference  by  lead  with normal physiological  pro-
cesses.  On the other  hand, the collective impact of all of the observed effects (representing
potentially impaired functioning and depleted reserve capacities of many different  tissues and
organs)  can,  at  some point distinctly  below  25-30  ug/dl,  be seen  as representing  an  adverse
pattern  of effects  worthy  of  avoidance  with some  added margin of safety.   The onset of signs
of detectable heme  synthesis  impairment in many different  organ  systems at blood  lead levels
starting around  10-15  ug/dl,  along  with indications of increasing degrees  of pyrimidine meta-
bolism  interference and signs of altered  nervous  system  activity,  could be viewed as  such  a
point.    Or,  alternatively,  the  collective  impact of such  effects  might be argued  as becoming
sufficiently  adverse  to warrant  avoidance (with a  margin of  safety)  only when  the  various
effects  come  to  represent  marked deviations  from  normal  as  blood lead  levels exceed  20-25
ug/dl.
     The frequency  of occurrence of  various  effects  among individual, affected  children  at
various  blood lead  levels  may have important  bearing on  the ultimate resolution of the above
issue regarding  the definition  of blood lead levels associated with adverse health effects  in
pediatric populations.   The porportion   of children likely  affected  (i.e., "responders")  1n
terms of experiencing  particular  types  of effects at various lead levels is also an important
consideration.  Some information bearing on this latter point is discussed  next.

1.13.5  Dose-Response Relationships  for  Lead Effects in Human Populations
     Information  summarized in the preceding section dealt with the various biological  effects
of lead  germane  to  the  general population and included comments about the various  levels  of
blood lead observed to  be  associated  with the  measurable onset of these  effects  in  various
population  groups.

                                           1-150

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     As  indicated  above,  inhibition of ALA-D activity  by  lead occurs at virtually all blood
lead levels measured  in  subjects  residing in industrialized countries.   If  any  threshold  for
ALA-D  inhibition  exists,  it  lies  somewhere below 10 ug  Pb/dl in blood  lead.   Also,  statis-
tically  significant reduction  in  hemoglobin production  occurs at a  lower blood  lead  level  in
children (40 ug/dl) than in adults (50 M9/dl).
     Elevation in  erythrocyte  protoporphyrin  for a given blood lead level is greater  in chil-
dren and women than in adult  males,  children  being  somewhat more sensitive  than women.   The
current  threshold  for  detectable  EP elevation in terms of  blood lead levels for children  was
estimated  at  approximately 16-17  ug/dl in  the  recent  studies  of Piomelli et al. (1982).   In
adult males, the corresponding blood lead value is 25-30 |jg/dl.
     Coproporphyrin elevation  in urine first occurs at a blood lead level of 40 ug/dl  and  this
threshold  appears  to  apply  for both  children  and  adults.   It also  appears  that urinary  ALA
shows  a correlation with  blood lead  levels  to below  40  ug/dl, but since  there is  no  clear
agreement  as  to the  meaning  of  elevated ALA-U below  40  ug/dl, this  value is  taken as  the
threshold  for pronounced  excretion  of ALA  into urine.   This value  appears  to  apply to  both
children and  adults.   Whether this blood  lead  level  represents a threshold for the potential
neurotoxicity  of circulating ALA cannot now be stated and requires further study.
     A  number of  investigators  have attempted  to  quantify  more  precisely dose-population
response relationships for some of the above lead effects in human populations.  That  is, they
have attempted to define  the  proportion  of a population exhibiting  a  particular effect  at a
given  blood lead  level.   To  date,  such  efforts at  defining  dose-response relationships for
lead effects  have been mainly  limited to the  following effects of  lead  on  heme biosynthesis:
inhibition  of  ALA-D activity;  elevation of  EP; and urinary excretion  of ALA.
     Dose-population response  relationships for  EP in children have  been  analyzed in detail by
Piomelli  et al.  (1982) and  the corresponding plot at 2 levels of elevation  (>1  S.D.,  >2 S.D.)
is  shown in Figure 1-23 using probit  analysis.  It can be seen that  blood lead  levels in half
of  the children showing EP  elevations at >1 and 2 S.D.'s closely bracket the blood lead level
taken  as the high end of  "normal"  (i.e., 30 ug/dl).   Dose-response  curves  for  adult men and
women  as well as  children prepared  by Roels et al.  (1976)  are set forth in Figure  1-24.  In
Figure 1-24,  it  may be seen  that the dose-response for  children  remains greater  across the
blood  lead range  studied,  followed  by women, then adult males.
     Figure 1-25  presents  dose-population  response  data  for urinary ALA exceeding two levels
(at mean  + 1 S.D.  and  mean  + 2 S.D.),  as  calculated by  EPA from the data of Azar et al.
(1975).   The percentages of the  study populations  exceeding  the corresponding  cut-off levels
as  calculated by  EPA  for  the  Azar data  are set forth  in  Table 1-18.   It should be noted  that
the measurement of ALA  in the Azar et al. study did  not account for  aminoacetone,  which may
influence the results  observed at the lowest  blood  lead levels.
                                            1-151

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93
3 95
< 90
O
> 75
5
5 50
u.
O
s 25
UI
3 10
2 5
ac
u.
1
1 1 1 1 /f 1
- / / —
— EP>x + 1SD / / — '
/ / 1
~ V* r)/EP>x'+2SD ~~j
~ „.,.//
— x u i ^—
_ ' f C = NATURAL FREQUENCY.
o - •' +
• •'
1 ' 1 I 1 1 1 ~
0 10 20 30 40 50 60 7(
BLOOD LEAD,M9/dl
Figure 1-23. Dose-response for elevation of EP as a
function of blood lead level using probit analysis.
Geometric mean plus 1 S.D. = 33 jug/dl; geometric
mean plus 2 S.D. = 53 M9/dl.
Source: Piomelli et al. (1982).
«g 100
^ IUU
1U
UI
O
LU
5 80
ft
A
a.
LU
u.
I 60
K
5
Z
g
-/
// T
•i /
• t^ /ADIll ( MAI ES

~ / // —
-<£,!/'
.' 4S^
^Cy-^^^ 1 1 1
10 20 30 40 5(
           BLOOD LEAD LEVEL, jug/dl
Figure 1-24.  Dose response curve for FEP as a
function of blood lead level in subpopulations.

Source:  Roels et al. (1976).
                 1-152

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3
Ul
It) 100 —
a


I'
A 80
3
       X
       t 60


       O 50
       P

       =i 40
        U.
        O
        tu
                                               I    I
                                  o MEAN + 1 S.D.
                                  A MEAN + 2 S.D.
                                   MEAN ALA-U - 0.32 FOR .
                                    BLOOD LEAD<13pQ/dl
                     I	I
                           I	I
I
                10   20   30   40    50   60

                       BLOOD LEAD LEVEL,
                                           70
                                               80
                                                   90
         Figure 1-25. EPA-calculated dose-response curve for ALA-U.

         Source: Azaretal. (1975).
          TABLE  1-18.   EPA-ESTIMATED PERCENTAGE OF SUBJECTS
      WITH ALA-U EXCEEDING LIMITS FOR VARIOUS BLOOD LEAD LEVELS
Blood lead  levels,
                                             Azar et al. (1975),
                                             percent population
10
20
30
40
50
60
70
2
6
16
31
50
69
84
                               1-153

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1.13.6  Populations at Risk
     Population at risk  is  a  segment of a defined population exhibiting characteristics  asso-
ciated with  significantly  higher  probability  of developing a condition, illness,  or  other  ab-
normal status.  This  high  risk may result from  either  (1) greater inherent susceptibility or
(2) exposure situations peculiar to that group.   What is meant by inherent susceptibility is a
host  characteristic  or  status that  predisposes  the  host  to  a  greater  risk of heightened
response to an external stimulus or agent.
     In regard to lead, three  such populations are definable:   they are  preschool  age children
(^6 years  old),  especially those  living in  urban settings,  pregnant women, and white  males
aged 40-59,  although  the  evidence concerning  this latter group  is much  more limited  than that
for the  other two.   Children  are such  a population for  both  of  the  reasons stated above,
whereas pregnant women are at  risk primarily due to the  inherent susceptibility of the concep-
tus.  Also,  for  reasons  not as yet fully  understood, the  limited information available  indi-
cates that  middle-aged white  males appear to  be differentially more at risk  for manifesting
elevations in  blood pressure  in response to lead  exposure (see the Addendum to this document
for a complete discussion of the evidence supporting this).
     Children as a Population  at Risk.   Children are developing and growing organisms exhibi-
ting certain  differences from  adults  in terms of  basic  physiologic mechanisms,  capability of
coping with  physiologic  stress,  and  their relative metabolism of lead.   Also,  the behavior of
children frequently places  them in different  relationship to sources of lead in  the environ-
ment,  thereby  enhancing  the opportunity for them to absorb lead.   Furthermore,  the occurrence
of excessive exposure  often is not realized until serious harm is done.   Young children do  not
readily communicate a  medical  history  of lead exposure, the  early signs of such  being common
to  so many  other  disease states that lead is  frequently not recognized  early on as a possible
etiological factor contributing to the manifestation of  other symptoms.
     Discussion  of the  physiological  vulnerability of  the young  must address  two  discrete
areas.   Not  only  should the  basic physiological  differences  be  considered  that  one  would
expect  to  predispose  children to  a  heightened  vulnerability  to  lead,  but also the actual
clinical evidence must be considered that shows such vulnerability does  indeed exist.
     In Chapter 10 and Section 1.13.2 above,  differences in relative exposure to lead and body
handling of lead for children  versus adults are noted.   The significant  elements of difference
include the  following:   (1) greater  intake of lead by  infants and young children  into the  re-
spiratory and  gastrointestinal  (GI) tracts  on  a  body  weight  basis  compared to adults;  (2)
greater absorption  and retention  rates  of lead  in children; (3)  much  greater prevalence of
nutrient deficiency in the case of nutrients which affect lead absorption  rates from the GI
tract; (4) differences  in  certain habits, i.e., normal  hand-to-mouth activity as  well as pica
resulting in  the  transfer  of  lead-contaminated dust and dirt to the GI  tract; (5) differences
                                           1-154

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in the efficiency of  lead  sequestration in the bones of  children,  such  that  not only  is  less
of the body burden of lead  in bone at any given time,  but  the  amount present may be  relatively
more  labile.   Additional  information discussed  in Chapter 12  suggests  that the blood-brain
barrier  in  children is less  developed, posing  the  risk for  greater entry  of lead into  the
nervous system.
     Hematological and neurological  effects  in children have  been  demonstrated to  have  lower
thresholds in  terms  of  blood lead levels than  in  adults.   Similarly,  reduced hemoglobin  pro-
duction  and  EP accumulation  occur  at  relatively  lower exposure levels  in  children  than  in
adults,  as indexed  by  blood lead thresholds.   With reference  to neurologic effects, the  onset
of encephalopathy and other injury to the nervous system appears to  vary  both  regarding likely
lower thresholds in children for some effects and in the typical pattern  of neurologic  effects
presented, e.g.,  in  encephalopathy  or other CMS deficits  being more common in children versus
peripheral neuropathy being more often seen in adults.   Not only are the  effects more acute in
children  than  in adults,  but also  the neurologic sequelae  are  usually  much more severe in
children.
     The  dietary habits  of  children  as well  as  the  diets  themselves  differ markedly  from
adults and,  as a  result,  place  children  in a  different relationship  to several  sources of
lead.  The dominance of canned milk and processed baby food in the diet of many young children
is an  important factor in  assessing their exposure  to  lead,  since both  those foodstuffs have
been  shown to  contain  higher amounts of  lead  than components of the  adult diet.   The impor-
tance  of these lead sources is  not  their  relationship  to airborne lead  directly but,  rather,
their  role  in  providing a  higher baseline  lead burden  to which  the  airborne contribution is
added.
     Children  ordinarily undergo a  stage of development  in which they exhibit normal mouthing
behavior, as manifested,  for example,  in the  form of thumbsucking.  At  this time they are at
risk  for picking  up  lead-contaminated soil and dust on their hands and hence  into their mouths
where  it can be absorbed.
     There is,  however,  an abnormal extension of mouthing behavior, called pica, which occurs
in  some   children.  Although  diagnosis  of this is difficult,  children who exhibit  this trait
have  been shown to purposefully  eat  nonfood  items.   Much of  the lead poisoning  due to lead-
based  paint  is  known to occur because children actively ingest  chips of  leaded paint.
      Pregnant  Women and the Conceptus as a Population at  Risk.   There are some  rather incon-
culsive  data indicating that women may  in general be at somewhat  higher  risk to lead than men.
However, pregnant women and their concepti as a subgroup are demonstrably at higher risk.  It
should be noted that,  in  fact,  it  really is not  the pregnant  woman  per se who is  at  greatest
risk  but, rather, the unborn child  she is carrying.  Because of  obstetric complications,  how-
ever,  the mother herself can also  be at somewhat greater  risk at  the time of delivery of her
                                           1-155

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child.  With  reference to  maternal  complication at  delivery,  information  in  the  literature
suggests  that the  incidence  of preterm  delivery  and premature  membrane  rupture relates  to
maternal  blood  lead  level.   Further study of this relationship as well  as  studies relating to
discrete  health effects in the newborn are needed.
     Vulnerability of the developing fetus to lead exposure arising from transplacental  trans-
fer of  maternal  lead is discussed in Chapter 10.  This process starts at the end of  the first
trimester.  Umbilical cord blood studies involving mother-infant pairs have repeatedly shown a
correlation between maternal and fetal blood lead levels.
     Further  suggestive  evidence,  cited  in  Chapter 12,  has  been advanced  for  prenatal  lead
exposures of  fetuses  possibly  leading to later  higher instances  of  postnatal  mental  retarda-
tion among the affected offspring.   The available data are insufficient  to  state with any cer-
tainty that such effects occur or to determine with any precision what levels of lead exposure
might be  required prior to or during pregnancy in order to produce such  effects.
     Studies have demonstrated that women in general,  like children,  tend to show a heightened
response  of  erythorcyte protoporphyrin  levels  upon exposure  to  lead.   The exact reason  for
this heightened  response  is not known but may relate  to  endocrine differences  between men and
women.
     Middle-Aged White Males (Aged 40-59) as a Population at Risk
     Recently-emerging  epidemiological  evidence  indicates that  increased blood pressure  is
associated with  blood  lead  concentrations ranging from >30-40 ug/dl  down to blood lead levels
possibly  as  low as  7 ug/dl.   This  relationship appears  to  be particularly  significant  for
middle-aged white males  (aged  40-59),  although a considerable degree of uncertainty  surrounds
the statistical  analyses  of the studies giving  rise  to  this  conclusion.   A detailed critique
of  the  various analyses  which  have been  performed on the available epidemiological  studies
concerning the  blood  lead/blood  pressure relationship, as well as a discussion of the plaus-
ible  biological  mechanisms  underlying  this  relationship, are  presented in Section 1  of  the
Addendum to this document.
     The  specific magnitudes of  risk obtained for serious cardiovascular outcomes in relation
to  lead exposure, estimated  on the  basis  of lead-induced blood pressure  increase,  depends
crucially upon  the  size  of  the coefficients estimated for the blood  lead/blood pressure asso-
ciation.  Given the fact that significant uncertainty  exists in regard to the most appropriate
blood-lead blood-pressure coefficient(s) to  use in attempting to project  serious  cardiovas-
cular outcomes,  the  further analysis of additional  large-scale epidemiological  data  sets will
be necessary in order to resolve more precisely the quantitative relationship(s) between blood
lead  and  blood pressure.   It  is possible,  however,  to  identify at this  time  the  population
subgroup of middle-aged white males (aged 40-59)  as being yet  another group at general  risk in
terms of manifesting notable health effects in response to lead exposure.
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     Description of the United States Population in Relation to Potential  Lead Exposure  Risk.
In this section,  estimates  are provided of the number of individuals in those segments  of  the
population which  have  been  defined as being potentially  at  greatest risk for lead exposures.
These segments  include  preschool  children (up to 6 years of age),  especially those living in
urban settings, women of child-bearing age (defined here as ages 15-44), and white males,  aged
40-59.  These  data,  which  are presented below in Table 1-19, were obtained from a provisional
report by  the  U.S.  Bureau  of  the  Census (1984).  Data from the 1980 Census  indicates  that
approximately  61  percent of the populace lives  in  urban areas (defined as central cities  and
urban  fringe).   Assuming that  the 61 percent  estimate  for  urban  residents also  applies to
children of preschool age,  then approximately 15,495,000 children of the total listed in Table
1-19  would  be  expected  to  be  at  greater risk  by virtue of  higher lead exposures generally
associated with their living in urban versus non-urban settings.  (NOTE:  The age distribution
of the percentage of urban residents may vary between SMSA's.)
     The risk  encountered with exposure to lead may be compounded by nutritional deficits (see
Chapter 10).   The most commonly seen deficit is iron deficiency, especially in young children
less  than  5 years of  age  (Mahaffey and Michael son, 1980).   Data available from the National
Center for  Health Statistics for 1976-1980  (Fulwood  et al., 1982)  indicate that  from 8 to 22
percent of  children  aged 3-5 may  exhibit  iron  deficiency, depending upon whether this condi-
tion  is  defined  as  serum  iron  concentration  (<40 ug/dl)  or as transferrin saturation  (<16
percent),  respectively.   Hence, of  the  22,029,000 children ^5 years of  age (Table 1-19), as
many  as 4,846,000 would be expected  to  be  at increased  risk,  depending  on their exposure to
lead, due to  iron deficiency.
      As pointed out  in  the preceding  section, the  risk to pregnant women  is mainly due to  risk
to  the  conceptus.    By dividing  the  total  number  of  women  of  child-bearing age  in   1984
(56,602,000)  into the  total  number  of  live births  in  1984  (3,697,000;  National Center for
Health Statistics,  1985),  it may  be  seen that approximately 7 percent of  this  segment of the
population  may be at increased  risk at any given  time.
      As  for white males,  aged 40-59,  defined as  being at  risk  notably for increased blood
pressure  in association with elevated blood lead levels,  approximately 20  million  individuals
can  be estimated  to  be at potential  risk based  on the  1980 Census data.
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         TABLE 1-19.   PROVISIONAL ESTIMATE OF THE NUMBER OF INDIVIDUALS IN URBAN AND
             RURAL POPULATION SEGMENTS AT GREATEST POTENTIAL RISK TO LEAD EXPOSURE
Population segment
Preschool children
Total
Women of
child-bearing age
Total
White males
Total
Actual age,
(yr)
0-4
5
6
15-19
20-24
25-29
30-34
35-39
40-44
40-44
45-49
50-54
55-59
Total number in U.S.
population
(1984)
18,453,000
3,576,000
3,374,000
25,403,000
9,019,000
10,481,000
10,869,000
10,014,000
9,040,000
7,179,000
56,602,000
6,064,000
4,960,000
4,600,000
4,760,000
20,384,000
Urban
population*
11,256,000
2,181,000
2,058,000
15,495,000
5,502,000
6,393,000
6,630,000
6,109,000
5,514,000
4,379,000
34,527,000
3,699,000
3,026,000
2,806,000
2,904,000
12,435,000
*An urban/total ratio of 0.61 was used for all  age groups.   "Urban"  includes central  city
 and urban fringe populations (U.S.  Bureau of the Census,  1983).
Source:   U.S.  Bureau of the Census (1984), Table 6.

1.13.7  Summary and Conclusions
     Among the  most significant  pieces  of  information and conclusions that  emerge  from the
present human health risk evaluation are the following:

     (1)  Anthropogenic activity  has clearly  led to vast  increases of lead  input  into
          those environmental compartments  which serve  as media (e.g.,  air, water, food,
          dust, and soil, etc.) by which significant human exposure to lead occurs.  Cur-
          rent blood levels  of  populations in industrialized societies  best reflect this
          impact of man's  activities,  such lead levels  being many fold  higher than blood
          lead  levels  found in  contemporary populations  remote  from industrial  activi-
          ties.
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(2)  Emission of lead into  the  atmosphere,  especially through leaded gasoline com-
     bustion, is of  major  significance  in  terms of  both the movement  of lead to
     other environmental compartments and the  relative  impact of such emissions on
     the  internal  lead  burdens  in  industrialized human  populations.   By means of
     both mathematical  modeling of available  clinical/epidemiological  data by EPA
     and the isotopic tracing of lead  from gasoline  to the atmosphere to  human  blood
     of  exposed  populations,  the  size  of  atmospheric  lead  contribution to  human
     blood  lead  levels  in  industrialized areas  is estimated to be  25-50  percent.

(3)  Given  this  magnitude  of  relative  contribution to human external and  internal
     exposure, reduction in levels  of  atmospheric lead would then result  in signifi-
     cant widespread  reductions  in  levels of lead  in human  blood (an outcome  which
     is  supported  by careful analysis  of the  NHANES II  study data).  Reduction  of
     lead  in food  (added  in the course  of harvesting,  transport,  and  processing)
     would  also  be  expected  to produce significant widespread  reductions  in  human
     blood  lead  levels  in the United States, as  would  efforts  to decrease the num-
     bers  of American children residing in  housing with  interior or exterior lead-
     based paint.

(4)  A  number of adverse effects in humans and other species are clearly associated
     with  lead exposure  and,  from an  historical perspective,  the observed "thres-
     holds"  for  these various effects (particularly neurological and heme biosynthe-
     sis  effects)  continue to decline  as more  sophisticated  experimental and clini-
     cal  measures  are employed  to detect more subtle, but  still significant effects.
     These   include  significant alterations  in  normal  physiological functions  at
     blood  lead  levels  markedly below  the  currently accepted 25 ug/dl "maximum safe
     level"  for  pediatric  exposures.

(5)  Preceding  chapters  of this  document  demonstrate  that young  children  are  at
     greatest risk for  experiencing lead-induced  health effects, particularly  in the
     urbanized,  low  income segments of  this pediatric population.  A second group at
     increased risk  is pregnant women,  because of  exposure  of the  fetus to lead in
     the absence of  any effective  biological (e.g., placental) barrier during  gesta-
     tion.   A third group at  increased risk  would  appear to  be white males, aged
     40-59, in that  blood  pressure elevations  appear to  be significantly correlated
     with elevations in blood lead  level  in this  group.
                                       1-159

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(6)  Dose-population response  information  for heme synthesis effects, coupled with
     information from various  blood  lead  surveys,  e.g., the NHANES  II study,  indi-
     cate  that  large  numbers  of  American children  (especially low-income,  urban
     dwellers) have blood lead levels  sufficiently high (in excess  of 15-20 ug/dl)
     that they are  clearly  at  risk for deranged heme  synthesis  and,  possibly,  other
     health effects of growing  concern  as  lead's role  as a  general systemic toxicant
     becomes more fully understood.
                                      1-160

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1.14  REFERENCES


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Beloian, A.;  McDowell,  M.  (1981)  Estimates of  lead  intakes among children up  to  5 years of
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Clark,  D.  R. ,  Jr.  (1979) Lead concentrations:  bats vs. terrestrial small  mammals collected
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De Jonghe, W. R.  A.;  Chakraborti,  D.; Adams, F. C. (1981) Identification and determination of
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Devi Prasad,  P.  V.;  Devi  Prasad,   P.  S.  (1982)  Effect of cadmium,  lead and  nickel  on three
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Jackson, D.  R. ; Watson,  A.  P.  (1977)  Disruption  of  nutrient  pools  and transport of heavy
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                                             1-175

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  LEAD EFFECTS ON CARDIOVASCULAR FUNCTION, EARLY
DEVELOPMENT, AND STATURE:   AN ADDENDUM TO U.S.  EPA
       AIR QUALITY CRITERIA FOR LEAD (1986)
                  September, 1986
   Environmental Criteria and Assessment Office
     Office of Research and Development (ORD)
       U.S. Environmental Protection Agency
         Research Triangle Park, NC  27711

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                                   CONTENTS
                                                                          Page


1.  INTRODUCTION 	      1

2.  LEAD EFFECTS ON THE CARDIOVASCULAR SYSTEM 	      1
    2.1   Cardiotoxic Effects in Overtly Lead-Intoxicated
          Human Adults and Chi 1 dren 	      1
    2.2   Epidemiologic Studies of Blood Lead/Blood Pressure
          Relationships 	      2
    2.3   Mechanisms Potentially Underlying Lead-Induced
          Hypertension Effects 	     18
          2.3.1   Role of Disturbances in Ion Transport by Plasma
                  Membranes 	     18
          2.3.2   Role of Renin-Angiotensin in Control of Blood
                  Pressure and Fluid Balance; Possible Role of
                  Kallikrein-Kinin in Control of Blood Pressure 	     20
    2.4   Experimental Studies of Lead Effects on Blood Pressure
          and the Renin-Angiotensin System 	     22
          2.4.1   Acute In Vivo Lead Exposure 	     22
          2.4.2   Chronic Lead Exposure 	     23
          2.4.3   Renin Secretion by Kidney Slices In Vitro 	     26
          2.4.4   Effects of Lead on Vascular Reactivity	     26
          2.4.5   Effects of Lead on Noradrenergic Hormones 	     27
          2.4.6   Effects of Lead on Cardiac Muscle 	     27
    2.5   Summary of Lead-Related Effects on the Cardiovascular
          System	     29

3.  EFFECTS OF LEAD ON DEVELOPMENT AND GROWTH 	     31
    3.1   Fetal Exposure Effects 	     31
          3.1.1   Results of Recent Human Studies 	     32
          3.1.2   Interpretation of Findings from Human Studies 	     40
    3.2   Effects of Lead on Postnatal Growth 	     49
          3.2.1   Epidemiologic Observations 	     49
          3.2.2   Animal Toxicology Studies 	     51
    3.3   Possible Mechanisms of the Effects of Lead on Growth
          and Development 	     52
          3.3.1   Genetic and Extrinsic Factors 	     52
          3.3.2   Endocrine Factors 	     52
          3.3.3   Additional Factors Affecting Growth	     55
    3.4   Summary and Conclusions Regarding Lead Effects on
          Growth and Development 	     55

4.  REFERENCES 	     57
                                      11

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                                LIST OF FIGURES


Number                                                                   Page

 A-l     Systolic blood pressure for 7371 middle-aged men
         categorized according to blood lead concentration 	       11
 A-2     Relationships among variables affecting 6-month MDI and
         PDI scores, as revealed through structural  equation
         analysis 	       37
                                LIST OF TABLES


Number                                                                   Page

 A-l     Body weight, blood pressure, and lipid values of lead
         workers and referents 	      5
 A-2     Systolic blood pressure means in relation to blood lead
         concentrati ons 	      7
 A-3     Coefficient for the natural log of blood lead concen-
         tration (In PbB) vs. blood pressure (BP) in men with
         and without adjustment for site variables 	     16
 A-4     Estimates of relative risk of pre-term delivery (by last
         menstrual date) based on multiple logistic analysis of
         maternal blood lead concentrations at delivery 	     34
 A-5     Covariate-adjusted Bayley Mental Development Index
         scores of infants classified by umbilical cord blood lead
         1 eve Is 	     36
 A-6     Partial linear regression coefficients for 24-month
         Bayley MDI scores against each blood lead measure, with
         and  without maternal IQ in the model 	     39
 A-7     Lead-related variance increments for neonatal neurological
         measures  	     40
 A-8     Percent additional  variance accounted for by different
         indices of lead exposure for various neurobehavioral tests,
         as determined by stepwise multiple regression analyses
         after correcti on for confoundi ng 	     41
 A-9     Summary of recent studies on the relationship between
         prenatal  lead exposure  and congenital malformations  	     41
 A-10   Summary of recent studies on the association of prenatal
         lead exposure with  gestational age and birth weight  	     44
 A-ll   Summary of recent studies on the relationship between
         prenatal  lead exposure  and  Bayley Mental Development
         Index  scores  	    47

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 AUTHORS AND CONTRIBUTORS


      The following  people served  as  authors  or  otherwise contributed  to
 preparation of  the  present addendum.   Names  are listed in  alphabetical  order.

 Dr.  J.  Michael  Davis
 Environmental Criteria  and Assessment  Office
 U.S.  Environmental  Protection  Agency
 Research Triangle Park,  NC 27711

 Dr.  Lester  D. Grant,  Director
 Environmental Criteria  and Assessment  Office
 U.S.  Environmental  Protection  Agency
 Research Triangle Park,  NC 27711

 Dr.  Peter Petrusz
 Department  of Anatomy
 University  of North Carolina School of Medicine
 Chapel  Hill, NC   27514

 Dr.  David J. Svendsgaard
 Health  Effects Research  Laboratory
 U.S.  Environmental Protection  Agency
 Research Triangle Park, NC  27711

 Dr.  Winona  Victory
 Applied  Pathology Section
 Biometry and Risk Assessment Program
 National Institute of Environmental Health Sciences
 Research Triangle Park, NC   27709

 Dr.  David E. Weil
 Environmental Criteria and Assessment Office
 U.S. Environmental Protection Agency
 Research Triangle Park, NC  27711


 REVIEWERS

     Drafts of  this Addendum were  circulated for public comment and for review
by  the  Clean Air Scientific  Advisory Committee (CASAC)  of  EPA's  Science
Advisory Board  (SAB).   Members of  the  CASAC  Subcommittee on Lead listed in the
 front matter  of the main  1986 document Air Quality Criteria  for Lead also
reviewed the present Addendum to the 1986~~3ocument.
                                      iv

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1.    INTRODUCTION

     The 1977  EPA criteria document,  Air Quality  Criteria  for Lead  (EPA-600/8-77-071)  has
been updated and  revised  pursuant to Sections 108-109 of  the  Clean Air Act, as  amended,  42
U.S.C.  7408 and  7409.   As part of this process,  EPA released  two external  review  drafts  of
the  revised  Criteria Document, Air  Quality Criteria  for  Lead  (EPA-600/8-82-028A&B),  which
were made  available  both for public  comment and  peer  review  by  the Clean Air  Scientific
Advisory Committee  (CASAC) of the Agency's  Science Advisory Board.   A final version  of  the
updated  criteria  document incorporating  revisions  made in  response to public  comments  and
CASAC  review  of earlier  drafts  has  been completed  (U.S.  EPA,  1986),  and will  be  used as a
basis  for  review  and,  as  appropriate,  revision of  the  National  Ambient Air Quality Standard
(NAAQS) for lead.
     Not fully  evaluated   in  the  revised  Criteria  Document, however,  are  recently published
papers concerning: (1) the relationship between blood lead levels and cardiovascular effects;
and  (2)  lead  exposure effects on early development and stature.   The present Addendum to  the
revised  document, Air Quality Criteria for  Lead  (U.S.  EPA,  1986),  evaluates newly published
information concerning both of these topics.
2.  LEAD EFFECTS ON THE CARDIOVASCULAR SYSTEM
     Lead  has  long  been reported to be associated with cardiovascular effects, in both human
adults and children.   This section assesses pertinent  literature  on the subject, including:
(1) studies of cardiotoxic effects in overtly lead-intoxicated individuals; (2) epidemiclogic
studies  of  associations  between  lead  exposure  and  increased  blood  pressure,  including
observations  for non-overtly  intoxicated  subjects;  (3) toxicologic data  providing  experi-
mental  evidence  for  lead-induced  cardiovascular effects  in animals and  (4) information on
possible mechanisms of  action underlying lead's cardiovascular effects.
2.1  Cardiotoxic Effects in Overtly  Lead-Intoxicated Human Adults and Children
     Structural  and  functional  changes suggestive of  lead-induced cardiac abnormalities have
been  described for  both  adults and children,  always  in  individuals  with clinical signs of
overt  intoxication.   For  instance,  in  reviewing  five  fatal  cases of  lead poisoning in young
children,  Kline (1960) noted that degenerative changes in  heart muscle were reported to be
the  proximate cause of death;  it  was not possible, however,  to establish that the observed
changes  were  directly due  to   lead intoxication  per se.   In another  study,  Kosmider and
Petelenz  (1962) found  that  66 percent of  a group of  adults  over  46 years old with  chronic
                                              A-l

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lead poisoning had  electrocardiographic  abnormalities,  a rate four times the adjusted normal
rate for that age group.   Additional evidence for a possible etiological  role of higher level
lead exposure  in  the  induction of disturbances in cardiac function derives from observations
of the disappearance of electrocardiographic abnormalities following chelation therapy in the
treatment of many cases  of lead encephalopathy (Myerson and Eisenhauer,  1963; Freeman, 1965;
Silver  and  Rodriguez-Torres,  1968).   The  latter investigators, for example,  noted  abnormal
electrocardiograms  in 21   (70 percent)  of  30  overtly  lead-intoxicated  children  prior  to
chelation therapy,  but abnormal  electrocardiograms  remained for only four (13 percent) after
such  therapy  (Silver and Rodriguez-Torres,  1968).   None  of the  above  studies  provide
definitive  evidence that  lead  induced the observed  cardiotoxic effects, although  they are
highly  suggestive  of  an  etiological role  of  lead in producing  such effects.   Some  recently
reported  human  autopsy  study  results  (Voors  et  al.,  1982)  showing  associations  between
heart-disease mortality  and elevated  aortic lead levels also point  toward possible involve-
ment of lead in cardiotoxic disease processes.
2.2  Epideiniologic Studies of Blood Lead/Blood Pressure Relationships
     Hypertension or, more  broadly,  increased blood pressure represents the single main type
of cardiovascular effect  long  studied as possibly being associated with excessive lead expo-
sure.  As  long  ago  as 1886, Lorimer  reported  that  high blood lead levels increased the risk
of hypertension.   However,  from  then until  recently, relatively mixed  and  often apparently
contradictory  results have  been  reported  concerning  lead-hypertension effects.  That  is,
numerous  investigators  reported  significant  associations   between  hypertension  and  lead
poisoning (Oliver, 1891;  Legge, 1901; Vigdortchik, 1935; Emmerson, 1963; Dingwall-Fordyce and
Lane, 1963;  Richet  et al.,  1966; Morgan, 1976; Beevers, et al., 1976),  whereas other studies
failed to  find  a statistically significant association at p <0.05  (Belknap,  1936; Fouts and
Page,  1942;  Mayers,  1947;  Brieger and  Rieders,  1959; Cramer  and Dahlberg,  1966;  Malcolm,
1971; Ramirez-Cervantes  et  al.,  1978).   The  potential contribution of  lead  to hypertension
was  difficult  to resolve based  on the  results  of  such studies, due to many methodological
differences and  problems  (e.g.,  lack of comparable definitions of lead  exposure and prospec-
tive control populations, variations  in how hypertension was  defined or measured as the key
health endpoint, etc.).
     In contrast  to  the  generally confusing array of results derived from the above studies,
a more consistent pattern of results has begun to emerge from recent investigations of rela-
tionships between lead exposures and increases in blood pressure or hypertension.  A variety
                                             A-2

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of  study designs  or approaches  have  been  used  in the  recent  studies  and  relationships
examined between a wide  range of blood lead levels and increases in blood pressure in various
clinically-defined, occupationally-exposed, or general population groups.
     In a case-control pilot study of clinically-defined groups, Khera et al.  (1980)  measured
lead and cadmium levels  in single-draw blood and urine samples from 50 patients being seen at
General Hospital, Birmingham, UK for moderate or severe cardiac condition and/or hypertension
and  from 75 other  patients with  no known cardiovascular  symptoms.   After  excluding  small
numbers  of  women,  non-Caucasians,  and patients <30  yrs old,  data for the  remaining 38 male
cardiovascular patients were  compared to those for  48  matched normotensive controls.  Urine
metal  levels  were highly  variable (24  hr samples  being  needed to  overcome  diurnal varia-
tions),  but average  levels were higher  in cardiovascular  (PbU x = 0.34 u mol/1) than normo-
tensive  (PbU x  = 0.27 u mol/1) patients.   The cardiovascular patients also had higher blood
lead  levels (x  = 2.17,  range 0.43-4.0 u mol/1) than the normotensives (x = 1.4, range 0.58 -
2.2  |j mol/1).*  Hypertensive  patients  (N = 13)  had somewhat  higher mean  blood lead levels
than  other  cardiovascular  disease  patients (N = 25), and both of these groups had distinctly
higher  PbB  values than  the 48  normotensive  subjects.   Furthermore,  blood lead levels were
consistently notably  higher for cardiovascular patients than  normotensive  subjects when com-
pared  within  4 different  age  groups  (i.e.,  30-39, 40-49,  50-59,  and >60 yrs).   The authors
noted  that  smoking habits were net determined well  enough to  allow for  firm  conclusions, but
overall  results  showed little  change  for smoking and lead  levels, whereas cadmium levels were
distinctly  higher  in smokers  and ex-smokers.  These  descriptive pilot  study  results, not
formally analyzed  for statistical  significance, qualitatively suggest higher  lead burdens in
cardiovascular   disease  (especially   hypertensive)  patients  than  in  matched   normotensive
control  subjects,  but do not permit  any  firm conclusions as to whether lead causally contrib-
uted to  the etiology  of the cardiovascular disease states.
      Batuman  et  al.  (1983),   in  another  study of  clinically-defined  groups,   evaluated
chelatable  lead burdens  in 48 male patients seen  for essential  hypertension at a  Veterens
Administration  Hospital  in New Jersey.  Patients  (N =  27)  having  essential hypertension with
reduced  renal  function  (serum creatinine  level  >1.5  mg/dl)  had  significantly (p <0.001)
larger amounts  of  chelatable  lead  (x =  860  ± 101 ug Pb/3  days)  in their urine after EDTA
challenge  than did 21 essential hypertension  patients  without renal  disease  (x  = 340 ± 39 ug
Pb/3 days).  EDTA  test  urine  lead  levels  for the latter  normal renal  function  hypertension
 *Note that 1 u  mole/1  s 20.7 ug/dl blood  lead.   Thus, the mean blood lead levels (x) s 44.9
  ug/dl  for  the  cardiovascular patients  and x  = 29.0 ug/dl  for the  normotensive subjects.
                                              A-3

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patients  did  not  differ significantly  from  22  control patients  with  known renal  failure
etiologies.   The authors interpreted their study as suggesting a possible etiological  role of
lead  in  the renal disease of  some  patients designated as having  essential  hypertension  (in
this  case patients  not currently  occupationally  exposed  to  lead  but  having  lead  burdens
indicative  of  likely past high exposures).   The  fact that control patients with  known  non-
gout  etiology  did  not  have elevated  lead levels,  as  well  as  evidence from other  studies
(Wedeen,  1982;  Wedeen et al.,  1985; Weeden,  1986), indicate  that  renal  failure  associated
with  hypertension did not  result  in impaired  renal  excretion  of Pb and  consequent increased
accumulation of greater  lead  body stores as a possible explanation for the observed results.
     Another approach  employed  in   recently  reported  studies  of  blood-lead  blood-pressure
relationships has been  the  study  of groups of  workers  with  varying levels of lead exposure.
As part of the Glostrup  study in Denmark, Kirkby and Gyntelberg (1985) evaluated  the coronary
risk  profiles for  96 heavily-exposed lead smelter workers employed between 9 and 45 years in
comparison  to  that  of a non-occupationally exposed reference group matched with  respect to
age,  sex,  height,  weight,  socioeconomic status,  and alcohol/tobacco  consumption.   The  lead
workers had mean  blood  lead (PbB x) levels of 51 ± 16  (S.O.) ug/dl, while  the  mean for the
referent  control group  was  11  ± 3 (S.D.) ug/dl.  Blood pressure was taken both with the  sub-
ject  in the supine position (with a random zero sphygmomanometer) and in  the sitting position
(with  a  more  usual  mercury  sphygmomanometer);  systolic ankle and arm blood  pressure levels
were  also measured  by the  Doppler ultrasound technique; resting electrocardiograms with  nine
leads  were  recorded  and coded  according  to the  Minnesota  Code by  a  trained expert;  and
participants were  administered  an extensive  questionnaire including  questions on  subjective
symptoms, chest pain, alcohol  and tobacco  usage, cardiovascular  disease among relatives and
other  pertinent information.   Table  A-l shows the  results obtained  for  the lead workers and
the referent group for body weight,  blood pressure measurements, and lipids.
     Statistical analyses of results were carried out by Mann-Whitney and chi-square tests of
significance for differences between the comparison groups.   No significant differences  were
obtained  for alcohol  consumption,  smoking habits, or other  life-style factors;  nor was  body
weight significantly different between the groups.  In regard to blood pressure determined by
sphygmomanometer,  no significant differences were obtained (at p <0.05) for systolic pressure
in  either the  supine  or  sitting  positions, whereas  diastolic pressure was  significantly
elevated  for  lead workers  in  both  the  supine  (+4  mm Hg) and  sitting (+5 mm  Hg)  positions.
Systolic  pressure  monitored by more sensitive ultrasound techniques  was,  however, signifi-
cantly  elevated  in  the  left  (but not right)  arm and the dorsal arteries of  both right and
left  feet.   As  for  other  cardiovascular  risk  factors,  a   significantly  (p <0.01) higher
percentage  (20  percent)  of  lead workers had  ischemic electrocardiographic (ECG)  changes  than
                                             A-4

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  Table A-l.  Body weight, blood pressure, and lipid values of lead workers and referents.
                                   (NS = not significant)
Lead Employees

Body weight (kg)
Blood pressure (mm Hg)
Sitting position
Systolic
Diastolic
Supine position
Systolic
Diastolic
Ultrasound systolic pressure
Right arm
Left arm
Right dorsal artery of foot
Left dorsal artery of foot
Lipids
Total cholesterol (mg%)
Triglycerldes (mmol/1)
High-density lipoprotein cholesterol
(•8%)
Mean
78.6


135
86

135
83

135
144
165
164

247.1
1.24

50.5
SO
11.9


21
12

18
12

18
19
28
27

50.1
0.87

9.5
Referents
Mean
76.0


133
82

129
78

133
135
154
155

247.1
1.33

54.9
SO
11.2


20
11

18
12

17
19
22
23

51.6
1.33

11.6
Level of
signifi-
cance
NSa


NS
0.04

NS
0.005

NS
0.03
0.05
0.03

NS
NS

0.004
aNS = not significant at p <0.05.
bl mm Hg = 0.133 kPa.
Source:   Kirkby and Gyntelberg (1985)

did referent control  subjects (6 percent); but no  significant  differences were observed for
percentages having angina  pectoris  or intermittent claudication or  in  regard to serum lipid
levels  (except  for  lower  mean high-density  lipoprotein  cholesterol for  the lead workers).
The lead workers  with ECG changes had significantly higher blood pressure levels than refer-
ents  with  ECG changes  for both  systolic  and diastolic measures in both  supine and sitting
positions  (p  <0.05  for all  four  comparisons).   The  authors  concluded that  long-term  lead
workers in this study have higher coronary risk profiles than a comparable referent group and
that  these  findings may  indicate a  greater risk for  major  cardiovascular diseases,  such as
myocardial infarction or stroke.
     Overall, the Kirkby and Gyntelberg (1985) study appears to have been carefully conducted
and to  have yielded results with a  considerable  degree of  internal consistency in regard to
blood-pressure determinations  obtained by  several different  procedures.  Also, these findings
do point toward higher  cardiovascular risk for lead smelter  workers, most  clearly  in terms of

                                              A-5

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increased blood pressure.  The evidence for increased blood pressure and other cardiovascular
risk  factors  being specifically  due to  lead  exposure  is less clear, given  that  a  correla-
tional analysis between blood lead levels, zinc protoporphyrin, and blood pressure  levels was
reported as yielding  no  statistically significant correlations and  the  workers  were exposed
to  other  toxic agents  in the workplace  (e.g.,  antimony,  smoke  and dust) that might  exert
cardiovascular effects.   On  the  other hand, neither did other factors with known association
with  high blood  pressure (e.g.,  body weight, smoking, etc.) explain the differences  observed
between  the lead  worker and referent  control  groups,  and  insufficient description of  the
correlational  analysis was  provided  to allow evaluation  of  its  soundness.   If lead  exposure
did  contribute to the  observed  higher blood  pressure  values seen  in the  lead  workers,  the
magnitude of  the  effect  did not  appear  to be very  large,  e.g.,  a difference of 4-5  mm Hg
diastolic increase associated with a difference in mean blood lead level  of ~40 ug/dl or 0.1-
0.125 mm Hg per (jg/dl blood  lead.
     Another recently reported study (deKort et al., 1986) examined blood pressure  in occupa-
tional ly exposed  workers  (from  a plant processing  lead and  cadmium compounds used as stabi-
lizers in the plastic industry)  in relation to a control group of workers (from a plant  where
insulation materials are produced).  Data were included only for workers employed longer than
1 yr  in  each  plant and  not  being  treated for hypertension.   Blood lead (PbB), blood cadmium
(CdB) and  urine   cadmium  (CdU) were  determined by atomic  absorption (AA)  spectrophotometry,
blood pressure by random-zero sphygmomanometer,  and  information concerning medical  history,
medications, smoking habits, and other personal characteristics by questionnaire.   Chi-square
and  two-tailed Student's t-tests  were  used to test for  significant  differences between the
comparison  groups.   Data were  included  in  the  analyses  for 53 male  workers in the  lead-
exposed group  and for  52 persons for the control  group.   The former were,  on  an average, 3.9
years older (p  <0.05)  and  had been  at work 3.9  years   longer  than control subjects,  but
smoking habits were  comparable.   Blood lead values  for the exposed group averaged  47.4  (jg/dl
(ranging up  to 60-70  ug/dl),  whereas  the  control  group  averaged 8.1 ug/dl  (none exceeding
20  |jg/dl).   Statistical  analyses  showed  blood pressure  levels  to  be  positively  correlated
with PbB and CdU but not CdB.  The correlation for systolic pressure and PbB remained signif-
icant after  controlling for  confounding  variables.   The  authors  concluded  that  a  positive
relationship existed  between blood  lead  and  blood  pressure at  levels  near   or below  60-70
ug/dl.
     Besides the  above  studies  of occupationally lead-exposed workers,  Moreau et  al.  (1982)
reported findings  for  431 male  civil service  employees (aged 24 to 55 yrs) belonging to the
Paris police  department.   For each  subject examined during a routine medical  visit (during
May, 1980 to February,  1981),  blood pressure was  measured by a mercury apparatus,  blood lead
levels determined  by AA  spectrometry,  and information on  alcohol  and tobacco usage  obtained
                                             A-6

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by questionnaire.   Statistical  analyses were carried out,  using log PbB values  which  appeared
to be normally distributed.  Significant  correlations  between blood lead and  systolic  blood
pressure were found, even after taking into account age,  wine consumption, and  tobacco  usage.
Correcting for body mass  (ratio  weight/height2) did  not  alter the results.  A weaker,  but
significant,  association was reported for  diastolic pressure in relation to  PbB levels.   In a
letter concerning the same data set, Orssaud et al.  (1985)  later reported additional  analyses
in which  systolic  blood pressure  values were adjusted for  body mass index, age,  and alcohol
consumption using  an  analysis  of  covariance.  The  results  are  summarized  in Table A-2, with
systolic blood pressure values  (both unadjusted and adjusted) grouped in relation to the same
blood lead classes used by Pocock et al. (1984), as discussed later.

      Table A-2.   Systolic blood pressure  means in relation to blood lead concentrations.
Blood
lead
(pmol/l)
<0.60
0.61-0.89
0.90-1.19
1.20-1.49
1.50-1.79
>1.80
Systolic
Mean (and 2 SE)
(mm Hg)
127 (3.6)
130 (1.8)
133 (2.4)
139 (4.8)
143 (13.6)
130 (5.4)
blood pressure
Adjusted
mean
129
130
132
138
142
129

No. of
subjects
46
212
126
34
7
6
Source:  Orssaud et al. (1985)

     Overall,  the  blood  pressure means differ  significantly  (p  <0.001) by blood lead group,
increasing consecutively from the first group (<0.60 (jmol/1 = 12.4 pg/dl) to the fourth (1.20
to 1.49 n mol/1 z  24.8 to 30.8 M9/dl).  The means for the  last two groups (>1.50 \i mol/1 = 31
|jg/dl)  are  based  on  very small  N's and were  not viewed by the  authors  as yielding useful
information.   The  overall correlation between blood lead level and systolic pressure was 0.23
(p  <0.001);   correlations  for  the   age  classes 24  to  34 years  (N = 145),  34 to  44 years
(N = 143),  and 45 to  55  years  (N = 142)  were 0.29  (p  <0.001),  0.20 (p  <0.05),  and 0.14
(N.S.),  respectively.   Adjusting for alcohol consumption  and body mass index, it was noted,
did  not  alter these results.  The  authors concluded that  blood pressure was related to blood
lead  values,   the  correlation  being  highest  in young  subjects  but  decreasing with age.  In
general, the  results are highly  suggestive of increases  in systolic  pressure being associated
with  blood  lead  values  in adult males across  a range of ~12 to  30 ng/dl»  the increase  not
being  particularly large (about 9  mm Hg  or 0.5 mm Hg  per ng/dl blood lead).   However,  it is
not  clear as  to  why  tobacco consumption (although measured) was  apparently not included in

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the  statistical  analyses and to what  extent  its inclusion would have affected  the  reported
results.  Nor  is  it  completely  clear as to what results were obtained for diastolic  pressure
in  the  analyses reported  on  later by  Orssaud et  al.  (1985).   For  example,  do the  weaker
associations for blood  lead-diastolic  pressure reported by Moreau et  al.  (1982) become  non-
significant or no longer evident when adjustments arc made for other  factors,  as  evaluated in
the analyses reported by Orssaud for systolic  pressure results?
     More recently, Weiss et al. (1986) examined blood-lead blood-pressure relationships  in a
longitudinal  study of  a  cohort of 89  Boston, MA  policemen.   During baseline  examination,
blood  lead  determinations  were obtained  (AA spectrophometry)  and  three consecutive blood
pressure  measurements  taken,   using  a  random-zero  instrument.   With  the  subject  seated,
systolic  blood pressure and  fifth  phase diastolic  pressure were  measured on the left  arm.
Triplicate  blood  pressure measurements were also taken  at years 3,  4,  and 5.   Multivariate
analyses showed that, after correction for previous  systolic blood  pressure, body mass index,
age,  and smoking,  high blood  lead level was a significant predictor  of subsequent blood
pressure  elevation.   More  specifically,  auto-regressive analyses were  performed for blood
lead  and blood pressure  data  from 70  subjects  providing 162 pairs  of  data  (by consecutive
examination)  for  the systolic  regression.   There was a  significant  association (p  = 0.036)
between  high  (£30  pg/dl)  blood  lead and subsequent  elevation  in blood pressure  (coefficient
= 5.804) but not for low (20 to  29 |jg/dl) blood lead (coefficient = 0.224).  Similar  analyses
for 172 pairs of data from 72 subjects for diastolic pressure revealed no significant associ-
ation between blood lead and diastolic pressure.   Further iterative cross-validation  analyses
(assessing  the impact  of  a few influential  data points)  improved the  relationship between
systolic pressure  and other independent variables (e.g., body mass index, age, etc.) but did
not dramatically alter the relationship with high blood lead (coefficient = 4.467, p  <0.097).
Overall,  the  authors concluded  that these data  suggest a  relationship between blood  lead
levels  and  systolic  (but  not  diastolic) blood  pressure.   The stronger association found
between  lead  and systolic  pressure than between lead and diastolic  pressure is consistent
with  the observations  by  Moreau  et al.  (1982)  and  Orssaud  et al.   (1985)  for   Paris civil
servants.  However, the latter had generally lower blood lead levels  than the  high lead group
of  Boston policemen  (£30  Mg/dl) for which Weiss  et al.  (1986)  found significant blood lead-
systolic pressure associations.
     One  other American study,  available  thus far  only in abstract  form (Hodgson  et  al.,
1985),  evaluated  blood-lead  blood-pressure  relationships  in  a cohort  of lead   workers  and
controls  (all  white  males  of similar socioeconomic  status).  Separate equations were gener-
ated for systolic and diastolic  blood pressure as dependent variables and blood  lead  and  zinc
protoporphyrin levels as independent variables, controlling for age,  body mass index, average

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daily alcohol consumption, smoking,  exercise  frequency,  and an index  of  lifetime  cumulative
lead exposure  (for lead workers).   Overall  R2  ranged  from 0.09  to 0.30; no index of  lead
exposure  accounted for  more than  2 percent  of the total  variance;  and  none  of the  lead
coefficients were significant (even at p <0.10).   Unfortunately,  insufficient information was
reported  in  the  published  abstract to allow adequate assessment  of  important aspects  of the
study (e.g., size of the study groups, how well matched they were, etc.).
     In addition  to the above  recent studies of clinically-defined populations or  specific
worker  cohorts,  Kromhout and Couland (1984)   and  Kromhout et al. (1985)  evaluated  a  cohort
drawn from the more general population.   More  specifically, data on trace metals  and  coronary
disease risk  indicators  were collected in 1977  for  152  men (aged 57-67 yrs)  in the town of
Zutphen,  The Netherlands.   Blood  lead,  blood  cadmium,  serum zinc,  and serum copper  were
determined  by AA spectrometry;  serum lithium was determined  by  flame  emission spectrometry.
Also,  the following coronary  heart disease  risk  indicators were measured:   total  and  high
density  lipoprotein cholesterol,  smoking  habits,  Quetelet  index  (weight/height2),  and  sys-
tolic  and diastolic blood  pressure.   A  standard  protocol and mercury sphygmomanometer was
employed  by a single internist  in obtaining blood pressure readings from  the right arm while
the  subjects  were in a  supine  position.   The  first reading was  taken  at the beginning, and
the  second  and  third at the end of the medical examination; only the systolic and diastolic
(fifth  phase)  values of the third  reading were  recorded.   Resting  heart  rate was calculated
from  an  electrocardiogram.    Statistical  analyses  were  carried  out  using SPSS  package
programs,  including calculation of correlation  coefficients,  ANOVA, and multiple regression
analyses.   For  skewed  distribution variables, log  transformations were used, but no differ-
ences were  found between analyses  using  transformed or  untransformed  variables.   The levels
of  coronary heart  disease  risk  indicators were generally  high  in  the  elderly  cohort; and
blood  lead  levels exceeded 30  ug/dl  in 8.6  percent and 40 ug/dl in 1.3  percent of the  study
group.   In  addition to several significant associations  found between  the other metals and
various  risk indicators,  blood lead was found  to  be  statistically  significantly related to
cigarette smoking (p <0.03), but  more  markedly related  to both  systolic  and  diastolic  blood
pressure.   Using multiple  regression  analyses  correcting for age  and body  mass index, the PbB
regression  coefficients  were   reduced  from 0.24  (p <0.01) to  0.21  (p  <0.01)  for systolic
pressure  and from 0.18  (p <0.05)  to 0.15 (p  <0.05) for diastolic.   However, in testing the
stability of the results by  excluding the highest blood  lead  (52.5 M9/dl)  subject with hyper-
tension (218/138  mm  Hg),  a borderline significant  correlation was  found between blood lead
and systolic  pressure, whereas the  blood  lead-diastolic pressure coefficient became  non-
significant.   Neither  blood lead  coefficient  for  systolic or diastolic  pressure  was  signif-
icant  after  multiple   regression  analyses were conducted  that  include other  determinants
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(e.g.,  age  and  body mass  index)  in  the  model  when  the data  for the  same  highest-lead
individual  was  excluded;  but the  coefficients between  blood  pressure  and age or body mass
index were unaffected by  his  exclusion.   The authors concluded that blood  lead is  probably  a
less important determinant of blood pressure than  age or body  mass index.
     The above  recent studies provide  generally consistent evidence of  increased blood pres-
sure  being associated  with elevated  lead body burdens  in adults, especially as  indexed by
blood lead levels  in various  cohorts  of working men.   None of  the individual  studies  provide
definitive evidence  establishing  causal  relationships between  lead  exposure and  increased
blood pressure.   Nevertheless,  they collectively  provide considerable qualitative evidence
indicative of significant associations  between blood lead and  blood pressure  levels.   Partic-
ularly  striking  are the  distinct  dose-response  relationship  seen for  systolic pressure
(correcting for  age, body  mass,  etc.)  by Moreau et al.  and the findings of significant asso-
ciations between  blood  lead  and  systolic pressure after extensive and conservative statisti-
cal analyses  by Weiss  et al.   However, estimates  of quantitative relationships between blood
lead  levels and blood  pressure  increases derived  from such study results  are subject  to much
uncertainty,   given the  relatively small  sample sizes and  limited  population  groups  studied.
Two larger-scale  recent  studies  of general  population groups,  reviewed next,  provide better
bases for estimation of quantitative blood-lead blood-pressure relationships.
     In one  such recent  study,  Pocock et al.  (1984)  evaluated  relationships  between blood
lead concentrations,  hypertension, and renal function indicators in a clinical  survey  of  7735
middle-aged men  (aged 40-49)  from 24 British  towns.   Each man's blood  pressure was measured
while seated  twice  in  succession by means  of a  London School  of Hygiene sphygmomanometer.
Diastolic pressure  was  recorded  at phase V  disappearance of  sounds.  The  mean  of  the  two
readings of  blood pressure was adjusted  for observed  variation within each town  to  correct
for any differences  among three  observers.   Results  for 7371 men  included  in  data  analyses
indicated  correlation   coefficients of  r = +0.03  and  r = +0.01  for  associations  between
systolic and  diastolic  blood pressure,  respectively,  and  blood  lead  levels.   The  systolic
blood pressure correlation, though small in magnitude,  was nevertheless  statistically  signif-
icant at p <0.01.  However,  analyses  of covariance using  data for men  categorized according
to blood lead concentrations  only suggested  increases in  blood  pressure  at  lower  blood  lead
levels;  no  further  significant  increments  in  blood  pressure  were observed at  higher blood
lead levels either before or after adjustment for  factors such as age, town,  body mass index,
alcohol  consumption, social  class,  and observer (see  Figure A-l).   Evaluation of  prevalence
of  hypertension defined as  systolic  blood  pressure  over 160 mm  Hg  revealed  no significant
overall  trend;  but  of  those  men with  blood lead levels over 37  ug/dl, a larger  proportion
(30 percent)   had hypertension when compared with the proportion  (21 percent)  for all  other

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                       152
                       160 -
                       148
                     S
                       142
I
                                      ii        ii
                               UNADJUSTED MEAN b 98 PERCENT CONFIDENCE LIMITS

                              | MEAN ADJUSTED FOR AGE. TOWN. BODY MACS. ALCOHOL
                               CONSUMPTION. SOCIAL CLASS. AND OBSERVER
                                                                           T
1.8
1
74
1
                            418(21)
                                     675(20)    349(25)    95(251     22(17)     22(30)
                                    NUMBER(PERCENT) WITH SYSTOLIC BP >160 mmHg
                     Figure A-1. Syitolic blood pressure for 7,371 middle-aged men categorized according
                     to blood lead concentration.
                     Conversion: SI to customary units - Lead: 1 /imol/Ls20.7 jig/100 ml.
                     Source: Pocock et al. (1984).
men  combined (p =0.08).   Similar results  were obtained  for diastolic  hypertension defined as
>100  mmHg,  i.e.,  a  greater  proportion  (15 percent) of  men  with blood lead  levels over 37
ug/dl  had diastolic  hypertension in  comparison with the proportion  (9 percent) for  all  other
men   (p =0.07).    Pocock  et al.  (1984)  interpreted  their  findings  as  being  suggestive  of
increased hypertension at  blood lead levels  over  37 pg/dl,  but  not  at  lower concentrations
typically found  in  British  men.   However, more recent analyses reported  by  Pocock  et al.
(1985) for  the  same data indicate  highly statistically  significant  associations  between both
systolic  (p =0.003)  and  diastolic  (p <0.001)  blood pressure  and  blood  lead  levels,  when
adjustments  are  made  for variation  due to  site (town)  in multiple  regression  analyses.  The
regression coefficients for log  blood lead versus  systolic and  diastolic pressure were +2.089
and +1.809,  respectively, when adjusted for town as well as body mass, age,  alcohol, smoking,
social class and  observer.   Noting the  small magnitude of  the  association observed and  the
difficulty   in  adjusting  for  all   potentially  relevant  confounders,  Pocock  et  al   (1985)
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cautioned against prematurely concluding that elevated body lead burden has a causal  influence
on blood pressure.
     Relationships between blood lead and blood pressure among American adults have also been
recently evaluated  in  another large-scale study, as reported by Harlan et al.  (1985),  Pirkle
et al.  (1985),  Landis and  Flegal  (1986), and  Schwartz (1985a,b;  1986a,b).   These  analyses
were  based on  evaluation  of NHANES  II  data,  which  provide careful  blood lead and  blood
pressure  measurements  on  a  large-scale  sample  representative  of  the U.S.  population  and
considerable  information  on  a wide variety of potentially confounding variables as well.   As
such, these analyses  avoided the problem of selection bias, the healthy-worker effect,  work-
place exposures to other toxic agents, and problems with appropriate choice of control  groups
that  often confounded  or  complicated  earlier,  occupational  studies  of blood-lead  blood-
pressure relationships.  Three blood pressure readings were recorded for each subject:   while
seated  early  in  the examination, supine midway  in  the  examination, and seated near the end.
First and  fifth phase sounds were taken as systolic and  diastolic pressures,  respectively.
The  second  seated blood  pressure  was  used  in statistical analyses, but  analyses  using  the
first  seated  pressure or a  mean  of the  first and second  seated pressure yielded  similar
results.   Blood  lead values,  determined  by  AA spectrometry,  were  transformed  to  log  values
used in statistical analyses.
     Relationships  between  blood pressure and  other variables  were evaluated  in  two  ways.
First,  men and  women  were stratified into normotensive  and  hypertensive categories and mean
values  for relevant variables contrasted across the categories.   For ages 21-55 yr, diastolic
high blood pressure  (>90 mm  Hg) male  subjects  (N = 475) had significantly (p <0.005)  higher
PbB  levels,  body mass index values, and  calcium foods than did  normotensive  male  subjects
(N = 1,043).   Similar  results were obtained  for aged 21-55 yr  diastolic high blood pressure
females  (N =  263)  in  comparison  to  normotensive  females  (N = 1,316).   For  ages 56-74  yr
subjects, significantly  (p  <0.05)  higher PbB levels were  found  for female subjects  (but  not
males)  defined  as  having  isolated  systolic  high  blood pressure  (i.e.,  systolic >160  and
diastolic <90 mm Hg).   Simple correlation analyses and step-wise multiple regression  analyses
were carried  out as a second statistical  evaluation approach;  PbB values were  entered  into
predictive models  for systolic  and diastolic  pressure  as well  as several  other  pertinent
variables (such  as  age,   body mass  index, etc.) entered sequentially  according to  greatest
magnitude of  variance  explained  for the dependent variable.   The simple correlation  analyses
reported by Harlan  et  al.  (1985) demonstrated  statistically significant  linear associations
(p <0.001) between blood  lead concentrations  and blood pressure  (both systolic and  diastolic)
among males and females,  aged 12 to 74 years.   Using multiple  regression analyses controlling
for a number  of other potentially confounding factors,  however,  the blood-lead blood-pressure

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associations remained significant for males but not for women after adjusting for the  effects
of other pertinent variables.
     Additional analyses of NHANES II data reported by Pirkle et al.  (1985) focussed on white
males  (aged  40 to  59  years)   in  order to  avoid  the effects  of collinearity between  blood
pressure and blood  lead concentrations evident at earlier ages and because of less extensive
NHANES II data being available for non-whites.   In the subgroup studied, Pirkle et al.  (1985)
found  significant associations  between blood lead and blood pressure even after including in
multiple  regression analyses  all  known factors previously  established as  being correlated
with  blood pressure.   The relationship  also  held when  tested  against  every  dietary  and
serologic  variable  measured in the NHANES II study.  Inclusion of both curvilinear transfor-
mations and interaction terms  altered little the coefficients for blood pressure associations
with  lead  (the strongest relationship was observed between the natural log of blood lead and
the  blood  pressure  measures).  The regression coefficients for log blood lead versus systolic
and  diastolic  blood pressure  were 8.436  and 3.954,  respectively.   No evident threshold was
found  below  which blood lead   level was not significantly related to  blood pressure across a
range  of 7  to 34 ug/dl.   In  fact,  the  dose-response  relationships characterized by Pirkle
et al.  (1985)  indicate  that  large initial increments  in  blood  pressure  occur at relatively
low  blood  lead levels, followed by leveling off of blood  pressure increments at  higher blood
lead  levels.   Pirkle et al. (1985) also found lead  to be a significant predictor  of diastolic
blood  pressure  greater than  or equal to 90 mmHg,  the  criterion  blood  pressure level  now
standardly employed in  the  United States  to  define  hypertension.   Additional analyses were
performed  by Pirkle et al. (1985) to  estimate  the  likely  public  health implications of their
findings  concerning blood-lead,  blood-pressure  relationships.   Changes in  blood  pressure that
might result from a specified  change  in blood  lead  levels  were  first estimated.   Then  coeffi-
cients from the Pooling Project  and  Framingham studies (Pooling  Project Research Group, 1978
and  McGee  and Gordon,  1976,   respectively)  of  cardiovascular  disease were  used as  bases:
(1)  to estimate the risk  for  incidence of serious cardiovascular events  (myocardial  infarc-
tion,  stroke,  or death) as a  consequence of  lead-induced  blood  pressure  increases and (2)  to
predict the change  in  the  number of serious outcomes  as  the result of a  37 percent  decrease
in  blood lead levels  for  adult white males (aged  40-59 years)  observed  during  the course  of
the  NHANES II  survey (1976-1980).
      Questions have been raised by Gartside (1985)  and E.I.  Ou Pont  de Nemours (1986)  regard-
ing  the  robustness of the findings  derived  from  the analyses  of  NHANES  II data  discussed
above and as to whether certain time trends in the  NHANES  II data set may have contributed  to
(or  account  for)  the  reported blood-lead blood-pressure relationships.    Gartside  reported
analyses of HNANES  II  data which found that the size and level  of statistical significance  of
coefficients obtained varied  depending upon  specific data aggregations used in analyzing the
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data.  The  largest and  most  significant coefficients  for blood lead versus blood  pressure
were obtained  by Gartside  for  data aggregated  by  age  groups that approximated that of  the
40-59  yr male  aggregation described  by Pirkle  et al.  (1985), with  coefficients  for  most
younger  cohorts  group aggregated  by  varying 20  yr age intervals  (e.g.,  21-40,  22-42  yrs,
etc.)  or older  groups not always being significant at p <0.05.   As  for the time trend  issue,
both blood lead and blood pressure declined substantially during the 4-yr NHANES II study and
different geographic sites were sampled without revisitation of  the  same  site  over  the  survey
period.  Thus,  variations  in  the sampling sites  over time,  coincident with changes  in blood
lead and/or blood  pressure,  might contribute to any observed associations  between  blood  lead
and blood pressure.  E.I. Du Pont de Nemours (1986) reported that multiple  regression coeffi-
cients decreased in magnitude and some became non-significant at p  <0.05  when  geographic  site
was  adjusted for  in analyses  of NHANES  II  data,  including analyses for  the male group (aged
12-74) reported on by Harlan et al. (1985) and for males (aged 40-59) reported on by Pirkle et
al.  (1986).  For  example,  E.I.  Du Pont  de  Nemours  reported unpublished  reanalyses of  NHANES
II data  confirming  significant  associations for both aged  12-74 yrs males  and 40-59 yr males
between  log PbB  and systolic  or diastolic blood pressure unadjusted for  geographic site,  but
smaller coefficients  (nonsignificant  for diastolic) when geographic site was  included  in the
analysis.  However,  neither the Gartside nor  E.I.  Du Pont de Nemours analyses  adjusted  for
all  of the variables  that were selected  for  stepwise  inclusion  in  the Harlan et  al.  (1985)
and Pirkle et al. (1986) published analyses by means of a priori  decision rules  for inclusion
of variables  having  significant  associations  with blood  pressure.   Also,  other differences
existed  in regard to   specific  aspects  of  the  modeling  approaches  employed,  making  it
extremely difficult to  assess  clearly the potential  impact  of  variation in selection  of age
groups and geographic site adjustment on NHANES II analyses results.
     In order to more definitively assess the robustness of the  Harlan et al.  (1985) findings
and,   also,  to  evaluate possible  time-trend  effects  confounded by variations in  sampling
sites, Landis  and Flegal (1986) carried out further analyses for NHANES II  males, aged  12-74,
using  a   randomization   model-based  approach to  test  the statistical  significance of  the
partial correlation between blood  lead and diastolic blood pressure, adjusting for age,  body
mass  index, and the  64 NHANES  II  sampling sites.   The resulting   analyses confirm  that  the
significant association  between  blood  lead (PbB) and blood pressure (BP) cannot be dismissed
as spurious  due  to concurrent  secular  trends  in  the  two  variables  over the  NHANES study
period.  Simple  linear  and multiple regression coefficients between log  PbB and diastolic BP
for all males  (aged 12-74) were 0.15 and 4.90, respectively; for various  groups broken  out by
age (<20, 21-39, >40 yrs) and body mass index levels, the respective coefficients ranged  from
0.04 to  0.15 and from 1.29 to 3.55 (predominantly between 2.3 and  3.6),  displaying consider-
able  consistency  across  age-body mass  comparison  groups.   Also,  the  most  stringent  or
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"conservative"  approach  used  to  calculate  a randomized  model  statistic  controlling  for
effects  due  to 64  sampling sites  yielded  a  test  statistic of  4.64  (still significant  at
P <0.05).
     In  order to  address  the "site" issue more definitively, Schwartz  (1985a,b;  1986a,b) has
also carried  out  a  series of additional reanalyses of the NHANES II data.   These unpublished
analyses  confirm  that  the  regression  coefficients  remain significant for both  systolic and
diastolic blood pressure when site is included as a variable in multiple regression analyses.
Of  several different  approaches  used by Schwartz, the most direct was  holding all aspects of
the  original  Pirkle et al.  (1985) analyses  the  same except for the addition of a variable
controlling  for  the  64  geographic  sites sampled  in NHANES  II.   Using this approach,  the
cofficients  for  log PbB in relation to either diastolic or systolic BP dropped somewhat from
those  of the original  analyses  when  site  was controlled  for (i.e.,  from  8.44  to 5.09 for
systolic  and  from 3.95 to 2.74  for  diastolic blood pressure), but the coefficients for each
still  remained  significant at p <0.05.  When  still other approaches were used to control for
site along with variations in other variables  included in the analyses, statistically signif-
icant  results were  still  consistently  obtained both  for males aged 40-59 and for males aged
20-74.   The  results obtained by Schwartz via  reanalysis of NHANES  II data (unadjusted versus
adjusted for  geographic site) are presented in Table  A-3 in comparison to results reported by
E.I.  Du Pont de  Nemours  and  in  relation  to the  findings presented by Pocock for British men
(also  unadjusted  versus adjusted for site).
     Overall,  the  analyses  of  data  from the  two  large-scale general  population studies
(British Regional Heart Study and  U.S. NHANES II Study) discussed  above collectively provide
highly convincing  evidence  demonstrating  small  but statistically significant  associations
between blood lead levels and increased  blood pressure in adult  men.   The  strongest associ-
ations  appear  to  exist  for males  aged 40-59  and  for  systolic  somewhat  more  so than  for
diastolic pressure.   Virtually  all of the  analyses  revealed  positive associations for  the
40-59  aged group, which  remain  or  become significant (at p  <0.05) when adjustments are  made
 for geographic site.   Furthermore, the  results  of these large-scale  studies are  consistent
with similar findings  of  statistically significant  associations between blood lead  levels and
 blood  pressure   increases  as  derived  from  other  recent  smaller-scale  studies  discussed
 earlier, which also  mainly found  stronger  associations for systolic  pressure  than for dia-
 stolic.  None of  the observational  studies in and of themselves can be  stated as definitively
 establishing causal  linkages  between  lead  exposure  and  increased blood pressure  of  hyper-
 tension.  However, the plausibility  of the observed associations reflecting causal relation-
 ships  between   lead  exposure   and  blood  pressure  increases  is supported   by:   (1)  the
 consistency  of the  significant  associations that have now been found by numerous independent
 investigators for  a  variety of study populations;  and (2)  by extensive toxicological data
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     Table A-3.  Coefficients for the Natural Log of Blood Lead Concentration (logPbB) vs.
           Blood Pressure (BP) in Men With and Without Adjustment for Site Variables
Analysis
Performed by
Pocock et al.
(1984, 1985)
Schwartz (1985a,b)
E.I. Du Pont
de Nemours(1986)
Schwartz (1986a,b)
E.I. Du Pont
de Nemours (1986)
Study
Group
British Regional
Heart Study
White males aged 40-59
Systolic (n=7371)
Oiastolic (n=7371)
NHANES II
Males aged 20-74
Systolic (n=2254)
Diastolic (n=2248)
NHANES II
Males aged 12-74
Systolic (n=2794)
Diastolic (n=2789)
NHANES II
White males aged 40-59
Systolic (n=543)
Diastolic (n=565)
NHANES II
White males aged 40-59
Systolic (n=553)
Diastolic (n=575)
Coefficient
loqPbB vs.
Unadjusted
for Site
1.68**
0.30
5.23***
2.96***
3.43***
2.02***
8.44**
3.95**
6.27**
4.01**
of
BP
Adjusted
for Site
2.09**
1.81***
3.23**
1.39*
1.95*
0.36
5.01*
2.74*
3.46*
1.93*
*p < 0.05
**p < 0.01
***p < 0.001
(see  below)  which clearly  demonstrate increases  in  blood pressure for animal  models  under
well-controlled  experimental  conditions.   The  precise  mechanisms  underlying  relationships
between  lead  exposure  and  increased  blood  pressure,  however,  appear  to  be  complex  and
mathematical  models   describing  the  relationships  still  remain to  be  more  definitively
characterized.   At  present,  log PbB-BP models  appear  to fit  best  the available  data,  but
linear relationships  between blood  lead and blood pressure cannot be ruled out at this  time.
The most appropriate  coefficients  characterizing PbB-BP relationships  also remain to be more
precisely determined, although those  reported by Landis and Flegal (1986)  and those in  Table
A-3 obtained by analyses adjusting  for site appear to be the currently  best available and most
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reasonable estimates of the  likely  strength of the association (i.e.,  generally in the  range
of 2.0-5.0  for log  PbB  versus systolic  and 1.4  to  2.7  for log PbB versus  diastolic  blood
pressure).
     Blood lead levels  that may be associated with increased blood pressure also remain  to  be
more clearly defined.  However,  the collective evidence from the above studies points toward
moderately elevated blood lead levels (:>30 (jg/dl) as being associated most clearly with  blood
pressure  increases,  but  certain evidence  (e.g.,  the  NHANES II data analyses  and  the Moreau
et  al.  study  results) also  indicates significant  (and  apparently  stronger)  relationships
between blood  pressure elevations  and still lower blood lead levels that range, possibly,  to
as low as 7 ug/dl.
     The  quantification  of likely  consequent risks  for  serious  cardiovascular outcomes,  as
attempted  by  Pirkle et  al.  (1985),  also  remains to  be  more  precisely  characterized.   The
specific  magnitudes  of risk obtained for  serious cardiovascular outcomes in relation to lead
exposure,  estimated  on the basis of  lead-induced  blood pressure increases, depend crucially
upon:   the form  of  the  underlying  relationship and size  of  the coefficients estimated for
blood-lead  blood-pressure  associations;  lead exposure  levels at which significant elevations
in  blood  pressure  occur;  and coefficients  estimating relationships between  blood pressure
increases  and  specific  more  serious cardiovascular  outcomes.   As  noted  above  uncertainty
still exists regarding the most appropriate  model  and blood-lead  blood-pressure coefficients,
which makes it difficult to resolve  which specific coefficients  should be  used in attempting
to  project more  serious  cardiovascular outcomes.   Similarly, it  is  difficult to determine
appropriate blood  lead  levels  at which  any  selected coefficients  might be appropriately
applied  in models predicting more  serious cardiovascular outcomes.   Lastly,  the selection of
appropriate models  and  coefficients  relating blood  pressure  increases  to more serious out-
comes  is  also fraught with uncertainty.   Questions exist regarding  the general applicability
of  coefficients derived from the  Pooling  Projects and  Framingham Study to  the  men aged  40-59
in  the general  U.S.  population.   Further analyses  of additional  large scale epidemiologic
data sets  may  be necessary in order to  determine more precisely quantitative  relationships
between   blood-lead  and  blood-pressure,  and  more serious  cardiovascular  outcomes  as   well.
      The  findings  discussed  here,  while  pointing toward  a likely  causal  effect of lead  in
contributing  to increased  blood  pressure  need to be placed  in  broader perspective  in  relation
to  other  factors involved in  the etiology  of  hypertension.   The  underlying causes  of  in-
creased blood  pressure  or "hypertension"  (diastolic  blood pressure  above  90 mm Hg),  which
occurs  in  as  many as  25 percent of  Americans,  are not yet fully delineated  (Frolich,  1983;
Kaplan,  1983).   However,  it is very clear that many factors contribute to development of this
disease,   including    hereditary traits,  nutritional  factors  and environmental  agents.   The
 relative roles of various  dietary and environmental factors in influencing blood pressure and
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the mechanisms  by  which  they do so are  a  matter of intense investigative  effort  and  debate
(see  proceedings   of  conference "Nutrition  and  Blood  Pressure:  Current  Status  of  Dietary
Factors and  Hypertension,"  McCarron  and Kotchen, 1983).  The  contribution  of  lead,  compared
to many other factors evaluated in various analyses discussed above,  appears to be  relatively
small,  usually  not accounting  for  more than  1-2 percent of the variation explained  by  the
models employed when other significant factors are controlled for in  the analyses.
2.3  Mechanisms Potentially Underlying Lead-Induced Hypertension Effects
     This  section  discusses  plausible  biochemical-physiological  mechanisms  by  which  lead
potentially influences the cardiovascular system to induce increased blood pressure,  followed
by  the  evaluation  of experimental  evidence  concerning the contribution of  lead  exposure  to
development of hypertension.
     Blood pressure is  determined  by  interaction  of two factors:   cardiac  output and  total
peripheral resistance.  An elevation  of either or both results in  an increase in  blood  pres-
sure.  A subsequent defect in a critical regulatory function (e.g., renal  excretory function)
may  influence  central  nervous  system  regulation of  blood  pressure, leading  to  a  permanent
alteration  in  vascular  smooth muscle  tone which  sustains  blood pressure  elevation.    The
primary defect in  the pathophysiology  of hypertension is thought  to  be due to alteration in
calcium binding to  plasma  membranes of cells;  this change in calcium handling may in turn be
dependent  upon an  alteration  in  sodium  permeability   of  the membrane  (Blaustein,  1977;
Rasmussen, 1983; Postnov and  Orlov, 1985; Hilton, 1986).  This  change  affects several  path-
ways capable of elevating pressure:  one is a direct alteration of the sensitivity  of  vascular
smooth muscle  to  vasoactive  stimuli;  another  is indirect, via  alteration  of neuroendocrine
input to vascular smooth muscle (including changes in renin secretion rate).

2.3.1  Role of Disturbances in Ion Transport by Plasma Membranes
     Many stimuli activate target  cells in the mammalian body via  changes  in ion  permeabili-
ties of the plasma  membrane,  primarily for sodium,  potassium, and  calcium ions (Carafoli  and
Penniston, 1985);  the change  in calcium ion concentration is  the primary intracellular signal
controlling muscle  contractions, hormone  secretion, and other  diverse activities.  Extra-
cellular fluid contains  high  concentrations of  sodium and calcium,  while intracellular potas-
sium is high.  Intracellular  calcium  is present in  two  forms,  bound and free  ion,  with  the
concentration of  the  free ion  normally about  0.1 uM.  These concentration  gradients across
cell membranes are  maintained  via  the  action of membrane-bound  energy-requiring  or  voltage-
dependent  exchange pumps.   For  sodium  and potassium,  the regulatory  pump  is a  sodium/
potassium-dependent ATPase which  extrudes sodium in  exchange for  potassium  ions and in  the
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process  is  important in maintaining  the cell  membrane  potential.   For calcium, there  is  a
membrane potential-dependent sodium/calcium exchange  pump  which extrudes one calcium  ion  in
exchange for three  sodium  ions.   In addition, there are  calcium ATPase pumps located at cell
membranes and  at intracellular membrane storage sites  (endoplasmic reticulum  and  mitochon-
dria).  As  calcium  ions  move in and out  of  the cell  and in and out of intracellular storage
sites,  the  intracellular free calcium ion ([Ca2+])  changes from its  resting value  to some-
thing higher or lower.  The ion interacts with several calcium-binding proteins  which in turn
activate cell contractile or secretory processes.
      It  has  been  postulated (Blaustein and Hamlyn, 1983) that sodium pump inhibition by some
endogenous  factor (thought  to  be  a hormone)  could be ultimately causatory for development of
both  essential and volume-expanded hypertension by affecting vascular tone or resistance.  As
explained above,  the sodium pump  maintains and restores the membrane potential  subsequent to
depolarization events.   Decreased  sodium pump activity may directly increase membrane perme-
ability  to  calcium  and  increase  reactivity  to calcium-dependent stimuli.   Small  changes  in
the distribution of  intracellular and extracellular sodium  ions affect the membrane potential
and cause a much larger decrease  in activity of the sodium/calcium exchange pump, resulting
in a  proportionately much  greater elevation  in  intracellular  free  calcium ion which in turn
increases  reactivity  to  calcium-activated  stimuli.   Some of  the  newest  antihypertensive
therapeutic  agents  (calcium channel  blockers) act to  lower intracellular [Ca2+] by reducing
movement  of  extracellular  calcium  into  cells,  thereby   reducing  activation   of  processes
requiring  such movement.   Diuretic drugs may reduce the postulated  rise  in  intracellular
sodium  concentration  related  to  the  decreased  Na /K -ATPase  activity  and thereby  reduce
elevated intracellular calcium by  stimulation of the Na/Ca  exchange pump.
      If  lead exposure  could  be shown to  affect  sodium transport  (which  then  indirectly alters
vascular  resistance)  or to  directly  affect  vascular  resistance  (by  changing  calcium ion
permeability  or  transport),  it  could  contribute  to the development  of  hypertension.  In
sections  previously presented  in  the revised  criteria  document (U.S.  EPA, 1986), abundant
experimental  evidence was  discussed  which indicates  that lead  affects  both;  that is, lead
inhibits  cell  membrane-bound  Na+/K+-ATPase  as well  as  interferes with  normal processes of
calcium transport across membranes of various  tissue types (see  sections 12.2.3 and 12.3.2.2
of  U.S.  EPA, 1986,   for  discussion).   Highlighted  concisely below is  evidence  that  lead acts
to  alter sodium balance  and  calcium-activated cell  activities of  vascular smooth  muscle.
Changes in   either  or both  of  these  could be  expected  to produce  changes in  blood pressure
regulation.
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2.3.2  Role of Renin-Angioterisin in Control of Blood Pressure and Fluid Balance;
       Possible Role of Kallikrein-Kinin in Control of Blood Pressure
     One  major endogenous  factor regulating  total  peripheral  resistance  of  the  vascular
smooth muscle  is  angiotensin  II (All), a small peptide generated in plasma via  the action of
a renal hormone, renin.  Renin is synthesized and stored in juxtaglomerular (JG)  cells of the
kidney and  is  released when JG cells receive stimuli indicating a decrease in arterial  pres-
sure, as sensed by cardiovascular baroreceptors and transmitted to the central nervous system
(CNS) with  subsequent  activation  of  efferent p-adrenergic signals to the kidney.   Changes in
the  intracellular  calcium  ion  concentration  of the  JG cell  are  thought to be  involved in
renin  release  (Churchill,  1985),  with  an  increase  in  intracellular  [Ca2+]  producing  a
decrease in renin secretion, while a  decrease in intracellular [Ca2+] produces an increase in
renin release.
     Renin  is  the  first enzyme in a series which  splits  a small peptide, angiotensin I (AI)
from angiotensinogen,  or  renin substrate,  a large protein  synthesized  by liver and found in
circulation.  AI  is  converted  to  All by angiotensin converting enzyme (ACE), an enzyme found
in plasma and  lung tissue.   All is degraded  to All I and other breakdown products by various
proteolytic enzymes.  Renin is cleared from plasma by the liver.
     All  acts to  increase total  peripheral  resistance by:   (1) direct action  on  vascular
smooth muscle to increase vasoconstriction (it is 10 to 40 times more potent than norepineph-
rine and acts to elevate cytosolic calcium of vascular smooth muscle to activate the contrac-
tion of actin  and myosin);  and (2) indirectly, by acting on the area postrema of the medulla
oblongata to  increase  the discharge  rate of sympathetic neurons (which increases norepineph-
rine release,  decreases  its reuptake,  and increases vascular sensitivity to norepinephrine).
     All also  influences  renal  function and overall  salt  and  fluid balance in  several  ways:
(1)  Renal   hemodynamics:   glomerular filtration  rate is  altered  by All-related  changes in
renal  blood flow  or  indirectly by  increased  noradrenergic transmission  to the  kidney re-
sulting from  CNS action  of All.   (2)   Salt and  water metabolism:  All-induced  changes in
renal sympathetic tone alter reabsorption of sodium and potassium; All stimulates aldosterone
secretion which affects sodium and potassium balance; All may have direct action on the renal
tubules to  increase electrolyte  and water  reabsorption.   In  addition,  All appears to act
directly on the CNS to increase thirst.
     The renin-angiotensin system thus has a major influence on regulation of blood pressure;
for this  reason,  investigators interested in hypertension have studied the system in detail.
Because  renal  disease  may be  an important  initiating event  in  subsequent development of
hypertension and  because  lead  is  an  important  renal  toxicant,  some investigative reports of
patients  with lead  intoxication  have  evaluated  blood  pressure changes  and changes  in the
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renirrangiotensin system.   For  example,  Sandstead  et  al.   (1970)  found that dietary  sodium
restriction produced  smaller  increases in  plasma  renin activity  and aldosterone  secretion
rates in  lead-poisoned men  than expected.   The mechanism of  action  on the renin-aldosterone
system was not known.   Gonzalez  et al.  (1979) studied renin  activity,  aldosterone,  and  plasma
potassium levels  in a group of  lead-intoxicated patients,  who  had  low plasma renin activity
(PRA) in  response to  a  furosemide challenge  (a  volume-depleting stimulus)  and were  hyper-
kalemic (evidence that aldosterone  levels  were low).  Bertel et  al.  (1978) also presented a
clinical  case  report  of  reduced  beta-adrenoceptor-mediated  function  in one  lead-toxic  man
(blood  lead  >250 ug/dl)  with hypertension  (160-170/100-105 mm  Hg).   Prior to administration
of  the  test  dose of  isoprenaline, the patient had high plasma norepinephrine levels and low
PRA activity.   The dose  of isoprenaline  required to increase  heart rate  25  beats/min was
15-fold greater  than  that required in control  subjects.
      Recently,  Campbell  et  al.  (1985) found  lead-related  increases  in the  concentrations of
PRA and angiotensin I in lead-exposed normotensive  men.  Mean plasma  renin  activity in these
men was 8.3  ± 5.0  ng/ml/h, a value they note  is slightly high  for normotensive not on sodium
restriction;  all  subjects with  PRA >12 ng/ml/h had blood lead concentration  of >2  umol/1, the
accepted  upper limit for the general  population.   Al was  positively  correlated with  PRA;  it
appeared  that  angiotensin  converting enzyme  was  augmented  with  lead exposure,  possibly  by
substrate induction due  to  increased  Al  concentration.
      These authors point out that  their findings appear to  be in conflict with others  which
 find depressed or unaltered renin activity in lead poisoning; however, the studies may not be
comparable because the men in  this study  had  chronic  sub-clinical  lead exposure as compared
 to  chronic  heavy  lead  exposure.   None  of the  subjects  in this  study had excessive  lead
 exposure—rather,  exposure which  would  be  considered "normal".   Yet  they tended  to  have
 elevated  PRA,  which  may  reflect  possible  low-grade  stimulation of  the renin-angiotensin-
 aldosterone  system that,  if   continued  through  chronic   cumulative  exposure,  might  affect
 blood pressure in sensitive individuals.
      There  is  another  hormone system which  has  postulated effects  in  regulation of  blood
 pressure:  the  kallikrein-kinin  system  (Carratero and  Scicli, 1983).   Kallikreins (found in
 plasma,  urine  and several  glands,  including the kidney)  are  proteases  which release kinins
 from plasma  substrates  called kininogens.  Kinins,  thought to be  antagonistic  to All, are
 vasoactive peptides  which  may  participate  in  blood pressure regulation by  altering vascular
 tone and regulating  sodium and water loss.   Kinins are inactivated  by plasma kininases (one
 of which is angiotensin I converting enzyme).   Urinary kallikreins can  be  measured by  their
 esterolytic  activity on synthetic substrates.  Many  reports suggest that  urinary  kallikrein
 is decreased in patients  with essential  hypertension, although others  do not find such an
 association, and indeed find normal excretion  rates.
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     Boscolo et  al.,  (1981)  studied urinary kallikrein activity and plasma renin activity in
22  men  occupationally exposed  to  lead.   Eight  of these men who  suffered  from hypertension
and/or  nephropathy  had low  or  absent PRA;  this finding  may  be related to the  presence of
renal disease rather than be contributory to it.   The remaining 14 non-symptomatic men showed
normal or reduced urinary kallikrein and variable PRA.   The authors concluded that the slight
but significant  correlation  between renin and kallikrein  that  was  found in the lead-exposed
patients might  be the result of a  correlated physiological response  of  these  renal  enzymes
due to  an  effect of  lead on one or more components of the blood pressure regulating system.
     The paucity of  experimental   data  linking  lead  and  changes in  the  renin-angiotensin
system  stimulated most  of  the  following experimental studies,  although many questions remain
unanswered.
2.4   Experimental Studies of Lead Effects on Blood Pressure and the Renin-Angiotensin System
     Several  questions  can be  posed  regarding how  lead might  affect  the renin-angiotensin
system, such as:

     (1)  Does lead affect sodium handling by the renal tubule?
     (2)  Does lead directly affect renin release?  If so, is All elevated to
          an appropriate level?  Do normal homeostatic mechanisms function to
          adjust renin levels under conditions of fluid and electrolyte loss?
     (3)  Does lead alter renin synthesis (as measured by renal renin content)?
     (4)  Does lead affect rate of production of All by altering angiotensin
          converting enzyme activity?
     (5)  Does lead alter All catabolism?
     (6)  Does lead affect renin substrate production?
     (7)  Does lead affect renin clearance by the liver?
     (8)  Does lead affect vascular reactivity directly?
     (9)  Does lead directly affect aldosterone release?
    (10)  Does lead alter  noradrenergic  activity (either in adrenal glands or systemically)?

Many of these questions have been addressed by studies discussed below.

2.4.1  Acute In Vivo Lead Exposure
     Lead injected  iv  in  dogs and rats,  at  doses  as low as 0.1  mg/kg  (whole blood lead < 5
(jg/dl and renal  lead  of 1.2 H9/9) produced over the next several hours significant increases

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in plasma renin activity  (PRA)  and in excretion of sodium,  other  cations,  and water  (Mouw et
al.,  1978).   There was  no  change  in  glomerular filtration  rate;  therefore,  the increased
sodium  excretion  could  be  attributed to  decreased sodium  reabsorption.   The  mechanism of
lead's  action  on  tubular reabsorption was not  determined,  but it was suggested  (though not
evaluated) that lead could affect mitochondria!  ATP production necessary  for active transport
processes or act  directly on carrier molecules  or enzymes,  e.g.,  Na /K -ATPase,  specifically
involved  in tubular  transport.   In this  report, the mechanism by which  lead increased renin
secretion was not determined.
     In a subsequent study, Goldman et al.  (1981) found that the rise in  PRA after acute lead
injection was  not due  to increased renin secretion  in  six of nine dogs;  rather, there was
elimination  of hepatic  renin clearance,  without  evidence  for  other interference  in  liver
function.  In the remaining three dogs, renin secretion increased; this was thought to be due
to  lead activation of  normal mechanisms  for  renin secretion, although none of  the classic
pathways  for  influencing renin  secretion were altered.   The authors postulated that lead
might  produce  alterations  in   cytosolic  calcium  concentration  in  renin-secreting  cells.
(Further  evidence that  cytosolic calcium concentration  is  indeed important in  renin release
has  been  reviewed in detail  by  Churchill, 1985.)   In addition, although angiotensin II (All)
levels  in lead-exposed animals  were  elevated  because of increased  PRA, the All  levels were
not  increased  proportionately  as  much  as  the PRA,  leading  to a  further suggestion that
angiotensin-converting  enzyme (which  converts  Al   to  All)  might  be suppressed  or that All-
degrading  enzyme  could  be  enhanced;  this  was  not tested  in the  experiment.   The authors
postulate  that there may be multiple actions  of  lead on  the renin-angiotensin  system which
may  help  explain  confusion  about the ability of  lead to  cause  hypertension.  At certain expo-
sure conditions,  there  could be  elevated  PRA without  simultaneous  inhibition of angiotensin-
converting  enzyme,  thereby contributing to  hypertension, while  higher doses or  longer expo-
sure might  inhibit  converting  enzyme  and thereby  cause  loss of  hypertension.   Neither
hypothesis was  addressed  in this experiment.

2.4.2  Chronic  Lead  Exposure
      The  literature  of  experimental  findings of lead-induced changes in  the renin-angiotensin
system  and blood pressure  in animals  is complicated by apparently  inconsistent  results when
comparing one study to another.   All  studies report  changes in  the renin-angiotensin  system,
yet some studies fail  to find  an effect on  blood  pressure  and others do report  hypertension.
Doses and exposure  periods  employed  vary widely, but  in general,  hypertension  is  observed
most consistently  with  relatively low doses   over  relatively  long exposure  periods.  The
papers  reviewed here make specific mention of  lead dose  employed and blood lead  concentration

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achieved (if measured).  For comparison with human exposure findings, it is helpful  to recog-
nize that blood lead concentrations seldom exceed 40 pg/dl in the general population.
     Perry and  Erlanger  (1978)  found that chronically feeding rats either cadmium or lead at
doses of 0.1,  1.0,  or 5.0 ppm produces statistically significant increases in systolic blood
pressure.    Blood  lead  concentrations were  not  determined  in  this experiment.  There  were
dose-dependent  changes  in blood  pressure,  measured  at  3 months,  and  the  increase observed
with 5  ppm Pb was  observed  at  3, 9, and 18  months  of observation.  Body burden of  lead in
rats fed 0.1 ppm Pb was estimated to be 0.4 mg at 18 months.   The mechanisms for this finding
were not discussed  but the  implications for  human  populations  exposed to very  low doses of
these metals  were pointed  out.   Victery et  al.  (1982a) reinvest!gated  the  question,  using
lead doses  of 100  and 500  ppm  administered in  the  drinking water to  rats  beginning while
animals were  HI  utero and continuing through six months  of  age.  At 3^  mo  of age, the male
rats drinking  100 ppm lead  first demonstrated  a statistically  significant  increase  in sys-
tolic  blood  pressure  (152 ± 3.7 vs.  135 ± 5.6  mm  Hg);  this  difference persisted  for the
remainder of  the experiment.  Animals  drinking 500  ppm  had lower  pressures  which were not
significantly  different  from  controls.   Female  rats drinking  100  ppm did  not demonstrate
pressure changes.   At termination of  the  experiment  PRA was significantly  decreased by 100
ppm  lead  exposure,  but  not  at  500  ppm.   All  values tended to  be lower  (controls:  22 ± 8
pg/ml,   100  ppm:  13 ± 7,  500 ppm: 10 ± 2).   There  was a dose-dependent  decrease  in AII/PRA
ratio for lead-exposed rats.   Renal  renin was depressed in lead-exposed animals.  The hyper-
tension observed  in  these  animals was not secondary to overt renal disease (as opposed to an
effect  on  renal  cell  metabolism),  as evidenced  by   lack of changes in  renal  histology and
plasma creatinine.
     With regard  to possible mechanisms  of  the  lead-induced hypertension,  the animals had
low-renin hypertension (which  is characteristic of 30 percent of  people  with hypertension).
Thus, elevated  renin  was  not responsible for maintenance of the hypertension.  Volume expan-
sion may be  a  factor, as suggested  by slight increases  in body weight and decreased hemato-
crit (also  possibly  related to  lead  effects on heme  synthesis).  There  was  no  change in
plasma  sodium  and  potassium,  although more  sensitive determinations  of fluid balance and
exchangeable  sodium were  not  done.   A second  potential  hypertensive  mechanism,  increased
vascular responsiveness to catecholamines,  was examined and is discussed below.
     Victery et al.  (1983)  examined  changes in the renin-angiotensin  system of rats exposed
to  lead  doses  of 5,  25, 100,  or 500 ppm  during gestation  until 1 month of  age.   All had
elevated plasma renin activity,  while those at 100 and 500 ppm also had increased renal renin
concentration.   Lead-exposed  animals anesthetized to obtain the  blood  sample secreted less
renin than control animals.   It appears that lead has  two chronic effects on renin secretion,

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one inhibitory  and one  stimulatory;  the magnitude  of  effect on  PRA reflects the dose  and
timing of the lead exposure as well  as the physiological  state of the animal.
     In another study, Victery  et al.  (1982b) reported that  rats  fed 5  or 25 ppm lead for  5
months (blood lead  of  5.6 and 18.2 ug/dl,  respectively)  did  not develop hypertension  but at
25 ppm had  significantly decreased  PRA.   Both groups of animals  had a decrease in the  All to
PRA ratio.   Thus,  lead   exposure  at  levels  generally present  in  human  population  caused
observable effects  in  renin  synthesis, and produced changes  in  All concentration which were
consistent with either inhibition of conversion of AI to  All  or  enhanced All catabolism.  No
measurements of ACE activity were made.  The failure to observe hypertension in these  animals
may have  been  due to a  number  of  factors,  but additional studies  may be required to  verify
this finding.
     lannaccone et al.   (1981)  administered 50  ppm  lead  to male rats for 160 days (average
blood  lead  of  38.4 ug/dl) and  found  a marked increase in arterial  pressure of lead-exposed
animals  (systolic/diastolic:   182±6/138±7 mmHg) versus pressures  in controls of 128±5/98±3.
No  measurements of  hormone  levels  were  performed;  determination  of  vascular reactivity in
these animals is discussed below.
     Male pigeons fed a diet containing  added  calcium  (100  ppm), magnesium (30 ppm),  lead
(0.8  ppm),   or  cadmium  (0.6 ppm)  in a  2x4  factorial   design  for a six-month  period were
observed  for alterations in aortic blood pressure and atherosclerotic changes (Revis et  al.,
1981).   Diastolic  pressures  were 25 mm Hg  higher in pigeons exposed to Mg, Pb, or Cd than in
Ca-exposed pigeons.  Systolic pressure was  greatest  in Cd-exposed birds.    Calcium in the  diet
resulted  in lowered systolic  pressures  in  animals  exposed  to  combinations of other metals
(presumably  by   decreasing  their  gastrointestinal  absorption).   Similarly,  there  was  a
decrease  in number  and  size of  aortic  plaques  in presence of  calcium  and an increase  with
lead exposure.
     Keiser  et  al. (1983b)  tested  lead-exposed  rats (500 or 1000  ppm for 3-4 mo, blood  lead
levels of 41 and  55 ug/dl)  f°r the ability of  the  liver to clear  exogenous  renin and a  test
substance (sulfobromophthalein)  following nephrectomy.  They  found  no difference  from control
clearance times.   Thus,  elevations in plasma renin  observed  in chronically exposed animals
must  be   the result of  increased renin  secretion.   However,  the  finding of decreased renin
activity after some  long-term exposure periods (see above)  illustrates that lead must  also
act  in   an  inhibitory  way  to  decrease   renin  secretion,   and  the  finding  of  decreased,
increased,  or  unchanged   renin  activity  depends  on the  balance of  the  stimulatory and  inhibi-
tory  input  to  the juxtaglomerular cells.
      In  a preliminary experiment,  there  were no differences in  urinary kallikrein excretion
rates  in lead-exposed  and control  rats (Victery  and  Vander,  unpublished  findings).
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 2.4.3  Renin Secretion by Kidney Slices In Vitro
     The  effects  of renin-secretion stimuli on the ability of kidney slices to secrete renin
 jin  vitro  either  after  chronic  HI  vivo or  HI  vitro  exposure  to lead  have been  studied
 by  several investigators.   Keiser  et  al.  (1983a) reported that  rabbit  kidney cortex slices
 exposed  to 10-5  or  10-6 M  lead  secreted  significantly  less  renin than  controls.   Slices
 obtained  from  lead-exposed  rabbits  (500 or 1000  ppm  for 7 wk, with blood  lead levels of 66
 and  109  ug/dl  respectively) secreted significantly more  renin  HI v itro than controls.  They
 postulated that  lead  could  compete  with  Ca2+  for  influx  into juxtaglomerular  cells  and
 thereby  stimulate renin  release.   Responsiveness to a beta-adrenergic  stimulus  was  less in
 the  higher-dose  slices.   Since p-adrenergic  stimuli  are thought  to  act via reduction of
 intracellular [Ca2+] (by  increased Ca efflux or intracellular sequestration), it was proposed
 that  lead  may  interfere with  these  calcium   fluxes and interfere with  the response to  p
 agonists.
     Meredith et  al.  (1985) found somewhat contradictory  results,  with  lead able to provoke
 renin secretion  from  rabbit kidneys both in vivo and jn vjtro (at comparable dose levels to
 that  used  by  Keiser).    Calcium  channel  blockers attenuated  this response.   These  authors
 propose that  lead is  able to act at the  cellular level to stimulate renin secretion.  Since
 most  experimental evidence  suggests   that  increased intracellular calcium  decreases renin
 release,  whereas  calcium efflux  stimulates  renin secretion,  the authors  further postulate
 that lead  uptake  by the juxtaglomerular cells promotes  calcium efflux which then leads to an
 increase in renin secretion.

 2.4.4  Effects of Lead on Vascular Reactivity
     Piccinini et al.  (1977) and Favalli et al.  (1977) studied the effects of lead on calcium
 exchanges  in the  isolated rat tail  artery; lead  in  concentrations of up to 15 umol in vitro
 produced  contractions  which  required   the  presence  of calcium  in the perfusion solution.
 Therefore, calcium influx was not affected by lead.  The fact that tissue calcium content  was
 increased  is  compatible with the  sites of  lead  action at the cell membrane;  lead inhibits
 calcium  extrusion,  and  at   intracellular  stores, lead decreases  calcium-binding capacity.
Both processes produce an increase in  intracellular exchangeable calcium.
     Tail  arteries obtained  from  the  hypertensive rats  in  the  study performed by Victery et
al.   showed an  increased maximal  contractile  force  when  tested  HI  vitro with  the alpha-
 adrenergic  agents  norepinephrine  and  methoxamine (Webb  et al.,  1981).    This   finding  is
apparently  related  to  an  increase in the intracellular  pool  of  activator calcium  in  the
 smooth muscle cells in the artery.   This change  may also be responsible for decreased relaxa-
 tion of the muscle after induced contractions.
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     I_n vivo tests  of  cardiovascular reactivity in rats  exposed  to  50 ppm lead (blood  lead
38.4 ± 3.6 (jg/dl)  for  160 days  were performed  by  lannaccone et  al.  (1981).   Systolic  and
diastolic  blood  pressure  readings obtained  under  anesthesia were 182 ± 6/138 ± 7 mm Hg  for
lead-exposed rats  versus  128 ± 5/98  ±  3  for controls.   Humoral agents,  i.e.,  norepinephrine
and angiotensin  II  (but  not  bradykinin and angiotensin I),  produced  significant increases in
systolic and diastolic pressure.   This suggests there is decreased  conversion  of  AI  to  All.
At high doses,  epinephrine produced an  equal increase in pressure  in  lead-exposed  and  control
animals;  at lower  doses, only  slight  increases  in  mean  arterial  pressure were  observed.
Bilateral  carotid artery occlusion under conditions of autonomic blockade produced a two-fold
greater decrease in blood pressure  and  heart  rate in lead-exposed rats.  The data  suggest
that  the  lead-related  increase  in  arterial  pressure is  due at least in part  to  greater
sympathetic tone, with the metal affecting neural control of blood pressure.

2.4.5  Effects of Lead on Noradrenergjc Hormones
     Lead exposure alters the  levels  of noradrenergic hormones  in  the  young  animal  exposed
via maternal milk from birth until day 21 of age (Goldman et al., 1980).  Lead  concentrations
in  the drinking  water of up  to  2000 ppm produced blood  lead  levels in pups of 47 ± 3 ng/dl
with dose-dependent increases in adrenal and plasma norepinephrine.   There were also changes
in  several  enzymes which alter turnover  rates of  norepinephrine.   Baksi  and Hughes (1983)
investigated the effect  of 6-wk tetraethyl  lead exposure (at 0.2, 2.0,  and 5  ng  Pb/g food)
on  adrenal catecholamine  levels  and  found significant  decreases in dopamine (perhaps due to a
decrease  in  synthesis) and significant  increases in norepinephrine and  epinephrine.  Both of
these  groups of  authors  felt that  the  change  in  adrenal   catecholamines  could  directly or
indirectly  be responsible for  the  hypertension  observed  in  lead-exposed  animals.

2.4.6   Effects of  Lead on Cardiac  Muscle
      Lead  has  been hypothesized to contribute  to  cardiomyopathy (Asokan,  1974)  and to  have
cardiotoxic  properties.   Rats fed 1 percent  lead acetate for  6 weeks  (with blood  lead levels
of  112 ± 5  (jg/dl) had  structural  changes  in  the myocardium.   These  included myofibrillar
fragmentation  and  separation  with  edema  fluid,  dilation of the sarcoplasmic  reticulum,  and
mitochondrial   swelling.   These  changes  were  observed  before any  measured   changes  in
myocardial  electrolyte concentrations.
      Williams  et  al.  (1977a,b)  exposed  young rats to 2000 ppm lead via maternal  milk,  from
birth  to  21 days of age  (blood lead  at 21 days  of age was 43 ug/dl but was not different from
 controls  at  170-200  days).   Animals  were  studied   for  cardiovascular response  to  norepi-
 nephrine  at 170-200 days of  age.  There  were no differences in the blood pressure increase in

                                              A-27

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response to norepinephrine, but there was a five- to ten-fold increase in cardiac arrhythmias
in lead-exposed animals.   There were no differences in the basal or norepinephrine-stimulated
cyclic AMP levels in cardiac tissue.
     In a subsequent study (Hejtmancik and Williams, 1979), it was reported that only part of
the  arrhythmogenic  activity of norepinephrine  in lead-exposed rats was due  to  reflex vagal
stimulation;  there  was also a direct  cardiac  effect,  probably at the  alpha  receptor level.
Lead appeared to have no effect on beta receptors.
     Kopp  et  al.  (1978) developed  an  j_n  vitro system for monitoring  the  cardiac electrical
conduction system (electrocardiogram or  ECG)  and systolic tension,  and demonstrated that jjn
vitro  lead  (3 x 10-2 mM)  or cadmium  (3  x 10-2 mM) depressed  systolic  tension  and prolonged
the  P-R  interval   of  the  ECG.   Both  ions increased  conduction times  in  the  His  bundle
electrograms  but  conduction blocks occurred  at  different  sites  (atrioventricular  node  for
cadmium and distal to the His-Purkinje cell junction for lead).
     In a  subsequent paper,  Kopp  and Barany (1980) found that cadmium or lead added to heart
tissue perfused j_n  vitro  (3 x 10-3 mM and 3  x 10-4 mM,  respectively) inhibited the positive
inotropic activation of the  heart by calcium and isoproterenol, and the concomitant increase
in phosphorylation  of  cardioregulatory proteins.   There was  no effect  of  lead or cadmium on
the positive chronotropic effects  of the beta-adrenergic agonist.
     Hearts obtained from  rats exposed to  low  levels  of cadmium and/or lead  (5 ppm)  for 20
months were found to have  similar changes  in  the heart's electrical conduction system (Kopp
et al., 1980)  with  significant prolongation of the  P-R  interval.   In lead-fed animals, this
was due to increased conduction time through the His-Purkinje cell  system.
     Williams et al.  (1983)  suggested  that much  of  the  negative  inotropic effect of lead on
cardiac tissue  and  ECG  abnormalities  can be related to  lead's interference with calcium ion
availability  and/or  membrane  translocation.   In  addition, even those  lead exposure-related
effects that  appear  to  occur  through autonomic nerves may be understood in terms of effects
on calcium ion, which is required  for neurotransmitter release.
     Evis et al. (1985) studied the effects of chronic low lead treatment (5 and 25 ppm, with
blood  lead  levels  < 10 ug/dl) and  hypertension  (spontaneously  hypertensive  rats)  on blood
pressure and  the  severity  of  cardiac arrhythmias in rats.  The animals were studied up to 16
months of age  and the authors  reported that there were no consistent lead-related effects on
ischemia-induced  cardiac   arrhythmias,  blood  pressure,  or  P-R   interval  in  the  electro-
cardiogram.
     Prentice and Kopp (1985)  examined functional  and metabolic responses of the perfused rat
heart  produced  by lead with varying  calcium  concentrations  in the  perfusate.   Lead altered
spontaneous contractile  activity,  spontaneous  electrical properties  and  metabolism  of  the
heart tissue.   The exact mechanisms were not completely resolved but did involve disturbances
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in cellular calcium metabolism,  although not by any single mechanistic model.   Other  possible
actions of lead were discussed,  and they included:   (1) lead-induced disturbances  in  calcium-
dependent  enzymatic  processes;  (2)  altered  calcium  binding  and  calcium  activation  of
phosphorylation-dependent  events  linked  to  transduction  of  chemical  energy  to  produce
mechanical  work;  (3)  modified  calcium  release and  sequestration  by  intracellular  storage
sites; and (4) disruptions in cellular energy production and utilization.
     In addition, hearts perfused with 30 uM lead had reduced coronary blood flow, presumably
by lead  acting  to directly constrict the vascular  smooth muscle  or by interference with the
local  metabolic  stimuli  for vasodilatation.   Increases  in perfusate  calcium concentration
partially  reversed  this effect,  although  at  the  highest calcium  levels  (5.0 mM),  coronary
blood  flow was  again  reduced.   These  authors concluded  that  their present  findings  were
consistent  with  those  of others  which  showed increased  vascular reactivity and  that the
chronic  lead  exposure-related changes in blood pressure  may  be  related to localized actions
of lead on vascular beds and arterial smooth muscle.
2.5  Summary of Lead-Related Effects on the Cardiovascular System
     Blood pressure is regulated and affected by many interactive forces and control systems;
some of  these  have been shown to be affected by lead exposure.  Understanding of the effects
of  lead  on  each system is  still  preliminary,  but sufficient evidence indicates that changes
which  occur in the  presence of  lead  can promote  development of  hypertension.   To briefly
summarize,  lead can directly inhibit renal tubule reabsorption of sodium, probably via action
on  the Na /K -ATPase.  Sodium/potassium-ATPase  inhibition may occur  in  other  cell  types as
well.   This may  alter the  concentrations  of intracellular  sodium and  calcium  ions.   Some
volume  depletion  may  occur which may  act to elevate plasma  renin activity.   The effect of
lead  exposure  on  plasma  renin activity  can be  stimulatory,  inhibitory,  or without effect,
depending  on  the  length  of exposure  and  the  exposure  level.    Lead exposure  reduces the
increase  in PRA  that occurs with noradrenergic stimulation.  Hepatic clearance  of renin is
not  affected by lead exposure and  is  thus apparently not responsible for an increase in PRA
during chronic  lead exposure.  Depending  on  the  length and dose of  lead exposure, renal  renin
concentration  is  elevated followed by  decreased concentrations.   Changes in renin  secretion
rate  in  animals do not appear  to be well correlated with changes  in  blood  pressure and may,
in  fact, reflect altered  homeostatic responses elicited  to regulate pressure.
     Additional changes  observed during  lead  exposure include the  following:   in  response to
elevations  in  PRA,  All  is  elevated,  but the levels are inappropriately low;  this does not
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appear  to  be due  to a  lead-related  decrease in  ACE  (angiostensin-converting enzyme),  but
rather  to  increased catabolism.  Aldosterone  levels are also  inappropriately  low,  possibly
due to  a lead-related  defect  in calcium  ion-dependent  release of  aldosterone.   Adrenergic
hormones  are elevated.   Vascular  smooth  muscle  isolated  from  lead-exposed  animals  has
increased reactivity to  noradrenergic  stimuli,  probably  due to an  increase  in intracellular
calcium  ion  concentration.    There  appears  to  be  increased  sympathetic  activity  in  lead-
exposed  animals.   Cardiac  arrhythmias are  usually observed  to  be  more  frequent  in  lead-
exposed animals.
     Although the exact  mechanisms  involved in lead-induced changes  in  renin  secretion rate
have not been examined,  it  is likely that lead could be  affecting the cytosolic free calcium
ion of  the juxtaglomerular cells.   When there  is  a stimulation  of  renin release,  there is
presumably a decrease  in intracellular [Ca2-1-] due to  lead blockage  of calcium entry through
voltage-sensitive calcium channels.  After  lead  enters the  juxtaglomerular cells,  lead could
enhance  or block calcium exit via Na/Ca  exchange  pumps,  or  increase or decrease  the intra-
cellular sequestration of calcium  in  storage compartments.   It is not yet  clear whether lead
stimulates or  antagonizes  calcium  fluxes  that occur  in  the  JG  cells;  therefore  it is  not
possible  to  state  definitely which  of  these  possibilities  is  correct.   Renin  release in
response to  adrenergic  stimuli  binding  to  receptor-operated calcium channels  appears  to be
inhibited.   The  reasons  for this are not known,  but lead may decrease the  number of receptor
sites  or change the  intracellular  calcium  response  which   is  normally  elicited  when  these
channels are stimulated.  For  example, if intracellular free  calcium ion  levels are already
elevated and  there were to be a smaller decrease  in  [Ca2+] than normal due  to  blocking of
calcium  efflux  via the  Na/Ca  exchange pumps  or lowered pumping  into  intracellular stores,
renin secretion would be less  under conditions of adrenergic  stimulation.
     The  changes in  vascular  reactivity  which  have  been  reported in animals  chronically
exposed to lead  are probably  the key  finding which  can  lead to an understanding of how lead
can contribute to development  of hypertension.   The vascular  smooth muscle  changes are neces-
sary and  sufficient  in themselves  to account for the increase in  blood pressure and the fact
that these  changes are  observed in animals  exposed to  relatively  low lead  levels  makes it
increasingly important  to evaluate  these findings in additional experimental  studies.  There
may be  additional  changes  in  the entire  sympathetic  neural control of vascular  tone which
acts to amplify the contractile response to any endogenous vasoconstrictor  substance.
     Two  authors (Audesirk,  1985,  and  Pounds,   1984)  have  recently reviewed  experimental
evidence on  the  influence  of  lead on calcium movements at the subcellular  level in a variety
of  cell types  (including  neurons,  neuromuscular  synapses,  and  hepatocytes).    The reader
should  consult   these  reviews for  experimental  documentation  of  the postulated  changes in
calcium-activated systems.   Lead may interact with any process normally influenced by calcium
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ions and,  depending on the system,  lead may act as  a calcium antagonist  or  as  an  agonist.   In
addition,  lead interferes with the  function of many proteins,  especially enzymes  such  as  Na/K
ATPase and the mitochondrial  respiratory  enzymes.   These interactions  may  influence  calcium
ion  concentrations  and  movements.   If  lead  interferes  with  calcium  ion movement  through
calcium channels, either by blocking entry or blocking efflux, there will be a decrease or an
increase in cytosolic  free  calcium ion.   Lead may  alter the distribution and uptake rates of
calcium ion  in cell storage  sites  with  the result that mitochondrial  and  endoplasmic reti-
culum levels  can  be increased or decreased; this in turn would affect cytosolic  free calcium
levels.   Lead  binds  to calcium-binding sites on calcium  regulatory proteins (calmodulin, in
particular [Cheung,  1984])  and thereby can alter  enzyme  systems  such as Ca-specific ATPase,
which would then alter calcium efflux from the cytosol.
     This  review  has  discussed  some of the major  experimental data concerning  lead-related
changes  in blood-pressure  regulatory systems.   Further research  efforts are  necessary to
evaluate more fully cellular  mechanisms  by which  lead exposure  produces  its effects.  Lead
(even at very low levels) produces measurable effects on the renin-angiotensin system.  With
the  blood  pressure changes observed in lead-exposed animals, changes in renin are not estab-
lished  to  be  the  cause of  hypertension;  rather,   hypertension  is  more likely  to  be due to
changes in vascular reactivity and  level of sympathetic tone, both of which may be dependent
on  lead-related changes  in  intracellular calcium ion concentration.
3.  EFFECTS OF LEAD ON DEVELOPMENT AND GROWTH
     The  effects  of  lead  exposure  early  in  development have  recently become  a  matter of
increasing  interest  and  potential concern  in  light of certain newly published epidemiologic
observations.   Coupled  with  earlier  findings  from  human and  experimental  animal studies,
these  recent  results  point  toward  a  number  of deleterious  effects  on  various aspects of
development  and  growth  associated  with relatively  low  exposure levels  encountered  by the
general  population.   For  convenience,  the  findings  are  grouped  here  under the headings of
fetal exposure effects and postnatal growth effects.
 3.1   Fetal  Exposure  Effects
      Numerous  investigations evaluating  the effects  of intrauterine lead exposure  on  fetal
 development are  reviewed  in Section 12.6 of the  revised Criteria Document  (U.S  EPA,  1986).
 Animal  studies  reviewed  there  tended to use rather  high exposure levels and were  sometimes
 confounded  by  nutritional  variables, but  such studies  collectively provide clear  evidence

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that prenatal  lead  exposure  can cause a number  of  fetotoxic  and teratogenic effects.   Among
the specific effects  observed  are reduced heme synthesis and  decreased fetus size  or weight.
Changes  in  heme metabolism—reduced  ALA-D  activity, in particular—have also  been  reported
for humans  perinatally,  even  at  average blood  lead levels  of  only 8  and  10 ug/dl  in  the
infants  and their  mothers,  respectively  (Lauwerys  et  al.,   1978).   Some  additional  human
studies  have  provided evidence suggestive  of an association between prenatal  lead  exposure
and shortened  gestation,  decreased birth weight,  or stillbirths (e.g., Fahim  et  al.,  1976;
Nordstrom et  al.,  1979;  Khera et al.,  1980b),  but others have found no  significant associ-
ation  between  such  effects  and  prenatal   lead  exposure (e.g.,  Clark,  1977;  Alexander  and
Delves, 1981; Roels et al., 1978).
     Part of  the difficulty  in drawing conclusions  from many  of  the human  studies,  espe-
cially the  earlier  ones,  derived  from the problems in accurately measuring blood  lead  levels
(see  Chapter 9 of  the  revised 1986  Criteria Document)  and  in  identifying  and  controlling
confounding variables.   In addition,  the power  of  these early studies was  often  limited by
the  small   number  of subjects  employed.   More  recently, several  new  human  studies,  using
improved analytic techniques and,  in  general, rather large numbers  of subjects, have focused
on  possible associations  of prenatal  lead exposure and  various  developmental outcomes  in
fetuses, infants,  or young  children.   These studies, most  of them  longitudinal  in  design,
have generally estimated  prenatal  lead exposure through maternal or  cord blood lead concen-
trations and have followed (or are still following) the children's postnatal  exposure through
periodic blood  lead measurements.  The studies have  also  been careful  to  consider  various
confounding factors that could affect developmental endpoints.

3.1.1  Results of Recent Human Studies
     Using logistic regression modeling techniques, Needleman  et al.  (1984) found  an associa-
tion between umbilical cord blood lead levels and certain minor congenital anomalies based on
hospital records for  4354  infants born in Boston.   Their analysis controlled for  a number of
demographic, socioeconomic, and other possible confounders,  including coffee, alcohol,  tobac-
co, and  marijuana  use,  and variables  such as gestational age, birth weight,  maternal parity,
and age.  The  most  common anomalies included hemangiomas and  lymphangiomas (14/1000 births),
hydrocele (27.6/1000 males), minor  skin anomalies such  as skin  tags  and papillae (12.2/1000
births), and undescended  testicles  (11/1000 males).   A statistically significant  association
was found  between  cord blood  lead levels  and  the  occurrence  of minor  malformations taken
collectively.  However, no individual  type  of malformation showed a significant relationship
to  lead  exposure,  nor were  major malformations found to be significantly  related  to lead.
Birth weight and gestational  age  also showed no evidence  of  being related to lead exposure.

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On the other  hand,  first trimester bleeding, premature  labor,  and  neonatal  respiratory dis-
tress were all significantly reduced at higher exposure levels of lead.
     Moore et al.  (1982)  reported that gestational age  was  significantly  reduced as  a func-
tion  of  increasing  cord or maternal  blood lead  levels in a  cross-sectional  study  of  236
mothers and  their infants in Glasgow,  Scotland.   Blood lead levels were  relatively  high in
the 11 cases  of  premature birth  (gestational age  less  than 38 weeks) that  were  observed in
this  study:   maternal  levels  averaged about 21 (jg/dl  and cord levels about 17 pg/dl  (geomet-
ric means).   Overall,  the geometric mean blood  lead  level  for the mothers was approximately
14 ug/dl  and  for the infants was  approximately  12 |jg/dl.   Stepwise forward multiple regres-
sion  analyses  using  log-transformed blood lead  levels  revealed  significant  negative  coeffi-
cients for  length of gestation against maternal blood lead (-0.056, p <0.01) as well  as cord
blood lead (-0.047, p <0.05).   Other variables considered in the analyses included:  mother's
age,  social   class,  birth  weight, and  total  parity,  of  which  only  total  parity was also
significant.   First-flush household water  lead levels  were  positively  associated with both
maternal and  cord blood  lead levels (p <0.001).
      A recent paper by Bryce-Smith  (1986) noted  that both birth weight and head circumference
were  reduced  as  a function of placental lead levels in a cohort of 100 normal infants born in
Yorkshire,  England.   Placental  lead concentrations averaged between 1 and a little more than
2  |jg/g.   Zinc and  cadmium  levels also showed significant  relationships  to  birth weight and
head  circumference.   Little information  is  provided  on the details of the  work, but a full
account of the study  is  said to be in preparation  for publication.
      A longitudinal  study of the  effects  of  lead exposure on child development  is  underway in
the  lead  smelter town and  environs  of  Port Pirie, South Australia.  McMichael et al.  (1986)
enrolled  831 pregnant women  and followed 774 of  the pregnancies to completion  (spontaneous
abortion,  stillbirth, or live birth).  Venous blood  lead concentrations were measured  in the
mothers  at  least three  times  during pregnancy:   at 14-20 weeks,  around  32  weeks,  and at
delivery.   In addition,   cord blood  lead  was measured.   Blood  lead  levels were significantly
higher  in the Port  Pirie women  than  in those  from adjacent towns and countryside (e.g.,  11.2
ug/dl at  delivery in  Port  Pirie  versus 7.5 ug/dl  outside).   Mean  blood  lead values  did not
vary  systematically through the  course of  pregnancy.    Information on demographic and socio-
economic  characteristics, medical  and  reproductive history,  smoking and  drinking habits, and
other variables  was  collected by a standardized questionnaire-interview.    A  number  of preg-
nancy outcomes  were  assessed.   Most  notably,  multivariate  analysis showed  that  pre-term
delivery  was  significantly  related to maternal  blood  lead  at delivery.   Pre-term  delivery was
defined  as  birth  before the  37th week of  pregnancy, and  was measured  by date   of  last
menstrual  period as  well as  by  the Dubowitz  et al.  (1970) assessment of  neonatal  maturity.
As shown  in  Table A-4,  the  relative  risk of pre-term delivery increased  over  four-fold  at
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Table A-4.  Estimates of relative risk of pre-term delivery (by last menstrual  date) based on
         multiple logistic analysis of maternal blood lead concentrations at delivery.
Maternal
  PbB                                               Relative risk
((jg/dl)                    Including stillbirths                    Excluding stillbirths
  ^8                                1.0                                      1.0
>8, m                             2.1                                      2.7
>11, £14                            3.0                                      6.1
  >14                               4.4*                                     8.7
*Significantly different from 1.0 based on 95% confidence interval  of 1.2-16.8;  confidence
 intervals not reported for relative risks excluding stillbirths.
Source:  McMichael et al.  (1986)

blood lead levels above 14 |jg/dl.  If cases of late fetal death are excluded, the association
is  even  stronger and  the  relative risk due  to  lead  exposure even greater  (see  Table  A-4).
     McMichael et al.  assessed a number of other  outcomes  as well.  Of 774 pregnancies,  23
ended  in spontaneous  abortion  before  the 20th  week.   All  but  one  of these  miscarriages
occurred  in  the higher-exposure Port Pirie  group.   Thus,  although the  Port  Pirie  mothers
constituted less than 80 percent of the study population, they accounted for about 96 percent
of  the spontaneous  abortions.   McMichael  et al.,  however, limited their statistical  analysis
to  the Port  Pirie  group alone and found no significant association between  spontaneous  abor-
tions  and  maternal  blood lead  levels,  mother's  age,  blood pressure, or certain  other  vari-
ables.   Of 740  non-twin pregnancies greater  than  20  weeks,  11 ended in stillbirth.  Ten of
the 11 occurred in Port Pirie women.   The proportion of stillbirths was  17.5/1000 live births
in  Port  Pirie versus 5.8/1000  outside  Port  Pirie  and 8.0/1000 for  South Australia  overall.
Interestingly, maternal  blood  lead   levels  at 14-20 weeks did  not differ  appreciably for
stillbirth versus live  birth  pregnancies,  but at delivery the  maternal  blood lead level for
stillbirths was significantly lower (7.9 (jg/dl) than that for live births  (10.4  ug/dl).
     As  for  neonatal  morphology, the incidence of  low  birth  weight (i.e.,  <2500 g at gesta-
tional age 37 weeks  or more) was greater  in  the  Port Pirie group  (3.9 percent)  than in the
non-Port Pirie group  (1.8  percent).   However, both maternal  blood  lead at  delivery  and cord
blood lead were  consistently  lower  (although not significantly so)  in  low  birthweight  preg-
nancies.    Head  circumference  was significantly  inversely  related to maternal  blood  lead
(-0.03 cm  per ug Pb/dl),  but  the  authors suggested  that  this finding could  have  been  an
artifact of  procedural  differences  between hospitals.  Crown-heel  length was not associated
with  lead exposure.   After  controlling for certain risk factors,  such as  smoking and alcohol
usage, no  association between  lead  exposure  and  the occurrence of  congenital  anomalies was
evident.   Difficulty  in conceiving  and premature rupture of  membranes  showed no association
                                             A-34

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with  lead  exposure;  but for  15  deliveries  with incomplete  placental  membranes, the  mean
maternal blood  lead  level  at  delivery was  13.4 ug/dl,  versus  10.7 ug/dl  for all  other
pregnancies.
     Other recent prospective studies have also assessed physical  development but have placed
particular emphasis  on neurobehavioral  aspects  of child development.  The  Bayley Scales  of
Infant Development  have  been  frequently used to assess mental  and psychomotor development  in
these studies because they are well suited for children 2 to 30 months of age and have satis-
factory reliability and validity.
     Bellinger  et  al. (1984) were  the  first  to report effects on  Bayley Mental Development
Index (MDI)  scores  that were inversely related to cord blood lead levels.  The subjects were
216  middle-  to upper-middle-class  Boston  children,   90  percent of whom  had cord blood lead
levels below 16 ug/dl  (the highest being 25 ug/dl).  Subjects were grouped into three catego-
ries:   low  (mean  =  1.8 ug/dl);  mid  (mean  =  6.5  ug/dl);  and  high  (mean =  14.6  ug/dl).
Multivariate  regression  analyses  were  used  to model  effects on  the  MDI.   Of  the  several
covariates  examined,  HOME scores  (Bradley and Caldwell, 1979) and  length  of gestation were
identified as  confounders of the association  between  cord  blood  lead and the MDI; both were
positively correlated with  cord blood  lead and  with the MDI, but not significantly so.  The
effect  of  this positive  relationship  was  to reduce the degree  of association between cord
blood  lead  levels  and  MDI  scores.   Thus,  when  length of  gestation and  HOME scores were
parti ailed out,  the bivariate correlation  between cord blood  lead and the MDI increased from
-0.11  to -0.19.  In  terms  of covariate-adjusted MDI scores,  the difference between low and
high lead groups was  nearly 6 points  (see  Table  A-5).
     As  the  longitudinal  study  by Bellinger  et  al.  (1985; 1986a,b)  has  continued,  the
association  between higher cord blood  lead and lower Bayley  MDI  scores  has persisted to 24
months,  at  which   point  the deficit  in  MDI performance  was still  approximately  5  points
(Table  A-5).   No association was  found using postnatal  blood  lead  levels, nor did the  Bayley
Psychomotor  Development Index show an effect.
     Some  of  the  first results  of a longitudinal  study  of  inner-city  children  born  in
Cincinnati,  Ohio,   have  been  reported by Dietrich et  al.  (1986).   These are interim  results
for 185 subjects  from a cohort of  approximately 400 subjects.   The investigators  measured
blood  lead concentrations of the  mothers  at  the first prenatal visit (PbB-Pre), generally in
either  the first or  second  trimester of pregnancy,  and of  the infants  at 10 days,  3 months,
and 6 months after  birth (PbB-1,  -3,  and  -6).   The mean  PbB-Pre was 8.3 ug/dl (range: 1-27
ug/dl); infant PbB-1,  -3, and  -6  mean averages were 4.9,  6.3, and 8.1,  respectively (overall
 range:  1-36 ug/dl).   The Mental Development Index,  Psychomotor  Development Index (PDI),  and
 Infant  Behavior Record (IBR) of  the  Bayley  Scales were administered  at  6  months.   Multi-
 variate analyses indicated an  inverse association  between blood  lead  levels at 3 months  and
                                              A-35

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  Table A-5.  Covariate-adjusted Bayley Mental Development Index scores of infants classified
                             by umbilical cord blood lead levels.
Cord PbB
(ug/dl)
<3
6-7
£10
Parameter estimatet
± standard error
p-value
95% confidence
interval


110.8
107.1
105.0
-2.9
0.
-1.1

6
± 1
± 1
± 1
± 0
0019
to


.2*
.3
.4
.9

-4.7


114.6
114.0
107.3
-3.6
0.
-1.4

12
± 1
± 1
± 1
± 1
0015
to
Age (months)

.5
.6
.6
.1

-5.8

114.
115.
110.
-2.

0.

18
3 ±
4 ±
3 ±
0 ±
0.15
7 to


1.8
1.9
2.0
1.4

-4.6


117.2
118.8
111.8
-2.7
0.
-0.2

24
± 1.7
± 1.8
± 1.8
± 1.3
038
to -5.2
*Mean ± standard error
tParameter estimate represents the estimated difference in mean covariate-adjusted MDI scores
 of adjacent exposure categories.  The lowest and highest exposure categories may be compared
 by multiplying the parameter estimate by two.
Source:  Bellinger et al. (1985)

performance on  the  MDI,  PDI, and Attention/Motor Maturity factor of the IBR.  However, these
effects were  evident only  for  the White  infants,  who  constituted  about  15  percent of the
study  population.   Otherwise,  no effect  was  evident for  prenatal  or  postnatal  exposure,
either in White or Black infants.
     Further analyses using  a method  known as structural equation modeling (based on regres-
sion techniques)  indicated  that prenatal  lead exposure had an indirect effect on MDI and PDI
scores through  its  effects  on  gestational age  and/or birth weight  (measured as continuous
variables).   That is, higher PbB-Pre  levels were associated with reduced gestational age and
reduced birth weight (p <0.05 in each case), which in turn were both significantly associated
with reduced MDI  and  PDI scores (see Figure A-2).  Thus, although the net effect of prenatal
lead  exposure  was  evident  in  neurobehavioral  deficits,  the  outcome was  mediated through
decreases in  gestational age and/or  birth weight.   (Gestational  age and  birth  weight were
independently  affected   by  lead exposure,  even  though gestational  age  may  have determined
birth weight  to some extent).   PbB-1 showed  a  similar relationship to MDI  scores,  but the
regression coefficients  were  not as  large as for PbB-Pre.   Structural equation analyses also
indicated that  tobacco and  alcohol  usage may  reduce  birth  weight both directly and (through
association with prenatal blood lead)  indirectly.  However,  the effect of prenatal blood lead
                                             A-36

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          TOBACCO AND
         ALCOHOL USAGE
  MENTAL
DEVELOPMENT
   INDEX
                                                                         PSYCHOMOTOR
                                                                         DEVELOPMENT
                                                                             INDEX
     Figure A-2.  Relationships among variables affecting 6-month MOI and PDI scores, as revealed through
     structural equation analyses.  Arrows represent hypothesized relational pathways, with covariate-adjusted
     parameter estimates (and standardized regression coefficients) indicated for each. All relationships are
     significant at p<0.05 (one-tail test).
     Source:  Dietrich et at. (1986).
on  gestational age  and  birth weight,  and  hence MDI and  PDI scores,  remained statistically
significant  even  after adjustment for  alcohol  and tobacco usage.   Race was not a significant
confounder  or covariate  for  prenatal  lead exposure  according  to the authors' multivariate
regression analyses  and therefore was not evaluated in the structural equation models.
     It should be noted that Dietrich et al. (1986) also found that higher 6-month blood lead
levels were  significantly  associated with higher Bayley  scores,  particularly the PDI.   They
interpreted  this  association  as  the result of  motorically  advanced  infants' (indicated by
higher  PDI   scores)  coming  into greater  contact with  lead  in  their immediate surroundings.
Post hoc  analyses supported this view, for those infants with the greatest increase in blood

-------
lead levels between  3  and 6 months tended  to  have  higher PDI scores at 6 months  (r =  +0.21,
p <0.01).   As summarized  by  the authors,  "while low  level  fetal  exposure to  lead  may  both
directly  (in   the  case  of  white  subjects)   and  indirectly  (for  all   infants)  compromise
neurobehavioral status  at 6 months, more precocious  infants may actually display higher blood
lead levels when postnatally  exposed  to sources of  lead  in  their  physical  environment."  It
remains to be  seen  what the ultimate developmental  outcome is for such children.
     In  a  continuation of the Port Pirie  study  described above, Vimpani et al.  (1985)  have
reported preliminary results  of  testing  592   children  at age 24  months on the MDI and PDI
Bayley Scales.  In addition to  prenatal maternal and cord blood lead levels,  capillary blood
lead levels at 6,  15, and 24 months were  assessed.   Geometric mean blood lead  levels  rose
sharply from about  14 ug/dl at 6 months  to around 21 |jg/dl at 15 months.   About 20 percent of
the subjects had estimated blood lead concentrations above 30 |jg/dl at 24 months,  after which
levels declined slightly.   Among the  sociodemographic variables assessed were  mother's  age,
each parent's education  level  and workplace, marital  status,  and  the child's  birth  rank.
HOME and maternal  IQ were assessed when  the children reached 3 years of age.
     Pearson correlation coefficients between  MDI scores and blood  lead measures were statis-
tically  significant  at all  sampling  stages except  for  delivery  and cord blood.   Multiple
regression analyses  using  a number of sociodemographic and other potential  covariates  (e.g.,
5-minute Apgar score, size for gestational age, mouthing behavior,  maternal  IQ) entered prior
to  blood lead indicated  that reduced  MDI  scores  were significantly  associated  with  higher
integrated postnatal blood  lead  levels  but not  with  prenatal  or perinatal  levels.  As shown
in Table A-6,  regression  coefficients for  specific postnatal  sampling  points  (6, 15,  and 24
months)  were  mixed  in  their significance  levels, the  highest occurring at 6  months and the
lowest at  24  months (after controlling  for maternal  IQ).   At  the  time  of this  preliminary
report,  maternal  IQ had  not  been measured   for  the  entire  cohort;  HOME  scores  were not
included in any of  the  reported analyses.
     A recent  study  by Ernhart  et al. (1985a,  1986) has also addressed the issue of prenatal
lead exposure  and postnatal  neurobehavioral function.   Maternal and  cord blood samples were
obtained at the time of delivery in  a  Cleveland,  Ohio, hospital.   The mean blood lead level
for 162  umbilical cord samples  was 5.8 ug/dl  (range:  2.6-14.7 ug/dl); mean blood lead level
for 185  maternal samples  was  6.5 ug/dl  (range: 2.7-11.8 ug/dl).   Of these totals, there were
132 mother-infant  pairs of data,  for  which the correlation of blood  lead levels was 0.80.
In  addition to size,  minor morphological  anomalies,  and 1-  and 5-minute Apgar performance,
the infants were evaluated on the Brazelton Neonatal  Behavioral Assessment Scale (NBAS) and
part of  the   Graham-Rosenblith  Behavioral Examination for Newborns (G-R).  The NBAS Abnormal
                                             A-38

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   Table A-6.   Partial  linear regression  coefficients  for 24-month  Bayley  MDI  scores  against
              each blood lead measure,  with  and without maternal  IQ in  the modelt
PbB Index
Average Prenatal
Del ivery
Cord
6 months
15 months
24 months
Integrated Postnatal
Ignoring
maternal IQ
-0.250
0.181
0.053
-0.231*
-0.084
-0.152*
-0.240*
Control 1 ing
For maternal IQ
-0.064
0.001
0.026
-0.396*
-0.103
-0.061
-0.310*
fModel contains 13 sociodemographic and neonate factors
*Statistically significantly different from zero at p <0.05 (one-tailed)
Source:   Vimpani et al.  (1985)

Reflexes  scale  focused  on  neonatal  neuromuscular  indicators  such  as walking,  standing,
Babinski reflexes, and ankle clonus.  The G-R scales included a Neurological Soft Signs scale
(jitteriness,  high-pitched/weak  cry,   hypersensitivity,  etc.)  and  a  Muscle  Tonus  scale.
Several   covariates  were  incorporated  in  the hierarchical  regression  analysis,  including
alc"h.3l, tobacco and drug use, nutrition, gestational age, and parental size measures.
     Of the 17 neonatal outcomes examined, three measures showed significant relationships to
blood lead  measures.  Abnormal  Reflexes and Neurological Soft  Signs  showed significant in-
creases  in  the  amount  of  variance  that cord blood lead accounted  for;  Muscle Tonus  scores
showed  significant  effects  only for maternal  blood lead  levels  (see  Table  A-7).   Further
analyses using data  solely from mother-infant pairs  showed only Neurological Soft Signs to be
significantly  related to cord blood  lead; maternal blood  lead showed no  significant relation-
ship  (Table A-7).   This  dissociation  of  maternal   and cord blood  lead effects,  despite the
rather  high correlation of  the  two independent  variables, was viewed  by  Ernhart  et  al. as
evidence  of  possible  increased  fetal  accumulation of  lead.   With  regard to morphological
anomalies,  Ernhart et al.  found  no evidence of any effects related to lead.   However,  they
did  find clear  evidence of  such effects  related  to maternal  alcohol  consumption (Ernhart
et al.,  1985b).
      A  brief report on  later outcomes  in this same cohort mentions a statistically signifi-
cant  effect of  the  Neurological  Soft  Signs measure on Bayley  MDI  scores at 12 months  (Wolf
et  al., 1985).  Apart from  this  indirect effect  of  cord  blood  lead, no effects on  MDI  scores
at  6-24 months  or  Stanford-Binet  IQ  scores  at  36 months were attributed to prenatal  lead
exposure.   A  more  detailed account of the  later  stages of  this  prospective study will  be
needed  to evaluate  its  findings  and their implications.

                                              A-39

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       Table A-7.  Lead-related variance increments for neonatal neurological  measures.
Variable

Covariate
Variance
Cord PbB
Pb Effect
Variance
Maternal PbB
Pt
Covariate
Variance
Pb Effect
Variance
Pt
                                      All Available Data*
Abnorm. Ref1.
Neur. Soft Sign
Muscle Tonus
0.07
0.05
0.13
0.033
0.038
0.008
0.023
0.016
0.260
0.07
0.04
0.09
0.002
0.004
0.024
                              Restricted Data (132 paired cases)
Abnorm. Refl.
Neur. Soft Sign
Muscle Tonus
0.09
0.06
0.12
0.006
0.056
0.015
0.373
0.008
0.162
0.09
0.06
0.12
0.001
0.007
0.016
0.717
0.354
0.153
tp values <0.05 are underlined.
*For cord PbB, n = 162; for maternal PbB, n = 185.
Source:  Ernhart et al. (1985a)

     The predictive value  of  different markers of  lead  exposure  for neurobehavioral perfor-
mance  has  been specifically  addressed by Winneke  et al.  (1985a,b).   Of an  original  study
population  of  383  children born in Nordenham,  F.R.G.,  114 subjects were followed  up  at age
6-7 years.   The mean average maternal  blood lead level was 9.3 pgAM (range:  4-31 ug/dl); the
mean cord blood  lead  level was 8.2 |jg/dl (range:  4-30 ug/dl).  Because of the high degree of
correlation between cord blood  and maternal  blood  lead  (r =  0.79),  the two were combined to
form an  estimate of  perinatal exposure.   Cord  blood  versus blood lead levels at  age  6-7 yr
correlated  at  r = 0.27.   Stepwise multiple  regression analyses  by Winneke et  al.  (1985a)
indicated that  maternal  blood  lead levels accounted  for  nearly  as much of  the  variance in
neurobehavioral test scores at age 6-7 years  as did contemporary blood lead levels (see Table
A-8).   Cord  blood  lead alone,  however,  showed less impact on  later performance.   Combining
maternal  and cord  blood  lead  levels to  form  an estimate of perinatal exposure resulted in a
significant association with only version 10  of the Wiener (Vienna) reaction performance test
(Winneke et al., 1985b).

3.1.2  Interpretation of Findings from Human  Studies
     As  reviewed  above,  three  recent  studies have investigated  an  association  between pre-
natal   lead  exposure  and congenital morphological  anomalies  (Table  A-9).  All  three studies
                                             A-40

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  Table A-8.   Percent additional  variance  accounted  for by  different  indices  of  lead  exposure
  for selected neurobehavioral  tests,  as determined  by  stepwise  multiple  regression analyses
                               after correction  for  confounding.
Test
wise
Verbal IQ
Performance IQ
Full-scale IQ
Wiener Reaction Performance
Version 12 errors
Version 10 errors
Cued Reaction Time (3-sec)
Lift-off latency
Push button latency

Perinatal
PbB

+0.2I
+0.0
-0.1

+2.8**
+7.5***

-2.5*
+3.8**
Marker of Lead Exposure
Cord
PbB

-0.1
+1.8
+0.3

+0.7
+3.0**

-1.4
-0.7

Current
PbB

+0.3
-2.4*
-0.3

+4 3***
+11 0***

+0.0
-0.1
tSign (+ or -) indicates direction of effect.

*p <0.10      **p <0.05      ***p <0.01

Source:   Winneke et al. (1985a)
   Table A-9.  Summary of recent studies on the relationship between prenatal lead exposure
                                 and congenital malformations.
Reference
Ernhart et al
Needleman et
McMichael et

. (1985a, 1986)
al. (1984)
al. (1986)
n
185
162
4354
749
Pb- Exposure
Index
delivery
cord
cord
prenatal
delivery
cord
Avg. PbB
(ug/dl)
6.5
5.8
6.5
11.0
11.0
10.0
Malformations
0
0
+*
0
0
0
Symbols:  0, no evident relationship; +, positive relationship; -, negative relationship;
statistically significant at p <0.05.
                                             A-41

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used  regression  analyses  to  control  for  numerous   possible  covariates  and  confounders,
including mother's age,  parity,  and tobacco and alcohol  usage.   Nutritional  information was
collected by McMichael  et al.  (1986) and by Ernhart et al.  (1985a,  1986),  but apparently not
by Needleman et al.  (1984).
     Of the  three studies,  only Needleman et al.  (1984) reported significant effects related
to  lead  exposure.   The sole deleterious effect was  for minor malformations as  a  group,  not
individually.   Unpredicted   significant  reductions  in first  trimester  bleeding,  premature
labor, and  neonatal  respiratory  distress were also associated with  higher  blood lead levels.
This  study  was  a retrospective  analysis;  that  is,  the investigators  themselves did  not
examine the  infants  but  instead relied on the routine observations  of hospital  staff pediat-
ric  residents,  as recorded  in chart notes.  While  ensuring  that the data were  collected in
blind  fashion,  this  method  suffers from a  lack of precision and uniformity that  could  have
affected the results in various ways.   Diagnosing  malformations,  particularly minor malforma-
tions, involves  judgment by  a clinician as  to  the degree of departure  from  normality.   The
fact  that  neither major malformations (which would  be more  obvious) nor any  specific  minor
malformation  showed  a  significant  relationship  to   blood  lead level  in  the analyses  of
Needleman et al.  suggests that diagnostic criteria were not  consistently  employed.   This  lack
of precision could  be  the  basis for the nonspecificity of their  reported effect (i.e.,  minor
malformations taken  as a whole  but not  individually).   Clearly, it would be  preferable to
have  specialists in  teratology make the diagnoses on the basis of predetermined criteria for
minor as well as major malformations.   Prior determination of diagnostic  criteria and assign-
ment  as to  their severity  would also eliminate the  possibility  of  grouping certain outcomes
to  achieve  statistical significance.  On  the other  hand,  diagnostic imprecision  would not
appear, in  itself,  to  bias  the investigation so  as  to promote detection of a spurious  asso-
ciation where none existed.
     The multiplicity and apparently exploratory nature of the statistical  analyses performed
by  Needleman et  al.,  coupled with the prima facie implausibility of a  protective  effect of
lead  (for   first  trimester   bleeding,  premature  labor,  and  neonatal respiratory  distress),
suggest the  possibility  that their findings were simply  due  to  chance,  i.e.,  an artifact of
conducting multiple statistical  tests.   However,  lead may have  highly specific and indepen-
dent  effects  within  a  given  organ  system (Silbergeld, 1983),  so  qualitatively  different
outcomes  are not  wholly  unlikely.   In  addition,   as  discussed  further  below,  seemingly
paradoxical  effects of prenatal  lead exposure could be due  to misleading indicators of  expo-
sure.  For example,  if in some cases the fetus served as a sink for  the mother's body burden,
then  the maternal blood  lead level could be  lower  than that registered  in  the cord.   Thus,
the mother  might be  "protected"  at the expense of  the fetus, or vice versa,  depending  upon
the dynamics of the  mother-fetus transfer of lead  at any particular  stage of gestation.
                                             A-42

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     McMichael  et  al.  (1986)  followed  749  pregnancies prospectively to completion but  also
apparently  used  hospital  records  to obtain  data on  congenital  malformations.   Apart  from
noting that 40 (5.4  percent) of the infants had anomalies at birth (29  of  which  were  classi-
fied  as  minor),   they simply  stated,  "After  controlling  for the  putative  risk factors  of
maternal  age, gravidity,  social  status,  smoking and alcohol  usage, no association with blood
lead  level  at 14-20  weeks or  later was  apparent."   Unfortunately, not enough information is
provided in their  report on their methods or analyses to judge the validity of their  conclu-
sion on this point.
     The investigation by Ernhart  et al. (1985a, 1986) was part of a prospective study using
cord and maternal blood samples taken at the time of delivery and employing a detailed proto-
col  for  the detection of birth anomalies.  Their success in detecting an effect of maternal
alcohol  consumption  (Ernhart  et  al.,  1985b)  suggests  that their  methodology was  basically
adequate to detect a teratological effect.   However, the maternal and cord blood lead levels
observed by Ernhart et al.  (1986) averaged only 6.5 and 5.8 ug/dl, respectively, with maximum
values  of  11.8  and 14.7  ug/dl.   This  restricted  range of  variation  in blood  lead levels
coupled with a comparatively small number of subjects (n = 185) and the relatively infrequent
occurrence  of congenital  anomalies (often less than 1-2 percent of births) would have made it
difficult to detect an effect  of lead in any case.
      The evidence  available from the above three studies allows no definitive conclusion at
this  time  regarding  the existence of an association  between  commonly  encountered  levels of
prenatal  lead  exposure  in  humans  and  the  occurrence  of  congenital  anomalies.   Further
prospective studies with large subject populations and clearly adequate statistical power are
needed to resolve  this question.   For example,  if the  natural occurrence of a  malformation is
2  percent,  5402  subjects per  group  would  be  required to  find a  relative  risk of 1.5 with an
alpha of 0.05 and  a  beta of 0.10 (Schlesselman and Stolley, 1982).
      More  evidence  is  available that bears  on the issue of  prenatal  lead exposure and the
developmental  outcomes  measured  as birth  weight and gestational  age.    All  of the  studies
summarized  in Table  A-10  included  gestational  age and  birth weight as  variables  in  their
analyses,  but  the  only significant  findings for  birth weight came from  Dietrich et al.
(1986).   No  evidence  of  an  association  was  reported  by  Ernhart  et  al.  (1985a,  1986),
Needleman  et al.  (1984),  and  Moore  et  al.  (1982).   Although  Bellinger et  al.  (1984)  found  no
evidence of an  effect on birth weight per se,  they  did report  an exposure-related  trend  in
the percentage  of small-for-gestational-age  infants  (1.2,  2.4,   and 8.1 percent for  the low,
mid, and high blood lead categories).
      The findings  of  McMichael et  al.  (1986)  are  not  entirely clear with  regard  to birth
weight.   The proportion of pregnancies  resulting in  low-birthweight  singleton infants  for
 Port Pirie women  (whose blood lead levels averaged  10.4 pg/dl) was more than twice that for
                                              A-43

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   Table A-10.  Summary of recent studies on the association of prenatal  lead exposure  with
                               gestational age and birth weight.
Reference

Ernhart et al.
Bellinger
Needleman
Dietrich
McMichael
Moore et
et al
et al
et al.
et al

(1985a, 1986)
. (1984)
. (1984)
(1986)
. (1986)
al. (1982)
n
185
162
216
4354
185
749
236
Pb-Exposure
Index
delivery
cord
cord
cord
prenatal
delivery
cord
delivery
cord
Avg. PbB Gestational
(ug/dl) Age
6.
5.
6.
6.
8.
11.
10.
14.
12.
5 ?
8 ?
5 +
5 0
3 -*
0 -*
0 -*
0 -*
0 -*
Birth
Wt.
0
0
-
0
-

1

*
+2
+2
00

Symbols:  0, no evident relationship;  +, positive relationship;  -, negative relationship;  *,
statistically significant at p <0.05;  ?, not reported.
:Birth weight showed no relationship, but the trend in percentage of small-for-gestational-
 age infants was nearly statistically significant at p <0.05.
2See text for possible explanation of reduced blood lead levels in mothers whose infants
 were low in birth weight.

non Port Pirie women (average blood lead level 5.5 ug/dl).   Yet in both groups the mean blood
lead levels (maternal as well as cord) for low-birth weight pregnancies were lower than those
for birth  weights greater than  2500 g.   Multiple regression  analysis  showed no  significant
association  between  low  birth  weight  and  maternal  blood lead.   Note that,  unlike  others
who used  birth weight as a  continuous  variable, McMichael et  al.  categorically  defined  low
birth weight as  less than 2500 g at  37  weeks or greater  gestational  age.   This  dichotomous
classification might have made  detection  of subtle effects on birth  weight  more difficult.
However,  using  "small-for-dates"  (i.e.,  weight  less   than   the  tenth  percentile  for  the
appropriate gestational age)  in multiple logistic regression analysis revealed no  evidence of
intrauterine growth retardation.
     It is  interesting that  McMichael et  al.  found low birth weight  as well  as  stillbirths
associated with  lower  maternal  blood lead level  (stillbirths  significantly so, birth weight
not).   These seemingly  anomalous findings could be explained by a greater than normal  trans-
fer of  lead  from the mother to the fetus and/or placenta in such cases.  As noted in Section
10.2.4 of the revised Criteria Document (U.S. EPA, 1986) and further confirmed by  some of the
                                             A-44

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studies reviewed  here,  maternal  and cord blood lead levels are in general  highly correlated,
with maternal  levels at birth typically  being somewhat greater than  cord  levels.   However,
average blood  lead  levels  at  birth may  not accurately reflect  individual  circumstances  or
past exposure  levels.   For  example, Ong et  al.  (1985)  analyzed maternal  and cord blood lead
concentrations for  114  women  at  delivery and found that, although the two  were significantly
correlated  (r =  0.63),  in  roughly one-fourth  of the  cases  the cord  blood lead  level  was
higher than the mother's.   The dissociation of maternal  and fetal blood lead noted by Ernhart
et  al.  (1985a,  1986)  in  their  statistical  analyses might  also reflect  increased transfer
and/or absorption of lead from the mother to fetus in certain individuals.
     In  addition,  exposure  levels during  the  course   of  pregnancy  may  not  be accurately
indexed by  blood lead levels at parturition.  Various studies  indicate that average maternal
blood lead  levels during pregnancy may tend to decline (Alexander and Delves, 1981; Bonithon-
Kopp  et al. , 1986), increase  (Gershanik  et  al., 1974;   Manton,  1985),  or  show no consistent
trend  (Barltrop,  1969;  Lubin et al.,  1978).   These divergent  results may simply reflect the
likelihood  that  the maternal  blood lead  pool  is subject both  to  increase  as  bone stores of
lead  are mobilized during  pregnancy  (Buchet  et  al.,  1978;  Manton, 1985;  Silbergeld and
Schwartz, 1986)  and to  decrease  as  lead is transferred to the placenta and fetus.
     Apparently,  then,  under  some conditions  the  fetus may be  exposed  to higher levels of
lead  than  indicated by  the  mother's  blood  lead  concentration.   This conclusion does not
establish  that  birth weight  is  reduced by  intrauterine exposure  to  lead.   It does  suggest,
however,  that attempts to detect  effects of prenatal lead exposure--including  not  only  birth
weight,  but morphological  anomalies,  pregnancy  outcomes,  and postnatal development—may be
complicated if,  for some  reason,  a  disequilibrium  exists  between maternal  and fetal body
burdens  at  the  time of  blood lead measurement.   Further research is needed  on the  dynamic
relationship between mother and fetus as lead  is  mobilized  and transferred from one to the
other  during gestation.
      For  gestational age, Dietrich et al.  (1986), Moore et  al.  (1982), and McMichael et  al.
 (1986)  reported  significant negative  relationships with prenatal  lead exposure;  in contrast,
 Needleman  et  al.  (1984)  reported no association,  and Bellinger et  al.  (1984)  reported a
 positive  (nonsignificant)  relationship  between  prenatal  lead exposure and gestational  age.
 Note,  however,  that infants  of less  than  34 weeks gestational  age were  excluded  from the
 study by Bellinger and his colleagues.   This selection criterion would interfere with detec-
 tion of  a  reduction  in  gestational  age.   Thus,  the evidence as  a whole  from these studies
 indicates  that  gestational  age  appears  to  be  reduced as prenatal  lead  exposure increases,
 even at  blood  lead levels below 15  ug/dl.   Based on the  parameter estimates  of  Dietrich
 et al. (1986),  the reduction in gestational  age amounts  to 0.6 week per natural  log unit of

                                              A-45

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blood  lead  increase.   In terms of risk  estimates,  according  to McMichael  et al.  (1986)  the
risk of pre-term  delivery  increases  signficantly by at least  4-fold as either the cord blood
lead or mother's blood lead concentration at delivery increases from ^8 to  >14 HQ/dl.
     Further evidence of a deleterious effect of prenatal  lead exposure on  infant development
comes from studies using the Mental Development Index of the Bayley Scales  of Infant Develop-
ment (Table  A-ll).   Bellinger  and his  colleagues  have reported persistent  deficits  of  4-7
points in MDI  scores  at ages 6 to 24 months, and have found that these deficits consistently
relate to the children's blood lead levels measured at birth in the umbilical cord (Bellinger
et al., 1984,  1985,  1986a,b).   Dietrich et al.  (1986) have also reported deficits on 6-month
MDI scores that  relate  to  prenatal maternal blood lead levels.   In both of these studies  the
results were  statistically significant  after  proper allowance  for various  factors  such as
SES, HOME scores, tobacco and alcohol usage, etc.   Both studies also provide estimates of  the
magnitude of the effects on MDI scores.   Parameter estimates from Bellinger et al.  range from
-2  to  -3.6  points  for  each increment  in  cord blood  lead classification  (see  Table A-5).
Consistent with these  figures  is  the estimate of  -2.25 points  per natural log unit maternal
blood  lead as  derived from the structural  equation  analyses  of Dietrich  et  al.  (see Figure
A-2).
     Vimpani  et  al.  (1985)  found  evidence more  clearly  relating MDI  deficits  to postnatal
lead exposure  than  to  prenatal  exposure.  They ascribed an average 4-point drop in 24-month
MDI scores  to  a  mean  increase of  10 pg/dl in  blood  lead levels  at 6 months  after birth.
Note,   however,  that they also  found  a  negative  relationship  between MDI  scores  and average
prenatal  exposure,  although not a statistically  significant  relationship.   Since postnatal
blood  lead levels increased by about 50 percent from 6 months to 15 months in the Port Pirie
study,  later  increases  in  exposure  may  have  overwhelmed   the  more  subtle  effects  of lower
prenatal  exposure  levels.   It should be  remembered  that  the  same cohort  of subjects showed
significantly  reduced  gestational  age  and possibly other  effects  as  a  result of  these
prenatal  exposure levels  (McMichael  et  al. ,  1986).   Also,  earlier  testing on  the  Bayley
Scales  (e.g.,  at  6  months  of age)  might have revealed a stronger effect of prenatal exposure
than could be detected at 24 months after birth.
     The  prospective  study of  Ernhart  et  al.   (1985a,  1986)  has thus  far provided evidence
relating  neonatal performance  on  a  Neurological  Soft Signs  scale  (jitteriness,  hypersensi-
tivity, etc.)  to prenatal   lead exposure as reflected in  cord blood  lead  levels.   A brief
follow-up report  by Wolf  et al. (1985)  indicates  that  lowered Bayley MDI  scores at one year
of age appear  to be  a statistically  significant sequela  of  the cord blood  lead effect on
Neurological  Soft Signs  shortly after birth.   Finally, Winneke  et  al.  (1985) noted a highly
significant relationship between perinatal  blood  lead levels  and  one  measure of psychomotor
performance at 6-7 years after birth.
                                             A-46

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         Table A-11.  Summary of recent studies on the relationship between prenatal
                  lead exposure and Bayley Mental Development Index scores.
Reference
Bellinger et al. (1984,
1985, 1986a,b)



Dietrich et al. (1986)



Vimpani et al. (1985)






Pb-Exposure
n Index
216 cord
6-mo PN
12-mo PN
18-mo PN
24-mo PN
185 prenatal
10- day PN
3-mo PN
6-mo PN
592 prenatal
delivery
cord
6-mo PN
15-mo PN
24-mo PN
integr. PN
Avg. PbB
(ug/dl)
6.5
6.2
7.7
?
?
8.3
4.9
6.3
8.1
•>
ii4
104
~145
~215
~215
?
Bayley MDI Scores
6-mo 12-mo 18-mo 24-mo
_* _* . _*
0000
0 00
0 0
0
_*1
-
_*2
+*3
-
0
0
_*
-
-
_*
Symbols:   0, no evident relationship;   +,  positive relationship;   -,  negative relationship;
 *, statistically significant at p <0.05;   ?,  not reported;   PN,  postnatal.
Effect of prenatal  (i.e., maternal) blood lead on MDI mediated through effects on
 gestational age and/or birth weight.
2Effect of blood lead at 3 months significant only for White children (15 percent
 of study population).
3Authors interpret positive relationship as due to greater lead exposure in developmentally
 advanced children.
4Blood lead levels for Port Pirie mothers only, as reported by McMichael et al. (1986).
5Geometric means estimated from graph.

     The  exposure levels  at which the  above neurobehavioral deficits  are observed can  be
inferred from some of the reported analyses.  Based on the blood lead classifications used by
Bellinger et al. (1984) and the 95 percent confidence intervals for the effects they reported
(see Table A-5), significant declines in Bayley MDI scores occurred at cord blood lead levels
of  10  ug/dl  and above.  Dietrich et al. (1986) did not group the prenatal blood  lead concen-
tration  in  their study,  and thus  it is  not possible to state a precise exposure level at
which  their effects  occurred.   However, with a mean  of 8.3 and standard deviation  of 3.8, it
appears  that  over 95 percent of their study  population had blood lead  levels  below 16 ug/dl.
Vimpani  et  al.  (1985)  noted that  subjects whose blood lead  concentrations  consistently fell
                                             A-47

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in the  top  quartile  at 6, 15, and  24  months had significantly lower MDI  scores  compared to
the remainder of the cohort.   Although the authors did not describe the  distribution of blood
lead  levels  in their  study,  they did note  that  about  20 percent of the  subjects  had blood
lead  levels  in excess  of 30 ug/dl  at age  2  years, which  was  the point of  peak  exposure.
Thus, their  levels appear to be somewhat  higher than  those  of  the other  studies reviewed
here.  However, the prenatal  levels for this cohort were considerably lower,  averaging around
11 ug/dl in Port Pirie mothers and about 8 ug/dl outside Port Pirie (McMichael  et  al., 1986).
     The  neurobehavioral  effects  noted by  Ernhart  et al.  (1985a,  1986)  and  Wolf  et  al.
(1985),  although "small" by the authors'  characterization, were significantly related to cord
blood lead levels that averaged only 5.8 (jg/dl  and ranged upward  to only 14.7 ug/dl.  Winneke
et al.(1985)  reported  that errors in reaction  test performance were associated with maternal
blood lead  levels averaging  9.3  ug/dl and  cord blood  lead levels averaging 8.2  ug/dl.   A
scatter plot of the mother-cord blood lead concentrations indicates that, except  for a couple
of outliers,  nearly all  of  the  values  were clearly below 20 ug/dl and  generally  did  not
appear  to  exceed about  15  ug/dl.  All  of  these studies taken together suggest  that neuro-
behavioral deficits,  including declines  in  Bayley Mental Development Index  scores  and other
assessments of  neurobehavioral  function, are  associated with prenatal  blood lead exposure
levels on the order of 10 to  15 ug/dl  and possibly even lower,  as  indexed by maternal or cord
blood lead concentrations.
     The evidence  reviewed  in this section supports  the conclusion that fetal  exposure to
lead at  relatively low and prevalent  concentrations can have undesirable effects  on infant
mental  development,  length  of gestation,  and   possibly  other  aspects of  fetal  development.
Further research  is  needed to assess  the complex dynamic  relationship  between maternal  and
fetal body  lead  burdens, particularly  with  regard to  possible individual  differences  in
transfer and/or uptake  from  mother  to fetus.   Further  research  is also needed to assess the
possible contribution  of paternal  lead  exposure  to these effects (cf.   Uzych, 1985; Trasler
et al.,  1985;  Brown,  1985).   At present, however, perinatal  blood  lead levels at  least as low
as 10 to  15 ug/dl  clearly warrant concern for  deleterious effects on early postnatal as well
as prenatal development.   The persistence  of   certain  types of  effects  remains  to  be more
fully investigated  as the present  long-term prospective  studies proceed.  For  example,  it
remains  to  be evaluated  as  to whether  delays in cognitive development indicated  by decre-
ments in MDI  scores  are reflected in later childhood by lowered  IQ scores  or poorer academic
performance.   The  evidence  from  other  studies  reviewed in the 1986 Criteria  Document (U.S.
EPA,  1986)  is indicative of  decrements  in  IQ measured  in schoolage children,  even at PbB
levels below 30 ug/dl.  Note  that additional evidence for IQ decrements  being associated with
blood lead levels  below 30 ug/dl  (Hazakis et  al,  1986) and, possibly,  as  low as  10-15 ug/dl
(Fulton  et  al,  1986)  in  schoolage children was presented at a  recent  Edinburgh symposium.
                                             A-48

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3.2  Effects of Lead on Postnatal  Growth
3.2.1  Epidemiclogic Observations
     Among the earliest  indications  of  lead effects on stature  in  children  are  observations
reported  by  Nye  (1929)  regarding  "runting,"  along with  squint and  foot drop,  as  physical
signs  characteristic  of overtly  lead-poisoned  Australian  children  seen  in  the   1920's.
Remarkably,  since  then  very few  systematic  evaluations  of  possible  stunting  of  physical
growth have  been  included  among the health endpoints examined  in  the numerous epidemiologic
studies of lead effects on early human development.
     In one  such  study,  Mooty et al. (1975)  obtained physical  measurements  (weight, height)
for children  (2-4  years  old) chosen according to low and  high blood lead levels  (x ± S.D.=
20.4 ± 4.3 and 56.9 ± 8.3 ug/dl,  respectively).  The  21 high-lead children, with  blood lead
levels in the range 50-80 |jg/dl, were  both shorter (x  = 32.1 percentile on Stuart's Boston
Growth Charts) and  weighed  less  (x =  43.8 percentile) than the  26  low-lead children with
blood leads  of 10-25 ug/dl (height = 41.1 percentile,  weight = 48.7 percentile).   The average
age  for  the control group, which was composed  of 12  Puerto  Rican, 8  Black, and 5 Caucasian
children,  was 34  months; the high-lead group had a mean age of 33 months and was composed of
4  Puerto  Rican,  17 Black, and  no Caucasian children.  Because of the slightly younger age and
lack  of  Caucasian children  in the  high-lead  group  (as   well  as other differences,  e.g.,
dietary  intakes),  it is not  possible to  clearly  determine the relative contribution of lead
to the observed smaller  stature of the  high-lead subjects versus other factors.
      In  a  later  study,  Johnson and  Tenuta (1979) studied the growth  and  diets  of 43 low-
income Milwaukee  children (aged 1-6 years) in relation to  their blood lead  levels.  Children
with  low  (12-29   ug/dl;  N = 15),  moderate (30-49 ug/dl;  N =  16),  and high (50-67 ug/dl;
N  =  12)  blood lead  levels had  average  daily  calcium intakes  of 615,  593, and  463 mg, respec-
tively.   Also, there was a  relative decrease (p  <0.075) in individual height  percentile with
increasing blood   lead level  (high-lead children  had  means of 25.7 percentile for height and
42.2  percentile  for weight;  no specific  data were  reported for other  lead groups) and  higher
incidence of pica  (eating of plaster and paint)  on the part of the  children  with blood lead
levels  ranging from 30  to 67 ug/dl.  Unfortunately, the specific  racial  composition and mean
ages  of the  different blood lead  groups  were not reported, making  it impossible to  determine
the  relative  contribution  of  such  factors (or  the  differences in  calcium intake  or  other
dietary  factors)  to the  observed  smaller  stature  among  the high-lead  children.
      In  another study,  Routh et  al.  (1979) examined a  sample of  nonurban children  (N = 100;
mainly from  lower socioeconomic  status  families  in North Carolina) with  developmental  and
 learning  disabilities  for  previously   undiagnosed   lead  intoxication.    One  child  with
 "moderately"  elevated  blood lead (according  to  the then-existing CDC  classification, 50-79
 pg/dl)  and  nine  with  "minimal"  elevations (30-49  pg/dl)  were  identified.  Of   these  10
                                              A-49

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children, seven  were microencephalic (defined  as  head circumferences at or below  the  third
percent!le for the  child's  age on standard growth charts).   This was  a markedly  greater pro-
portion of microencephaly than that seen among the remaining children with  blood lead  levels
below 29  |jg/dl  (17  of  62;  25 percent).   Most of the microencephaly  syndrome children were
Black.  Five of the elevated blood-lead children also showed more general  growth  retardation,
in that  their  height, weight,  or both were at or below the  third percentile for  age and sex.
These results, as are those  from the previously discussed studies, are suggestive of possible
stunting of growth  due  to  lead exposure early  in  development resulting in  blood lead  levels
generally above 30 ug/dl.   However, again it is not possible to clearly separate  the relative
contribution of lead from other factors (racial, dietary, etc.) that may have affected  growth
of the children studied by Routh et al.  (1979).
     Much stronger  evidence  for  lead exposure producing retardation  of  growth  and decreased
stature  has  more recently  emerged in the  1980's from both  animal toxicology studies  (dis-
cussed  below)  and  evaluation  of  larger scale  epidemiologic data sets.   In  regard to  the
latter, Schwartz et al.  (1986) have reported  results  of analyses of  data from  the NHANES II
study described earlier in relation to evaluation of blood lead/blood  pressure relationships.
More  specifically,  Schwartz  et al. (1986) analyzed  results  for  anthropometric  measurements,
as well  as  numerous other  factors (age, race,  sex,  dietary,  etc.) likely to affect rates of
growth and development,  among the NHANES II children.
     Linear regressions of adjusted data from 2695 children  (aged 7 yrs or younger) indicated
that  9 percent of  the  variance in height, 72  percent  of the variance in weight, and 58 per-
cent  of  the  variance in chest circumference were  explained by the following five variables:
age,  race, sex,  blood  lead,  total calories or protein, and  hematocrit or transferrin satura-
tion.  The  step-wise multiple  regression  analyses further  indicated  that  blood lead  levels
were a statistically significant predictor of childrens'  height (p <0.0001), weight (p  <0.001)
and chest circumference (p <0.026), after controlling for age in months, race,  sex and  nutri-
tional covariates.   The strongest relationship was found between blood lead and  height, with
threshold regressions indicating no evident threshold for the relationship down  to the  lowest
observed blood lead level of 4 ug/dl.   At their average age (59 months),  the mean blood lead
level of the  children  appears  to  be associated  with a reduction of  about  1.5 percent  below
the height expected if their blood lead level had been zero.  Similarly, the relative impacts
on weight and chest circumference were of the same magnitude.
     Overall, the  above findings  of Schwartz  et  al.  (1986)  appear  to  be  highly credible,
being based on well-conducted  statistical  analyses of a large-scale national survey data set
(which was subjected to  rigorous quality assurance procedures) and having taken into account
numerous  potentially  confounding  variables.    Other  recent  results newly  emerging  from
independent, well-conducted  prospective studies of prenatal  and early  postnatal  lead exposure
                                             A-50

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effects on  human  development, also appear  to  substantiate the likelihood of  lead  retarding
early  growth,  as  reviewed above.   For example,  Dietrich  et al.  (1986) report that  prenatal
maternal blood  lead levels  and  early postnatal  (10-day)  blood lead  levels were  negatively
correlated with birth  weight (p <0.001) and gestational  age  (p <0.05) for 185  infants  from
low  socio-economic  inner-city Cincinnati families.   The  plausibility of  reported  epidemio-
logic  findings  of  associations  between  early  lead  exposure  and  retardation  of growth  re-
flecting a causal  relationship  is  supported by animal toxicology results  concisely discussed
below.

3.2.2  Animal Toxicology Studies
     The impairment of physical growth or stature as an effect of lead exposure during prena-
tal  or early postnatal life  has been  well  established by animal  studies  (see below).   How-
ever,  although  preceeding  sections   of  the  Addendum cite  several  recent  epidemiological
studies which strongly support  the notion  that lead exposure  during early  development can
lead   to  retardation  of   growth  in  humans as  well, additional  carefully designed  animal
toxicology  studies  are needed to better substantiate and further extend the epidemiological
findings.
     A computer search for the relevant animal  experimental studies  published during the last
decade yielded  43 papers which described significant retardation  of growth (measured by gain
in  weight or  length)  after  low-level exposure  during intrauterine  life,  during early post-
natal  life,  or both.  An  additional  22 papers  specifically  stated  that  growth  of the lead-
exposed animals  was not  affected.    However,  a close examination  of this latter  group of
studies revealed  that in the  great  majority  of the cases  the treatment started  too late
(e.g., after weaning) or  the doses  were too low (e.g.,  less than 10  ppm  in drinking water).
On  balance, then,  it  seems  very clear that low-level chronic  lead  exposure  during pre- and
early  postnatal  development does  indeed result in  retarded growth even  in  the absence of
overt  signs  of  lead poisoning.
      One  study on  rats, by  Grant  et al. (1980), provides  detailed experimental  data relating
external  lead  exposure  doses to  consequent blood  lead  levels and growth rate measured  in
terms  of both  weight and length.   Continuous  prenatal and postnatal exposures to  lead  were
accomplished via  lead  adulteration of the  drinking  water:  (1) of  dams prior to  conception,
throughout  pregnancy, and nursing; and (2) of  the drinking water consumed  post-weaning  by
their offspring through 180 days  (6 months).   Females from lead exposure groups with average
blood  lead  levels  in the  range of  18-48  ug/dl were significantly shorter  in  crown-to-rump
 length from postnatal days  7 to 180; lead-exposed  males  exhibited  only a transient retarda-
 tion of growth and were not  significantly  different in length from  control animals by the end

                                              A-51

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of the  180  day observation period.  Decreased body weight (with no decrease in food consump-
tion  per  unit of  body weight) was found  in  animals  with blood lead  levels  of  40-60 pg/dl,
whereas deficits  in  rate of neurobehavioral development  and  indications  of specific organic
or  functional  alterations  (Fowler  et al., 1980)  were observed at blood  lead  levels in the
range of 20-40 ug/dl.
3.3  Possible Mechanisms of the Effects of Lead On Growth and Development
     Considering  the  numerous  reports  of  growth  impairment  in  lead-exposed  experimental
animals,  as  well as  emerging evidence concerning  similar effects in  human  subjects,  it is
surprising to  find that  out of the more  than  60 studies alluded to above,  none  was speci-
fically designed  to  investigate the mechanism of lead-induced growth retardation,  and only a
very few  even  commented upon possible, speculative mechanisms.   Thus, it can clearly be con-
cluded that experimental studies specifically addressing this question are needed.
     What  are  the mechanisms  to  be considered?  At  the low dose  levels  of  interest (those
relevant  to  human populations),  general  malaise resulting  from severe poisoning  or one or
more  of  its  manifestations, e.g. ,  marked damage  to blood, brain,  kidney,  or the cardio-
vascular  system,  are  not  likely to  be   important.   On  the other  hand, consideration  of
established  factors  that affect the regulation  of  normal growth may enable  one  to identify
measurable parameters that are likely to be affected by lead.
     Growth  is  a complex  phenomenon that  is  accompanied by an  orderly  sequence  of matura-
tional changes which  involve accretion of protein and increases in length and size, not just
weight.   While growth  hormone (GH) is the  most  abundant hormone of the pituitary gland, and
its primacy  in controlling postnatal somatic growth is unquestioned, growth is also affected
by  thyroid  hormones,   androgens,  estrogens,  glucocorticoids,  and  insulin.   Extrinsic  and
genetic factors also play a part in regulating growth.

3.3.1  Genetic and Extrinsic Factors
     Food  supply is  the  most  important  extrinsic factor  affecting  growth.   Food  must be
adequate  in  proteins,  essential   vitamins,  minerals,  and  calories.   Several  studies  have
demonstrated that  nutritional  deficits aggravate the effects of lead poisoning (e.g., Bell &
Spickett,   1983;  Hsu,  1981;  Leeming  & Donaldson,  1984; Ashraf & Fosmire,  1985;  Woolley and
Woolley-Efigenio, 1983; Harry et al., 1985).

3.3.2  Endocrine  Factors
     The  major hormones  that are  involved  in postnatal  growth  are GH,  thyroid hormones, and
androgens.  These should be measured in the blood of lead-exposed animals during the critical
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stages of life and  correlated  with growth and developmental  parameters.   Practically  none  of
this information is available  at this time.   Of the many  animal  studies  reviewed (plus  many
other  human  studies),  none  included  GH measurements  in the  lead-exposed  growth-impaired
subjects.   However, known  facts  regarding neuroendocrine control  of GH secretion and poten-
tial effects of  lead  on such neuroendocrine  regulatory mechanisms provide plausible hypothe-
ses regarding ways by which lead-induced growth retardation could  be mediated.
     The  secretion  of  GH  from  the  pituitary  is controlled   by  the  hypothalamus.  Two
neuropeptides,  a stimulating one (GRF) and an inhibiting  one  (SRIF),  have been isolated and
characterized.   In addition,  dopamine (DA) appears to be important in GH regulation, although
its effects (which may be exerted at several  different levels) are not entirely clear.  These
substances can now  be assayed  in  blood  and  in small  pieces of tissue, and the neurons which
produce them can be identified by  immunohistochemical methods.   It is not yet known in detail
how  GH secretion  is  regulated.    GH  itself  can  inhibit its own secretion via  a so-called
short-loop feedback mechanism.   The anatomical substrate for such a mechanism has been demon-
strated when  it was  shown that  blood in some of  the  hypothalamo-hypophysial  portal  vessels
does actually flow upward, from the pituitary to the hypothalamus.  This blood supply reaches
the  area of  the  arcuate nucleus where  the GRF-containing  neurons  are  located.   SRIF may
influence GH  release  not only directly  at the level  of the pituitary  but also via  interac-
tions  within the median eminence, and  through  innervation of the GRF-producing  cells in the
arcuate  nucleus.   The  reverse interaction may  also  occur,  i.e.,  GRF,  via axon collaterals
ending  in  the  vicinity of SRIF-producing neurons  in the anterior periventricular area of the
hypothalamus,  may influence the production  and release of  SRIF.  Finally, somatomedin (SM)
may  play an important  role  in the GH-regulating  feedback mechanisms  (cf.  Underwood and van
Ryk,  1985,  and  discussion below).   Direct injection of SM  into  the cerebral ventricles has
been  shown  to  inhibit GH  secretion.   This can occur by  at least  two mechanisms:  stimulation
of  SRIF production in the hypothalamus,  and inhibition of the synthesis of GH  in  the pitui-
tary  in response to GRF.
      Endogenous  opiates (enkephalins and endorphins) are  also known to stimulate the release
of GH,  probably  through  activation of  hypothalamic mechanisms (e.g., Casanueva et al., 1980).
In the  only study which  looked at  the  effects  of perinatal lead exposure  on enkephalin levels
in  one brain region, namely the striatum (Winder et al., 1984), up to a 50  percent  decrease
was  found;  however,  enkephalin  levels  in the hypothalamus  of lead-intoxicated  animals were
not  investigated.
      Although  the effects of  lead  on the  nervous  system have  been studied  extensively,  no
study has  so far attempted to  determine its  influence  on hypothalamic  releasing or inhibiting
factors,  including GRF  and SRIF.   One recent study addressed the  question of how chronic lead
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treatment influenced the dopaminergic control  of prolactin,  a pituitary hormone whose  regula-
tion is similar to that of GH (Govoni et al.,  1984).   Although DA content in the hypothalamus
was unchanged, the  content  of one of its metabolites,  dihydroxyphenyl  acetic  acid,  showed a
highly significant decrease.  The amount of  DA receptors in  the pituitary was also  decreased.
These  findings  explain,  at  least  partially, previous  findings that circulating prolactin
levels were  elevated in chronically lead-exposed rats (Govoni et al.,  1978).   The  importance
of  DA  in the  control  of normal  growth is  emphasized  by a  recent  study by  Huseman et  al.
(1986),  in  which they establish  endogenous dopaminergic dysfunction as a  possible cause  of
human growth  hormone deficiency  and short stature.   According to these authors, decreased GH
production can result  from  decreased dopaminergic or noradrenergic tone in the hypothalamus,
from decreased GRF  production by hypothalamic neurons,  and  finally  from decreased pituitary
responsiveness to  GRF  and/or  DA.   All  these  parameters can  now  be measured  and should  be
carried out in studies  of chronically lead-exposed animal models.
     As  pointed  out above,  it has  become  clear that  many  (but not all) effects of GH  are
mediated by  peripherally produced  growth  factors called somatomedins  (SM).   These  interact
with receptors  in target tissues,  the  most  important of which from the  point of  view  of
linear growth is cartillage.  Only one study (Rohn et al., 1982) is so far available  in  which
SM  levels  were correlated with  lead  intoxication  in 21 children before  and after chelation
therapy.   Somatomedin levels in these children were found to be increased, and  became  further
elevated after  chelation; plasma  GH or other  pituitary hormones were  not determined.   The
mechanism of the changes found in this study is not clear, but the most likely  explanation is
that some  sort  of compensatory  overproduction of  SM  was  occurring.   Again,  experimental
studies of the appropriate design would  be most useful.
     Somatomedin secretion  is  reduced in  diabetes and  can be restored by insulin  treatment.
The overlapping biological  activities of  insulin and SM  might be  due to the fact  that  these
two hormones react with each other's receptors.   Insulin is  clearly the primary stimulator of
somatic growth in  the  fetus, and in  postnatal  life  insulin  deficiency (diabetes)  is  associ-
ated with  growth  failure,   while  hyperinsulinism is  accompanied by  overgrowth  in  several
conditions.   None of the references found  in the literature  survey alluded to above addressed
the question of whether lead affects insulin secretion in the fetus or during early postnatal
life.
     With regard  to thyroid  function,  impairment of  the iodine-concentrating  mechanism  by
lead has been  shown in rats (Sandstead, 1967) and in man (Sandstead  et al., 1969).  In  addi-
tion,  one  of two patients  studied  had  decreased secretion  of  thyroxine.   Since the  iodine-
uptake deficit was  readily  corrected by the  injection  of thyroid  stimulating  hormone (TSH),
it  can  be  assumed  that  TSH  deficiency was  at  least  a factor  in these patients.   However,
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neither in this nor in any other studies were direct measurements of thyroid hormone (or TSH)
levels have been  performed  at the ages when  the  involvement  of these hormones  in  growth  is
critical.
     Androgens in  lead-exposed  animals  have been measured only in one recent study (Sokol  et
al., 1985) which  was  designed to evaluate  the  effects  of lead on the hypothalamo-pituitary-
testicular axis in post-pubertal  (52- to 82-day old) rats.   Significantly reduced levels  of
testosterone  were found both  in  testicular  tissue  and  in blood.   Also,  the weight  of the
ventral prostate  (a sensitive indicator of androgen activity)  was reduced.
     The  androgens responsible for  the peripubertal growth spurt  orginate from the adrenal
cortex, which (perhaps  through  the  hypothalamo-pituitary axis)  is  also affected by lead
(Sandstead et al., 1970b).   However, other  steroids besides  androgens may also be important
here.   For example,  the inhibition  of growth in  immature animals  is  one of  the cardinal
effects of glucocorticoids.  Again,  specific studies  assessing the possible  involvement  of
the adrenal gland in the effect of lead on  growth are completely  lacking.

3.3.3  Additional  Factors Affecting Growth
     There  are additional  growth factors  other  than  those discussed above.   These include
some  broad-spectrum,  hormone-like growth factors such  as epidermal growth factor, platelet-
derived  growth factor,  and fibroblast  growth  factor,  as  well  as  more restricted, tissue-
specific  growth   factors  such as  nerve  growth  factor,  erythropoietin,  colony-stimulating
factors,  and  lymphocyte growth factors  (interleukins).   The great  importance of these  growth
factors — besides their  specific roles  in  particular tissues  and growth processes  — lies in
the  fact  that several  of  them  (or their receptors)  have been found  to  be related to oncogenes
and  their products,  i.e.,  substances  that are responsible  for malignant transformation of
cells.   These or similar substances  are now being  recognized with  increasing frequency as
normal  constituents of  cells and regulators of normal  cell  growth.   The loss of cellular
control  over  the  production  or  function of these  substances may be responsible  for malignant
growth.   These growth factors and related  gene  products have been recognized only recently
and  are the subject of intensive  current research.   Thus, it  is not surprising that they have
not  yet  been correlated  with lead toxicity.  However, given  the general effects  of lead on
body growth,   it  seems quite  likely that  one  or more  of these growth factors or oncogene
products  may  be  influenced by lead toxicity.
 3.4  Summary and Conclusions Regarding Lead Effects on Growth and Development
      The earlier  epidemiologic  studies  discussed  above  (Mooty et  al.,  1975;  Johnson  and
 Tenuta, 1979;  Routh  et al.,  1979) provided  suggestive evidence  for lead effects  on early
                                              A-55

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growth and stature.  However,  it is difficult to apportion  relative  degrees of contribution
of lead to observed growth deficits in comparison to other factors due to the manner in  which
the data  from these small scale  studies  were reported.   Much stronger  evidence  has  emerged
from the  Schwartz  et al.  (1986) evaluation of the large-scale NHANES  II  nationwide data set,
and some  additonal data  are  beginning to  emerge  from  prospective studies, such  as  that  of
Dietrich et al.  (1986).
     The  plausibility  that the  observed  epidemiological  associations between  lead exposure
and retarded  growth reflect  causal  relationships  is supported  by certain  limited parallel
experimental   toxicology observations  in numerous animal studies,  including  especially  find-
ings reported  in the  rat by Grant  et al.  (1980),  albeit at blood  lead  levels  distinctly
higher than the  lower  values  in the range  of blood lead  levels  of children  included in the
Schwartz  et  al.  (1986)   analysis.   Furthermore, the possibility of  lead  effects on  neur-
oendocrine mechanisms  mediating  lead-induced retardation  of growth  is also  supported  by
certain studies, e.g., those  of Petrusz et al. (1979) and others, showing effects of lead in
neuroendocrine functions  in animals  and man.  In view of  the lack of thorough  evaluation of
lead effects  on  GH and other plausible mechanisms affecting growth,  much remains to be  done,
however,  with  regard  to  more  fully characterizing  quantitative relationships  between lead
exposure  and  growth retardation  in children, as  well  as  determining the  specific  physio-
logical mechanisms underlying such effects.
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